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  • ASTM
    E1567-93(2001) Standard Guide for Biopharmaceutical Facilities Architectural Design Considerations (Withdrawn 2010)
    Edition: 2001
    $103.58
    Unlimited Users per year

Description of ASTM-E1567 2001

ASTM E1567-93-Reapproved2001

Withdrawn Standard: Standard Guide for Biopharmaceutical Facilities Architectural Design Considerations (Withdrawn 2010)




ASTM E1567

Scope

1.1 This guide covers architectural design considerations for buildings and facilities used in the biological processing industry to make drugs, chemicals, and other products.

1.2 These designs are intended to meet current good manufacturing practices (cGMP) criteria and guidelines published by the U.S. Food and Drug Administration (FDA) for processes and products manufactured under CFR Title 21.

1.3 While the guidelines described are general in nature, they are not expected to apply to all of the possible biotechnical processes used in the industry today. Accordingly, the user of this guide must exercise good engineering judgment in specific design applications to select the proper guidelines that apply.

1.4 In addition to the cGMP guidelines provided herein, other regulations and guides should be considered that are promulgated by other federal agencies such as the Occupational Safety and Health Administration (OSHA), the U.S. Environmental Protection Agency (EPA), the U.S. Drug Administration (USDA), the National Institute of Health (NIH), and so forth.

1.5 While the buildings will be designed to meet specific functional requirements and comply with local zoning ordinances, building codes, handicapped employee standards, and so forth, these considerations are not included in this guide.

1.6 The values stated in SI units are to be regarded as the standard.

1.7 This standard does not purport to address all of the safety problems, 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

architectural; biopharmaceutical; cGMP; containment; controlled environment; facilities; layout


ICS Code

ICS Number Code 11.120.10 (Medicaments)


DOI: 10.1520/E1567-93R01

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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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