“Sterile pharmaceutical and medical device manufacturing environments require an effective cleaning and disinfection program to maintain aseptic conditions and prevent the microbial contamination of the product. The qualification of the chemical disinfectants used in these environments is extremely important, yet it is often overlooked,”
In fact, “disinfectant qualifications require more planning, time, and resources than many companies realize,” she said.
“Any time a new disinfectant is introduced into the cleaning process within the facility, a qualification should be performed. From start to finish, a disinfectant qualification can require from 2 to 12 months.
“The timeline for a disinfectant qualification will depend on a number of variables, including the number of disinfectants and challenge organisms being tested as well as the number of surfaces (for the coupon method) being evaluated,” Ensign noted.
“The bottom line is that no matter whether the disinfectant qualification is performed internally — or by an outside testing laboratory — these six steps must be addressed,” she warned.
Download a free copy of the white paper, “Six Steps to Qualifying Disinfectants”
Deborah Ensign is supervisor, R&D Lab, at Microtest Laboratories Inc. She has over 20 years of experience in regulatory microbiology and contract laboratory operations. Ms. Ensign supervises Microtest’s Specialized Microbiology department. She holds a bachelor of arts degree in microbiology and is a nationally registered microbiologist. Ms. Ensign oversees all reusable testing (cleaning, disinfecting, and sterilization)