Carrying out biological qualification, the control operation of moist-heat (steam sterilization) processes for producing sterile pharmaceuticals and medical devices.

In this report we will first discuss the principles behind the practices that are used today in the design and qualification of moist-heat (steam sterilization) microbial-control processes used to produce sterile pharmaceutical products and medical devices. Secondly, we will work through example applications of how to design and qualify processes of three levels of complexity which we call Empirical Overkill, Empirical, and Product Specific. Empirical Overkill is specifically for the microbial-control processes for indirect items, such as tanks, pipes, pumps and other hardware. Empirical is for pharmaceutical and medical-device products that are produced under good manufacturing conditions and, therefore, there is control of the level of the microbial bioburden. Product Specific is for microbial-control processes designed and qualified for a specific product on the basis of the numbers and resistance of the bioburden of that product. We will treat design in this report; however, the major thrust is in setting up and carrying out the biological qualification of the process, which is the mode of control used to assure the adequacy of these microbial-control processes.