English to Russian Medical Biology (-tech,-chem,micro-) Валидация, контроль качества

Additionally, this half-cycle revalidation study has to validate Sterigenics 9.26 Tubing Test Pack that had been evatuated under PRNV-10828 Rev. A. The intent is to use the Sterigenics 9.26 Tubing Test Pack as a replacement for the current PCD 2.8, supplied by PCD LLC, Sunnyvale, CA.

This half length revalidation cycle included 53 EPCD (i.e., Sterigenics 9.26 Tubing Test Pack with Steris Bacitlus atrophaeus spore strips, Lot Number 2082, Expiration Date 01/26/2014) and 53 IPCD (NAMSA Bacitlus atrophaeus spore strips, Part Number STN-062, Lot#N28701, Expiration Date: 7/12/2013) packaged inside the hub of Echelon 10 Micro Catheter as the worst case to challenge Biological Indicator (Bl). The Bl Test of Sterility results demonstrate that all IPCDs and EPCDs were effectively sterilized at one (1) minute less than half the gas dwell time and 5°F lower than the certified process temperature.
Это в отчете по валидации метода стерилизации.
Спасибо!