Monday, 7 August 2017

Santitization of Pharmaceutical Facilities

A new paper on cleaning and disinfecting pharmaceutical and healthcare facilities has been published. Here is the abstract:

Maintaining environmental control including microbiological contamination in a pharmaceutical manufacturing environment is primarily dependent on the facility sanitization program. Sanitization considerations are specific for facility rooms, equipment, and personnel. Sanitization comprises cleaning and disinfection. Cleaning is necessary prior to the application of disinfectant to enable sufficient contact time of the disinfecting agent with the surface. Disinfectants vary in their spectrum of activity, modes of action, sites of action in microorganisms, and efficacy. Disinfectants kill vegetative micro-organisms but do not necessarily kill bacterial spores. There are many different types and categorizations of disinfectants such as non-oxidizing disinfectants and oxydizing agents. Many pharmaceutical manufacturers will have two “in-use” disinfectants and a third disinfectant for major contamination incidents. Rotation of disinfectants is often implemented to satisfy the requirements of regulators. Cleaning and disinfection must be detailed in a Standard Operating Procedure (SOP) to ensure consistency of practice. The effectiveness of cleanroom sanitization is assessed through the site environmental monitoring program. Viable monitoring is undertaken using microbiological growth medium. Regulatory agencies expect the pharmaceutical manufacturer to have evaluated the efficacy of disinfectants. While suspension testing is useful for initial screening, comparative surface (or carrier) testing is more relevant. USP <1072> lists common materials used in clean rooms that should be considered when developing disinfectant surface testing. To demonstrate the effectiveness of a disinfectant, it must be challenged using a panel of organisms that is reflective of the natural microflora of the facility. The biocidal activity of the disinfectant should be taken into account when selecting the panel of organisms. The use of microbial isolates from the manufacturing facility is increasingly becoming a regulatory expectation. Surface tests cannot demonstrate the effect of a range of environmental factors in actual environmental conditions. Field trials are an important part of the qualification of a sanitizer to determine if cleaning techniques are suitable and if the cleaning frequencies of cleanrooms require modification.

The reference is:

Sandle, T. (2017) Santitization of Pharmaceutical Facilities, IVT Special Edition Utility Qualification Volume II, pp56-62

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 Posted by Dr. Tim Sandle