Aseptic processing is a processing technique wherein commercially thermally sterilized liquid products (typically food or pharmaceutical) are packaged into previously sterilized containers under sterile conditions to produce shelf-stable products that do not need refrigeration. [1]

replaces the 1987 Industry Guideline on Sterile Drug Products Produced by Aseptic Processing (Aseptic Processing Guideline). This revision updates and clarifies the 1987 guidance.

2021年10月2日 · What is aseptic processing? A. Aseptic processing is a manufacturing method that can produce product that is absent of bacteria without subjecting the product to terminal sterilization processes. Many products degrade and become ineffective when subjected to the harsh conditions of terminal sterilization.

2010年12月11日 · Aseptic processing is the processing of commercially sterile and cooled food products being filled into commercially sterile containers under aseptic conditions. The package is hermetically sealed to produce a shelf-stable product that can be stored at ambient conditions.

Aseptic processing refers to heat treatment of a fluid sufficiently to sterilize it, holding for a specified length of time and then cooling before filling into a separately sterilized container in a sterile environment. It is a special case of fluid thermal processing (David et al., 1996).

Simply put, “Operating in a manner that prevents contamination of the process”. However, principle of Aseptic processing, cGMP for sterile m edicinal product is applicable to entire processes such as cell bank, DS and DP manufacturing.

Such procedures shall include validation of all aseptic and sterilization processes. Refer to PDA Technical Report 26 (Sterilizing Filtration of Liquids) for general guidance. Peristaltic pump...

2024年11月5日 · What is the aseptic process in food processing? In food processing, the aseptic technique involves sterilizing heat-sterilized food products and their appropriate packaging materials independently prior to their combination in non-airtight or airtight container.

Both aseptic processing and terminal sterilization remove contamination from drug products, but the two methods are not the same, and they are not interchangeable. Get guidance on the appropriate sterility method for your facility.

Aseptic manufacturing is the method used to commercially sterilize a product and fill and seal it into a sterile container under aseptic conditions. The final filled package is hermetically