1.1 This practice is applicable to all single-use systems that are used in pharmaceutical and biopharmaceutical manufacturing processes including, but not limited to, bag chambers, tubings/fittings, connectors, sensors, filter capsules, membranes, bio-containers, bioreactors, and cell culture equipment that can be affected on their structural integrity. 1.2 For brevity, these are referred to throughout the rest of this practice as SuS (single-use systems). 1.3 Single-use filter, container, and tubing/fitting assembly are considered as the most critical components of the system. The functionality of the filter (bacterial retention) and the time/contact surfaces of the container and tubing/fitting assembly (leak appearance) increase the risk to impact structural and mechanical integrity. 1.4 This practice provides a standardized approach to ensure the sterile state of SuS that could be impacted by microbiological ingress or product loss that relates to leak appearance, which is inherent to composition, structure, mechanical, and integral properties. 1.5 Leak appearance, which could be at the origin of microbial ingress or product loss, could be either identified: 1.5.1 During single-use components design, development, first manufacturing batch, and apparition of a leak into a materials following unidentified events or 1.5.2 During routine manufacturing, the identification and characterization of a leak that appeared following a manufacturing process injury into the materials in construction. 1.6 This practice is intended to be used by SuS manufacturers or assemblers or both. They are referred to throughout the rest of this practice as suppliers. 1.7 The supplier shall set up a testing methodology to detect leak appearance of SuS based on a risk assessment with regard to structural and mechanical integrity. 1.8 For brevity, this is referred to throughout the rest of this practice as SMI (structural and mechanical integrity). 1.9 Sterile barriers and biosafety barriers are to be defined with regard to the intended use of the SuS. 1.9.1 Sterile or biosafety barriers or both are characteristics of SuS that contribute to maintain system integrity based on SMI. 1.9.2 Additional efforts, materials, and/or process steps and verifications are required to ensure the sterile or biosafety barriers or both. 1.9.3 For brevity, this is referred to throughout the rest of this practice as SBB (sterile or biosafety barriers or both). 1.10 This practice is applicable to both new and existing SuS. The approach may be used for the implementation of changes to existing SuS and their continuous improvement during operation. 1.11 This practice is applicable throughout the lifetime of the SuS from concept to delivery to end users. 1.12 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 and health practices and determine the applicability of regulatory limitations prior to use.
Keywordsintegrity; testing procedure; SuS manufacturing process; SMI; SBB
The title and scope are in draft form and are under development within this ASTM Committee.Back to Top
Draft Under Development