Microbial Risk Management During Cleanroom Operations

The course will provide a basic understanding of the Risk Management of Contamination (RMC) system that can be utilised for the control of contamination during manufacturing operations in clean rooms.

Microbial contamination of aseptically prepared pharmaceutical products will be considered but the methods presented can also be applied to various cleanroom healthcare products and other manufacturing activities. The mechanisms of microbial contamination explained are also applicable to inert particle contamination and the principles covered can also be utilised for this application.

The course will provide an understanding of the fundamental mechanism of contamination transfer, via surface contact or from airborne deposition, and how this mechanism is used to provide the most accurate methods of assessing risk, defined as the number of microbes likely to be deposited into a product. All general sources of cleanroom contamination, their routes of transfer and the associated control methods will be discussed and a method of assessing their risks to product explained.

Further methods, to assess the risks to product from activities associated with a particular manufacturing process within the critical cleanroom areas, will be detailed. An understanding of how the identified risks, or their methods of control, can be monitored and limits set to ensure that contamination is adequately controlled are outlined. Additionally, a method for determining the risk to the patient, from aseptically manufactured products, by considering factors relating to the chance that it contains sufficient microbes to initiate an infection, will be presented.