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ASTM E3336-22

(Test Method)

Standard Test Method for Physical Integrity Testing of Single-Use Systems

Standard Test Method for Physical Integrity Testing of Single-Use Systems

SIGNIFICANCE AND USE
4.1 The test methods outlined in this standard allow for suppliers and end users of SUSs in (bio)pharmaceutical manufacturing processes to detect a leak and/or confirm the barrier properties of empty, clean, and dry SUSs. Performing integrity testing can be a significant contribution to the overall integrity assurance of SUSs.  
4.2 The two types of physical test methods outlined in this standard are:  
4.2.1 Section 5, Pressure-Based Test Methods.  
4.2.2 Section 6, Tracer Gas-Based Test Methods.
Note 3: Other test methods are currently being adapted for robust, reliable, and reproducible testing SUS, for example, Vacuum Decay Test Method as described in Test Method F2338.  
4.3 Pressure-based test methods are generally less sensitive compared to tracer gas-based test methods but have a lower complexity and cost. To assist in selecting a method that will fit an application, refer to Table 1 in Practice E3244 for a more detailed comparison of the two methods.  
4.4 Both types of test methods can be used to detect leaks of any sizes in a SUS (referred to as leak testing) or confirm the barrier properties of the SUS (referred to as integrity testing).  
4.5 To ensure that integrity testing performed on SUSs is effective and accurate, the properties of the SUS (pressure capabilities, volume, material properties, etc.) must be considered. Also, a validation should be performed on the chosen test method as further described in 5.11 and 6.11.  
4.6 Practice E3244 should be referenced to determine the maximum allowable leakage limit for a SUS, along with the routine testing requirements that are suitable for each application.  
4.7 The purpose of the described test methods is not to stress the SUS until a potential defect occurs. The testing parameters, mainly test pressure, are independent from the use-case conditions. The robustness of the SUS under use-case conditions should be proven during product qualification.  
4.8 This standard test method describes the...
SCOPE
1.1 The test methods described in this standard are applicable for single-use manufacturing equipment, further called Single-use Systems (SUSs), used for (bio)pharmaceutical products.  
1.2 The test methods described in this standard are not intended to be used on single-use technology for primary containers, combination products (products composed of any combination of a drug, device, or biological product), or devices. Appropriate procedures related to these products are discussed in documents covering the integrity assurance for primary containers (1)2 or medical products (2-4).  
1.3 The test methods and their validation are described to only cover testing of empty and dry SUSs. Residual liquid in the SUS can impact the test reliability and reproducibility.  
1.4 The test methods are intended to be used to confirm the barrier properties of the test article, further called integrity testing, or test the SUS for leaks of certain sizes, further called leak testing.
Note 1: To verify that an integrity test can confirm the intended barrier properties of the SUS, its detection limit must be equal or better than the respective maximum allowable leakage limit.  
1.5 The physical test methods covered by this standard are:  
1.5.1 Pressure-based test methods.  
1.5.2 Tracer gas-based test methods.  
1.6 The physical test methods described are in general non-destructive and allow further use of the SUS.
Note 2: Some variations can be used in a destructive way, for example, to perform root cause analysis of the leak.  
1.7 The standard describes the test apparatuses, operation procedures, environment requirements, and discusses specific challenges with testing SUSs, as well as how to perform robust validation of the test method.  
1.8 This standard does not include methods to determine the maximum allowable leakage limit for maintaining the barrier properties of the SUS. For that, refer to Practice E3244 and Test Me...

General Information

Status
Published
Publication Date
31-Jan-2022
ICS
11.120.99 - Other standards related to pharmaceutics
Technical Committee
E55 - Manufacture of Pharmaceutical and Biopharmaceutical Products
Drafting Committee
E55.07 - Single Use Systems
Current Stage
Ref Project

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ASTM E3336-22 - Standard Test Method for Physical Integrity Testing of Single-Use Systems
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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: E3336 − 22
Standard Test Method for
1
Physical Integrity Testing of Single-Use Systems
This standard is issued under the fixed designation E3336; 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 1.8 This standard does not include methods to determine the
maximum allowable leakage limit for maintaining the barrier
1.1 The test methods described in this standard are appli-
properties of the SUS. For that, refer to Practice E3244 and
cable for single-use manufacturing equipment, further called
Test Method E3251.
Single-use Systems (SUSs), used for (bio)pharmaceutical
products. 1.9 This standard does not describe how to select the
appropriate test method. For that, refer to Practice E3244.
1.2 The test methods described in this standard are not
intended to be used on single-use technology for primary 1.10 Furthermore, it does not discuss whether an integrity
containers, combination products (products composed of any test should be conducted, at what frequency and where in the
combination of a drug, device, or biological product), or life cycle of a SUS. For that refer to Practice E3244.
devices. Appropriate procedures related to these products are
1.11 Filter membrane integrity testing that additionally tests
discussed in documents covering the integrity assurance for
the integrity of the SUS is excluded from the scope. Certain
2
primary containers (1) or medical products (2-4).
components of the SUS may require additional testing.
1.3 The test methods and their validation are described to
1.12 This standard does not purport to address all of the
only cover testing of empty and dry SUSs. Residual liquid in
safety concerns, if any, associated with its use. It is the
the SUS can impact the test reliability and reproducibility.
responsibility of the user of this standard to establish appro-
priate safety, health, and environmental practices and deter-
1.4 The test methods are intended to be used to confirm the
mine the applicability of regulatory limitations prior to use.
barrier properties of the test article, further called integrity
testing, or test the SUS for leaks of certain sizes, further called
1.13 This international standard was developed in accor-
leak testing.
dance with internationally recognized principles on standard-
NOTE 1—To verify that an integrity test can confirm the intended barrier ization established in the Decision on Principles for the
properties of the SUS, its detection limit must be equal or better than the
Development of International Standards, Guides and Recom-
respective maximum allowable leakage limit.
mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
1.5 The physical test methods covered by this standard are:
1.5.1 Pressure-based test methods.
2. Referenced Documents
1.5.2 Tracer gas-based test methods.
3
2.1 ASTM Standards:
1.6 The physical test methods described are in general
E3244 Practice for Integrity Assurance and Testing of
non-destructive and allow further use of the SUS.
Single-Use Systems
NOTE 2—Some variations can be used in a destructive way, for
E3251 Test Method for Microbial Ingress Testing on Single-
example, to perform root cause analysis of the leak.
Use Systems
1.7 The standard describes the test apparatuses, operation
F2095 Test Methods for Pressure Decay Leak Test for
procedures, environment requirements, and discusses specific
Flexible Packages With and Without Restraining Plates
challenges with testing SUSs, as well as how to perform robust
F2338 Test Method for Nondestructive Detection of Leaks
validation of the test method.
in Packages by Vacuum Decay Method
F2391 Test Method for Measuring Package and Seal Integ-
rity Using Helium as the Tracer Gas
1
This test method is under the jurisdiction of ASTM Committee E55 on
Manufacture of Pharmaceutical and Biopharmaceutical Products and is the direct
responsibility of Subcommittee E55.07 on Single Use Systems.
3
Current edition approved Feb. 1, 2022. Published May 2022. DOI: 10.1520/ For referenced ASTM standards, visit the ASTM website, www.astm.org, or
E3336-22. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
2
The boldface numbers in parentheses refer to the list of references at the end of Standards volume information, refer to the standard’s Document Summary page on
this standard. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, P
...

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Standard Test Methods for Measuring Water Vapor Transmission Rate (WVTR) of Pharmaceutical Bottles and Blisters

SIGNIFICANCE AND USE
5.1 The purpose of these test methods is to obtain reliable values for WVTR that can be used to discriminate among barrier packages for pharmaceutical products. These test methods will establish a WVTR value that represents the water vapor transmission of the container closure system being evaluated. They are intended for use in evaluating or comparing, or both, the water vapor barrier performance of alternative packages for use in packaging of pharmaceutical products.  
5.2 While these methods were developed for a specific, limited application, they should be suitable for most types and sizes of consumer packages.
SCOPE
1.1 The three test methods described herein are for measurement of water vapor transmission rates (WVTRs) of high-barrier multiple-unit containers (bottles), high-barrier single-unit containers (blisters), and quasi-barrier single-unit containers used for packaging pharmaceutical products. The containers are tested closed and sealed. These test methods can be used for all consumer-sized primary containers and bulk primary containers of a size limited only by the dimensions of the equipment and the weighing capacity and sensitivity of the balance.  
1.2 These test methods are intended to be of sufficient sensitivity and precision to allow clear discrimination among the levels of barrier packages currently available for pharmaceutical products.  
1.3 There are three methods: Method A is for bottles, Method B is for formed barrier blisters, and Method C is for formed quasi-barrier blisters. Methods B and C can be adapted for use with flexible pouches.  
1.4 These test methods use gravimetric measurement to determine the rate of weight gain as a result of water vapor transmission into the package and subsequent uptake by a desiccant enclosed within the package. The packages are exposed to environments typical of those used for accelerated stability testing of drug products in the package (typically 40 °C/75 % relative humidity [RH]).  
1.5 For these methods, balance sensitivity, amount of desiccant, number of blisters per test unit, and weighing frequency were developed in an experiment based on Test Methods E96/E96M.  
1.6 Test Methods E96/E96M gives specific instruction on the interactions among weighing frequency, number of data points necessary to establish steady state, minimum weight gain in a weighing period, and balance sensitivity.  
1.7 The test methods in this standard were developed specifically for pharmaceutical bottles and blisters as closed container-closure systems. The experiment from which the methods were developed provided an inter-laboratory study from which the precision and bias statement was written. The packages in the study were small bottles and blisters used regularly for pharmaceutical solid oral dosage forms.  
1.8 In spite of the specific nature of their application, the test methods in this standard should be suitable for other pharmaceutical packages and most types and sizes of other consumer packages.  
1.9 The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard. The units of measure for bottles are milligrams per bottle per day (mg/bottle-day) and for blisters, milligrams per blister cavity per day (mg/cavity-day). These units may be used for both standard and referee testing.  
1.10 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.  
1.11 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 Ba...

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