ASTM F2559-06
(Guide)Standard Guide for Writing a Specification for Sterilizable Peel Pouches
Standard Guide for Writing a Specification for Sterilizable Peel Pouches
SIGNIFICANCE AND USE
Medical device peel pouches are universally used by the industry and produced by a myriad of suppliers. They may be constructed of many different materials including films, foils, paper, nonwovens such as Tyvek, and combinations thereof. However, even with the diversity of materials, there are still basic requirements that all pouches should exhibit. Above all, the pouches must contain and protect the device while maintaining sterility during all physical handling.
Pouch requirements may be divided into two categories, initial pouch and material qualification, and routine production and receipt requirements to ensure the purchaser receives exactly what is ordered. While all requirements should be included in the written specification, initial qualification tests may only be needed prior to the first order. Routine production and receipt requirements should be adhered to on every order. Initial qualification requirements are indicated within each clause, where applicable.
This guide provides an understanding of the requirements needed for the manufacture, purchase, and acceptance of a preformed peelable pouch. Appropriate test methods for compliance are also cited.
Note 1—All test methods for a particular requirement may not be cited due to specific or unique circumstances. For additional guidance on applicable methods, refer to Guide F 2097.
The specification and its requirements should be mutually agreed to by the supplier and purchaser of pouches. This helps ensure that pouches will comply to specified requirements.
SCOPE
1.1 This guide defines the requirements and considerations for flexible peel pouches with one open, unsealed end that are intended to be sterilized containing medical devices. These are also known as preformed sterile barrier systems.
1.2 Pouch styles are categorized as chevron, header, and corner peel. These pouches are typically manufactured by heat sealing, or in some cases, by cohesive cold sealing. The sealing bond is intended to be peeled open to aseptically dispense the contents.
1.3 Pouch materials may be either porous, nonporous, or any combination of the two.
1.4 This guide addresses some critical printing requirements on the pouch.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
General Information
Relations
Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F2559 – 06
Standard Guide for
Writing a Specification for Sterilizable Peel Pouches
This standard is issued under the fixed designation F2559; 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 F2097 Guide for Design and Evaluation of Primary Flexible
Packaging for Medical Products
1.1 This guide defines the requirements and considerations
F2203 Test Method for Linear Measurement Using Preci-
for flexible peel pouches with one open, unsealed end that are
sion Steel Rule
intended to be sterilized containing medical devices. These are
F2250 Practice for Evaluation of Chemical Resistance of
also known as preformed sterile barrier systems.
Printed Inks and Coatings on Flexible Packaging Materials
1.2 Pouch styles are categorized as chevron, header, and
F2475 Guide for Biocompatibility Evaluation of Medical
corner peel. These pouches are typically manufactured by heat
Device Packaging Materials
sealing, or in some cases, by cohesive cold sealing.The sealing
2.2 TAPPI Standards:
bond is intended to be peeled open to aseptically dispense the
T437 Dirt in Paper and Paperboard
contents.
1.3 Pouch materials may be either porous, nonporous, or
3. Terminology
any combination of the two.
3.1 Definitions—For definitions and terms used in this
1.4 Thisguideaddressessomecriticalprintingrequirements
guide, see Terminology F17.
on the pouch.
3.2 Definitions of Terms Specific to This Standard:
1.5 This standard does not purport to address all of the
3.2.1 pouch, n—a flexible package constructed of one or
safety concerns, if any, associated with its use. It is the
more materials sealed together to form a preformed sterile
responsibility of the user of this standard to establish appro-
barrier system. When purchased, one end or side is open to
priate safety and health practices and determine the applica-
allow for product loading and final sealing.
bility of regulatory limitations prior to use.
3.2.2 specification, n—an explicit set of requirements to be
2. Referenced Documents satisfied by a material, product, system, or service. Examples
of specifications include, but are not limited to, requirements
2.1 ASTM Standards:
for; physical, mechanical, or chemical properties, and safety,
E122 Practice for Calculating Sample Size to Estimate,
quality, or performance criteria. A specification identifies the
With Specified Precision, the Average for a Characteristic
test methods for determining whether each of the requirements
of a Lot or Process
is satisfied.
F17 Terminology Relating to Flexible Barrier Packaging
F88 Test Method for Seal Strength of Flexible Barrier
4. Summary
Materials
4.1 This guide provides guidance for writing a peel pouch
F1140 Test Methods for Internal Pressurization Failure
material specification. Materials, method of manufacture,
Resistance of Unrestrained Packages
physical properties, performance requirements, dimensioning,
F1886 Test Method for Determining Integrity of Seals for
appearance, and printing are all issues that need to be ad-
Medical Packaging by Visual Inspection
dressedinapeelpouchspecification.Appropriaterequirements
F2054 Test Method for Burst Testing of Flexible Package
and test methods are suggested for preparing a specification.
Seals Using Internal Air Pressurization Within Restraining
Plates
5. Significance and Use
5.1 Medical device peel pouches are universally used by the
industry and produced by a myriad of suppliers. They may be
This guide is under the jurisdiction of ASTM Committee F02 on Flexible
constructed of many different materials including films, foils,
Barrier Packaging and is the direct responsibility of Subcommittee F02.50 on
paper, nonwovens such as Tyvek, and combinations thereof.
Package Design and Development.
Current edition approved Nov. 1, 2006. Published November 2006. DOI:
10.1520/F2559-06.
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 Available from TechnicalAssociation of the Pulp and Paper Industry (TAPPI),
Standards volume information, refer to the standard’s Document Summary page on 15 Technology Parkway South, Norcross, GA 30092, http://www.tappi.org.
the ASTM website. In accordance with ASTM International Form and Style for ASTM Standards.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F2559 – 06
However, even with the diversity of materials, there are still
basic requirements that all pouches should exhibit. Above all,
the pouches must contain and protect the device while main-
taining sterility during all physical handling.
5.2 Pouch requirements may be divided into two categories,
initial pouch and material qualification, and routine production
and receipt requirements to ensure the purchaser receives
exactly what is ordered. While all requirements should be
included in the written specification, initial qualification tests
may only be needed prior to the first order. Routine production
and receipt requirements should be adhered to on every order.
Initial qualification requirements are indicated within each
clause, where applicable.
5.3 This guide provides an understanding of the require-
ments needed for the manufacture, purchase, and acceptance of
a preformed peelable pouch. Appropriate test methods for
compliance are also cited.
FIG. 2 Header Bag
NOTE 1—All test methods for a particular requirement may not be cited
due to specific or unique circumstances. For additional guidance on
NOTE 2—There are numerous test methods associated with determining
applicable methods, refer to Guide F2097.
physical and chemical properties of flexible materials used in the
5.4 The specification and its requirements should be mutu-
fabrication of pouches. Care should be taken in selecting the most
appropriate test for the user’s particular application and use. For guidance
ally agreed to by the supplier and purchaser of pouches. This
in determining which methods to use, refer to Guide F2097.
helps ensure that pouches will comply to specified require-
ments.
6.2.2 The ability of the materials to demonstrate compliance
with predetermined requirements may be addressed by either
6. Specification
the certification from raw or component materials supplier or
6.1 Classification:
by actual testing performed by the pouch manufacturer in
6.1.1 Style:
compliance with quality systems.These requirements are often
6.1.1.1 Chevron pouch (see Fig. 1),
evaluated during the initial package qualification and not
6.1.1.2 Corner peel pouch (see Fig. 2), and
typically performed on a routine production basis.
6.1.1.3 Header bag (see Fig. 3).
6.2.3 Pouches should be manufactured within a formal
6.2 Materials and Manufacture:
quality system.
6.2.1 Materials used in the construction of medical device
6.2.4 The process of converting materials into pouches
peel pouches should be specified as non-toxic, providing a
should be validated to demonstrate it is capable of consistently
microbial barrier and any other appropriate physical barrier
producing a product that complies with predetermined require-
(oxygen, water vapor, light, and so forth), and being compat-
ments such as dimensions, quality attributes, seal strength and
ible with the intended sterilization process.These requirements
seal integrity.
shouldbeevaluatedduringtheinitialpackagequalificationand
6.3 Physical Properties:
are not typically performed on a routine production basis.
6.3.1 The critical physical property for a peel pouch is how
well the seal is fabricated and how well it will stand up to the
stresses of sterilization, distribution, storage, and handling
environments.
6.3.2 A seal strength should be specified. This requirement
may be a minimum or maximum value, or both, the user has
qualified, or it may be an average or range value based on the
sealing process capability.
NOTE 3—Minimum seal strength is typically that which maintains
package integrity through the processing, sterilization, handling, and
distribution systems. Maximum seal strength is that which, if exceeded,
mayresultintheperceptionthatthepouchistoodifficulttoopenorcauses
fiber tear or delamination between one or more of the bonded substrates.
6.3.2.1 Seal strength is measured using a tensile test method
suchasTestMethodF88orbursttestusingTestMethodF2054
or Test Method F1140.
NOTE 4—Burst testing is more commonly used for in-process testing
rather than acceptance testing. If burst strength is to be used for in-process
NOTE—Dimension “I” or “J” but not both. control, then concurrent tensile and burst testing should be performed at
FIG. 1 Chevron Pouch the time of validation.
F2559 – 06
NOTE—Dimension “J” or “K” but not both.
FIG. 3 Corner Peel
6.3.2.2 Test Method F88 indicates three different tail hold- 6.4.1.3 Onethird( ⁄3)pouchlengthifgreaterthan45cm(18
ing methods for the test sample: unsupported, supported 90° in.) long.
(by hand) and supported 180°. Because the effect of each of
NOTE 6—Peeling or opening technique, as well as pouch geometry and
these on test results is varied, consistent use of one technique
materials, may affect the visual characteristics of the pouch seal. The
should be negotiated with the supplier and indicated in the
peeling technique should be one continuous motion.
specification.
6.5 Dimensions and Tolerance:
6.3.3 The visual seal appearance either in the intact or
6.5.1 Dimensions critical to product fit and function should
peeled state should be specified as continuous around the
be specified. These typically include, but are not limited to,
perimeterofthesealwithnoskips,channels,orunsealedareas.
overall length and width, inside length (to the apex of a
The seal pattern, which can be solid, ribbed, or grid, should be
chevron pouch) and width, chevron or peel angle, and seal
homogeneous over the entire seal area with no spotty or
width. Other dimensions should be determined based on
mottled appearance, which typically indicates an insufficient
individual applications and requirements. Refer to Fig. 1, Fig.
seal. Refer to Test Method F1886.
2,or Fig. 3.
6.3.4 Pouch seals should be able to withstand the intended
6.5.1.1 Linear dimensions should be measured in accor-
sterilization process(es). This requirement should be evaluated
dance wit
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.