Disinfectant Qualification Studies

Cleaning validations have become an essential part of GMP and our consultants have experience in developing and executing appropriate microbiological cleaning validations, whether it be for sterile or non-sterile manufacturers. An adjunct to this has become the qualification of disinfectants/sanitizers for use in GMP facilities.

The proper selection of disinfecting agents combined with in-house qualification testing is a key element to a successful disinfection program. A sound cleaning and sanitization program is needed for controlled environments used in the manufacture of pharmacopeial articles to prevent the microbial contamination of these articles. For disinfectant qualification we need the following information from the sponsor.

List of organisms to be tested. Preferably include some environmental isolates as well apart from reference cultures.
Surfaces to be tested. You need to provide coupons of 2 x 2 cm size. Number will depend on the no of organisms and no of disinfectants.
Disinfectants to be tested.
Contact time
Mode of application.