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Pumps & Systems, December 2008
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.
Fluid Sealing Association
Sealing Sense is produced by the Fluid Sealing Association as part of our commitment to industry consensus technical education for pump users, contractors, distributors, OEMs, and reps. This month's Sealing Sense was prepared by FSA Member Bill Adams. As a source of technical information on sealing systems and devices, and in cooperation with the European Sealing Association, the FSA also supports development of harmonized standards in all areas of fluid sealing technology. The education is provided in the public interest to enable a balanced assessment of the most effective solutions to pump technology issues on rational Total Life Cycle Cost (LCC) principles.
The Mechanical Seal Division of the FSA is one of six with a specific product technology focus. As part of their educational mission they develop publications such as the Mechanical Seal Handbook, a primer intended to complement the more detailed manufacturer's documents produced by the member companies. This document served as the basis for joint development of the more comprehensive Hydraulic Institute publication: Mechanical Seals for Pumps: Application Guidelines. Joint FSA/ESA publications such as the Seal Forum, a series of case studies in pump performance, are another example as is the Life Cycle Cost Estimator, a web-based software tool for determination of pump seal total Life Cycle Costs. The Sealing Systems Matter initiative also was launched to support the case for choosing mechanical seals that optimize life cycle cost, reliability, safety and environmental compliance.
The following members of the Mechanical Seal Division sponsor this Sealing Sense series:
Advanced Sealing International (ASI)
Ashbridge & Roseburgh Inc.
A.W. Chesterton Co.
CoorsTek
Daikin America, Inc.
DuPont Performance Elastomers LLC
EagleBurgmann Industries LP
Flex-A-Seal, Inc.
Flowserve Flow Solutions Div. - Seal Group
Garlock Sealing Technologies
Greene, Tweed & Co./Palmetto, Inc.
Industrias Vago de Mexico SA de CV
John Crane
KC America
Latty International S.A.
Metallized Carbon Corp.
Morgan AM&T
Nippon Pillar Corp. of America
Parker Hannifin - Seal Group
PPC Mechanical Seals
SEPCO - Sealing Equipment Products Co.
SGL Technic Polycarbon Division
Tags: December 2008 Issue , Fluid Sealing Association's Sealing Sense , Mechanical Seals , Seals
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