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ASTM E3244-20

(Practice)

Standard Practice for Integrity Assurance and Testing of Single-Use Systems

Standard Practice for Integrity Assurance and Testing of Single-Use Systems

SIGNIFICANCE AND USE
4.1 This practice provides:  
4.1.1 A holistic approach to evaluate risks associated with an integrity breach in a SUS, considering its life cycle from development to disposal.  
4.1.2 An overview of physical and microbial test methods that could be applicable to SUS testing, for qualification and validation purposes, as well as for routine testing.  
4.1.3 Information on the main challenges faced when testing SUSs for integrity.  
4.2 This practice can be used by SUS suppliers and SUS end users to define an integrity assurance strategy for SUSs, with the relevant tests when appropriate.
SCOPE
1.1 This practice uses quality risk management (QRM) and life-cycle approach to establish integrity assurance of single-use systems (SUSs), such as but not limited to bag assemblies and liquid transfer sets for processing, storage, and shipping of (bio)pharmaceutical products. It gives recommendations to identify failure modes and risks associated with such systems and their use-cases and how to identify the relevant leak(s) of concern. Integrity assurance in this context is limited to the barrier properties of the SUS, linked to microbial integrity and bioburden control (product quality) and liquid product loss (operator and environmental contamination). The required level of integrity assurance will depend on how critical the application is and can be interpreted in different ways. Other package barrier properties different from that, such as but not limited to gas barrier properties for gas headspace preservation, are not considered.  
1.2 The test method overview provides descriptions that focus on the standard test setup and the identification of challenges in combination with SUSs. Details, including specific test setups, test parameter, and result interpretation, are not discussed.  
1.3 This practice is not intended to apply to the use of 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, 3).  
1.4 Techniques and procedures for complaint management and root cause analysis related to integrity failures are also not discussed.  
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this 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, health, and environmental 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.

General Information

Status
Historical
Publication Date
31-Jan-2020
ICS
55.020 - Packaging and distribution of goods in general
Technical Committee
E55 - Manufacture of Pharmaceutical and Biopharmaceutical Products
Drafting Committee
E55.04 - General Biopharmaceutical Standards
Current Stage
Ref Project

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ASTM E3244-20 - Standard Practice for Integrity Assurance and Testing of Single-Use SystemsASTM E3244-20 - Standard Practice for Integrity Assurance and Testing of Single-Use Systems
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ASTM E3244-20 - Standard Practice for Integrity Assurance and Testing of Single-Use Systems
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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: E3244 − 20
Standard Practice for
1
Integrity Assurance and Testing of Single-Use Systems
This standard is issued under the fixed designation E3244; 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 1.6 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
1.1 This practice uses quality risk management (QRM) and
responsibility of the user of this standard to establish appro-
life-cycle approach to establish integrity assurance of single-
priate safety, health, and environmental practices and deter-
use systems (SUSs), such as but not limited to bag assemblies
mine the applicability of regulatory limitations prior to use.
and liquid transfer sets for processing, storage, and shipping of
1.7 This international standard was developed in accor-
(bio)pharmaceutical products. It gives recommendations to
dance with internationally recognized principles on standard-
identify failure modes and risks associated with such systems
ization established in the Decision on Principles for the
and their use-cases and how to identify the relevant leak(s) of
Development of International Standards, Guides and Recom-
concern. Integrity assurance in this context is limited to the
mendations issued by the World Trade Organization Technical
barrier properties of the SUS, linked to microbial integrity and
Barriers to Trade (TBT) Committee.
bioburden control (product quality) and liquid product loss
(operator and environmental contamination). The required
2. Referenced Documents
level of integrity assurance will depend on how critical the
3
2.1 ASTM Standards:
application is and can be interpreted in different ways. Other
E3051 Guide for Specification, Design, Verification, and
package barrier properties different from that, such as but not
Application of Single-Use Systems in Pharmaceutical and
limited to gas barrier properties for gas headspace preservation,
Biopharmaceutical Manufacturing
are not considered.
F2095 Test Methods for Pressure Decay Leak Test for
1.2 The test method overview provides descriptions that
Flexible Packages With and Without Restraining Plates
focus on the standard test setup and the identification of
F2391 Test Method for Measuring Package and Seal Integ-
challenges in combination with SUSs. Details, including spe-
rity Using Helium as the Tracer Gas
cific test setups, test parameter, and result interpretation, are 4
2.2 ICH Documents:
not discussed.
ICH Q9 Quality Risk Management
1.3 This practice is not intended to apply to the use of
3. Terminology
single-use technology for primary containers, combination
products (products composed of any combination of a drug,
3.1 Definitions:
device, or biological product), or devices. Appropriate proce-
3.1.1 artificial leak/representative leak, n—a leak which is
dures related to these products are discussed in documents
applied or introduced into a SUS, a SUS’s material, or
2
covering the integrity assurance for primary containers (1) or
component for the purposes of positive test controls.
medical products (2, 3).
3.1.1.1 Discussion—This may or may not be a calibrated
leak; however, only leaks which have been calibrated can be
1.4 Techniques and procedures for complaint management
used to make a specific integrity assurance claim.
and root cause analysis related to integrity failures are also not
discussed.
3.1.2 bioprocess container (biocontainer), n—a container
(bag, bottle, tank, etc.) used primarily for liquid (or frozen
1.5 The values stated in SI units are to be regarded as
liquid) storage during various stages of biopharmaceutical
standard. No other units of measurement are included in this
manufacturing processing.
standard.
3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
1
This practice is under the jurisdiction of ASTM Committee E55 on Manufac- contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
ture of Pharmaceutical and Biopharmaceutical Products and is the direct responsi- Standards volume information, refer to the standard’s Document Summary page on
bility of Subcommittee E55.04 on General Biopharmaceutical Standards. the ASTM website.
4
Current edition approved Feb. 1, 2020. Published April 2020. DOI: 10.1520/ Available from International Conference on Harmonisation of Technical
E3244-20. Requirements for Registration of Pharmaceuticals for Human Use (ICH), ICH
2
The boldface numbers in parentheses refer to a list of references at the end of Secretariat, 9, chemin des Mines, P.O. Box 195, 1211 Geneva 20, Switzerlan
...

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SIGNIFICANCE AND USE
4.1 This practice provides:  
4.1.1 A holistic approach to evaluate risks associated with an integrity breach in a SUS, considering its life cycle from development to disposal.  
4.1.2 An overview of physical and microbial test methods that could be applicable to SUS testing, for qualification and validation purposes, as well as for routine testing.  
4.1.3 Information on the main challenges faced when testing SUSs for integrity.  
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1.3 This practice is not intended to apply to the use of 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 (2) or medical products (1, 3).  
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4.1 The purpose of this guide is to provide direction for uniform conditioning methodology when conducting special preparations of plastic packagings as prescribed for conducting United Nations (UN) drop test. This guide provides a uniform approach for conditioning of plastic packaging intended for liquid hazardous materials (dangerous goods).  
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1.1 This guide is intended to provide a standardized method and a set of basic instructions for special preparation conditioning of drop test samples being subjected to United Nations (UN) performance-oriented packaging certification as required by United States Department of Transportation Title 49 Code of Federal Regulations (49 CFR) and the United Nations Recommendations on the Transport of Dangerous Goods (UN).  
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SIGNIFICANCE AND USE
4.1 This practice provides:  
4.1.1 A holistic approach to evaluate risks associated with an integrity breach in a SUS, considering its life cycle from development to disposal.  
4.1.2 An overview of physical and microbial test methods that could be applicable to SUS testing, for qualification and validation purposes, as well as for routine testing.  
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5.1 Regulations prescribing the test procedures for hazardous materials packaging allow for the substitution of non-hazardous fill materials for packaging performance tests with certain limitations prescribed and guidance offered (see 49 CFR 178.602(c)). This regulatory guidance has proven to be flexible enough, in common industry practice, to produce variations in the selection of fill materials for package performance tests sufficient to cause inconsistent and non-repeatable test results. This variation creates significant problems in product liability, packaging selection and regulatory enforcement in this highly regulated industry. Use of this guide should enhance uniformity in test procedures.  
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This guide identifies the key information required to ensure that selected packaging will pass the United Nations (UN) packaging certification at the level that is appropriate for its intended use. This guide covers test procedures for transportation of hazardous material packagings for net masses except those used for infectious substances, radioactive materials, cylinders, and other receptacles for gases and does not replace domestic or international requlatory requirements for hazardous material packagings. The UN performance tests are based on the degree of hazard posed by the proposed materials to be packaged which are also assigned to a specific packing group. Only packaging designs that meet the UN performance standards are to be marked with a UN mark. Tests include drop test, leakproofness test, stack test, vibration test, pressure differential test, hydrostatic pressure test, and cobb water absorption test.
SIGNIFICANCE AND USE
4.1 The UN performance tests are based on the degree of hazard presented by the proposed hazardous material(s) to be packaged.  
4.2 Substances and articles which are hazardous are assigned to a specific packing group as defined in 3.8.1 and may be determined by referencing 49 CFR 172.101 hazardous materials table.  
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1.3 This guide covers the testing for transportation of hazardous materials (dangerous goods) packagings for net masses not exceeding 400 kg (880 lb) or capacities not exceeding 450 L (119 gal), excepting packagings for infectious substances, radioactive materials, cylinders and other receptacles for gases.  
1.4 This guide does not replace domestic or international regulatory requirements for hazardous materials packaging but is strongly recommended to be used in conjunction with those regulations.  
1.5 The user of this guide must be trained in accordance with the United States Department of Transportation Title 49 Code of Federal Regulations (49 CFR) as required by 172.700 and should be familiar with other applicable hazardous materials regulations such as: International Civil Aviation Organization (ICAO) Technical Instructions for the Safe Transport of Dangerous Goods by Air, and the International Maritime Dangerous Goods Code (IMDG Code) and carrier rules such as International Air Transport Association (IATA) Dangerous Goods Regulations.  
1.6 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not...

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  • Guide
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ASTM
ASTM D7860-14(2022)(Test Method)
Standard Test Methods for Measurement of Torque Retention for Child Resistant and Non-Child Resistant Packages with Continuous Thread Closures Using Automated Torque Testing Equipment

SIGNIFICANCE AND USE
5.1 This test method allows for the measurement of the torque retention properties of container/continuous thread closure systems of various designs, materials, and manufacture, and is suitable for package development and engineering evaluation.  
5.2 Each test method can be used for the evaluation of non child resistant container/continuous thread closure systems under controlled conditions such as when the application torque is known and the applied downward force to the closure is zero or for Type I, style “A” push down and turn child resistant container/continuous thread closure systems under controlled conditions such as when the application torque and the applied downward force to the closure is known.  
5.3 This test method measures torque retention properties of container/continuous thread closure systems with the use of an automated transducer based torque meter operating at a known rotational velocity (rpm) or known torque ramp.  
5.4 This test method is intended for measurement of dry torque only.
SCOPE
1.1 These test methods evaluate the torque retention of continuous thread closures on containers with matching finishes, for predetermined environmental conditions over time. Methods are defined for both Type I, style “A” push down and turn Type II2 child resistant and non child resistant type closures.  
1.2 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.
Note 1: The SI unit system is the recommended system.  
1.3 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.  
1.4 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.

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