Ask any Las Vegas, NV local about Dr. Dipak Desai and they will likely cringe; once recovered, they will tell you about how in 2009, unsanitary practices exposed nearly 50,000 patients at his endoscopy clinic to hepatitis C. (1) This type of extreme scenario is a central motivator for strict sanitary regulations in the food, medical, and pharmaceutical industries. Specifically for pharmaceutical products, sanitation in both equipment and process ensures that potentially harmful contaminants are kept separate. Following is an overview of the two central standards that dictate sanitary homogenization and practices in pharmaceutical product development.
GMP Standards
Good Manufacturing Practices (GMPs) are a set of guidelines and and requirements that dictate the manufacture of food and drug products. Specific to drug manufacturers, the Current Good Manufacturing Practices (CGMPs) specify the minimum requirements for all aspects of drug development; these include manufacturing, processing, and packaging and are regulated in their methods, facilities, and controls. When a drug applies for FDA approval, FDA inspectors will check the manufacturer’s compliance with CGMP regulations by analyzing the manufacturer’s compliance history, taking samples, and inspecting the manufacturing facilities. (2)
3-A Standards
Originally developed in the 1920’s as a response to the hygienic design of dairy equipment, 3-A Sanitary Standards, Inc. (3-A SSI) is now an independent corporation that uses hygienic equipment to promote food safety. The abbreviation ‘3-A’ comes from three associations, regulatory sanitations, equipment fabricators, and processors, that collaborated to develop the currently existing standards. The Pharmaceutical 3-A (P3-A) standards were developed by API manufacturers when they saw a need for standards around equipment design; these standards dictate the materials and design for equipment that will produce APIs. Appropriate implementation of these standards ensures API purity, safety, and quality. The 3-A Pharmaceutical Standards are available for purchase here.
Pion: Manufacturer of Sanitary Systems
The stringent regulations dictated by GMP and 3-A have yielded a wide array of sanitary pharmaceutical laboratory equipment, such as mixers, transducers, coolers, priming valves, and more. Pion's Technology is trusted by pharmaceutical researchers and lab managers around the world, and provides an array of high quality sanitary systems that can be customized to any Pion homogenizer.
In addition, we have extensive experience in the challenges that our pharmaceutical customers face as they transition from concept, through to R&D, clinical trials, all-important FDA approval and finally, to manufacturing.
