ASTM F2559/F2559M-06(2015)

Standard Guide for Writing a Specification for Sterilizable Peel Pouches

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 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.  
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 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 F2097.  
5.4 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 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.  
1.6 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

• Status: Historical
• Publication Date: 30-Sep-2015
• ICS: 11.120.99 - Other standards related to pharmaceutics
• Technical Committee: F02 - Primary Barrier Packaging
• Drafting Committee: F02.50 - Package Design and Development

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/F2559M −06 (Reapproved 2015)
Standard Guide for
1
Writing a Specification for Sterilizable Peel Pouches
ThisstandardisissuedunderthefixeddesignationF2559/F2559M;thenumberimmediatelyfollowingthedesignationindicatestheyear
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 F88 Test Method for Seal Strength of Flexible Barrier
Materials
1.1 This guide defines the requirements and considerations
F1140 Test Methods for Internal Pressurization Failure Re-
for flexible peel pouches with one open, unsealed end that are
sistance of Unrestrained Packages
intended to be sterilized containing medical devices. These are
F1886 Test Method for Determining Integrity of Seals for
also known as preformed sterile barrier systems.
Medical Packaging by Visual Inspection
1.2 Pouch styles are categorized as chevron, header, and
F2054 Test Method for Burst Testing of Flexible Package
corner peel. These pouches are typically manufactured by heat
Seals Using InternalAir PressurizationWithin Restraining
sealing, or in some cases, by cohesive cold sealing.The sealing
Plates
bond is intended to be peeled open to aseptically dispense the
F2097 Guide for Design and Evaluation of Primary Flexible
contents.
Packaging for Medical Products
F2203 TestMethodforLinearMeasurementUsingPrecision
1.3 Pouch materials may be either porous, nonporous, or
any combination of the two. Steel Rule
F2250 Practice for Evaluation of Chemical Resistance of
1.4 Thisguideaddressessomecriticalprintingrequirements
Printed Inks and Coatings on Flexible Packaging Materi-
on the pouch.
als
1.5 The values stated in either SI units or inch-pound units
F2475 Guide for Biocompatibility Evaluation of Medical
are to be regarded separately as standard. The values stated in
Device Packaging Materials
each system may not be exact equivalents; therefore, each
2.2 TAPPI Standards:
3
system shall be used independently of the other. Combining
T437 Dirt in Paper and Paperboard
values from the two systems may result in non-conformance
3. Terminology
with the standard.
1.6 This standard does not purport to address all of the 3.1 Definitions—For definitions and terms used in this
safety concerns, if any, associated with its use. It is the guide, see Terminology F17.
responsibility of the user of this standard to establish appro-
3.2 Definitions of Terms Specific to This Standard:
priate safety and health practices and determine the applica-
3.2.1 pouch, n—a flexible package constructed of one or
bility of regulatory limitations prior to use.
more materials sealed together to form a preformed sterile
barrier system. When purchased, one end or side is open to
2. Referenced Documents
allow for product loading and final sealing.
2
2.1 ASTM Standards:
3.2.2 specification, n—an explicit set of requirements to be
E122 Practice for Calculating Sample Size to Estimate,With
satisfied by a material, product, system, or service. Examples
Specified Precision, the Average for a Characteristic of a
of specifications include, but are not limited to, requirements
Lot or Process
for; physical, mechanical, or chemical properties, and safety,
F17 Terminology Relating to Flexible Barrier Packaging
quality, or performance criteria. A specification identifies the
test methods for determining whether each of the requirements
4
is satisfied.
1
This guide is under the jurisdiction of ASTM Committee F02 on Flexible
Barrier Packaging and is the direct responsibility of Subcommittee F02.50 on
4. Summary
Package Design and Development.
4.1 This guide provides guidance for writing a peel pouch
Current edition approved Oct. 1, 2015. Published October 2015. Originally
approved in 2006. Last previous edition approved in 2010 as F2559/F2559M-
material specification. Materials, method of manufacture,
ϵ1
06(2010) . DOI: 10.1520/F2559_F2559M-06R15.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
3
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Available from Technical Association 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.
4
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
1

---------------------- Page: 1 ----------------------
F2559/F2559M−06 (2015)
physical properties, performance requirements, dimensioning, 6.1.1.2 Corner peel pouch (see Fig. 2), and
appearance, and printing are all issues that need to be ad- 6.1.
...

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.
´1
Designation: F2559/F2559M − 06 (Reapproved 2010) F2559/F2559M − 06 (Reapproved
2015)
Standard Guide for
1
Writing a Specification for Sterilizable Peel Pouches
This standard is issued under the fixed designation F2559/F2559M; 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
ε NOTE—Units information was editorially revised in November 2010.
1. 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 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each
system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the
two systems may result in non-conformance with the standard.
1.6 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.
2. Referenced Documents
2
2.1 ASTM Standards:
E122 Practice for Calculating Sample Size to Estimate, With Specified Precision, the Average for a Characteristic of a Lot or
Process
F17 Terminology Relating to Flexible Barrier Packaging
F88 Test Method for Seal Strength of Flexible Barrier Materials
F1140 Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
F1886 Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection
F2054 Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates
F2097 Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
F2203 Test Method for Linear Measurement Using Precision Steel Rule
F2250 Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials
F2475 Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
2.2 TAPPI Standards:
3
T437 Dirt in Paper and Paperboard
3. Terminology
3.1 Definitions—For definitions and terms used in this guide, see Terminology F17.
3.2 Definitions of Terms Specific to This Standard:
1
This guide is under the jurisdiction of ASTM Committee F02 on Flexible Barrier Packaging and is the direct responsibility of Subcommittee F02.50 on Package Design
and Development.
Current edition approved Oct. 1, 2010Oct. 1, 2015. Published November 2010October 2015. Originally approved in 2006. Last previous edition approved in 20062010
ϵ1
as F2559 – 06.F2559/F2559M-06(2010) . DOI: 10.1520/F2559_F2559M-06R10E01.10.1520/F2559_F2559M-06R15.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Available from Technical Association of the Pulp and Paper Industry (TAPPI), 15 Technology Parkway South, Norcross, GA 30092, http://www.tappi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2559/F2559M − 06 (2015)
3.2.1 pouch, n—a flexible package constructed of one or more materials sealed together to form a preformed sterile barrier
system. When purchased, one end or side is open to allow for product loading and final sealing.
3.2.2 specification, n—an explicit set of requirements to be satisfied by a material, product, system, or service. Examples of
specifications include, but are not limited to, requirements for; physical, mechanical, or chemical properties, and safety, quality,
4
or performance
...