FOR IMMEDIATE RELEASE
August 15, 2008
Contact: Timothy R. Rugh, CAE
Email: trugh@3-a.org
3-A SSI Introduces First New Pharmaceutical (P3-A) Equipment Standards
McLEAN, Virginia - 3-A Sanitary Standards, Inc. (3-A SSI) announces the availability of the first three American National Standards for equipment and systems used to produce and package active pharmaceutical ingredient (APIs).
The new pharmaceutical 3-A equipment (P3-A) standards include:
1. General Glossary of Terminology Used In Pharmaceutical 3-A® Standards, P3-A 001 - This reference document is intended to support and facilitate the use of other P3-A Standards. Specifically, this standard provides users of P3-A standards and accepted practices with definitions of acronyms and terms widely used in these documents.
2. Pharmaceutical 3-A® Sanitary/Hygienic Standards for Materials for Use in Process Equipment and Systems, P3-A 002 - These standards provide minimum materials and surface property requirements, including minimum fabrication related materials and surface property requirements for equipment and components utilized in the pharmaceutical manufacturing environment whereby those material and surface properties may directly, indirectly, or incidentally impact the strength, identity, safety, purity or quality of the active pharmaceutical ingredient, excipient, or drug product.
3. P3-A® End Suction Centrifugal Pumps for Active Pharmaceutical Ingredients, P3-A 003 - This standard covers the sanitary design requirements of mechanically sealed end-suction centrifugal pumps, conforming to ANSI/ASME B73.1, whereby those design criteria may directly, indirectly, or incidentally impact to the strength, identity, safety, purity or quality of the active pharmaceutical ingredient, excipient, or drug product.
The new standards were developed by the Pharmaceutical Equipment Standards (P3-A) Steering Committee of 3-A SSI. The committee oversees the development of new standards for equipment used in the production of APIs.
Four other new standards for API equipment are currently under development, including Agitated Filter Dryers, Vessels and Agitators, Mills and Classification Equipment, Process Heat Exchangers. P3-A invites all interested stakeholders to participate in the new standards development.
Copies of the new standards are now available for purchase in electronic format or printed version through the 3-A SSI web site at: www.3-a.org. Details on participating in the P3-A standards activities and the role of the new standards for API equipment/materials relative to other standards or industry guidelines are available at the 3-A SSI web site at www.3-a.org under ‘Pharmaceutical 3-A Standards’.
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3-A Sanitary Standards, Inc. is a not-for-profit 501(c)(3) organization whose mission is to enhance product safety for consumers of food, beverages, and pharmaceutical products through the development and use of 3-A Sanitary Standards and 3-A Accepted Practices. Visit the 3-A SSI web site at www.3-a.org.