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ASTM International - ASTM E1567-93(2001)

Standard Guide for Biopharmaceutical Facilities Architectural Design Considerations (Withdrawn 2010)

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Organization: ASTM International
Publication Date: 1 January 2001
Status: inactive
Page Count: 5
ICS Code (Medicaments): 11.120.10
significance And Use:

This guide is intended for use in designing laboratory, pilot plant, commercial production buildings that will use processes involving living organisms to produce products. These products are also... View More

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.

Document History

January 1, 2001
Standard Guide for Biopharmaceutical Facilities Architectural Design Considerations
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...
ASTM E1567-93(2001)
January 1, 2001
Standard Guide for Biopharmaceutical Facilities Architectural Design Considerations (Withdrawn 2010)
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...
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