ASTM F3263-17
(Guide)Standard Guide for Packaging Test Method Validation
Standard Guide for Packaging Test Method Validation
SIGNIFICANCE AND USE
4.1 Addressing consensus standards with inter-laboratory studies (ILS) and methods specific to an organization. Test methods need to be validated in many cases, in order to be able to rely on the results. This has to be done at the organization performing the tests but is also performed in the development of standards in inter-laboratory studies (ILS), which are not substitutes for the validation work to be performed at the organization performing the test.
4.1.1 Validations at the Testing Organization—Validations at the test performing organization include planning, executing, and analyzing the studies. Planning should include description of the scope of the test method which includes the description of the test equipment as well as the measurement range of samples it will be used for, rationales for the choice of samples, the amount of samples as well as rationales for the choice of methodology.
4.1.2 Objective of ILS Studies—ILS studies (per E691-14) are not focused on the development of test methods but rather with gathering the information needed for a test method precision statement after the development stage has been successfully completed. The data obtained in the interlaboratory study may indicate however, that further effort is needed to improve the test method. Precision in this case is defined as the repeatability and reproducibility of a test method, commonly known as gage R&R. For interlaboratory studies, repeatability deals with the variation associated within one appraiser operating a single test system at one facility whereas reproducibility is concerned with variation between labs each with their own unique test system. It is important to understand that if an ILS is conducted in this manner, reproducibility between appraisers and test systems in the same lab are not assessed.
4.1.3 Overview of the ILS Process—Essentially the ILS process consists of planning, executing, and analyzing studies that are meant to assess the precision of a tes...
SCOPE
1.1 This guide provides information to clarify the process of validating packaging test methods specific for an organization utilizing them as well as through inter-laboratory studies (ILS), addressing consensus standards with inter-laboratory studies (ILS) and methods specific to an organization.
1.1.1 ILS discussion will focus on writing and interpretation of test method precision statements and on alternative approaches to analyzing and stating the results.
1.2 This document provides guidance for defining and developing validations for both variable and attribute data applications.
1.3 This guide provides limited statistical guidance; however, this document does not purport to give concrete sample sizes for all packaging types and test methods. Emphasis is on statistical techniques effectively contained in reference documents already developed by ASTM and other organizations.
1.4 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.5 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
Relations
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: F3263 − 17
Standard Guide for
1
Packaging Test Method Validation
This standard is issued under the fixed designation F3263; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
Thetestsoftenusedbyengineersinregulatedindustriessuchasmedicaldeviceorpharmaceuticals
are well known and referenced in both ASTM and ISO literature. However, questions around the
validation of these tests are not nearly as well understood. Questions that often arise are; how should
one validate these test methods? Should they be validated at all? To what degree should they be
validated?
OneanswertothisistheguidanceprovidedbyISO11607-1andISO11607-2whereitisstatedthat
“all test methods used to show compliance with this part of ISO 11607 shall be validated and
documented.”
Unfortunately, this does not answer all questions as little is provided in how to demonstrate
conformance to these requirements. This is due to the fact that there needs to be a great deal of
flexibilityinhowthesetestmethodsareused.Notallcircumstancesandtestmethodsrequirethesame
degree of scrutiny.Therefore, when assessing when, why, and how a test method should be validated,
it is critical to keep this flexibility in mind and use the best tools available to answer the above
questionsappropriatelyforagivensituation.Arobustriskassessmentprocessisarguablythebesttool
for determining the risk associated with a particular design element being tested. For example, there
are clear differences in the risk associated with testing the adhesion of a label versus testing the
integrity of a sterile barrier when viewed from the perspective of patient safety. If a label is missing,
theproductwouldbediscarded,andanewonethatisproperlylabeledchosen.However,ifthesterile
barrier has been compromised due to a seal breach or pinhole in the web of the material, this may go
undetected, a contaminated device may be used, and the patient may become infected.
The typical process for determining the level of risk associated with medical device packaging
components is the failure mode effects analysis tool, commonly referred to as an FMEA. The FMEA
process is intended to identify potential failure modes for a product or process, to assess the risk
associated with those failure modes, to rank the issues in terms of importance, and to identify and
document mitigation strategies that address the most serious concerns. There are many guides and
standards available that describe this process, such as SAE J1739, AIAG FMEA-3 and MIL-STD-
1629A. The present guide will be helpful in proposing ways to go about defining what approaches to
testmethodvalidationthatwillworkbestinagivenapplicationbasedontheassociatedrisk,andwill
also provide guidance on the execution of the validation.
1. Scope addressing consensus standards with inter-laboratory studies
(ILS) and methods specific to an organization.
1.1 Thisguideprovidesinformationtoclarifytheprocessof
1.1.1 ILSdiscussionwillfocusonwritingandinterpretation
validating packaging test methods specific for an organization
of test method precision statements and on alternative ap-
utilizingthemaswellasthroughinter-laboratorystudies(ILS),
proaches to analyzing and stating the results.
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ThistestmethodisunderthejurisdictionofASTMCommitteeF02onPrimary
1.2 This document provides guidance for defining and
Barrier Packaging and is the direct responsibility of Subcommittee F02.50 on
developing validations for both variable and attribute data
Package Design and Development.
applications.
Current edition approved Dec. 15, 2017. Published March 2018. DOI: 10.1520/
F3263–17.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F3263 − 17
1.3 This guide provides limited statistical guidance; acceptance criteria. When a test method falls under this
however, this document does not purport to give concrete category another option may be no testing required.
sample sizes for all packaging types and test methods. Empha-
3.1.5 attribute test method, n—tests that return a pass/fail
sisisonstatisticaltechniqueseffectivelycontainedinreference
output measurement on a characteristic that is either conform-
documents already developed by ASTM and other organiza-
ing or nonconforming. Variable measurement data treated as
tions.
attribute also qualifies.
1.4 This standard does not purport to addr
...
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