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J 4 C 5 19 92 T0000732 Revision: 05 PEOPLE>SCIENCE>SOLUTIONS Test Process Specification/Document Test: Sterility Company: NAMSA Customer ID: 20303 Test Article Name: Spore Strips/Spore Discs- No photograph per exception clause in NAMSA nonembedded SOP 00706. Description: Biological indicators Test Method: Direct Transfer(Immersion) Culture Medium (check all that apply): USP Soybean Casein Digest Broth(SCDB) ❑ Supplemented Soybean Casein Digest Broth(S-SCDB) ❑ USP Fluid Thioglycollate Medium(FTM) ❑ USP Dilution Fluid A(DFA) ❑ USP Dilution Fluid D(DFD) ❑ USP Sterile Water for Injection(SWFI) ❑ Other: Media Container: ❑ 100 mL jar(-58 x 135 mm) ❑ 400 mL(-89 x 170 mm) ❑ 600 mL jar(-89 x 170 min) ❑ 600 mL jar(-110 x 138 mm) ❑ 1000 mL(-110 x 230 mm/-105 x 230 mm) 10-20 mL tube(-25 x 150 min) ❑ 30 ml,tube(-25 x 150 mm) ❑ 80 mL tube(-25 x 300 mm) ❑ Bag: ❑ Cylinder: ❑ Other: Sample Preparation: Wipe the outer package with sterile cleanroom wipe moistened with a NAMSA approved germicide. Avoid wetting through outer package. Testing performed utilizing a 9 primary technician or 0 primary and secondary technician. Test Procedure: In an ISO class 5 laminar flow hood,0 aseptically open sample packaging. ❑with flamed forceps and scissors,aseptically open sample packaging. With 0 flamed forceps❑flamed forceps and scissors,grasp the sample and 0 transfer directly to media container.❑cut into sections directly into the media container. ❑ Steritest specific preparation 1. ❑ Client specific preparation 1. ❑ With flamed forceps and scissors,grasp the sample and disassemble by: 1. ❑ Test half the number of samples received in SCDB and the other half in FTM. ❑ Cut filter in half and place half the filter in SCDB and the other half in FTM. ❑ Test the whole filter ❑ Place the whole filter in SCDB and the other whole filter in FTM Page I of 2 Printed on:09 Sep 2014,01:04:52 pm,