The question of whether to use externally sourced prepared media or whether to produce in-house is one that goes beyond cost and preference. For some manufacturers, there is simply no other option but to create a bespoke product in-house.
A major industry survey, started by Pharmig at its 24th Annual Conference in Nottingham, followed by a questionnaire sent to Pharmig members, revealed 91 per cent of respondents source some or all of their prepared media plates from external suppliers. The survey was devised to investigate quality control activities around prepared culture media within the pharmaceutical and healthcare industry.
In this third instalment of our Recommended Research Papers series, I have included a collection of six articles. All of them have piqued my interest as they tackle some extremely pertinent issues in our industry.
Cleanroom technology is an evolving industry. Most facilities have pre-existing guidelines and protocols on decontamination products, techniques and regulatory measures; but these are based on lessons learned through retrospective research or actual cases of accidental contamination.
Maintaining a validated cleanroom is undoubtedly the best way to ensure the highest standards in your controlled environments. It demonstrates that your facility was designed to meet stringent compliance and that you also regularly test and monitor airborne particulate levels, surface particulate levels, viable microbial particulates, relative humidity, differential pressure, temperature and more.
Now and again I get some unusual requests as part of my job. One was a request made by Tim Sizer, Regional QA Officer for NHS QA South West. He approached me towards the end of the APDM event at Leeds and Bradford University in July 2017. Tim asked me to find out more information about the reason dilution was recommended as the best way to neutralise alcohols. The explanation was slightly more complex than that but it will take me too long to explain!...
As tragic events like the NECC meningitis outbreak have shown, maintaining a sterile cleanroom is a complex process that requires continual evaluation. It must keep up with the challenges of keeping out a complicated external environment, be resilient to evolving microbial threats, meet strict environmental standards and still offer a safe place in which humans can work.
Our first edition of Recommended Research Papers for Cleanroom Operators gathered quite an audience. Thanks to each of you who responded to our call for recommendations for this and future editions.
As the pharmaceutical community takes on board the sheer scale of
By definition, the