ASTM WK46541

    New Guide for for Specification, Design and Verification of Single Use Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment.

    (What is a Work Item?)

    Developed by Subcommittee: E55.03 | Committee E55 | Contact Staff Manager


    1. Scope

    1.1 This guide is intended as a complement to ASTM Standard E2500-07, Standard Guide for Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment. 1.2 Since its publication in 2007 there has been a significant increase in the use of single use systems n the industry. Many of the general principles described in E 2500-07 remain relevant for single use systems. However, the nature of the technology places constraints on the ability of the user to test assemblies non-destructively, and the complexity of the supply chain increases the dependency of end users on supplier documentation. 1.3 This guide is applicable to the range of manufacturing systems described in E 2500-07. 1.4 This guide is applicable to changes throughout the lifecycle of the manufacturing system design, and may be used for implementation of changes to existing systems and their continuous improvement and operation. 1.5 This approach may be applied by the end-user, by the supplier of single use assemblies, and sub-suppliers of materials and components further back in the supply chain to assure fitness for purpose of the Single Use System (SUS) during its implementation.


    Risk-based approach; Science-based approach; Critical Aspects of Manufacturing Systems; Quality by Design; Good Engineering/Manufacturing Practice; Subject Matter Expert; Use of Vendor Documentation; Continuous Process Improvement; Transportation; design, vertification, pharmaceuticals, biopharmaceuticals:

    The title and scope are in draft form and are under development within this ASTM Committee.

    Citing ASTM Standards
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    Work Item Status

    Date Initiated:

    Technical Contact:
    Duncan Low


    E55 (15-06)

    Ballot Item Approved as E3051-2016 and Pending Publication