8. Conclusion
8.1 The plate counts for each product and the recovery results:
8.1.1 Shu average finished good blood circuit plate count 361 CFU / SIP (5 sets of average), recovery of 93.34%.
8.2 The proof of the physical features:
Full validation of a sterilization cycle parameters are scheduled to reach specifications.
8.3 The proof of microbial deactivation features:
8.3.1 Sterilization of biological indicator products, after the sterile, sterile conditions in to remove it, and, after breaking its internal laminated glass, put in 30 ~ 35 ℃ constant temperature incubator 48 hours. After training, biological indicator color to orange.
8.3.2 Using the whole-cycle approach: a determination of the biological indicator points were highly negative, can push the level of sterilization quality assurance of 10-6 (SAL of 10-6.)
8.3.3 sterility test culture for 14 days, the sample continued to show a negative reaction.
9. To determine
The above test results show that the sterilization cycle, the product of the SAL is less than 10-6, and its sterilization effect judged as "acceptable."
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