FOR IMMEDIATE RELEASE
February 12, 2009
Email: trugh@3-a.org
The P3-A Symbol was designed for voluntary display on equipment or machinery that conforms to a P3-A Standard. Use of the P3-A Symbol is subject to the general licensing provisions of 3‑A SSI, including the inspection of sample equipment by an accredited independent inspection authority, known as a Certified Conformance Evaluator (CCE). A prospective licensee must submit a report of conformance for specific names/models of equipment to obtain authorization to display the mark. The third party verification inspection requirement for use of the P3-A Symbol enhances the recognition and the value of the P3-A Symbol for equipment fabricators, regulatory professionals and processors alike.
The commercial display of the P3-A Symbol is intended to benefit equipment fabricators and customers:
- Equipment fabricators gain broad acceptance of their products because the P3-A Symbol conveys the equipment conforms to materials, design and fabrication criteria critical to acceptance by customers and regulatory authorities. P3-A Standards criteria help reduce the cost of dies, tools and intended delivery time that would result without uniform criteria.
- Users and specifiers of equipment used for the production of Active Pharmaceutical Ingredients (APIs) gain confidence in the compatibility of equipment because experts on equipment design, pharmaceutical production and other authorities helped develop each P3-A Standard. They know the equipment meets basic criteria for the intended application.
Complete details on the new P3-A Symbol and the application for authorization are available on the 3-A SSI web site under Pharmaceutical 3-A and P3-A Symbol Authorization or go to: www.3-a.org/pharmaceutical/symbol_authorization.html.
In August 2008, 3-A SSI announced approval of the first three American National Standards for equipment and systems used to produce and package active pharmaceutical ingredient (APIs).
The new P3-A standards include:
- 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.
- 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.
- 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.
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. The P3-A Council 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. 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 also available at the 3-A SSI web site.# # #
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.