Millipore Technical Publications |
 | DS- SDS1701ENEU | |
MicroSafe Biosafety Solutions Laboratory, Europe - Sterility Testing | ||
| Lit No: | SDS1701ENEU | |
| Year: | 2006 | |
| Sterility testing is one of the most crucial steps in pharmaceutical product release. False positives, false negatives, equipment failure and human error cost time, money and ultimately the end product. The two types of product sterility testing are pre-release testing and quality assurance testing. In general, microbiological quality control includes pre-release testing to prevent non-sterile admixtures from being dispensed. Ongoing quality assurance programs include testing random samples of the product, testing the environment where the products are processed to monitor sterile conditions, and testing personnel for proper aseptic technique. Validation is essential to both quality control and quality assurance programs. Validation verifies that the other variables – the procedures, materials and personnel – inherently do not introduce contamination into the process and that the program is adequate to detect contamination during production of sterile products. Click the PDF above for the full document. | |
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