Dairy Establishment Inspection Manual – Chapter 14 - Aseptic Processing and Packaging Systems
1.14.01 APPS Flow Schematic

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The APPS, although similar to a high temperature short time (HTST) pasteurizer, operates at higher temperatures and pressures. It also uses steam seals and other means to ensure a commercially sterile product. Because of the importance of maintaining sterility in the system, and the number of factors involved, any changes made to the processing system must be done with the full involvement of the qualified Process Authority responsible for the scheduled process. Even slight modifications made to the aseptic processing and packaging system may have an impact on its operation and safety.

This task will evaluate the flow schematic of the aseptic processing and packaging system, aseptic storage tank, associated piping/components and aseptic packaging (i.e. from the constant level tank to packaging).

1.14.01.01 Flow Schematic [Process and Instrumentation Diagram (P&ID)]

Plant management must have a flow schematic outlining the APPS system which is maintained and kept in the plant's file. When equipment and/or pipelines are installed or changed, plant management must ensure that the flow schematic is updated. All components of the aseptic processing and packaging system (e.g. constant level tank, feed pump, regeneration system, pressure differential recorder-controller, flow control device, heat exchangers, thermometers, holding tube, Safety Thermal Limit Recorder (STLR), flow diversion device, aseptic barriers, aseptic packaging etc.) must be on the flow schematic.

1.14.01.02 No Cross Connections

A cross connection is a direct connection allowing one material to contaminate another. There needs to be a complete segregation of incompatible products such as raw materials and pasteurized or sterilized food products, cleaning products and food products, and waste materials or utility materials and food products, as outlined under task 1.10.01.02 of Chapter 10. Consideration also needs to be given to preventing inadvertent cross contamination of independent food products (e.g. soy beverages and milk) which may pose allergenic concerns.

Segregation of incompatible products must be accomplished by the use of separate pipelines and vessels for incompatible products, and establishing effective physical breaks at connection points. The installation of segregating valves for the purpose of separating cleaning solutions from food products does not constitute a physical break and is not acceptable, except that a properly designed valve arrangement (raw side) meeting the requirements of or a properly designed aseptic barrier (sterilized side) may be used (e.g. while cleaning the packaging line and/or surge tank while processing product). A properly designed aseptic barrier could, for example include one or more steam blocks, with a temperature sensor alarm to indicate barrier failure due to leaks or loss of steam.

Attention must also be paid to the design of the constant level tank and piping, and the product divert device, as these are areas where potential cross-connections could exist if the design or installation is improper. Tasks 1.4.03.04 and 1.14.09.01 to 1.14.09.05 of Chapter 14 provide more details for the evaluation of these tasks.

A physical verification by the inspector must be done to check the accuracy of the schematic and to ensure that no cross connections exist. Even if the plant does not have a schematic on file, an assessment for cross connections must be completed on the aseptic processing and packaging system.

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