Active pharmaceutical ingredient (API) manufacturers have identified the need for standards for the design of equipment that is more efficiently cleanable to enhance acceptance by QA and inspection agencies and advance the state-of-the-art for production equipment. The new Pharmaceutical 3-A (P3-A) standards provide the requirements for materials of construction and for the design of cleanable equipment for the manufacture of active pharmaceutical ingredients.
Set Contents:
- P3-A 001:2008, General Glossary of Terminology Used In Pharmaceutical 3-A Standards. This standard provides users of Pharmaceutical 3-A® (P3-A) Standards and Accepted Practices with definitions of acronyms and terms widely used in these documents.
- P3-A 002:2008, Pharmaceutical 3-A Sanitary/Hygienic Standards for Materials for Use in Process Equipment and Systems. This standard provides minimum materials and surface property requirements, including minimum fabrication related materials and surface property requirements, for new 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.
- P3-A 003:2008, P3-A End Suction Centrifugal Pumps for Active Pharmaceutical Ingredients. This standard covers the sanitary design requirements of mechanically sealed end-suction centrifugal pumps, conforming to ANSI/ASME B73.1, pertinent to active pharmaceutical ingredient (API) manufacturing in order to maintain product integrity.
A web-based multi-user Subscription Service is also available. The Subscription Service allows one or more users to access the P3-A Pharmaceutical Standards simultaneously from any location in electronic format. Any updates to the documents are included for the one-year license period.
Click here for more information or email
[email protected].
