Description Of The Aseptic Processing System

Although the equipment for aseptic processing systems varies, all systems have certain common features:

1. A pumpable product

2. A means to control and document the flow rate of product through the system

3. A method of heating the product to sterilizing temperatures

4. A method of holding product at an elevated temperature for a time sufficient for sterilization

5. A method of cooling product to filling temperature

6. A means to sterilize the system before production and to maintain sterility during production

7. Adequate safeguards to protect sterility and prevent nonsterile product from reaching the packaging equipment

Preproduction Sterilization

Producing a commercially sterile product cannot be assured unless the processing system and filler have been adequately sterilized before starting production. It is important that the system be thoroughly cleaned before sterilization; otherwise the process may not be effective. Some systems, or portions thereof, use saturated steam for sterilization. However, for most systems, equipment sterilization is accomplished by circulation of hot water through the system for a sufficient length of time to render it commercially sterile. When water is used, it is heated in the

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