ABSTRACT
Aseptic processing and packaging systems are complex and require extensive work to validate and maintain the “validated state” of such systems. A new perspective on validation of the systems is introduced in this chapter. Due to its continuous nature, aseptic systems have very little room for variations and errors. Generally, the consequences of such errors are very costly. As Chapter 14 has outlined potential risks and mitigation plans for the aseptic systems, this particular chapter will focus on those identified risks as part of the qualification and challenging events under the worst-case conditions.
An aseptic system has many interconnected pieces of equipment that need to function flawlessly to avoid any issues of food safety and spoilage. Series of the equipment in the aseptic system, from batching to all the way to the palletizer, one unit operation is considered the supplier of the downstream unit operation. Therefore, interconnectivity and corresponding signal exchanges must be part of the validation. In this chapter, the reader will get a holistic view of the planning and execution of the commissioning and validation of aseptic systems along with the regulatory aspects and supporting programs such as change management and preventive maintenance. The authors of this chapter have shared their views and recommendations based on their collective experiences of nearly 80 years in industry and academia.
