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4 C 5 1092 <br /> T0000732 <br /> Revision: 05 <br /> PEOPLE>SCIENCE>SOLUTIONS Test Process Specification/Document <br /> ❑ Test half the sample in SCDB and the other half in FTM. <br /> Z Test all samples received in SCDB. <br /> ❑ Test all samples received in FTM. <br /> Incubate cultures at: ❑20 25°C for SCDB and 30-35°C for FTM ❑30-35'C ❑45°C❑55-60*C <br /> ❑28-32°C ❑20-25°C 0 Other Stearn or Geobacillus stearothennophilus <br /> bioindicators at 55-60°C, Ethylene oxide or Bacillus atrophaeus bioindicators at 30-350C,or <br /> incubate per manufacturer's recommendations. <br /> Incubation time: ❑Minimum of Z 7 days ❑ 10 days ❑ 14 days ❑30 days <br /> ❑Other <br /> Background Info: ❑ USP ❑ AAMI: ❑ VD max ❑ EP Other:Not Applicable <br /> B/F Testing performed on: Date:Not Applicable <br /> Lab Number(if test performed at NAMSA):Not Applicable <br /> Reference(s): NAMSA Sterility test SOP series <br /> Page 2 of 2 <br /> Printed on:09 Sep 2014,01:04:52 pm. <br /> --------------------------- <br />