SterilAmp 5230 - Mesa Labs

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Bozeman Manufacturing FacilityBI Lot NumberTable 2: Resistance Performance Data at 121°CNumber Positive Out of 20Exposure Times(in minutes)1 1.5 2 2.5Population/UnitD-value (1)(Minutes)SASU-223 20 2 0 0 2.1 x 10 6 0.2SASU-224 20 1 0 0 3.8 x 10 6 0.2SASU-225 20 7 1 0 1.3 x 10 6 0.2(1) Calculated according to USP methods.POPULATION DETERMINATIONDetailed population assay instructions are available in PDF format on the SGM Biotech website. Logonto the www.sgmbiotech.com home page, and select Accessories → Population Assay Kit → ProductManuals (on the right-hand side).10 Evergreen Drive Bozeman, MT 59715 Phone: 406-585-9535 FAX: 406-585-9219www.sgmbiotech.com e-mail: info@sgmbiotech.comPage 4 of 5
Bozeman Manufacturing FacilityCERTIFICATEUnits are manufactured in compliance with <strong>Mesa</strong> Laboratories, Bozeman Manufacturing Facility’s,quality standards, USP, and ISO 11138 guidelines and all appropriate subsections.Reorder No:BIOLOGICAL INDICATORFOR INDUSTRIAL USE ONLYSCERTIFICATE OF ANALYSISSASU/6ABiological Indicator for: Low Tempera Sterilization of Solutions.Bacillus subtilis ‘<strong>5230</strong>’ 35021ture SteamMLot No: SASU-000 Manufacture Date: YP10 Evergreen DriveBozeman, MT 59715406/585-9535www.sgmbiotech.comCulture: 35-39°C. The supplied bacteriological medium will meet requirements for growthpromoting ability.Purity: No evidence of contaminants using standard plate count techniques.EAR MONTH DAYExpiration: 15 months from Manufacture Date.Heat Shocked Population: 0.0 x 10 6 Spores / UnitAssayed Resistance: D-Value (2) SurviLSteam (115°C) 0.0 0.0 0.0 (4) minESteam (110°C) 0.000.00val(4)(3)Kill00.00 (3) minSteam (121°C) 0.0 0.0 (4) 0.0 (4) minZ-value:0.0°CD-value reproducible only when exposed in an AAMIBIER vessel and cultured under the exact conditionsused to obtain results reported here. MPN method used.Units are manufactured in compliance with SGM Biotech's quality standards.Culture is traceable to a recognized culture collection identified in USP and ISO 11138.(2) D-value calculated using the Limited-Holcomb-Spearman-Karber method.(3) Survival/Kill values are calculated according to a formula in USP and ISO 11138. SGM uses a D-value rounded to four decimal places inthis calculation.(4) Empirically derived data/F 0 data.Certified By: _____________________________________________10 Evergreen Drive Bozeman, MT 59715 Phone: 406-585-9535 FAX: 406-585-9219www.sgmbiotech.com e-mail: info@sgmbiotech.comPage 5 of 5
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SterilAmp 5230 - Mesa Labs

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