Aseptic processing definition

Aseptic processing means the technique involving procedures designed to preclude contamination of drugs, packaging, equipment, or supplies by microorganisms during processing.

Aseptic processing means a method of preparing pharmaceutical and medical products that involves the separate sterilization of the product and of the package, the transfer of the product into the container, and closure of the container under at least ISO Class 5 conditions and using procedures designed to preclude contamination of drugs, packaging, equipment, or supplies by microorganisms during processing.

Aseptic processing means a mode of processing pharmaceutical and medical products that involves the separate sterilization of the product and the package; and the transfer of the product into the container and its closure under at least ISO Class 5 conditions.

Examples of Aseptic processing in a sentence

• Aseptic processing: The technique involving procedures designed to preclude contamination of drugs, packaging, equip- ment, or supplies by microorganisms during processing.

• Aseptic processing involves more variables than terminal sterilization.

• Aseptic processing and packaging" means the filling of a commercially sterilized cooled product into presterilized containers followed by aseptic hermetical sealing with a presterilized closure, in an atmosphere free of microorganisms.

• Aseptic processing: The technique involving procedures designed to preclude contamination of drugs, packaging, equipment, or supplies by microorganisms during processing.

• ASEPTICALLY PROCESSED AND PACKAGED Aseptic processing and packaging is designed to produce a milk product that is shelf stable (does not require refrigeration).

• APPENDIX 1: ASEPTIC PROCESSING ISOLATORS‌ Aseptic processing using isolation systems separates the external cleanroom environment from the aseptic processing line and minimizes its exposure to personnel.

• Aseptic processing of PET drugs should involve microbiological control over various types of components, as discussed below.

• Aseptic processing in PET drug production normally consists of, but is not limited to,(1) the aseptic assembly of the container/closure system (syringe, needle, sterilizing filter and vial) and (2) sterile filtration of the PET drug.

• In addition, the following records shall be maintained:* * * * *(4) Aseptic processing and packaging systems.

• Aseptic processing and packaging and retort processed after packaging shall be performed in accordance with the applicable requirements of 21 CFR Parts 108, 110 113 and 117 and 113.

More Definitions of Aseptic processing

Aseptic processing means a process that is used to subject dairy product to a sufficient heat treatment process and packaged aseptically in a hermetically sealed container to maintain commercial sterility of the product under normal non-refrigerated conditions;

Aseptic processing means a method by which separate, sterile components (e.g., drugs, containers, or closures) are brought together under conditions that maintain their sterility. The components can either be purchased as sterile or, when starting with nonsterile components, can be separately sterilized prior to combining [mode of processing pharmaceutical and medical products that involves the separate sterilization of the product and of the package containers, closures or packaging material for medical devices and the transfer of the product into the container and its closure under at least ISO Class 5 conditions].

Aseptic processing means the technique involving procedures designed to preclude