ASTM F2559/F2559M-21

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: F2559/F2559M − 06 (Reapproved 2015) F2559/F2559M − 21
Standard Guide for
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. 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 safety, health, and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.
1.7 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:
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 Primary 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 Flexible Packaging by Visual Inspection
F2054 Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates
This guide is under the jurisdiction of ASTM Committee F02 on FlexiblePrimary Barrier Packaging and is the direct responsibility of Subcommittee F02.50 on Package
Design and Development.
Current edition approved Oct. 1, 2015Oct. 1, 2021. Published October 2015November 2021. Originally approved in 2006. Last previous edition approved in 20102015
ϵ1
as F2559/F2559M-06(2010)F2559/F2559M . DOI: 10.1520/F2559_F2559M-06R15. – 06 (2015). DOI: 10.1520/F2559_F2559M-21.
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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F2559/F2559M − 21
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:
T213 Dirt in Pulp – Chart Metho
T437 Dirt in Paper and Paperboard
T564 Transparent Chart for the Estimation of Defect Size
2.3 ISO Standards:
ISO 11607-1 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems,
and packaging systems
ISO 11607-2 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing, and
assembly processes
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:
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,
or performance criteria. A specification identifies the test methods for determining whether each of the requirements is satisfied.
4. Summary
4.1 This guide provides guidance for writing a peel pouch material specification. Materials, method of manufacture, physical
properties, performance requirements, dimensioning, appearance, and printing are all issues that need to be addressed in a peel
pouch specification. Appropriate requirements and test methods are suggested for preparing a specification.
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
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.
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 Organization for Standardization (ISO), ISO Central Secretariat, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva, Switzerland,
https://www.iso.org.
In accordance with ASTM International Form and Style for ASTM Standards.
F2559/F2559M − 21
5.5 Standards such as ISO 11607-1 and ISO 11607-2 have established criteria for consideration in material testing and for
validation. This guide supports the expectations of appropriate materials and package testing occurring within a system of
validations supporting demonstration of compliance to ISO 11607-1 and ISO 11607-2.
6. Specification
6.1 Classification:
6.1.1 Style:
6.1.1.1 Chevron pouch (see Fig. 1),
6.1.1.2 Corner peel pouch (see Fig. 2), and
6.1.1.3 Header bag (see Fig. 3).
6.2 Materials and Manufacture:
6.2.1 Materials used in the construction of medical device peel pouches should be specified as non-toxic, providing a microbial
barrier and any other appropriate physical barrier (oxygen, water vapor, light, and so forth), and being compatible with the intended
sterilization process. These requirements should be evaluated during the initial package qualification and are not typically
performed on a routine production basis.
NOTE 2—There are numerous test methods associated with determining physical and chemical properties of flexible materials used in the fabrication of
pouches. Care should be taken in selecting the most appropriate test for the user’s particular application and use. For guidance in determining which
methods to use, refer to Guide F2097.
6.2.2 The ability of the materials to demonstrate compliance with predetermined requirements may be addressed by either the
certification from raw or component materials supplier or by actual testing performed by the pouch manufacturer in compliance
with quality systems. These requirements are often evaluated during the initial package qualification and not typically performed
on a routine production basis.
6.2.3 Pouches should be manufactured within a formal quality system.
6.2.4 The process of converting materials into pouches should be validated to demonstrate it is capable of consistently producing
a product that complies with predetermined requirements such as dimensions, quality attributes, seal strength and seal integrity.
6.3 Physical Properties:
NOTE 1—Dimension “I” or “J” but not both.
FIG. 1 Chevron Pouch
F2559/F2559M − 21
NOTE 1—Dimension “J” or “K” but not both.
FIG. 32 Corner Peel
FIG. 23 Header Bag
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, may result in the perception that the pouch is too difficult to open or causes 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 such as Test Method F88 or burst test using Test Method F2054 or
Test Method F1140.
F2559/F2559M − 21
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 control,
then concurrent tensile and burst testing should be performed at the time of validation.
6.3.2.2 Test Method F88 indicates three different tail holding methodstechniques for the test sample: (a) unsupported, (b)
supported 90° (by hand)hand), and (c) supported 180°. Because the effect of each of these on test results is varied, consistent use
of one technique should be negotiated with the supplier and indicated in the specification.
6.3.3 The visual seal appearance either in the intact or peeled state should be specified as continuous around the perimeter of the
seal with no skips, channels, or unsealed areas. The seal pattern, which can be solid, ribbed, or grid, should be homogeneous over
the entire seal area with no spotty or mottled appearance, which typically indicates an insufficient seal. Refer to Test Method F1886.
6.3.4 Pouch seals should be able to withstand the intended sterilization process(es). This requirement should be evaluated on
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