Laserfiche WebLink
SHAMA <br /> PEOPLE>SCIENCE>SOLUTIONS Test Facility <br /> 6750 Wales Road <br /> Northwood,OH 43619 <br /> 419.666.9455 <br /> STUDY TITLE <br /> Test of Sterility <br /> 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#-20140920 <br /> TEST ARTICLE PHYSICAL DESCRIPTION <br /> See test specification. <br /> TEST ARTICLE RECEIVED <br /> October 24,2014 <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 @ 106BI 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 15 mL 30-35 7 0 <br /> Positive Control 1 SCDB 15 mL 30-35 1 1 <br /> SCDB=Soybean Casein Digest Broth <br /> Test Start Date: October 24,2014 Test Termination Date: October 31,2014 <br /> METHOD <br /> See the attached sterility test specification T0000732-05. <br /> APPROVAL <br /> Lisa A.Schwalenberg,BS Date <br /> Laboratory Supervisor,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 here conducted in <br /> conformance with good manufacturing practices,certified to ISO 13485:2003 and accredited to ISO 17025:2005. <br /> P.O.No.: Lab Number: MS005 00S Page 1 of 1 <br /> 276 14T 57492 01 <br />