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Cherwell Publishes a Growth Promotion Testing Guide
Providing key considerations and best practices when undertaking GPT for microbiological media QC
Cherwell Laboratories, specialist supplier of products for environmental monitoring and process validation, has drawn on its extensive pharmaceutical and related industry knowledge to publish an eBook titled, “Growth Promotion Testing: A Guide to Good Practices” which is available to download from Cherwell’s website.
The guide is intended for anyone involved in growth promotion testing of microbiological media, providing an overview of key considerations and best practice for this key quality control (QC) test. It particularly focuses on media used for pharmaceutical and sterile medical device industry applications; including environmental monitoring; process and operator validation; and product sterility testing.
Given the critical nature of microbiological quality tests employed to ensure the safety of pharmaceutical products for human use, it is essential to undertake QC tests confirming the media used is fit for purpose. Before a new batch of culture media can be released for any microbiological tests, particularly under pharmaceutical industry regulations, it must be properly tested for its ability to ensure consistent and reliable results. Growth promotion testing (GPT) is central to this.
The guide helps readers to ensure their GPT provides assurance of the final results of pharmacopoeial microbiology testing programmes by showing that the media used will perform as expected against accepted criteria. The eBook starts with the importance of good quality microbiological media; what GPT is, why it is essential and key pharmacopoeial requirements. It then details how GPT is performed, including best practices, frequently asked questions and tips for reliable results. The guide also highlights areas for consideration, such as: the need for a detailed QC certificate; using 3rd party labs for testing and how choice of media supplier impacts GPT.
Cherwell’s well established in-house Quality Team undertakes thousands of prepared media quality tests per month to ensure customers can be 100% confident in the quality of its Redipor® media. This enables them to share in-depth knowledge in the new eBook. Steven Brimble, Cherwell Laboratories’ Quality Manager and Microbiologist comments: “I hope this guide helps advise users on best practices to assist them with fine tuning their GPT procedures for their own site and testing needs. That said, we are also only too happy to personally help with any specific questions that our customers may have when setting up their GPT programmes.”
With over thirty-five years’ experience in manufacturing Redipor® prepared media, Cherwell has in-depth insight and expertise that ensures it continually delivers prepared media of the highest calibre to its clients. Cherwell also maintains the personal touch that accompanies an ability to accommodate customers’ unique needs with bespoke solutions.
Cherwell’s new Growth Promotion Testing Guide is available for download.
About Cherwell Laboratories
Located in Bicester, central England, Cherwell Laboratories provides standard and bespoke cleanroom microbiology solutions that help customers effectively manage their controlled environments and processes. Established for 50 years, the company has built a strong reputation as a leading supplier of prepared microbiological media and environmental monitoring equipment, with considerable expertise within the pharmaceutical and related industries. Cherwell manufactures its extensive range of Redipor® prepared media products in its ISO9001 registered facility, and has the flexibility to respond to varying customer requirements - from routine high volume down to low volume specialist applications. In-house engineering facilities support production and the development of bespoke solutions, as well as the supply, service and calibration of its environmental air monitoring equipment solutions.
Cherwell builds strong partnerships through professional, responsive and open communication, and by delivering high quality products and a flexible and reliable service with expert support, Cherwell ultimately helps its customers to reduce risk.