A sterilization method where the steam in place cycle is capable of meeting or exceeding both an FBIO and FPHYS of 12 minutes and worst case bioburden assumptions are made to demonstrate an SAL of 10-6. (Note: For typical SIP systems, the FPHYS will need to be greater than the FBIO .)
对于一个SIP 程序能够保证FBIO 和 FPHYS都达到或超过12 分钟或能证明可使微生物负荷降低到10-6（注意： 对于 SIP 系统，FPHYS 值需大于 FBIO 值）的无菌保障水平的设计方法。
