Already frequently cited for pharmaceutical industry applications, 3-A Sanitary Standards, Inc., McLean, Va., has announced plans to develop a line of standards specifically for equipment used in the manufacture of active pharmaceutical ingredients (APIs).
The new standards, to be called P3-A Standards, represent the first major expansion of 3-A standards outside of the dairy and food processing industry, according to Tim Rugh, 3-A SSI executive director. The development of P3-A Standards will bring new assurance to pharmaceutical equipment buyers, equipment fabricators and regulatory authorities that equipment built to P3-A Standards meets specific criteria for hygienic design and cleanability, Rugh says.
3-A Standards, which originated in the 1920s, have grown and evolved to meet the critical sanitation requirements of today's dairy and food processing industry. 3-A Standards exist today for nearly 70 different types of equipment. Conforming equipment may display the widely recognized 3-A symbol, which certifies that machinery meets the 3-A standards in hygienic design and cleanability.
A new P3-A Steering Committee will oversee general project management and the designation of task groups to draft the new standards for use in the domestic and international pharmaceutical industry. The committee will follow the essential requirements of the American National Standards Institute (ANSI) in developing the new standards.
"The Steering Committee agreed the pharmaceutical industry needs new ways to streamline capital equipment project specification time and assure compliance with sanitary codes and principles," explains Rugh. "Having common equipment standards applied across site locations will help pharmaceutical companies in many ways, and it will enhance acceptance by inspection authorities."
For more information, contact 3-A SSI at 703-790-0295 or visit www.3-a.org
