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Nearly all drugs recalled due to nonsterility or lack of sterility assurance in the period spanning 1980-2000 were produced via aseptic processing.
Aseptic process is very important aspect of pharmaceutical products which are required to be sterile and othere method of sterilisation can not be adapted.
Cellular products , which require that the cells remain viable ,are aseptically processed at an earlier stage in the manufacturing process, or in their entirety. Cellular therapy products are an example. All components and excipients for these products are rendered sterile, and release of the final product is contingent on determination of sterility.
There are basic differences between the production of sterile drug products using aseptic processing and production using terminal sterilization.
Terminal sterilization usually involves filling and sealing product containers under high-quality environmental conditions. Products are filled and sealed in this type of environment to minimize the microbial and particulate content of the in-process product and to help ensure that the subsequent sterilization process is successful. In most cases, the product, container, and closure have low bioburden, but they are not sterile. The product in its final container is then subjected to a sterilization process such as heat or irradiation. In an aseptic process, the drug product, container, and closure are first subjected to sterilization methods separately, as appropriate, and then brought together. Because there is no process to sterilize the product in its final container, it is critical that containers be filled and sealed in an extremely high-quality environment. Aseptic processing involves more variables than terminal sterilization. Before aseptic assembly into a final product, the individual parts of the final product are generally subjected to various sterilization processes. For example, glass containers are subjected to dry heat sterilisation; rubber closures are subjected to moist heat sterilisation ; and liquid dosage forms are subjected to sterilisation by filtration.
Each of these manufacturing processes requires validation and control.
Each process could introduce an error that ultimately could lead to the distribution of a contaminated product. Any manual or mechanical manipulation of the sterilized drug, components, containers, or closures prior to or during aseptic assembly poses the risk of contamination and thus necessitates careful control.
A terminally sterilized drug product, on the other hand, undergoes final sterilization in a sealed container, thus limiting the possibility of error. Sterile drug manufacturers should have a keen awareness of the public health implications of distributing a nonsterile product. Poor CGMP conditions at a pharmaceuticals manufacturing facility can ultimately pose a life-threatening health risk to a patient.
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