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.
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.
| Edition : | 1st |
| Number of Pages : | 12 |
| Published : | 04/01/2008 |
