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  • ASTM
    E3051-16 Standard Guide for Specification, Design, Verification, and Application of Single-Use Systems in Pharmaceutical and Biopharmaceutical Manufacturing
    Edition: 2016
    $86.11
    Unlimited Users per year

Description of ASTM-E3051 2016

ASTM E3051-16

Active Standard: Standard Guide for Specification, Design, Verification, and Application of Single-Use Systems in Pharmaceutical and Biopharmaceutical Manufacturing




ASTM E3051

Scope

1.1 This guide is intended as a complement to Guide E2500.

1.2 This guide is applicable to the range of manufacturing systems described in Guide E2500, specifically all elements of single-use systems, or hybrids of single-use and traditional components, used for the manufacturing of pharmaceutical and biopharmaceutical products, including: materials of construction, components, assembly, manifolds, supporting utilities, associated process monitoring and control systems, automation systems, and controlled environment that have the potential to affect product quality and patient safety.

1.3 This guide is applicable for the implementation of changes to manufacturing system design for existing systems. It may be used for continuous improvement and changes in operation from clinical through to commercial scale.

1.4 For brevity, single-use systems are referred to as SUS throughout the rest of this guide.

1.5 The approach may be applied by the end user, the supplier of SUS, and raw materials sub-suppliers further back in the supply chain.

1.6 This guide is not intended to apply to the use of single-use technology for packaging, primary containers, combination products (products composed of any combination of a drug, device, or biological product) or devices.

1.7 This guide does not address specific local requirements, which remain the responsibility of the end user.

1.8 This guide does not address employee health and safety, environmental, nor other good engineering and manufacturing practices (GXP) requirements. 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.


Keywords

biopharmaceutical manufacturing process; end users; quality risk management; single-use system; suppliers; SUS;


ICS Code

ICS Number Code 11.120.99 (Other standards related to pharmaceutics)


DOI: 10.1520/E3051-16

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About ASTM

ASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide.
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