Tuesday, 29 September 2015

Innovations in cleanrooms and environmental monitoring



Pharmaceutical manufacturers of both sterile and non-sterile products, and medical devices, are required to demonstrate that manufacturing processes and procedures minimise any potential contamination to the product from the manufacturing environment. Contamination can arise from a number of sources: water, air, surfaces and personnel, each of which poses a potential risk to product.

These risks of contamination are avoided by putting environmental controls in place (through correct grade of air-supply, satisfactory cleaning and disinfection practices and so on). Where controls cannot off-set every contamination risk, and also as a means to demonstrate the level of control, environmental monitoring programmes are devised and put into action.

In addressing this, Tim Sandle surveys the latest innovations in cleanrooms and environmental monitoring for Express Pharma.

The reference is:

Sandle, T. (2015) Innovations in cleanrooms and environmental monitoring, Cleanrooms: Express Pharma Special Supplement, July 2015, pp12-14

The article can be accessed here.

Posted by Tim Sandle