ASTM E3336-22 PDF
Standard Test Method for Physical Integrity Testing of Single-Use Systems
Standard Test Method for Physical Integrity Testing of Single-Use Systems
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 15
- Дата публикации:
- 1 февраля 2022 г.
- Издание:
- E3336
- ICS:
- 11.120.99
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...
Abstract
Overview
ASTM E3336-22: Standard Test Method for Physical Integrity Testing of Single-Use Systems provides guidelines and requirements for confirming the physical integrity of single-use systems (SUSs) utilized in (bio)pharmaceutical manufacturing. By enabling both suppliers and end users to consistently detect leaks or verify barrier properties, this standard supports safety, product quality, and regulatory compliance across critical manufacturing processes.
The standard focuses on testing empty, clean, and dry single-use systems. It details both pressure-based and tracer gas-based methods for integrity testing, ensuring reliable assurance of barrier properties without affecting the future usability of the tested equipment. While predominantly non-destructive, certain variations may be used for root cause analysis. ASTM E3336-22 is essential for organizations seeking to implement robust, standardized leak and integrity testing protocols for SUSs.
Key Topics
-
Scope and Applicability
- For testing the physical integrity of empty, dry single-use systems (SUSs) used in (bio)pharmaceutical production.
- Excludes primary containers, combination products, and devices; refer to other standards for these applications.
- Focuses on non-destructive test methods, but allows destructive variations for investigative purposes.
-
Test Methods
- Pressure-Based Testing:
- Utilizes pressurization of the SUS to monitor for pressure decay, indicating the presence of leaks.
- Generally less sensitive than tracer gas-based methods but offers lower complexity and operational cost.
- Tracer Gas-Based Testing:
- Employs a detectable tracer gas (such as helium) to identify leaks via sensitive detectors.
- Delivers higher sensitivity, suitable for strict integrity requirements.
- Pressure-Based Testing:
-
Validation and Method Selection
- Emphasizes that test methods must be validated considering SUS characteristics (pressure rating, volume, materials).
- Recommends referencing ASTM E3244 to determine the maximum allowable leakage limits and suitable routine testing requirements.
- Highlights that the choice of test method depends on sensitivity, cost, complexity, and the specific SUS application.
-
Routine Testing and Qualification
- Testing ensures SUS integrity before introduction into (bio)pharmaceutical workflows.
- Test methods should not stress the SUS beyond its intended pressure ratings.
- Encourages establishing traceable procedures for sampling, equipment setup, and result management.
Applications
Implementing ASTM E3336-22 presents clear benefits for:
-
(Bio)Pharmaceutical Manufacturing:
- Assures the sterility and containment of production batches by verifying the integrity of single-use systems including bags, tubing, connectors, and related assemblies.
- Reduces the risk of product contamination, material loss, or cross-contamination by early detection of leaks and faults.
-
SUS Suppliers and End Users:
- Provides a uniform test standard to align manufacturers and end users, streamlining equipment qualification and acceptance criteria.
- Facilitates compliance with current Good Manufacturing Practice (cGMP) and global regulations regarding process equipment integrity.
-
Quality Control and Risk Management:
- Enhances integrity assurance programs by integrating non-destructive leak and barrier property testing into routine quality workflows.
- Provides documented validation processes that can be referenced during quality audits or regulatory inspections.
Related Standards
To complement and refine the testing of single-use systems, consider these related ASTM standards and industry references:
- ASTM E3244: Practice for Integrity Assurance and Testing of Single-Use Systems
- ASTM E3251: Test Method for Microbial Ingress Testing on Single-Use Systems
- ASTM F2338: Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method
- ASTM F2095: Test Methods for Pressure Decay Leak Test for Flexible Packages
- USP <1207>: Sterile Product Packaging Integrity Evaluation
- EU GMP Annex 1 & Annex 2: Requirements for sterile and biological medicinal product manufacturing
By referencing ASTM E3336-22 alongside these documents, organizations can build a comprehensive and compliant integrity testing program for single-use systems in the (bio)pharmaceutical sector.
Keywords: ASTM E3336-22, single-use system integrity, physical integrity testing, leak detection, barrier properties, (bio)pharmaceutical manufacturing, pressure-based testing, tracer gas test, non-destructive test method, quality assurance, SUS validation, GMP compliance
Технические детали
- Технический комитет
- E55 - Manufacture of Pharmaceutical and Biopharmaceutical Products
- SKU
- ASTM E3336-22
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