ASTM F2097-23
(Guide)Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
SIGNIFICANCE AND USE
4.1 This design and evaluation guide describes multiple categories for evaluating flexible medical packages and packaging materials. These include safety, barrier, material and package performance attributes and characteristics, package integrity, visibility and appearance, processing, printed ink, distribution simulation, and conditioning.
4.2 The intent of this design and evaluation guide is to evaluate all cited categories and select those that are applicable. Once the product has been characterized and the sterilization methodology has been defined, there are numerous sets of requirements for any specific package. This design and evaluation guide provides an avenue for assessing these requirements and choosing test methods for both evaluating the package design and monitoring package compliance.
Note 1: Many of the standards included in this guide are consensus standards that are recognized by the United States Food and Drug Administration (FDA). Selection and use of a U.S. FDA recognized consensus standard is voluntary and the sole responsibility of the user in determining its applicability. For further information, consult the U.S. FDA Standards and Conformity Assessment Program at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatoryassistance/standards-and-conformity-assessment-program
4.3 Product characterization shall include mass or weight, geometry (length and width, height, and shape) and product composition.
4.4 All categories must be considered for applicability.
4.5 The Summary of Test Methods for Medical Packaging Design and Evaluation (Fig. 1) provides a compact graphical presentation of the test methods referenced in this guide.
SCOPE
1.1 This guide provides directions for the design and evaluation of primary flexible packages for medical products. The package materials must be selected appropriately for manufacturing process, end use, and the product being packaged.
1.2 This guide provides a compendium of test methods, practices, and procedures. Specific individual test methods must be selected based on the pertinent characteristics of the specific product to be packaged and the purpose for testing, research and development, or compliance. Not all test methods will be applicable.
1.3 This guide does not address acceptability criteria, which need to be determined jointly by the package producer and the medical products manufacturer.
1.4 This guide does not assess the product to be packaged or the sterilization method to be used.
1.5 The units cited in the referenced standard should be used.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
General Information
- Status
- Published
- Publication Date
- 30-Sep-2023
- Technical Committee
- F02 - Primary Barrier Packaging
- Drafting Committee
- F02.50 - Package Design and Development
Relations
- Effective Date
- 01-Oct-2023
- Refers
ASTM D4169-23e1 - Standard Practice for Performance Testing of Shipping Containers and Systems - Effective Date
- 01-Dec-2023
- Effective Date
- 01-Dec-2023
- Effective Date
- 15-Nov-2023
- Effective Date
- 01-Jan-2022
- Effective Date
- 01-Oct-2015
- Effective Date
- 01-May-2015
- Referred By
ASTM F1980-21 - Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices - Effective Date
- 01-Oct-2023
- Effective Date
- 01-Oct-2023
- Effective Date
- 01-Oct-2023
- Effective Date
- 01-Oct-2023
- Effective Date
- 01-Oct-2023
- Referred By
ASTM F99-21 - Standard Guide for Writing a Specification for Flexible Barrier Rollstock Materials - Effective Date
- 01-Oct-2023
- Referred By
ASTM F2559/F2559M-21 - Standard Guide for Writing a Specification for Sterilizable Peel Pouches - Effective Date
- 01-Oct-2023
Overview
ASTM F2097-23: Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products provides comprehensive guidance for selecting, designing, and evaluating flexible packaging systems used for medical products. Developed by ASTM International, this standard supports stakeholders in choosing appropriate packaging materials and test methods to ensure safety, integrity, and functionality throughout a medical product’s lifecycle. The guide is aligned with international principles and is recognized as an important resource by regulatory authorities such as the United States FDA.
Key Topics
ASTM F2097-23 addresses critical categories that must be considered when designing and evaluating flexible medical packaging:
- Safety: Ensuring packaging materials protect against contamination and adverse health effects.
- Barrier Properties: Evaluating the ability of packaging to block moisture, gases, light, or contaminants, maintaining sterility.
- Material and Package Performance: Assessing physical and mechanical characteristics to ensure robust protection.
- Package Integrity: Verifying the absence of leaks or faults that could compromise product sterility.
- Visibility and Appearance: Balancing transparency and clarity to suit product presentation and inspection needs.
- Processing: Confirming packaging materials are compatible with manufacturing and sterilization procedures.
- Printed Ink Durability: Ensuring inks and coatings remain stable and legible under expected conditions.
- Distribution Simulation: Testing packaging to withstand physical hazards encountered during transportation and storage.
- Conditioning: Simulating environmental factors like temperature and humidity to evaluate long-term performance.
Each category encompasses a range of ASTM and other recognized test methods, allowing users to tailor evaluation strategies to their specific product and package needs.
Applications
The ASTM F2097-23 standard is applicable to a wide variety of medical products, including devices and instruments requiring sterile packaging. Key uses include:
- Product Design and Development: Guiding manufacturers in material selection, geometric characterization, and early design testing (R&D evaluation).
- Regulatory Compliance and Quality Control: Providing a compendium of validated test methods to monitor ongoing packaging compliance in manufacturing.
- Sterile Barrier System Evaluation: Ensuring packages can maintain a sterile environment for the duration of the product's intended shelf life.
- Distribution Validation: Simulating shipping and handling stresses to verify package durability for global supply chains.
- Risk Management: Identifying potential failure points in packaging to minimize the risk of sterility breaches or contamination.
- Customization to Product Needs: Allowing flexibility in selecting only relevant test methods, depending on the product type, sterilization process, and intended use.
By referencing ASTM F2097-23, packaging engineers, quality assurance professionals, and regulatory specialists can ensure that medical device packaging meets the stringent standards required for patient safety and product efficacy.
Related Standards
ASTM F2097-23 incorporates and references numerous other standards and test methods for a holistic approach to medical packaging evaluation, including:
- ASTM F88 - Seal Strength of Flexible Barrier Materials
- ASTM F1140 / F2054 / F2096 - Integrity and Leak Testing of Packages
- ASTM F1608 / F2638 - Microbial Barrier Testing for Porous Packaging
- ISO 11607 - Packaging for Terminally Sterilized Medical Devices
- ISO 10993 - Biological Evaluation of Medical Devices
- TAPPI T 460 / T 437 - Paper and Packaging Air Resistance and Dirt Level
- ISTA 3A / ISTA 6 - Distribution Simulation for Packaged Products
Utilizing these referenced standards helps organizations align with regulatory expectations and industry best practices in medical packaging.
Keywords: ASTM F2097-23, flexible medical packaging, medical device packaging, package integrity, barrier properties, packaging test methods, sterile barrier, medical packaging standards, FDA recognized consensus standard, packaging compliance.
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Frequently Asked Questions
ASTM F2097-23 is a guide published by ASTM International. Its full title is "Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products". This standard covers: SIGNIFICANCE AND USE 4.1 This design and evaluation guide describes multiple categories for evaluating flexible medical packages and packaging materials. These include safety, barrier, material and package performance attributes and characteristics, package integrity, visibility and appearance, processing, printed ink, distribution simulation, and conditioning. 4.2 The intent of this design and evaluation guide is to evaluate all cited categories and select those that are applicable. Once the product has been characterized and the sterilization methodology has been defined, there are numerous sets of requirements for any specific package. This design and evaluation guide provides an avenue for assessing these requirements and choosing test methods for both evaluating the package design and monitoring package compliance. Note 1: Many of the standards included in this guide are consensus standards that are recognized by the United States Food and Drug Administration (FDA). Selection and use of a U.S. FDA recognized consensus standard is voluntary and the sole responsibility of the user in determining its applicability. For further information, consult the U.S. FDA Standards and Conformity Assessment Program at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatoryassistance/standards-and-conformity-assessment-program 4.3 Product characterization shall include mass or weight, geometry (length and width, height, and shape) and product composition. 4.4 All categories must be considered for applicability. 4.5 The Summary of Test Methods for Medical Packaging Design and Evaluation (Fig. 1) provides a compact graphical presentation of the test methods referenced in this guide. SCOPE 1.1 This guide provides directions for the design and evaluation of primary flexible packages for medical products. The package materials must be selected appropriately for manufacturing process, end use, and the product being packaged. 1.2 This guide provides a compendium of test methods, practices, and procedures. Specific individual test methods must be selected based on the pertinent characteristics of the specific product to be packaged and the purpose for testing, research and development, or compliance. Not all test methods will be applicable. 1.3 This guide does not address acceptability criteria, which need to be determined jointly by the package producer and the medical products manufacturer. 1.4 This guide does not assess the product to be packaged or the sterilization method to be used. 1.5 The units cited in the referenced standard should be used. 1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
SIGNIFICANCE AND USE 4.1 This design and evaluation guide describes multiple categories for evaluating flexible medical packages and packaging materials. These include safety, barrier, material and package performance attributes and characteristics, package integrity, visibility and appearance, processing, printed ink, distribution simulation, and conditioning. 4.2 The intent of this design and evaluation guide is to evaluate all cited categories and select those that are applicable. Once the product has been characterized and the sterilization methodology has been defined, there are numerous sets of requirements for any specific package. This design and evaluation guide provides an avenue for assessing these requirements and choosing test methods for both evaluating the package design and monitoring package compliance. Note 1: Many of the standards included in this guide are consensus standards that are recognized by the United States Food and Drug Administration (FDA). Selection and use of a U.S. FDA recognized consensus standard is voluntary and the sole responsibility of the user in determining its applicability. For further information, consult the U.S. FDA Standards and Conformity Assessment Program at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatoryassistance/standards-and-conformity-assessment-program 4.3 Product characterization shall include mass or weight, geometry (length and width, height, and shape) and product composition. 4.4 All categories must be considered for applicability. 4.5 The Summary of Test Methods for Medical Packaging Design and Evaluation (Fig. 1) provides a compact graphical presentation of the test methods referenced in this guide. SCOPE 1.1 This guide provides directions for the design and evaluation of primary flexible packages for medical products. The package materials must be selected appropriately for manufacturing process, end use, and the product being packaged. 1.2 This guide provides a compendium of test methods, practices, and procedures. Specific individual test methods must be selected based on the pertinent characteristics of the specific product to be packaged and the purpose for testing, research and development, or compliance. Not all test methods will be applicable. 1.3 This guide does not address acceptability criteria, which need to be determined jointly by the package producer and the medical products manufacturer. 1.4 This guide does not assess the product to be packaged or the sterilization method to be used. 1.5 The units cited in the referenced standard should be used. 1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
ASTM F2097-23 is classified under the following ICS (International Classification for Standards) categories: 11.020 - Medical sciences and health care facilities in general; 55.020 - Packaging and distribution of goods in general. The ICS classification helps identify the subject area and facilitates finding related standards.
ASTM F2097-23 has the following relationships with other standards: It is inter standard links to ASTM F2097-20, ASTM D4169-23e1, ASTM D4169-23, ASTM F1929-23, ASTM D4169-22, ASTM F1929-15, ASTM D4321-15, ASTM F1980-21, ASTM D8233-19, ASTM F2902-16e1, ASTM F3263-17, ASTM F392/F392M-23, ASTM F99-21, ASTM F2559/F2559M-21. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ASTM F2097-23 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F2097 − 23
Standard Guide for
Design and Evaluation of Primary Flexible Packaging for
Medical Products
This standard is issued under the fixed designation F2097; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope minant A, 89 % Reflectance Backing and Paper Backing)
(Withdrawn 2010)
1.1 This guide provides directions for the design and evalu-
D638 Test Method for Tensile Properties of Plastics
ation of primary flexible packages for medical products. The
D645/D645M Test Method for Thickness of Paper and
package materials must be selected appropriately for manufac-
Paperboard (Withdrawn 2010)
turing process, end use, and the product being packaged.
D685 Practice for Conditioning Paper and Paper Products
1.2 This guide provides a compendium of test methods,
for Testing
practices, and procedures. Specific individual test methods
D726 Test Method for Resistance of Nonporous Paper to
must be selected based on the pertinent characteristics of the
Passage of Air (Withdrawn 2009)
specific product to be packaged and the purpose for testing,
D882 Test Method for Tensile Properties of Thin Plastic
research and development, or compliance. Not all test methods
Sheeting
will be applicable.
D1003 Test Method for Haze and Luminous Transmittance
of Transparent Plastics
1.3 This guide does not address acceptability criteria, which
D1251 Test Method for Water Vapor Permeability of Pack-
need to be determined jointly by the package producer and the
ages by Cycle Method (Withdrawn 1999)
medical products manufacturer.
D1434 Test Method for Determining Gas Permeability Char-
1.4 This guide does not assess the product to be packaged or
acteristics of Plastic Film and Sheeting
the sterilization method to be used.
D1709 Test Methods for Impact Resistance of Plastic Film
1.5 The units cited in the referenced standard should be
by the Free-Falling Dart Method
used.
D1777 Test Method for Thickness of Textile Materials
D1894 Test Method for Static and Kinetic Coefficients of
1.6 This international standard was developed in accor-
Friction of Plastic Film and Sheeting (Withdrawn 2023)
dance with internationally recognized principles on standard-
D1922 Test Method for Propagation Tear Resistance of
ization established in the Decision on Principles for the
Plastic Film and Thin Sheeting by Pendulum Method
Development of International Standards, Guides and Recom-
D1938 Test Method for Tear-Propagation Resistance (Trou-
mendations issued by the World Trade Organization Technical
ser Tear) of Plastic Film and Thin Sheeting by a Single-
Barriers to Trade (TBT) Committee.
Tear Method
D2019 Test Method for Dirt in Paper and Paperboard (With-
2. Referenced Documents
drawn 2010)
2.1 ASTM Standards:
D2457 Test Method for Specular Gloss of Plastic Films and
D374 Test Methods for Thickness of Solid Electrical Insu-
Solid Plastics
lation (Metric) D0374_D0374M
D3078 Test Method for Determination of Leaks in Flexible
D589 Test Method for Opacity of Paper (15° Diffuse Illu-
Packaging by Bubble Emission
D3079 Test Method for Water Vapor Transmission of Flex-
ible Heat-Sealed Packages for Dry Products (Withdrawn
This guide is under the jurisdiction of ASTM Committee F02 on Primary
2018)
Barrier Packaging and is the direct responsibility of Subcommittee F02.50 on
D3335 Test Method for Low Concentrations of Lead,
Package Design and Development.
Cadmium, and Cobalt in Paint by Atomic Absorption
Current edition approved Oct. 1, 2023. Published November 2023. Originally
approved in 2001. Last previous edition approved in 2020 as F2097 – 20. DOI: Spectroscopy
10.1520/F2097-23.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on The last approved version of this historical standard is referenced on
the ASTM website. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F2097 − 23
D3420 Test Method for Pendulum Impact Resistance of F1608 Test Method for Microbial Ranking of Porous Pack-
Plastic Film aging Materials (Exposure Chamber Method)
D3718 Test Method for Low Concentrations of Chromium F1884 Test Methods for Determining Residual Solvents in
in Paint by Atomic Absorption Spectroscopy
Packaging Materials
D3776 Test Methods for Mass Per Unit Area (Weight) of
F1886 Test Method for Determining Integrity of Seals for
Fabric
Flexible Packaging by Visual Inspection
D3985 Test Method for Oxygen Gas Transmission Rate
F1921 Test Methods for Hot Seal Strength (Hot Tack) of
Through Plastic Film and Sheeting Using a Coulometric
Thermoplastic Polymers and Blends Comprising the Seal-
Sensor
ing Surfaces of Flexible Webs
D4169 Practice for Performance Testing of Shipping Con-
F1927 Test Method for Determination of Oxygen Gas Trans-
tainers and Systems
mission Rate, Permeability and Permeance at Controlled
D4279 Test Methods for Water Vapor Transmission of Ship-
Relative Humidity Through Barrier Materials Using a
ping Containers—Constant and Cycle Methods
Coulometric Detector
D4321 Test Method for Package Yield of Plastic Film
F1929 Test Method for Detecting Seal Leaks in Porous
D4332 Practice for Conditioning Containers, Packages, or
Medical Packaging by Dye Penetration
Packaging Components for Testing
F1980 Guide for Accelerated Aging of Sterile Barrier Sys-
D4754 Test Method for Two-Sided Liquid Extraction of
tems and Medical Devices
Plastic Materials Using FDA Migration Cell
F2029 Practices for Making Laboratory Heat Seals for
D5264 Practice for Abrasion Resistance of Printed Materials
Determination of Heat Sealability of Flexible Barrier
by the Sutherland Rub Tester
Materials as Measured by Seal Strength
D7386 Practice for Performance Testing of Packages for
F2054 Test Method for Burst Testing of Flexible Package
Single Parcel Delivery Systems
Seals Using Internal Air Pressurization Within Restraining
E167 Practice for Goniophotometry of Objects and Materi-
Plates
als (Withdrawn 2005)
F2095 Test Methods for Pressure Decay Leak Test for
E171/E171M Practice for Conditioning and Testing Flexible
Flexible Packages With and Without Restraining Plates
Barrier Packaging
F2096 Test Method for Detecting Gross Leaks in Packaging
E398 Test Method for Water Vapor Transmission Rate of
by Internal Pressurization (Bubble Test)
Sheet Materials Using Dynamic Relative Humidity Mea-
F2203 Test Method for Linear Measurement Using Precision
surement
Steel Rule
F17 Terminology Relating to Primary Barrier Packaging
F2217 Practice for Coating/Adhesive Weight Determination
F88 Test Method for Seal Strength of Flexible Barrier
Materials F2227 Test Method for Non-Destructive Detection of Leaks
F99 Guide for Writing a Specification for Flexible Barrier
in Non-sealed and Empty Packaging Trays by CO Tracer
Rollstock Materials
Gas Method
F151 Test Method for Residual Solvents in Flexible Barrier
F2228 Test Method for Non-Destructive Detection of Leaks
Materials (Withdrawn 2004)
in Packaging Which Incorporates Porous Barrier Material
F372 Test Method for Water Vapor Transmission Rate of
by CO Tracer Gas Method
Flexible Barrier Materials Using an Infrared Detection
F2250 Practice for Evaluation of Chemical Resistance of
Technique (Withdrawn 2009)
Printed Inks and Coatings on Flexible Packaging Materi-
F392 Practice for Conditioning Flexible Barrier Materials
als
for Flex Durability
F2251 Test Method for Thickness Measurement of Flexible
F748 Practice for Selecting Generic Biological Test Methods
Packaging Material
for Materials and Devices
F2252 Practice for Evaluating Ink or Coating Adhesion to
F813 Practice for Direct Contact Cell Culture Evaluation of
Flexible Packaging Materials Using Tape
Materials for Medical Devices
F2338 Test Method for Nondestructive Detection of Leaks
F895 Test Method for Agar Diffusion Cell Culture Screening
in Packages by Vacuum Decay Method
for Cytotoxicity
F2391 Test Method for Measuring Package and Seal Integ-
F904 Practice for Separation of Plies for Bond Strength of
rity Using Helium as the Tracer Gas
Laminated Flexible Materials
F2475 Guide for Biocompatibility Evaluation of Medical
F1140 Test Methods for Internal Pressurization Failure Re-
Device Packaging Materials
sistance of Unrestrained Packages
F2476 Test Method for the Determination of Carbon Diox-
F1249 Test Method for Water Vapor Transmission Rate
ide Gas Transmission Rate (CO TR) Through Barrier
Through Plastic Film and Sheeting Using a Modulated 2
Materials Using an Infrared Detector
Infrared Sensor
F2559 Guide for Writing a Specification for Sterilizable Peel
F1306 Test Method for Slow Rate Penetration Resistance of
Pouches
Flexible Barrier Films and Laminates
F2622 Test Method for Oxygen Gas Transmission Rate
F1307 Test Method for Oxygen Transmission Rate Through
Dry Packages Using a Coulometric Sensor Through Plastic Film and Sheeting Using Various Sensors
F2097 − 23
F2638 Test Method for Using Aerosol Filtration for Measur- TAPPI T 404 Tensile Breaking Strength and Elongation of
ing the Performance of Porous Packaging Materials as a Paper and Paperboard
Surrogate Microbial Barrier TAPPI T 425 Opacity of Paper (15/D Geometry, Illuminant
F2714 Test Method for Oxygen Headspace Analysis of A/2 Degrees, 89% Reflectance Backing and Paper Back-
Packages Using Fluorescent Decay ing)
F2824 Test Method for Mechanical Seal Strength Testing for TAPPI T 437 Dirt in Paper and Paperboard
Round Cups and Bowl Containers with Flexible Peelable TAPPI T 460 Air Resistance of Paper (Gurley Method)
Lids TAPPI T 494 Tensile Breaking Properties of Paper and
F2825 Practice for Climatic Stressing of Packaging Systems Paperboard (Using Constant Rate of Elongation Appara-
for Single Parcel Delivery tus)
F2981 Test Method for Verifying Nonporous Flexible Bar- TAPPI T 519 Diffuse Opacity of Paper (D/0 Paper Backing)
rier Material Resistance to the Passage of Air TAPPI T 536 Resistance of Paper to Passage of Air (High
F3004 Test Method for Evaluation of Seal Quality and Pressure Gurley Method)
Integrity Using Airborne Ultrasound TAPPI T 547 Air Permeance of Paper and Paperboard (Shef-
F3039 Test Method for Detecting Leaks in Nonporous Pack- field Method)
aging or Flexible Barrier Materials by Dye Penetration 2.5 ISTA Procedures:
F3136 Test Method for Oxygen Gas Transmission Rate ISTA 3A Packaged Products for Parcel Delivery System
through Plastic Film and Sheeting using a Dynamic Shipments 70 kg (150 lb) or Less (standard, small, flat, or
Accumulation Method elongated)
F3169 Test Method for Leak Detection in Blister Packaging ISTA 3E Unitized Loads of Same Product
by Vacuum Deflection Method by Laser Measurement ISTA 4AB Packaged-Products for Shipment in Known
F3287 Test Method for Nondestructive Detection of Leaks Distribution Channels
in Packages by Mass Extraction Method ISTA 6–FEDEX-A FedEx Procedures for Testing Packaged
F3299 Test Method for Water Vapor Transmission Rate Products Weighing Up to 150 lbs
Through Plastic Film and Sheeting Using an Electrolytic
3. Terminology
Detection Sensor (Coulometric P O Sensor)
2 5
F3300 Test Method for Abrasion Resistance of Flexible 3.1 Definitions of Terms Specific to This Standard:
Packaging Films Using a Reciprocating Weighted Stylus 3.1.1 barrier requirements, n—the need to promote or
inhibit moisture, gas, or light, or a combination thereof, while
2.2 EN/ISO Standards:
maintaining necessary levels of sterility.
ISO 187 Paper, Board and Pulps—Standard Atmosphere for
Conditioning and Testing and Procedure for Monitoring
3.1.2 conditioning requirements, n—exposure to specific
the Atmosphere and Conditioning of Samples
temperature, humidity, and time conditions to simulate particu-
ISO 2556 Plastics—Determination of Gas Transmission
lar field conditions, mimic the effects of aging, or to minimize
Rate of Films and Thin Sheets Under Atmospheric
the variation in test results.
Pressure—Manometric Method
3.1.3 distribution simulation, n—conditioning or stressing
ISO 5636–5 Paper and Board—Determination of Air Per-
of the packaging system, so that its ability to withstand the
meance (Medium Range)—Part 5: Gurley Method
hazards of handling, distribution, and storage can subsequently
ISO 10993 Biological Evaluation of Medical Devices
be evaluated.
ISO 11607–1 Packaging for Terminally Sterilized Medical
3.1.4 material and package performance attributes and
Devices, Annex C
characteristics requirements, n—material properties relevant to
ISO 15105–1 Plastics—Film and Sheeting—Determination
the ability of the package to protect the product while preserv-
of Gas Transmission Rate—Part 1: Differential-Pressure
ing intended opening for use features.
Method
3.1.5 package performance, n—the ability of the packaging
ISO 15105–2 Plastics—Film and Sheeting—Determination
of Gas Transmission Rate—Part 2: Equal-Pressure system, including the sterile barrier system and protective
packaging, to withstand the hazards of handling, distribution
Method
and storage as approximated via distribution simulation.
2.3 Military Specification:
Mil Spec 36954C Bacterial Filtration Efficiency
3.1.6 printed ink requirements, n—the printed ink properties
2.4 TAPPI Standards:
needed to ensure physical and chemical resistance to degrada-
TAPPI T 402 Standard Conditioning and Testing Atmo- tion.
spheres for Paper, Board, Pulp Handsheets, and Related
3.1.7 processing requirements, n—the material characteris-
Products
tics needed to ensure the consistent and reliable production of
the package.
3.1.8 safety requirements, n—safeguard product against
Available from International Organization for Standardization (ISO), 1 rue de
Varembé, Case postale 56, CH-1211, Geneva 20, Switzerland, http://www.iso.ch.
contamination and deleterious health effects.
Available from Standardization Documents Order Desk, Bldg. 4 Section D, 700
Robbins Ave., Philadelphia, PA 19111-5094, Attn: NPOPS.
6 7
Available from Technical Association of the Pulp and Paper Industry (TAPPI), Available from International Safe Transit Association (ISTA), 1400 Abbot Rd.,
15 Technology Parkway South, Norcross, GA 30092, http://www.tappi.org. Suite 160, East Lansing, MI 48823-1900, http://www.ista.org.
F2097 − 23
3.1.9 visibility and appearance requirements, n—the desired “R&D Evaluation” in Table 1. Testing during this phase is
package aesthetics needed to permit or inhibit viewing of the characterized by the generation of quantitative data on the
product or to enhance product presentation.
performance of the component materials and the package
assembly. These test methods are lengthy, making them inap-
3.2 For other terms used in this guide, see Terminology F17.
propriate for the manufacturing environment where rapid
4. Significance and Use
response is required for process control. Often, they are
expensive and require specialized equipment not readily avail-
4.1 This design and evaluation guide describes multiple
able at a medical packaging or device manufacturing facility.
categories for evaluating flexible medical packages and pack-
aging materials. These include safety, barrier, material and 4.6.1.2 Package Compliance: Routine Monitoring of Adher-
package performance attributes and characteristics, package
ence to Specifications—This is referred to as “Compliance
integrity, visibility and appearance, processing, printed ink, Testing” in Table 1. Testing during this phase must be rapid,
distribution simulation, and conditioning.
inexpensive, and readily implemented in a manufacturing
environment. The objective is not to develop design data, but to
4.2 The intent of this design and evaluation guide is to
ensure that the design specifications are being met. These test
evaluate all cited categories and select those that are appli-
methods do not necessarily make direct measurements of
cable. Once the product has been characterized and the
critical values, but detect variations in material, process, or
sterilization methodology has been defined, there are numerous
product that are indicative of all critical characteristics.
sets of requirements for any specific package. This design and
evaluation guide provides an avenue for assessing these
4.6.2 It is important to note that no individual test method is
requirements and choosing test methods for both evaluating the
entirely predictive of final package performance. Filled pack-
package design and monitoring package compliance.
ages must be evaluated under conditions of use.
4.6.2.1 Distribution simulation is intended to provide a
NOTE 1—Many of the standards included in this guide are consensus
standards that are recognized by the United States Food and Drug
standardized, uniform, and repeatable basis of conditioning or
Administration (FDA). Selection and use of a U.S. FDA recognized
stressing a package system so that the packaging system’s
consensus standard is voluntary and the sole responsibility of the user in
ability to withstand routine distribution can subsequently be
determining its applicability. For further information, consult the U.S.
evaluated. The damage-producing motions, forces, conditions,
FDA Standards and Conformity Assessment Program at https://
www.fda.gov/medical-devices/device-advice-comprehensive-
and sequences of transport environments are simulated within
regulatoryassistance/standards-and-conformity-assessment-program
a laboratory setting. The intended test sequences and intensity
4.3 Product characterization shall include mass or weight,
levels can be adjusted to address the specifics of the distribu-
geometry (length and width, height, and shape) and product tion cycle.
composition.
4.6.2.2 Performance testing must be conducted to confirm
product protection and sterile package integrity in design
4.4 All categories must be considered for applicability.
validation. Confirmation is by means of product testing and
4.5 The Summary of Test Methods for Medical Packaging
package integrity testing. The specific tests used for evaluation
Design and Evaluation (Fig. 1) provides a compact graphical
will be dependent upon the product and the sterile barrier
presentation of the test methods referenced in this guide.
system. Consideration should be given to evaluating the effects
4.6 Test Description and Applicability (see Table 1):
of environmental extremes.
4.6.1 Table 1 lists the test methods commonly used to
4.7 Once the design of the package and/or packaging
evaluate flexible medical packaging. The test methods are used
materials has been determined, it may be appropriate to create
in two phases.
4.6.1.1 Package Design: Characterization of the Materials a package and/or material specification. Guides F99 or F2559
and Evaluation of the Resultant Package—This is referred to as may provide useful guidance.
F2097 − 23
FIG. 1 Summary of Test Methods for Medical Packaging Design and Evaluation
F2097 − 23
FIG. 1 Summary of Test Methods for Medical Packaging Design and Evaluation (continued)
F2097 − 23
TABLE 1 Test Description and Applicability Table
Test Category Test Method Usage Description Applicability
Safety/Chemical ASTM D4754 R&D This test method covers the use of the This test method has been applied to a
Properties/ FDA migration cell in the extraction of variety of migrant/polymer systems in
Extractables components and permits quantitation of contact with numerous foods and food
individual migrants from plastic materials simulants. Though most of the migrants
by suitable extracting liquids, including examined were radiolabeled, the use of
liquid foods and food-stimulating sol- the FDA cell has been validated for mi-
vents. This test method provides a two- gration studies of unlabeled styrene from
sided, liquid extraction test for plastic polystyrene.
materials that can be formed into film, This test method has been shown to
sheet, or disks. yield reproducible results under the con-
ditions for migration tests requested by
the FDA. However, if the data is to be
submitted to the FDA, it is suggested
that their guidelines by consulted.
Because it employs two-sided extraction,
this test method may not be suitable for
multilayered plastics intended for single-
sided food contact use.
The size of the FDA migration cell as
described may preclude its use in deter-
mining total nonvolatile extractives in
some cases.
Safety/Chemical ASTM F748 R&D This practice recommends generic bio- The biocompatibility of materials used in
Properties/ logical test methods for materials and single-component or multicomponent
Toxicity - devices according to end-use applica- medical devices for human use depends
Biocompatibility tions. Tests include those performed on to a large degree on the particular nature
materials, end products, and extracts. of the end-use application. It is not pos-
Rationale and comments on current state sible to specify a set of biocompatibility
of the art are included for all test proce- test methods which will be necessary
dures described. Biological evaluation of and sufficient to establish biocompatibility
materials and devices, and related sub- for all materials and applications.
jects such as pyrogen testing and batch While chemical testing for extractable
testing of production lots are also dis- additives and residual monomers or resi-
cussed. dues from processing aids is necessary
for most implant materials, such testing
is not included as a part of this practice.
The reader is cautioned that the area of
materials biocompatibility testing is a rap-
idly evolving field, and improved methods
are evolving rapidly, so this practice is by
necessity only a guideline. These test
protocols are intended to apply to materi-
als and medical devices for human appli-
cation.
Safety/Chemical ASTM F813 R&D This practice describes a reference This practice tends to be used less fre-
Properties/ method of direct contact cell culture test- quently due to the risk of inducing a re-
Toxicity - ing that may be used in evaluating the sponse from mechanical damage due to
Biocompatibility cytotoxic potential of materials for use in direct placement of the sample onto the
the construction of medical materials and cell layer. This practice may be suitable
devices. This practice may be used ei- for products which have leachates that
ther directly to evaluate materials or as a are not able to diffuse through agar and
reference against which other cytotoxicity are not too heavy.
test methods may be compared.
F2097 − 23
TABLE 1 Continued
Test Category Test Method Usage Description Applicability
Safety/Chemical ASTM F895 R&D The agar diffusion assay is an indirect This is one of a series of reference test
Properties/ contact test in which the test material is methods for the assessment of cytotoxic
Toxicity - placed onto an agar layer that protects potential, employing different techniques.
Biocompatibility the cells. Assessment of cytotoxicity is one of sev-
This test method is commonly used to eral tests employed in determining the
evaluate the response of small samples biological response to a material, as rec-
that have at least one flat surface such ommended in Practice F748.
as elastomeric closures. This test method is appropriate for mate-
rials in a variety of shapes and for mate-
rials that are not necessarily sterile.
This test method would be appropriate in
situations where the amount of material
is limited. For example, small devices or
powders could be placed on the agar
and the presence of a zone of inhibition
of cell growth could be examined. While
the agar layer can act as a cushion to
protect the cells from the specimen,
there may be materials which are suffi-
ciently heavy to compress the agar and
prevent diffusion or to cause mechanical
damage to the cells.
This test method is not appropriate for
leachables that are not water soluble be-
cause they may not diffuse through agar
or agarose and thus not be detected.
This test method would not be appropri-
ate for these materials. The L 929 cell
line was chosen because it has a signifi-
cant history of use in assays of this type.
This is not intended to imply that its use
is preferred; only that the L 929 is an
established cell line, well characterized
and readily available, that has demon-
strated reproducible results in several
laboratories.
Safety/Chemical ASTM F2475 R&D Evaluation This guide provides information to deter- This method applies to packaging for
Properties/ mine the appropriate testing for biocom- medical devices.
Toxicity - patibility of packaging materials used to
Biocompatibility contain a medical device.
Safety/Chemical ISO 10993 R&D Evaluation This entails a series of standards for When selecting the appropriate tests for
Properties/ evaluating the biocompatibility of a medi- biological evaluation of a medical device,
Toxicity - cal device prior to clinical study. Part 1 of one must consider the chemical charac-
Biocompatibility the standard uses an approach to test teristics of device materials and the
selection that is very similar to the Tripar- nature, degree, frequency, and duration
tite Guidance. of its exposure to the body. Note: FDA
has made several modifications to the
testing required by ISO 10993–Part 1.
F2097 − 23
TABLE 1 Continued
Test Category Test Method Usage Description Applicability
Safety/Chemical ASTM F1884 R&D Evaluation These test methods cover determination These test methods do not address the
Properties/ Compliance Testing of the amount of residual solvents re- determination of total retained solvents in
Retained Solvents leased from within a packaging material a packaging material. Techniques such
contained in a sealed vial under a given as multiple headspace extraction can be
set of time and temperature conditions employed to this end.
and is a recommended alternative for For purposes of verifying the identity of
Test Method F151. or identifying unknown volatile
These test methods cover a procedure compounds, the analyst is encouraged to
for quantifying volatile compounds whose incorporate techniques such as gas
identity has been established, and are chromatography/mass spectroscopy, gas
retained in packaging materials. chromatography/infrared spectroscopy, or
other suitable techniques in conjunction
with this test method.
This is an off-line head space analysis. It
is sensitive to technique and sampling
equipment resulting in large variations
(;25 %) between laboratories.
It is a simplified version of Test Method
F151 providing about the same level of
accuracy. This method differs from Test
Method F151 in that it specifies certain
conditions. Test Methods F1884, for
example, specifies a pre-heat condition
of 90 °C for 20 min. Test Method F151
defines a procedure for determining opti-
mum heating time and temperature con-
ditions for the preheat.
Because solvents will escape from sur-
face wraps on a roll of film, this test
should be performed immediately after
manufacturing to provide an indication of
solvent levels in the inner wraps of the
roll of film.
Safety/Chemical ASTM F151 R&D Evaluation This test method provides an index for This method is essentially identical to
Properties/ Compliance Testing comparing the level of solvents retained Test Methods F1884 except for a compli-
Retained Solvents in flexible barrier materials of the same cated determination of the optimum heat-
construction, which result from casting, ing time and temperature for the films in
coating, printing, or laminating opera- the head space container. There is no
tions. This test method does not yield improvement in the interlaboratory varia-
absolute quantitative measurements of tion. All other comments under Test
solvents retained in flexible barrier mate- Method F1884 apply equally to Test
rials. Method F151.
Safety/Chemical ASTM D3335 R&D Evaluation This test method covers the determina- Higher levels of all three elements can
Properties/ tion of lead con- tents between 0.01 and be determined by this test method, pro-
Heavy Metals 5 %, cadmium contents between 50 and vided that appropriate dilutions and ad-
150 ppm (mg/kg), and cobalt contents justments in specimen size and reagent
between 50 and 2000 ppm (mg/kg) pres- quantities are made. This test method is
ent in the nonvolatile portion of liquid not applicable to the determination of
coating or contained in dried films by lead in samples containing antimony pig-
means of atomic absorption. ments (low recoveries are obtained). If
lead is present in the sample to be ana-
lyzed in the form of an organic lead com-
pound at a concentration greater than
0.1 %, small losses of lead may occur,
resulting in slightly poorer precision.
Safety/Chemical ASTM D3718 R&D Evaluation This test method covers the determina- Higher concentrations of chromium can
Properties/ tion of the content of chromium (includ- be determined by this test method pro-
Heavy Metals ing chromium oxide) in the range from vided that appropriate dilutions and ad-
0.005 to 1.0 % present in the solids of justments in specimen size and reagent
liquid coatings or in dried films obtained quantities are made.
from previously coated substrates by
means of atomic absorption.
F2097 − 23
TABLE 1 Continued
Test Category Test Method Usage Description Applicability
Safety/Particulate/ ASTM D2019 R&D Evaluation This test method is intended for the nu- This test method can be used to size
Visual inspection merical estimation of dirt in paper or pa- characteristics other than dirt.
perboard in terms of equivalent black Frequently used for estimation of gels,
area. This test method is satisfactory fisheyes, ink splashes, and other visual
only for the estimation of visual charac- defects.
teristics and it may be entirely inad-
equate when nonvisual effects such as
grittiness of dirt are of importance. This
is ASTM’s version of TAPPI T 437. It re-
fers to the TAPPI Dirt Estimation Chart.
Safety/Particulate/ TAPPI T 437 Compliance testing This test method is suited for the visual This test method can be used to size
Visual inspection estimation of dirt in paper or paperboard characteristics other than dirt.
in terms of equivalent black area. Dirt in Frequently used for estimation of gels,
paper or paperboard is defined as any fisheyes, ink splashes, and other visual
foreign matter embedded in the sheet, defects.
which, when examined by reflected, not
transmitted, light has a contrasting color
to the rest of the surface and has an
equivalent black area of 0.04 mm or
over.
Barrier/Porous/ ASTM D726 R&D Evaluation This test method is applicable in papers This test method cannot be used in
Porosity Compliance Testing that permit the passage of up to 25 mL those cases where the paper cannot be
of air/0.785 in. in 15 s. clamped securely against surface and
edge leakage, such as, crepe or corru-
gated papers. For testing porous and
semiporous paper, refer to TAPPI T 460,
and T 536, respectively. Since the three
test methods (D726, T 460, and T 436)
do not give the same results, it is recom-
mended that a specific method be
agreed upon in specifications covering
paper between the seller and the
purchaser, and that the test method be
chosen to conform to the principle range.
Barrier/Porous/ TAPPI T 460 R&D Evaluation This test method references the use of a The pressure differential used in this test
Porosity Compliance Testing Gurley densometer that measures the method is 1.22 kPa. The recommended
amount of time required for a certain vol- range of time measured is from 5 to
ume of air (100 cm ) to pass through a 1800 s/100-mL cylinder displacement.
test specimen of a given area. The air For more impermeable materials the time
pressure is generated by a gravity- requirements become so excessive that
loaded cylinder that captures an air vol- other techniques are preferable. Since
ume within a chamber using a liquid this test method measures air passage
seal. The pressurized volume of air is through the specimen, as well as, leak-
directed to the clamping gasket ring, age across the surface, it is unsuitable
which holds the test specimen. Air that for rough-surfaced materials that cannot
passes through an area of the test speci- be securely clamped in the mechanism
2 2
men of 6.4 cm (1 in. ) escapes to atmo- and may allow significant surface and
sphere through the holes in the down- edge leakage. For measurement of ma-
stream clamping plate. terials at higher pressure (3 kPa) refer to
TAPPI T 536.
To measure materials at pressures up to
9.85 kPa, TAPPI T 547 references the
use of a Sheffield tester which measures
the amount of air passing through a ma-
terial of a given area over a specific time
period.
Barrier/Porous/ TAPPI T 536 R&D Evaluation This test method measures the amount This test method cannot be used in
Porosity Compliance Testing of time required for a certain volume of those cases where the paper cannot be
air to pass through a test specimen of a clamped securely against surface and
given size. This test method measures at edge leakage, such as, crepe or corru-
a higher pressure differential (3 kPa) and gated papers. Since the three test meth-
is recommended for papers that require ods (D726, T 460, and T 536) do not
10 or more seconds for 10 mL of air to give the same results, it is recommended
pass through. that a specific test method be agreed
upon in specifications covering paper
between the seller and the purchaser,
and that the test method be chosen to
conform to the principle range.
F2097 − 23
TABLE 1 Continued
Test Category Test Method Usage Description Applicability
Barrier/Porous/ TAPPI T 547 R&D Evaluation This method is used to measure the air In order to accommodate a wide range
Porosity Compliance Testing permeance of a circular area of paper of paper products, rubber clamping
using a pressure differential of approxi- plates are available for five commonly
mately 10 kPa (1.5 psig). used orifice diameters: 9.5 mm (0.375
in.), 19.1 mm (0.75 in.), 38.1 mm (1.5
in.), 57.2 mm (2.25 in.), and 76.2 mm
(3.00 in.). The air flow range for this
method is 0 to 3348 mL/min (0 to 400
Sheffield units). Instruments are available
with either variable flowmeters (glass
tubes with internal tapers and floats) or
electronic mass flowmeters.
Barrier/Porous/ ASTM F1608 R&D Evaluation This test method is used to determine A round-robin study was conducted with
Microbial Barrier the passage of airborne bacteria through eleven laboratories participating. Each
porous materials intended for use in laboratory tested duplicate samples of
packaging sterile medical devices. This six commercially available porous materi-
test method is designed to test materials als to determine the LRV. Materials
under conditions that result in the detect- tested under the standard conditions de-
able passage of bacterial spores through scribed in this test method returned aver-
the test material. age values that range from LRV 1.7 to
4.3. Results of this round-robin study in-
dicate that caution should be used when
comparing test data and ranking
materials, especially when a small num-
ber of sample replicates are used. In
addition, further collaborative work
should be conducted before this test
method would be considered adequate
for purposes of setting performance stan-
dards.
Barrier/Porous/ ASTM F2638 R&D Evaluation This test method measures the aerosol This test method is applicable to porous
Microbial Barrier filtration performance of porous packag- materials used to package terminally
ing materials by creating a defined aero- sterilized medical devices. The porous
sol of 1.0 μm particles and assessing the nature of some materials used in sterile
filtration efficiency of the material using packaging applications might preclude
either single or dual particle counters. evaluation by means of this test method.
The intent of this test method is to deter- The maximum penetration point of a par-
mine the flow rate through a material at ticular material could occur at a flow rate
which maximum penetration occurs. that exceeds the flow capacity of the test
apparatus. As such, this test method
may not be useful for evaluating the
maximum penetration point of material
with a Bendtsen flow rate above 4000
mL/min as measured by ISO 5636-3.
Barrier/Porous/ Mil Spec 36954C R&D Evaluation This test method is performed at high Test methods based on this specification
Microbial Barrier flow rates. The challenge particles are are intended to evaluate materials for
microbial clusters with a mean diameter use in surgical masks. This test method
of 3 μm. Removal of challenge particles is not applicable for materials intended
is therefore almost entirely by impaction. for low flow rate, barrier applications
such as medical packaging where par-
ticulate removal is almost exclusively a
diffusion mechanism.
Barrier/Non-Porous/ ASTM F2981 R&D Evaluation This test method provides a means to This material challenge is presented in
Impermeability verify that a flexible barrier material is ISO-11607-1, Annex C as a normative
nonporous by challenging a material with test method to demonstrate that a mate-
a given volume of air under pressure rial is nonporous and satisfies the micro-
over a specific time period. bial barrier requirements. This test
method is not intended to measure the
diffusion properties of a material nor to
identify or quantify the presence of pin-
hole damage to the design that may re-
sult in leaks.
Barrier/Non-Porous/ ISO 5636/5, R&D Evaluation Each of these test methods includes the These test methods have similar test in-
Impermeability ISO 11607–1, use of a permeability tester to determine struction for impermeability. All reference
Annex C the ability of a material to inhibit the pas- testing with Gurley Densometer. EN
sage of air. 868-/1 includes another permeance tes-
ter and a dye penetration test as options.
F2097 − 23
TABLE 1 Continued
Test Category Test Method Usage Description Applicability
Barrier/Non-Porous/ ASTM D3985 R&D Evaluation This test method covers a procedure for This test method uses coulometric sen-
Oxygen Transmission determination of the steady-state rate of sors to determine the steady state trans-
transmission of oxygen gas through plas- mission rate through plastic film and
tics in the form of film, sheeting, sheeting. Suitable for product develop-
laminates, coextrusions, or plastic-coated ment. Generally, it is not used for pro-
papers or fabrics. It provides for the de- cess or quality control except in circum-
termination of oxygen gas transmission stances where materials may be
rate (O GTR), permeance of the film to compromised by cracking.
oxygen gas (PO ), and oxygen perme-
ability coefficient (PO ) of homogeneous
materials. Transmitted oxygen is used to
generate a current through a load resis-
tor to produce an output voltage propor-
tional to the oxygen content of the carrier
gas.
Barrier/Non-Porous/ ASTM F1307 R&D Evaluation This test method covers a procedure for This method is applicable to packages
Oxygen Transmission the determination of the steady-state rate that in normal use will enclose a dry en-
of transmission of oxygen gas into pack- vironment.
ages. It employs a coulometric oxygen
sensor and associated equipment in an
arrangement similar to that described in
Test Method D3985.
Barrier/Non-Porous/ ASTM F1927 R&D Evaluation This test method covers a procedure de- By controlling the relative humidity of the
Oxygen Transmission termination of the rate of transmission of purge gases, the test environment will
oxygen gas, at a steady state, at a given more closely simulate actual shelf condi-
temperature and percent relative humid- tions. This test method uses coulometric
ity through film sheeting, laminates, co- sensors to determine the steady state
extrusion, orplastic-coated papers or fab- transmission rate through plastic film and
rics. By controlling humidity, it extends sheeting. This method is suitable for
Test Method D3985, which addresses product development.
zero humidity or assumed humidity. It
provides for the determination of oxygen
gas transmission rate, the permeance of
the film to oxygen gas, the permeation
coefficient of the film to its thickness, and
oxygen permeability coefficient in the
case of homogeneous materials at a
given temperature and relative humidity
level.
Barrier/Non-Porous/ ASTM F2622 R&D Evaluation This test method covers a procedure for This test method allows for the use of
Oxygen Transmission determination of the steady-state rate of various sensors, devices, and proce-
transmission of oxygen gas through plas- dures and applies to non-porous materi-
tics in the form of film, sheeting, als that are to be tested with or without
laminates, coextrusions, or plastic-coated humidity. The precision and bias section
papers or fabrics. It provides for the de- of this method compares select instru-
termination of (1) oxygen gas transmis- ments with other sensors to the instru-
sion rate (O GTR), (2) the permeance of ments specifically described in Test
the film to oxygen gas (PO ), and (3) Method D3985.
oxygen permeability coefficient (P’O ) in
the case of homogeneous materials.
Barrier/Non-Porous/ ASTM F2714 R&D Evaluation This test method covers a procedure for The package must be either transparent,
Oxygen Transmission using fluorescent decay to determine the translucent, or a transparent window
oxygen concentration in the headspace must be affixed to the package surface
within a sealed package without opening without affecting the package’s integrity.
or compromising the integrity of the
package. It requires that chemically
coated components be placed on the
inside surface of the package before
closing. As this test method determines
the oxygen headspace over time, the
oxygen permeability can easily be calcu-
lated as ingress per unit time as long as
the volume of the container is known.
F2097 − 23
TABLE 1 Continued
Test Category Test Method Usage Description Applicability
Barrier/Non-Porous/ ASTM F3136 R&D Evaluation This test method covers a procedure for This test method tests samples dry and
Oxygen Transmission determination of the transmission rate of therefore does not provide information
oxygen gas through plastics in the form about the effect of humidity on the oxy-
of film, sheeting, laminates, coextrusions, gen transmission rate of the sample.
coated or uncoated papers or fabrics.
The oxygen sensor incorporates a fluoro-
phore that fluoresces in response to a
certain wavelength of light, but is
quenched in the presence of oxygen.
The oxygen quenching effect is cali-
brated to oxygen concentration.
Barrier/Non-Porous/ ASTM D3079 R&D Evaluation This test method covers the determina- This method measures the water vapor
Water Vapor tion of the amount of water vapor trans- barrier properties of a package. With
Transmission mission for flexible heat-sealed packages proper precautions and background
by weight gain of a desiccant. Measure- experience, reproducible results can be
ments of mass are taken at intervals obtained. This method is not used for
over at least a month to determine the process or quality control. Given the
average rate of mass change. length and accuracy of this test method,
instrumentation methods such as Test
Methods F372 and F1249 are generally
preferred.
Barrier/Non-Porous/ ASTM D4279 R&D Evaluation This test method measures the water Intended for use on fully configured con-
Water Vapor vapor transmission rate (WVTR) by tainers either as packed or after perfor-
Transmission weight gain of a desiccant. These test mance tests such as drop, impact, or
methods cover the determination of wa- vibration. It is not suitable as a material
ter vapor transmission rates for bulk
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F2097 − 20 F2097 − 23
Standard Guide for
Design and Evaluation of Primary Flexible Packaging for
Medical Products
This standard is issued under the fixed designation F2097; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 This guide provides directions for the design and evaluation of primary flexible packages for medical products. The package
materials must be selected appropriately for manufacturing process, end use, and the product being packaged.
1.2 This guide provides a compendium of test methods, practices, and procedures. Specific individual test methods must be
selected based on the pertinent characteristics of the specific product to be packaged and the purpose for testing, research and
development, or compliance. Not all test methods will be applicable.
1.3 This guide does not address acceptability criteria, which need to be determined jointly by the package producer and the
medical products manufacturer.
1.4 This guide does not assess the product to be packaged or the sterilization method to be used.
1.5 The units cited in the referenced standard should be used.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
2.1 ASTM Standards:
D374 Test Methods for Thickness of Solid Electrical Insulation (Metric) D0374_D0374M
D589 Test Method for Opacity of Paper (15° Diffuse Illuminant A, 89 % Reflectance Backing and Paper Backing) (Withdrawn
2010)
D638 Test Method for Tensile Properties of Plastics
D645/D645M Test Method for Thickness of Paper and Paperboard (Withdrawn 2010)
D685 Practice for Conditioning Paper and Paper Products for Testing
D726 Test Method for Resistance of Nonporous Paper to Passage of Air (Withdrawn 2009)
D882 Test Method for Tensile Properties of Thin Plastic Sheeting
This guide is under the jurisdiction of ASTM Committee F02 on Primary Barrier Packaging and is the direct responsibility of Subcommittee F02.50 on Package Design
and Development.
Current edition approved May 1, 2020Oct. 1, 2023. Published September 2020November 2023. Originally approved in 2001. Last previous edition approved in 20162020
as F2097 – 16.F2097 – 20. DOI: 10.1520/F2097-20.10.1520/F2097-23.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
The last approved version of this historical standard is referenced on www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F2097 − 23
D1003 Test Method for Haze and Luminous Transmittance of Transparent Plastics
D1251 Test Method for Water Vapor Permeability of Packages by Cycle Method (Withdrawn 1999)
D1434 Test Method for Determining Gas Permeability Characteristics of Plastic Film and Sheeting
D1709 Test Methods for Impact Resistance of Plastic Film by the Free-Falling Dart Method
D1777 Test Method for Thickness of Textile Materials
D1894 Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting (Withdrawn 2023)
D1922 Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method
D1938 Test Method for Tear-Propagation Resistance (Trouser Tear) of Plastic Film and Thin Sheeting by a Single-Tear Method
D2019 Test Method for Dirt in Paper and Paperboard (Withdrawn 2010)
D2457 Test Method for Specular Gloss of Plastic Films and Solid Plastics
D3078 Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
D3079 Test Method for Water Vapor Transmission of Flexible Heat-Sealed Packages for Dry Products (Withdrawn 2018)
D3335 Test Method for Low Concentrations of Lead, Cadmium, and Cobalt in Paint by Atomic Absorption Spectroscopy
D3420 Test Method for Pendulum Impact Resistance of Plastic Film
D3718 Test Method for Low Concentrations of Chromium in Paint by Atomic Absorption Spectroscopy
D3776 Test Methods for Mass Per Unit Area (Weight) of Fabric
D3985 Test Method for Oxygen Gas Transmission Rate Through Plastic Film and Sheeting Using a Coulometric Sensor
D4169 Practice for Performance Testing of Shipping Containers and Systems
D4279 Test Methods for Water Vapor Transmission of Shipping Containers—Constant and Cycle Methods
D4321 Test Method for Package Yield of Plastic Film
D4332 Practice for Conditioning Containers, Packages, or Packaging Components for Testing
D4754 Test Method for Two-Sided Liquid Extraction of Plastic Materials Using FDA Migration Cell
D5264 Practice for Abrasion Resistance of Printed Materials by the Sutherland Rub Tester
D7386 Practice for Performance Testing of Packages for Single Parcel Delivery Systems
E167 Practice for Goniophotometry of Objects and Materials (Withdrawn 2005)
E171/E171M Practice for Conditioning and Testing Flexible Barrier Packaging
E398 Test Method for Water Vapor Transmission Rate of Sheet Materials Using Dynamic Relative Humidity Measurement
F17 Terminology Relating to Primary Barrier Packaging
F88 Test Method for Seal Strength of Flexible Barrier Materials
F99 Guide for Writing a Specification for Flexible Barrier Rollstock Materials
F151 Test Method for Residual Solvents in Flexible Barrier Materials (Withdrawn 2004)
F372 Test Method for Water Vapor Transmission Rate of Flexible Barrier Materials Using an Infrared Detection Technique
(Withdrawn 2009)
F392 Practice for Conditioning Flexible Barrier Materials for Flex Durability
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F813 Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
F895 Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
F904 Practice for Separation of Plies for Bond Strength of Laminated Flexible Materials
F1140 Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
F1249 Test Method for Water Vapor Transmission Rate Through Plastic Film and Sheeting Using a Modulated Infrared Sensor
F1306 Test Method for Slow Rate Penetration Resistance of Flexible Barrier Films and Laminates
F1307 Test Method for Oxygen Transmission Rate Through Dry Packages Using a Coulometric Sensor
F1608 Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
F1884 Test Methods for Determining Residual Solvents in Packaging Materials
F1886 Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
F1921 Test Methods for Hot Seal Strength (Hot Tack) of Thermoplastic Polymers and Blends Comprising the Sealing Surfaces
of Flexible Webs
F1927 Test Method for Determination of Oxygen Gas Transmission Rate, Permeability and Permeance at Controlled Relative
Humidity Through Barrier Materials Using a Coulometric Detector
F1929 Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
F1980 Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices
F2029 Practices for Making Laboratory Heat Seals for Determination of Heat Sealability of Flexible Barrier Materials as
Measured by Seal Strength
F2054 Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates
F2095 Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates
F2096 Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
F2203 Test Method for Linear Measurement Using Precision Steel Rule
F2217 Practice for Coating/Adhesive Weight Determination
F2097 − 23
F2227 Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Packaging Trays by CO Tracer Gas
Method
F2228 Test Method for Non-Destructive Detection of Leaks in Packaging Which Incorporates Porous Barrier Material by CO
Tracer Gas Method
F2250 Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials
F2251 Test Method for Thickness Measurement of Flexible Packaging Material
F2252 Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using Tape
F2338 Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method
F2391 Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas
F2475 Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
F2476 Test Method for the Determination of Carbon Dioxide Gas Transmission Rate (CO TR) Through Barrier Materials Using
an Infrared Detector
F2559 Guide for Writing a Specification for Sterilizable Peel Pouches
F2622 Test Method for Oxygen Gas Transmission Rate Through Plastic Film and Sheeting Using Various Sensors
F2638 Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate
Microbial Barrier
F2714 Test Method for Oxygen Headspace Analysis of Packages Using Fluorescent Decay
F2824 Test Method for Mechanical Seal Strength Testing for Round Cups and Bowl Containers with Flexible Peelable Lids
F2825 Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery
F2981 Test Method for Verifying Nonporous Flexible Barrier Material Resistance to the Passage of Air
F3004 Test Method for Evaluation of Seal Quality and Integrity Using Airborne Ultrasound
F3039 Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration
F3136 Test Method for Oxygen Gas Transmission Rate through Plastic Film and Sheeting using a Dynamic Accumulation
Method
F3169 Test Method for Leak Detection in Blister Packaging by Vacuum Deflection Method by Laser Measurement
F3287 Test Method for Nondestructive Detection of Leaks in Packages by Mass Extraction Method
F3299 Test Method for Water Vapor Transmission Rate Through Plastic Film and Sheeting Using an Electrolytic Detection
Sensor (Coulometric P O Sensor)
2 5
F3300 Test Method for Abrasion Resistance of Flexible Packaging Films Using a Reciprocating Weighted Stylus
2.2 EN/ISO Standards:
ISO 187 Paper, Board and Pulps—Standard Atmosphere for Conditioning and Testing and Procedure for Monitoring the
Atmosphere and Conditioning of Samples
ISO 2556 Plastics—Determination of Gas Transmission Rate of Films and Thin Sheets Under Atmospheric Pressure—
Manometric Method
ISO 5636–5 Paper and Board—Determination of Air Permeance (Medium Range)—Part 5: Gurley Method
ISO 10993 Biological Evaluation of Medical Devices
ISO 11607–1 Packaging for Terminally Sterilized Medical Devices, Annex C
ISO 15105–1 Plastics—Film and Sheeting—Determination of Gas Transmission Rate—Part 1: Differential-Pressure Method
ISO 15105–2 Plastics—Film and Sheeting—Determination of Gas Transmission Rate—Part 2: Equal-Pressure Method
2.3 Military Specification:
Mil Spec 36954C Bacterial Filtration Efficiency
2.4 TAPPI Standards:
TAPPI T 402 Standard Conditioning and Testing Atmospheres for Paper, Board, Pulp Handsheets, and Related Products
TAPPI T 404 Tensile Breaking Strength and Elongation of Paper and Paperboard
TAPPI T 425 Opacity of Paper (15/D Geometry, Illuminant A/2 Degrees, 89% Reflectance Backing and Paper Backing)
TAPPI T 437 Dirt in Paper and Paperboard
TAPPI T 460 Air Resistance of Paper (Gurley Method)
TAPPI T 494 Tensile Breaking Properties of Paper and Paperboard (Using Constant Rate of Elongation Apparatus)
TAPPI T 519 Diffuse Opacity of Paper (D/0 Paper Backing)
TAPPI T 536 Resistance of Paper to Passage of Air (High Pressure Gurley Method)
TAPPI T 547 Air Permeance of Paper and Paperboard (Sheffield Method)
2.5 ISTA Procedures:
ISTA 3A Packaged Products for Parcel Delivery System Shipments 70 kg (150 lb) or Less (standard, small, flat, or elongated)
ISTA 3E Unitized Loads of Same Product
Available from International Organization for Standardization (ISO), 1 rue de Varembé, Case postale 56, CH-1211, Geneva 20, Switzerland, http://www.iso.ch.
Available from Standardization Documents Order Desk, Bldg. 4 Section D, 700 Robbins Ave., Philadelphia, PA 19111-5094, Attn: NPOPS.
Available from Technical Association of the Pulp and Paper Industry (TAPPI), 15 Technology Parkway South, Norcross, GA 30092, http://www.tappi.org.
Available from International Safe Transit Association (ISTA), 1400 Abbot Rd., Suite 160, East Lansing, MI 48823-1900, http://www.ista.org.
F2097 − 23
ISTA 4AB Packaged-Products for Shipment in Known Distribution Channels
ISTA 6–FEDEX-A FedEx Procedures for Testing Packaged Products Weighing Up to 150 lbs
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 barrier requirements, n—the need to promote or inhibit moisture, gas, or light, or a combination thereof, while maintaining
necessary levels of sterility.
3.1.2 conditioning requirements, n—exposure to specific temperature, humidity, and time conditions to simulate particular field
conditions, mimic the effects of aging, or to minimize the variation in test results.
3.1.3 distribution simulation, n—conditioning or stressing of the packaging system, so that its ability to withstand the hazards of
handling, distribution, and storage can subsequently be evaluated.
3.1.4 material and package performance attributes and characteristics requirements, n—material properties relevant to the ability
of the package to protect the product while preserving intended opening for use features.
3.1.5 package performance, n—the ability of the packaging system, including the sterile barrier system and protective packaging,
to withstand the hazards of handling, distribution and storage as approximated via distribution simulation.
3.1.6 printed ink requirements, n—the printed ink properties needed to ensure physical and chemical resistance to degradation.
3.1.7 processing requirements, n—the material characteristics needed to ensure the consistent and reliable production of the
package.
3.1.8 safety requirements, n—safeguard product against contamination and deleterious health effects.
3.1.9 visibility and appearance requirements, n—the desired package aesthetics needed to permit or inhibit viewing of the product
or to enhance product presentation.
3.2 For other terms used in this guide, see Terminology F17.
4. Significance and Use
4.1 This design and evaluation guide describes multiple categories for evaluating flexible medical packages and packaging
materials. These include safety, barrier, material and package performance attributes and characteristics, package integrity,
visibility and appearance, processing, printed ink, distribution simulation, and conditioning.
4.2 The intent of this design and evaluation guide is to evaluate all cited categories and select those that are applicable. Once the
product has been characterized and the sterilization methodology has been defined, there are numerous sets of requirements for
any specific package. This design and evaluation guide provides an avenue for assessing these requirements and choosing test
methods for both evaluating the package design and monitoring package compliance.
NOTE 1—Many of the standards included in this guide are consensus standards that are recognized by the United States Food and Drug Administration
(FDA). Selection and use of a U.S. FDA recognized consensus standard is voluntary and the sole responsibility of the user in determining its applicability.
For further information, consult the U.S. FDA Standards and Conformity Assessment Program at https://www.fda.gov/medical-devices/device-advice-
comprehensive-regulatoryassistance/standards-and-conformity-assessment-program
4.3 Product characterization shall include mass or weight, geometry (length and width, height, and shape) and product
composition.
4.4 All categories must be considered for applicability.
F2097 − 23
FIG. 1 Summary of Test Methods for Medical Packaging Design and Evaluation
4.5 The Summary of Test Methods for Medical Packaging Design and Evaluation (Fig. 1) provides a compact graphical
presentation of the test methods referenced in this guide.
4.6 Test Description and Applicability (see Table 1):
4.6.1 Table 1 lists the test methods commonly used to evaluate flexible medical packaging. The test methods are used in two
phases.
F2097 − 23
FIG. 1 Summary of Test Methods for Medical Packaging Design and Evaluation (continued)
4.6.1.1 Package Design: Characterization of the Materials and Evaluation of the Resultant Package—This is referred to as “R&D
Evaluation” in Table 1. Testing during this phase is characterized by the generation of quantitative data on the performance of the
component materials and the package assembly. These test methods are lengthy, making them inappropriate for the manufacturing
environment where rapid response is required for process control. Often, they are expensive and require specialized equipment not
readily available at a medical packaging or device manufacturing facility.
4.6.1.2 Package Compliance: Routine Monitoring of Adherence to Specifications—This is referred to as “Compliance Testing” in
Table 1. Testing during this phase must be rapid, inexpensive, and readily implemented in a manufacturing environment. The
F2097 − 23
TABLE 1 Test Description and Applicability Table
Test Category Test Method Usage Description Applicability
Safety/Chemical ASTM D4754 R&D This test method covers the use of the This test method has been applied to a
Properties/ FDA migration cell in the extraction of variety of migrant/polymer systems in
Extractables components and permits quantitation of contact with numerous foods and food
individual migrants from plastic materials simulants. Though most of the migrants
by suitable extracting liquids, including examined were radiolabeled, the use of
liquid foods and food-stimulating sol- the FDA cell has been validated for mi-
vents. This test method provides a two- gration studies of unlabeled styrene from
sided, liquid extraction test for plastic polystyrene.
materials that can be formed into film, This test method has been shown to
sheet, or disks. yield reproducible results under the con-
ditions for migration tests requested by
the FDA. However, if the data is to be
submitted to the FDA, it is suggested
that their guidelines by consulted.
Because it employs two-sided extraction,
this test method may not be suitable for
multilayered plastics intended for single-
sided food contact use.
The size of the FDA migration cell as
described may preclude its use in deter-
mining total nonvolatile extractives in
some cases.
Safety/Chemical ASTM F748 R&D This practice recommends generic bio- The biocompatibility of materials used in
Properties/ logical test methods for materials and single-component or multicomponent
Toxicity - devices according to end-use applica- medical devices for human use depends
Biocompatibility tions. Tests include those performed on to a large degree on the particular nature
materials, end products, and extracts. of the end-use application. It is not pos-
Rationale and comments on current state sible to specify a set of biocompatibility
of the art are included for all test proce- test methods which will be necessary
dures described. Biological evaluation of and sufficient to establish biocompatibility
materials and devices, and related sub- for all materials and applications.
jects such as pyrogen testing and batch While chemical testing for extractable
testing of production lots are also dis- additives and residual monomers or resi-
cussed. dues from processing aids is necessary
for most implant materials, such testing
is not included as a part of this practice.
The reader is cautioned that the area of
materials biocompatibility testing is a rap-
idly evolving field, and improved methods
are evolving rapidly, so this practice is by
necessity only a guideline. These test
protocols are intended to apply to materi-
als and medical devices for human appli-
cation.
Safety/Chemical ASTM F813 R&D This practice describes a reference This practice tends to be used less fre-
Properties/ method of direct contact cell culture test- quently due to the risk of inducing a re-
Toxicity - ing that may be used in evaluating the sponse from mechanical damage due to
Biocompatibility cytotoxic potential of materials for use in direct placement of the sample onto the
the construction of medical materials and cell layer. This practice may be suitable
devices. This practice may be used ei- for products which have leachates that
ther directly to evaluate materials or as a are not able to diffuse through agar and
reference against which other cytotoxicity are not too heavy.
test methods may be compared.
objective is not to develop design data, but to ensure that the design specifications are being met. These test methods do not
necessarily make direct measurements of critical values, but detect variations in material, process, or product that are indicative
of all critical characteristics.
4.6.2 It is important to note that no individual test method is entirely predictive of final package performance. Filled packages must
be evaluated under conditions of use.
4.6.2.1 Distribution simulation is intended to provide a standardized, uniform, and repeatable basis of conditioning or stressing
a package system so that the packaging system’s ability to withstand routine distribution can subsequently be evaluated. The
damage-producing motions, forces, conditions, and sequences of transport environments are simulated within a laboratory setting.
The intended test sequences and intensity levels can be adjusted to address the specifics of the distribution cycle.
F2097 − 23
TABLE 1 Continued
Test Category Test Method Usage Description Applicability
Safety/Chemical ASTM F895 R&D The agar diffusion assay is an indirect This is one of a series of reference test
Properties/ contact test in which the test material is methods for the assessment of cytotoxic
Toxicity - placed onto an agar layer that protects potential, employing different techniques.
Biocompatibility the cells. Assessment of cytotoxicity is one of sev-
This test method is commonly used to eral tests employed in determining the
evaluate the response of small samples biological response to a material, as rec-
that have at least one flat surface such ommended in Practice F748.
as elastomeric closures. This test method is appropriate for mate-
rials in a variety of shapes and for mate-
rials that are not necessarily sterile.
This test method would be appropriate in
situations where the amount of material
is limited. For example, small devices or
powders could be placed on the agar
and the presence of a zone of inhibition
of cell growth could be examined. While
the agar layer can act as a cushion to
protect the cells from the specimen,
there may be materials which are suffi-
ciently heavy to compress the agar and
prevent diffusion or to cause mechanical
damage to the cells.
This test method is not appropriate for
leachables that are not water soluble be-
cause they may not diffuse through agar
or agarose and thus not be detected.
This test method would not be appropri-
ate for these materials. The L 929 cell
line was chosen because it has a signifi-
cant history of use in assays of this type.
This is not intended to imply that its use
is preferred; only that the L 929 is an
established cell line, well characterized
and readily available, that has demon-
strated reproducible results in several
laboratories.
Safety/Chemical ASTM F2475 R&D Evaluation This guide provides information to deter- This method applies to packaging for
Properties/ mine the appropriate testing for biocom- medical devices.
Toxicity - patibility of packaging materials used to
Biocompatibility contain a medical device.
Safety/Chemical ISO 10993 R&D Evaluation This entails a series of standards for When selecting the appropriate tests for
Properties/ evaluating the biocompatibility of a medi- biological evaluation of a medical device,
Toxicity - cal device prior to clinical study. Part 1 of one must consider the chemical charac-
Biocompatibility the standard uses an approach to test teristics of device materials and the
selection that is very similar to the Tripar- nature, degree, frequency, and duration
tite Guidance. of its exposure to the body. Note: FDA
has made several modifications to the
testing required by ISO 10993–Part 1.
4.6.2.2 Performance testing must be conducted to confirm product protection and sterile package integrity in design validation.
Confirmation is by means of product testing and package integrity testing. The specific tests used for evaluation will be dependent
upon the product and the sterile barrier system. Consideration should be given to evaluating the effects of environmental extremes.
4.7 Once the design of the package and/or packaging materials has been determined, it may be appropriate to create a package
and/or material specification. Guides F99 or F2559 may provide useful guidance.
F2097 − 23
TABLE 1 Continued
Test Category Test Method Usage Description Applicability
Safety/Chemical ASTM F1884 R&D Evaluation These test methods cover determination These test methods do not address the
Properties/ Compliance Testing of the amount of residual solvents re- determination of total retained solvents in
Retained Solvents leased from within a packaging material a packaging material. Techniques such
contained in a sealed vial under a given as multiple headspace extraction can be
set of time and temperature conditions employed to this end.
and is a recommended alternative for For purposes of verifying the identity of
Test Method F151. or identifying unknown volatile
These test methods cover a procedure compounds, the analyst is encouraged to
for quantifying volatile compounds whose incorporate techniques such as gas
identity has been established, and are chromatography/mass spectroscopy, gas
retained in packaging materials. chromatography/infrared spectroscopy, or
other suitable techniques in conjunction
with this test method.
This is an off-line head space analysis. It
is sensitive to technique and sampling
equipment resulting in large variations
(;25 %) between laboratories.
It is a simplified version of Test Method
F151 providing about the same level of
accuracy. This method differs from Test
Method F151 in that it specifies certain
conditions. Test Methods F1884, for
example, specifies a pre-heat condition
of 90 °C for 20 min. Test Method F151
defines a procedure for determining opti-
mum heating time and temperature con-
ditions for the preheat.
Because solvents will escape from sur-
face wraps on a roll of film, this test
should be performed immediately after
manufacturing to provide an indication of
solvent levels in the inner wraps of the
roll of film.
Safety/Chemical ASTM F151 R&D Evaluation This test method provides an index for This method is essentially identical to
Properties/ Compliance Testing comparing the level of solvents retained Test Methods F1884 except for a compli-
Retained Solvents in flexible barrier materials of the same cated determination of the optimum heat-
construction, which result from casting, ing time and temperature for the films in
coating, printing, or laminating opera- the head space container. There is no
tions. This test method does not yield improvement in the interlaboratory varia-
absolute quantitative measurements of tion. All other comments under Test
solvents retained in flexible barrier mate- Method F1884 apply equally to Test
rials. Method F151.
Safety/Chemical ASTM D3335 R&D Evaluation This test method covers the determina- Higher levels of all three elements can
Properties/ tion of lead con- tents between 0.01 and be determined by this test method, pro-
Heavy Metals 5 %, cadmium contents between 50 and vided that appropriate dilutions and ad-
150 ppm (mg/kg), and cobalt contents justments in specimen size and reagent
between 50 and 2000 ppm (mg/kg) pres- quantities are made. This test method is
ent in the nonvolatile portion of liquid not applicable to the determination of
coating or contained in dried films by lead in samples containing antimony pig-
means of atomic absorption. ments (low recoveries are obtained). If
lead is present in the sample to be ana-
lyzed in the form of an organic lead com-
pound at a concentration greater than
0.1 %, small losses of lead may occur,
resulting in slightly poorer precision.
Safety/Chemical ASTM D3718 R&D Evaluation This test method covers the determina- Higher concentrations of chromium can
Properties/ tion of the content of chromium (includ- be determined by this test method pro-
Heavy Metals ing chromium oxide) in the range from vided that appropriate dilutions and ad-
0.005 to 1.0 % present in the solids of justments in specimen size and reagent
liquid coatings or in dried films obtained quantities are made.
from previously coated substrates by
means of atomic absorption.
F2097 − 23
TABLE 1 Continued
Test Category Test Method Usage Description Applicability
Safety/Particulate/ ASTM D2019 R&D Evaluation This test method is intended for the nu- This test method can be used to size
Visual inspection merical estimation of dirt in paper or pa- characteristics other than dirt.
perboard in terms of equivalent black Frequently used for estimation of gels,
area. This test method is satisfactory fisheyes, ink splashes, and other visual
only for the estimation of visual charac- defects.
teristics and it may be entirely inad-
equate when nonvisual effects such as
grittiness of dirt are of importance. This
is ASTM’s version of TAPPI T 437. It re-
fers to the TAPPI Dirt Estimation Chart.
Safety/Particulate/ TAPPI T 437 Compliance testing This test method is suited for the visual This test method can be used to size
Visual inspection estimation of dirt in paper or paperboard characteristics other than dirt.
in terms of equivalent black area. Dirt in Frequently used for estimation of gels,
paper or paperboard is defined as any fisheyes, ink splashes, and other visual
foreign matter embedded in the sheet, defects.
which, when examined by reflected, not
transmitted, light has a contrasting color
to the rest of the surface and has an
equivalent black area of 0.04 mm or
over.
Barrier/Porous/ ASTM D726 R&D Evaluation This test method is applicable in papers This test method cannot be used in
Porosity Compliance Testing that permit the passage of up to 25 mL those cases where the paper cannot be
of air/0.785 in. in 15 s. clamped securely against surface and
edge leakage, such as, crepe or corru-
gated papers. For testing porous and
semiporous paper, refer to TAPPI T 460,
and T 536, respectively. Since the three
test methods (D726, T 460, and T 436)
do not give the same results, it is recom-
mended that a specific method be
agreed upon in specifications covering
paper between the seller and the
purchaser, and that the test method be
chosen to conform to the principle range.
Barrier/Porous/ TAPPI T 460 R&D Evaluation This test method references the use of a The pressure differential used in this test
Porosity Compliance Testing Gurley densometer that measures the method is 1.22 kPa. The recommended
amount of time required for a certain vol- range of time measured is from 5 to
ume of air (100 cm ) to pass through a 1800 s/100-mL cylinder displacement.
test specimen of a given area. The air For more impermeable materials the time
pressure is generated by a gravity- requirements become so excessive that
loaded cylinder that captures an air vol- other techniques are preferable. Since
ume within a chamber using a liquid this test method measures air passage
seal. The pressurized volume of air is through the specimen, as well as, leak-
directed to the clamping gasket ring, age across the surface, it is unsuitable
which holds the test specimen. Air that for rough-surfaced materials that cannot
passes through an area of the test speci- be securely clamped in the mechanism
2 2
men of 6.4 cm (1 in. ) escapes to atmo- and may allow significant surface and
sphere through the holes in the down- edge leakage. For measurement of ma-
stream clamping plate. terials at higher pressure (3 kPa) refer to
TAPPI T 536.
To measure materials at pressures up to
9.85 kPa, TAPPI T 547 references the
use of a Sheffield tester which measures
the amount of air passing through a ma-
terial of a given area over a specific time
period.
Barrier/Porous/ TAPPI T 536 R&D Evaluation This test method measures the amount This test method cannot be used in
Porosity Compliance Testing of time required for a certain volume of those cases where the paper cannot be
air to pass through a test specimen of a clamped securely against surface and
given size. This test method measures at edge leakage, such as, crepe or corru-
a higher pressure differential (3 kPa) and gated papers. Since the three test meth-
is recommended for papers that require ods (D726, T 460, and T 536) do not
10 or more seconds for 10 mL of air to give the same results, it is recommended
pass through. that a specific test method be agreed
upon in specifications covering paper
between the seller and the purchaser,
and that the test method be chosen to
conform to the principle range.
F2097 − 23
TABLE 1 Continued
Test Category Test Method Usage Description Applicability
Barrier/Porous/ TAPPI T 547 R&D Evaluation This method is used to measure the air In order to accommodate a wide range
Porosity Compliance Testing permeance of a circular area of paper of paper products, rubber clamping
using a pressure differential of plates are available for five commonly
approximately 10 kPa (1.5 psig). used orifice diameters: 9.5 mm (0.375
in.), 19.1 mm (0.75 in.), 38.1 mm (1.5
in.), 57.2 mm (2.25 in.), and 76.2 mm
(3.00 in.). The air flow range for this
method is 0 to 3348 mL/min (0 to 400
Sheffield units). Instruments are available
with either variable flowmeters (glass
tubes with internal tapers and floats) or
electronic mass flowmeters.
Barrier/Porous/ ASTM F1608 R&D Evaluation This test method is used to determine A round-robin study was conducted with
Microbial Barrier the passage of airborne bacteria through eleven laboratories participating. Each
porous materials intended for use in laboratory tested duplicate samples of
packaging sterile medical devices. This six commercially available porous materi-
test method is designed to test materials als to determine the LRV. Materials
under conditions that result in the detect- tested under the standard conditions de-
able passage of bacterial spores through scribed in this test method returned aver-
the test material. age values that range from LRV 1.7 to
4.3. Results of this round-robin study in-
dicate that caution should be used when
comparing test data and ranking
materials, especially when a small num-
ber of sample replicates are used. In
addition, further collaborative work
should be conducted before this test
method would be considered adequate
for purposes of setting performance stan-
dards.
Barrier/Porous/ ASTM F2638 R&D Evaluation This test method measures the aerosol This test method is applicable to porous
Microbial Barrier filtration performance of porous packag- materials used to package terminally
ing materials by creating a defined aero- sterilized medical devices. The porous
sol of 1.0 μm particles and assessing the nature of some materials used in sterile
filtration efficiency of the material using packaging applications might preclude
either single or dual particle counters. evaluation by means of this test method.
The intent of this test method is to deter- The maximum penetration point of a par-
mine the flow rate through a material at ticular material could occur at a flow rate
which maximum penetration occurs. that exceeds the flow capacity of the test
apparatus. As such, this test method
may not be useful for evaluating the
maximum penetration point of material
with a Bendtsen flow rate above 4000
mL/min as measured by ISO 5636-3.
Barrier/Porous/ Mil Spec 36954C R&D Evaluation This test method is performed at high Test methods based on this specification
Microbial Barrier flow rates. The challenge particles are are intended to evaluate materials for
microbial clusters with a mean diameter use in surgical masks. This test method
of 3 μm. Removal of challenge particles is not applicable for materials intended
is therefore almost entirely by impaction. for low flow rate, barrier applications
such as medical packaging where par-
ticulate removal is almost exclusively a
diffusion mechanism.
Barrier/Non-Porous/ ASTM F2981 R&D Evaluation This test method provides a means to This material challenge is presented in
Impermeability verify that a flexible barrier material is ISO-11607-1, Annex C as a normative
nonporous by challenging a material with test method to demonstrate that a mate-
a given volume of air under pressure rial is nonporous and satisfies the micro-
over a specific time period. bial barrier requirements. This test
method is not intended to measure the
diffusion properties of a material nor to
identify or quantify the presence of pin-
hole damage to the design that may re-
sult in leaks.
Barrier/Non-Porous/ ISO 5636/5, R&D Evaluation Each of these test methods includes the These test methods have similar test in-
Impermeability ISO 11607–1, use of a permeability tester to determine struction for impermeability. All reference
Annex C the ability of a material to inhibit the pas- testing with Gurley Densometer. EN
sage of air. 868-/1 includes another permeance tes-
ter and a dye penetration test as options.
F2097 − 23
TABLE 1 Continued
Test Category Test Method Usage Description Applicability
Barrier/Non-Porous/ ASTM D3985 R&D Evaluation This test method covers a procedure for This test method uses coulometric sen-
Oxygen Transmission determination of the steady-state rate of sors to determine the steady state trans-
transmission of oxygen gas through plas- mission rate through plastic film and
tics in the form of film, sheeting, sheeting. Suitable for product develop-
laminates, coextrusions, or plastic-coated ment. Generally, it is not used for pro-
papers or fabrics. It provides for the de- cess or quality control except in circum-
termination of oxygen gas transmission stances where materials may be
rate (O GTR), permeance of the film to compromised by cracking.
oxygen gas (PO ), and oxygen perme-
ability coefficient (PO ) of homogeneous
materials. Transmitted oxygen is used to
generate a current through a load resis-
tor to produce an output voltage propor-
tional to the oxygen content of the carrier
gas.
Barrier/Non-Porous/ ASTM F1307 R&D Evaluation This test method covers a procedure for This method is applicable to packages
Oxygen Transmission the determination of the steady-state rate that in normal use will enclose a dry en-
of transmission of oxygen gas into pack- vironment.
ages. It employs a coulometric oxygen
sensor and associated equipment in an
arrangement similar to that described in
Test Method D3985.
Barrier/Non-Porous/ ASTM F1927 R&D Evaluation This test method covers a procedure de- By controlling the relative humidity of the
Oxygen Transmission termination of the rate of transmission of purge gases, the test environment will
oxygen gas, at a steady state, at a given more closely simulate actual shelf condi-
temperature and percent relative humid- tions. This test method uses coulometric
ity through film sheeting, laminates, co- sensors to determine the steady state
extrusion, orplastic-coated papers or fab- transmission rate through plastic film and
rics. By controlling humidity, it extends sheeting. This method is suitable for
Test Method D3985, which addresses product development.
zero humidity or assumed humidity. It
provides for the determination of oxygen
gas transmission rate, the permeance of
the film to oxygen gas, the permeation
coefficient of the film to its thickness, and
oxygen permeability coefficient in the
case of homogeneous materials at a
given temperature and relative humidity
level.
Barrier/Non-Porous/ ASTM F2622 R&D Evaluation This test method covers a procedure for This test method allows for the use of
Oxygen Transmission determination of the steady-state rate of various sensors, devices, and proce-
transmission of oxygen gas through plas- dures and applies to non-porous materi-
tics in the form of film, sheeting, als that are to be tested with or without
laminates, coextrusions, or plastic-coated humidity. The precision and bias section
papers or fabrics. It provides for the de- of this method compares select instru-
termination of (1) oxygen gas transmis- ments with other sensors to the instru-
sion rate (O GTR), (2) the permeance of ments specifically described in Test
the film to oxygen gas (PO ), and (3) Method D3985.
oxygen permeability coefficient (P’O ) in
the case of homogeneous materials.
Barrier/Non-Porous/ ASTM F2714 R&D Evaluation This test method covers a procedure for The package must be either transparent,
Oxygen Transmission using fluorescent decay to determine the translucent, or a transparent window
oxygen concentration in the headspace must be affixed to the package surface
within a sealed package without opening without affecting the package’s integrity.
or compromising the integrity of the
package. It requires that chemically
coated components be placed on the
inside surface of the package before
closing. As this test method determines
the oxygen headspace over time, the
oxygen permeability can easily be calcu-
lated as ingress per unit time as long as
the volume of the container is known.
F2097 − 23
TABLE 1 Continued
Test Category Test Method Usage Description Applicability
Barrier/Non-Porous/ ASTM F3136 R&D Evaluation This test method covers a procedure for This test method tests samples dry and
Oxygen Transmission determination of the transmission rate of therefore does not provide information
oxygen gas through plastics in the form about the effect of humidity on the oxy-
of film, sheeting, laminates, coextrusions, gen transmission rate of the sample.
coated or uncoated papers or fabrics.
The oxygen sensor incorporates a fluoro-
phore that fluoresces in response to a
certain wavelength of light, but is
quenched in the presence of oxygen.
The oxygen quenching effect is cali-
brated to oxygen concentration.
Barrier/Non-Porous/ ASTM D3079 R&D Evaluation This test method covers the determina- This method measures the water vapor
Water Vapor tion of the amount of water vapor trans- barrier properties of a package. With
Transmission mission for flexible heat-sealed packages proper precautions and background
by weight gain of a desiccant. Measure- experience, reproducible results can be
ments of mass are taken at intervals obtained. This method is not used for
over at least a month to determine the process or quality control. Given the
average rate of mass change. length and accuracy of this test method,
instrumentation methods such as Test
Methods F372 and F1249 are generally
preferred.
Barrier/Non-Porous/ ASTM D4279 R&D Evaluation This test method measures the water Intended for use on fully configured con-
Water Vapor vapor transmission rate (WVTR) by tainers either as packed or after perfor-
Transmission weight gain of a desiccant. These test mance tests such as drop, impact, or
methods cover the d
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