| Title |
Revision |
Abstract |
Download |
| Bacillus cereus, 14579 Inherent Spore Clumping |
11/28/2006 |
The user of B. cereus spore suspensions must be aware that the preparations are susceptible to clumping. |
PDF (0.05MB) |
| Browning of Media from Prolonged Thermal Insult |
02/11/2003 |
A brief paper answering questions that are often asked regarding the color of media contained in SGM Sterilamp and MagnaAmp biological indicators after prolonged sterilization cycles. |
PDF (0.13MB) |
| Developing a Sterilization Process |
06/18/2001 |
The objective of this document is to provide a general overview on how to correctly use the D-value study data along with Biological Indicators to develop, validate, and monitor a steam sterilization process of a liquid pharmaceutical product. |
PDF (0.07MB) |
| Effects of Delaying Post-Exposure Incubation Times on D-Value |
09/16/2003 |
The effect of delaying incubation times after saturated steam or ethylene oxide exposure of EZTest Steam or EZTest EO units and of SGMStrips for steam or gas was assessed under controlled laboratory conditions. |
PDF (0.1MB) |
| Evaluation of effects of transient shipping conditions on biological indicators containing spores of Bacillus atropaeus: population and resistance performance |
05/02/2002 |
The effect of transient shipping conditions on biological indicators was investigated by sending three sets of SGMStrip biological indicators and three sets of EZTest self-contained units each containing three different lots of Bacillus atrophaeus ATCC 9372 on separate occasions to a distributor in Europe, on to a customer in Sweden and back to SGM Biotech in Bozeman, MT to simulate a regular shipping routine. |
PDF (0.57MB) |
| Generic Protocol for Liquid Pharmaceutical D-Value Studies |
02/24/2003 |
The objective of this study is to determine the D-value of Geobacillus stearothermophilus spores suspended in a liquid pharmaceutical product. |
PDF (0.13MB) |
| Report #000802 - Cross Testing Different Lots of Releasat Spore Strips with Different Lots of Releasat Growth Media |
03/19/2002 |
The purpose of this study was to determine if using different lots of Releasat spore strips with different lots of Releasat growth media resulted in D-values similar to those obtained during initial qualification testing. |
PDF (0.14MB) |
| Sub-culture of a Positive EZTest Biological Indicator |
04/03/2008 |
Procedure for sub-culturing a positive EZTest biological indicator. |
PDF (0.06MB) |
| The Effects of Transient Conditions During Shipping on SGMStripTM Biological Indicators Containing Bacillus stearothermophilus Spores |
04/02/2001 |
Customers and regulatory agencies are frequently asking manufacturers for data to document the effects of transient conditions during shipment of biological indicators.
This report documents the effects of shipping on SGM biological indicators from the U.S. to Europe and back. |
PDF (0.51MB) |
| Understanding Biological Indicator Grow-Out Times |
01/01/2010 |
The data collected in this study are being submitted to facilitate ISO development of a globally accepted RIT protocol. This study used BIs containing 105 Geobacillus stearothermophilus spores and a new technology that continuously monitors incubated BIs and records nonsterile (growth-positive) results on a minute-by-minute basis,
which allowed for a deeper understanding of spore germination and generation capabilities. Published with the permission of Pharmaceutical Technology. |
PDF (2.53MB) |
| Z-Value Calculation |
08/18/1999 |
A paper covering the fundamentals of mathematical Z-value calculation, as well as approximating D-values from known Z and D-values. |
PDF (0.08MB) |
