Sterility assurance calculation

While the minimum irradiation dose (MID) to achieve a 10" probability of sterility assurance may be calculated by Eq. (2) ... 

Use in the production of vaccines As assay organisms to determine antibiotic, vitamin and amino acid concentrations Quality control of immunological products Assay methods Sterilization methods Sterilization monitoring and validation procedures Sterility testing Assessment and calculation of sterility assurance Aseptic manufacture... 

If the number of spores per spore strip and the number of spores per validation load is to be related to the individual product item and a sterility assurance level of 10. h is first necessary to know the average number of contaminants per product item. In the interests of conservatism this number may be rounded up or supplemented by a safety factor. The target is to use as many spore strips as is necessary to provide assurance that this bioburden is being inactivated to an SAL of 10 This can be calculated from... 

Each monograph contains the following information name of the substance or medicinal product, definition, packaging, storage, labeling requirements and specifications (tests, procedures for the tests and acceptance criteria). The USP also contains several general chapters. There are five general chapters about pharmaceutical preparation sterile preparations, non-sterile preparations, pharmaceutical calculations in extemporaneous preparation, quality assurance, and prescription balances and volumetric apparatus. 

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