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REPORT <br /> PEOPLE>SCIENCE>SOLUTIONS Test Facility <br /> 9 Morgan <br /> Irvine,CA 92618 <br /> 949.961.3110 <br /> STUDY TITLE <br /> Test of Sterility SPONSOR <br /> TEST ARTICLE NAME Jason Mercer <br /> BI Lab testing for full cycle EO gas Kingpin Tattoo Supply <br /> sterilization 9715 International Court North <br /> St.Petersburg,FL 33716 <br /> TEST ARTICLE IDENTIFICATION <br /> Lot#-20140820 <br /> TEST ARTICLE PHYSICAL DESCRIPTION <br /> See test specification. <br /> TEST ARTICLE RECEIVED <br /> September 9,2014 <br /> SUMMARY <br /> This qualitative test was performed according to a NAMSA specification to determine if the biological indicators were sterile. <br /> RESULTS <br /> Bioindicator: Bacillus atrophaeus @ 106 131 Lot Number: N30507 <br /> Article Tested Number of Type of Medium Incubation Number of Number of <br /> Articles Tested Temperature Days Positive <br /> (Degrees C) Incubated Articles <br /> Spore Strip 10 SCDB 10 ml, 30-35 7 0 <br /> Positive Control I SCDB 10 mL 30-35 1 <br /> SCDB=Soybean Casein Digest Broth <br /> Test Start Date: 09-09-14 Test Termination Date: 09-16-14 <br /> METHOD <br /> See the attached sterility test specification T0000732-05. <br /> APPROVAL Ke.I <br /> Robert D.Hughes,BS Date <br /> Laboratory Operations Manager,Sterility Assurance <br /> Results apply only to the test article tested. Any extrapolation of these data to other articles is the sponsor's responsibility. All procedures were conducted in <br /> conformance with good manufacluringpractices,certified to ISO 13485:2003 and accredited to ISO 17025:2005, <br /> P.O.No.: Lab Number. MS00500S Page I of 1 <br /> 275 14C 51092 <br /> ............ <br />