EZTest Steam TECHNICAL REPORT - Mesa Labs

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Bozeman Manufacturing FacilityThe incubation time of the EZTest Steam product was validated according to the Center for Devices andRadiological Health, FDA protocol entitled “Guide for Validation of Biological Indicator IncubationTime”. Six lots of EZTest Stem were prepared according to internal Standard Operating Procedures. Foreach lot, 100 biological indicators were exposed to a steam BIER. Exposure conditions were 121C 0.5C. The exposed biological indicators were incubated at 55-60C for seven days. Table 1 displaysthe results where 30% - 80% of the tubes positive for microbial growth.Table 1: Results of the Reduced Incubation Time Study at 121 CBiological Indicator # Positive# PositiveLot Number24 Hours7 DaysPercent Positive (1)S-234 54 54 100%S-246 72 73 98.6%S-269 67 67 100%S-278 45 46 97.8%S-296 64 64 100%S-302 57 57 100%(1) Acceptable protocol results require greater than 97% of the base number of biological indicators to test positive. This % iscalculated by using the number of positive biological indicators on day 7 as the base number (denominator data) and usingthe number of positive biological indicators at 24 hours as the numerator.This data shows that the 24 hour incubation time claim was valid (ratio of positives at 24 hours vs. 7 daysgreater than 97%). A 24 hour incubation time provides users with a rapid release of sterilized product. Itshould be emphasized that incubator performance is critical to achieve these incubation times.RESISTANCE PERFORMANCE TESTINGD-value determination was performed by fraction negative analysis and a population assay was performedon the biological indicators. EZTest Steam biological indicators were exposed in a steam BIER vesselthat meets the AAMI BIER standard (3/81). Exposure conditions were at 121°C ± 0.5°C, 132°C ± 0.5°C,134°C ± 0.5C and 135°C ± 0.5°C in saturated steam using a pre-vacuum cycle. 20 units per exposurewere used. Following exposure, samples were activated and incubated at 55° to 60°C for 24 hours.Performance data is presented below.Crop Number121°CNumber Positive Out of 20Exposure Times(in minutes)7 8 9 10 11 12 13 14 15 16Population / UnitD-value (1)(Minutes)BST 020399 20 20 18 20 14 11 2 2 3 0 2.1 x 10 6 1.8BST 081398 20 18 12 15 6 1 1 2 0 0 1.4 x 10 5 1.9BST 020299 20 18 17 11 11 13 7 0 0 0 1.3 x 10 5 2.1(1) Calculated according to USP methods.10 Evergreen Drive ♦ Bozeman, MT 59715 ♦ Phone: 406-585-9535 ♦ FAX: 406-585-9219www.mesalabs.com ♦ www.sgmbiotech.com ♦ info@sgmbiotech.com
Bozeman Manufacturing FacilityCrop Number132°CNumber Positive Out of 20Exposure Times(in minutes)1 1.5 2 2.5 3 3.5 4 4.5Population / UnitD-value (1)(Minutes)BST 020399 20 20 20 14 7 3 7 0 2.1 x 10 6 0.5BST 081398 20 19 2 4 0 0 0 0 1.4 x 10 5 0.3BST 020299 N/A 20 12 5 9 0 N/A N/A 1.3 x 10 5 0.4(1) Calculated according to USP methods.Crop Number134°CNumber Positive Out of 20Exposure Times(in minutes)1 1.5 2 2.5 3 3.5Population / UnitD-value (1)(Minutes)BST 020399 20 19 15 2 1 0 2.1 x 10 6 0.3BST 081398 20 17 2 0 0 0 1.4 x 10 5 0.3BST 020299 20 20 20 0 0 0 1.3 x 10 5 0.4(1) Calculated according to USP methods.Crop Number135°CNumber Positive Out of 20Exposure Times(in minutes)0.5 1 1.5 2 2.5 3 3.5Population / UnitD-value (1)(Minutes)BST 020399 20 20 17 11 1 2 0 2.1 x 10 6 0.3BST 081398 20 20 18 0 0 N/A N/A 1.4 x 10 5 0.3BST 020299 20 0 0 0 N/A N/A N/A 1.3 x 10 5 0.1(1) Calculated according to USP methods.POPULATION DETERMINATIONDetailed population assay instructions are available in PDF format on the company website. Log onto thewww.sgmbiotech.com home page, and select Accessories → Population Assay Kit → Product Manuals(on the right-hand side).10 Evergreen Drive ♦ Bozeman, MT 59715 ♦ Phone: 406-585-9535 ♦ FAX: 406-585-9219www.mesalabs.com ♦ www.sgmbiotech.com ♦ info@sgmbiotech.com
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EZTest Steam TECHNICAL REPORT - Mesa Labs

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