Q. How Will the P3-A Equipment Standards Affect You?
A. The pharmaceutical industry has frequently cited 3-A sanitary standards (used primarily in dairy and other food processing) when specifying equipment for their processes. Equipment manufacturers with sanitation requirements, pharmaceutical processors and regulators have been working together to create the first end suction centrifugal pump standard expressly for the API (Active Pharmaceutical Ingredient) segment of the pharmaceutical industry.
The new Pharmaceutical 3-A, or P3-A, standards represent the first major expansion of 3-A sanitary standards beyond the food and dairy processing industry. 3-A Sanitary Standards, Inc. (3-A SSI) created the new P3-A standards in accordance with the accreditation requirements of ANSI. The first group of P3-A Standards includes:
- P3-A 001:2008, General Glossary of Terminology Used in Pharmaceutical 3-A Standards
- P2-A 002:2008, Pharmaceutical 3-A Sanitary/Hygienic Standards for Materials for Use in Process Equipment and Systems
- P3-A 003:2008, P3-A End Suction Centrifugal Pumps for Active Pharmaceutical Ingredients
The P3-A standards will assure pharmaceutical equipment buyers, equipment fabricators, contractors and regulatory authorities that equipment is built to specific criteria for API production and cleanability.
Q. What Are the Advantages of These Standards?
A. These standards are expected to provide uniform practices for hygienic design, materials of construction and fabrication of equipment within the API industry. Ultimately, the harmonization of equipment, material and design standards should help reduce costs for component suppliers and end-users while providing a clear, more consistent path to equipment design. Part of the cost savings is expected from decreased capital budgeting for specification time and the standardization of equipment design across the industry. Design standards are based on a well-established starting point of current P3-A standards and a third party verification inspection process.
Third Party Verification
A third party verification inspection program is key to the success of the new standards. Third party inspectors, with 3-A SSI credentials, will conduct an on-site inspection to ensure that equipment conforms to the P3-A standards. Based on the inspection report and license application to 3-A SSI, a P3-A symbol will be licensed to the equipment manufacturer to convey that specific models or types of equipment conform to the new standard.
Q. How Does a P3-A Pump Vary From an ASME/B73.1 Pump?
A. Pumps specified to the ANSI accredited ASME B73.1 Standard are typically employed in the chemical process industry (CPI). Standard B 73.1 is a dimensional and feature focused specification primarily directed to ensure dimensional interchangeability and operational reliability. Design features of the new P3-A standard for end suction centrifugal pumps modify those of the B 73.1 pumps to maintain product integrity and ensure effective in-process sanitation and cleanability.
Key differences between pumps specified to the new P3-A standard and B73.1 are shown in Table 1.
Conclusion
The introduction of the new series of standards for active pharmaceutical ingredients contributes to the pharmaceutical industry's efforts to improve the economy and efficiency of the entire manufacturing process and maintain the strict requirements of hygienic design and cleanability throughout their production process. This in turn will help ensure the reliability of products from that important industry. These new standards address the unique requirements of process equipment essential to product manufacturing.
