Sterilization process primary processes

Cleaning of primary packaging material is normally considered to be a GMP issue, although data may be requested. Sterilization processes applied to packaging materials need to be described in the application in the normal manner. 

So what value, if any, do physical measurements have with respect to the validation of sterilization processes Their primary utility is in the comparison of one process to another. This can be done in myriad ways (process to process, load to load, item to item, etc.), and forms the basis for claims of uniformity and reproducibility for the process. 

Although there are many sterilization processes used in association with the manufacture of sterile drug products, the three primary processes are steam sterilization, dry heat sterilization, and sterile filtration. Dry heat sterilization is, in the context of the manufacture of sterile parenteral products, a subset of dry heat depyrogenation (see the following). 

There is no compounding or mixing in this process. The dosage form is received sterile from primary manufacture and is passed into the sterile area through a laminar flow protected interlocked transfer hatch. The dosage form containers are thoroughly decontaminated before being placed in the transfer... 

The manufacture of sterile excipients for use in aseptic/sterile processing present technical challenges. The operators are the primary source of contamination in an aseptic operation, and... 

Sterile Filtration of Gases. Primary appHcations for sterile gas filtration are the sterilization of fermentor inlet air, fermentor vent gas, vents on water for injection tanks, and vacuum break filters during lyophilization. Operational and process considerations apply. Typically, the membrane in gas... 

The stoppers and primary contact filling equipment are transferred from the sterile storage area into a filling room. Eor the filling process, the filtration set-up and filling equipment are aseptically assembled under class 100 conditions in the filling room. 

A problem associated with beef sterilized by irradiation at approximately room temperature is the production of an unpleasant flavor and aroma. This paper summarizes knowledge of the volatile components of enzyme-inactivated irradiated and nonirradiated beef, reviews the effects of concurrent and nonconcurrent irradiation procedures and of storage on these components, and presents evidence that methional (3-methylmercaptopropion-aldehyde), 1-nonanal, and phenylacetaldehyde are of primary importance to irradiation off-odor in beef thus processed. 

The production of sterile products is profoundly impacted both by formulation and the selection of primary packaging components. Design parameters for a facility and selection of appropriate manufacturing technologies for the product require that the formulation process and packaging components be chosen and evaluated in advance. 

If the product is not freeze dried, the primary closure or stopper is applied shortly after completion of the filling process to better assure the sterility of the contents. When the product is to be lyophilized, the stopper may be partially inserted after filling and be fully seated after completion of the lyophilization cycle. Alternatively, the container could be left open and a stopper applied after completion of the drying. 

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