To optimize bioburden testing of mammalian cell culture samples by use of a Rapid Micro Method (RMM), a one-step closed system differential lysis method was developed and is described.
Here, we show the Growth Direct™ Sterility Test used in conjunction with a novel microbiological media, modified Schaedler Chocolate Broth (mSCB), is able to detect stressed microorganisms within 7 days.
This study examined the relative growth performance of three vendor preparations vs. freshly grown in-house cultures. Comparison of the preparations was performed using the Growth Direct™ System.
This study looked at how automation and new technologies provide an opportunity to take Lean to the next level in your pharmaceutical quality control lab.
The studies presented here investigate potential weaknesses of the Compendial “Gold Standard” method that may compromise validation of new technologies.
The goal of this poster is to introduce a new approach to EM testing using an automated RMM that facilitates greater efficiencies for the QC micro laboratory that can also generate a suitable ROI. Data will be shown to support the validation approach used.
This poster shows the benefit of using the Growth Direct™ System to determine the best incubation strategy to obtain equivalent or better results faster than the traditional method.
The examples presented in this poster highlight the fact that many materials considered to be non-filterable can be processed using membrane filtration for subsequent analysis by a rapid detection technology: The Growth Direct™ System.
Details advances in sterility testing methods, including the Growth DirectTM Sterility Test, allowing for the use of media that may have been previously discounted due to incompatibility with the traditional sterility.
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