Aseptic processing validation program

Perhaps the simplest means of establishing an acceptance criteria (and perhaps to define one s entire program) is to follow the pack, and develop a firm s entire aseptic processing validation program based... 

The major source of microbial contamination of controlled environments is personnel. Since the major threat of contamination of product being aseptically processed comes from the operating personnel, the control of microbial contamination associated with these personnel is one of the most important elements of the environmental control program. Personnel training should be conducted before the qualification and validation practice [13]. 

In virtually all aseptic processing activities, operator interventions are required to complete the process. Understanding the types of interventions required and how they are incorporated into the validation program is essential to protocol development. 

Aseptic Assembly. The first interventions performed are those that prepare the equipment for the aseptic process. This entails the removal of sterilized materials and equipment items from the autoclave and transfer to the location where the aseptic processing activities will be performed. This is ordinarily followed by the assembly/preparation of the equipment for the process. Aseptic assembly in which sterilized parts are removed from protective materials, installed and adjusted in preparation for the aseptic process are perhaps the most potentially invasive of all of the activities which must be performed. The operator must be meticulous in their execution of these tasks to prevent the inadvertent contamination of product contact surfaces. Strict adherence to the principles of aseptic technique described earlier is essential. These interventions are a necessary part of every aseptic activity, and it is common to identify the first containers filled as they may be more indicative of potential problems with the aseptic assembly. For this reason, the validation program should include process simulations that include containers filled immediately after the set-up of the equipment. 

Korczynski, M. Validation of Aseptic Process by Media Fills—Survey Report and Discussion, Proceedings of the Second PMA Seminar Program on Validation of Sterile Manufacturing Processes, Aseptic Processing, PMA, 1979 186-213. 

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