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Is your Cleanroom Annex 1 compliant?

Posted 3rd March 2023 by Dr. Lynne Murdoch

At Wickham Micro we offer services to our clients across a whole suite of microbiological tests, including environmental monitoring of client facilities and cleanrooms.

At Wickham Micro we offer services to our clients across a whole suite of microbiological tests, including environmental monitoring of client facilities and cleanrooms. With over 60 years of experience GMP testing to pharmacopoeial standards in the pharmaceutical and medical device sectors we are the perfect partner to ensure your ongoing compliance to existing standards and those undergoing updates such as Annex 1. We understand many of our clients do not have microbiological laboratory facilities or an experienced microbiologist on site that can incubate, assess, and identify the microorganisms found in their environment. Microbiology requires experience, space and lots of equipment and monitoring. As such, one of our solutions is to offer our clients offsite management of these processes - we do all the hard work and leave our clients to focus on their core business.

One of our service offerings is routine cleanroom monitoring where our team come to the client site to perform an assessment of their cleanroom and determine the number and position of any microbial monitoring required for their processes. We will take into account working areas, flow of materials, current cleaning regimes and other microbiological considerations. We offer further consultancy following assessment to help address any microbiological concerns that have been identified, for example cleaning validation of equipment, disinfectant usage or cleaning agents used and their frequency. Following production of our report we will assist the client in either managing their own routine monitoring or we can perform the monitoring for them. If we come to site to perform the monitoring directly, we handle everything for the client; we supply the plates, set out the plates at the correct locations, remove plates at the end of the session and return the plates for incubation at our site. Some clients have a hybrid where they use plates supplied by us and then ship these to us for incubation and further examination. Upon completion of incubation, we enumerate the plates and if necessary, offer further identification using our MALDI-ToF biotyper. This allows clients to understand where contaminants may be in the cleanroom, what the likely source is, and we can then offer further assistance on how to clean or disinfect the area regularly to prevent reoccurrence of the contamination.

We have large microbiology laboratories with an assortment of incubators to allow capacity of testing and coverage of a wide range of temperatures and conditions to recover microorganisms successfully. We also have ongoing monitoring and recording of temperature in our incubators for added assurance and compliance. At WML we understand the importance of the products produced in cleanroom environments and apply a consultative approach to ensure continued operation of the cleanroom to the standards required for patient safety.

Part of our role is in education of clients and offering the best practical microbiological advice to meet the ever changing regulatory landscape. One of the outcomes from the recent changes with Annex 1 is that media used for environmental monitoring should be tested for its growth promotion, which would need to incorporate the impact of transportation between sampling and incubation. If this is prolonged, utilises couriers or other transportation then it is pivotal to understand what impact the transportation has had on the environmental isolates and the media itself. There is a possibility that stressed microorganisms that were in the environment are not grown on the media as a result of the transportation and are not a true reflection of the microbiological status of the laboratory.

In Grade A cleanrooms this is especially important as the limits are incredibly low at <1 CFU. Therefore, it is entirely possible to be getting a false picture of the results. In a sterile manufacturing plant 1 CFU, particularly of an objectionable organism, is important as it may be all that is necessary to cause harm in a vulnerable patient receiving the pharmaceutical or medical device being produced.

At Wickham Micro as part of our service offering, we work with clients to determine the best method to ensure their environmental monitoring is robust, including offering post transportation fertility testing. We have extensive consultative experience and microbiological expertise to advise on best practices to ensure on-going regulatory compliance and safety. If you use our services, you can be assured, we have taken the extra steps necessary to assess media fertility, sterility and shelf-life, in addition to the original manufacturer supplied data, to ensure you have confidence in materials used or supplied to you for testing in your cleanroom environment. We can also conduct additional validation of transportation methods upon request and also perform all necessary controls to ensure you can trust the results you receive from us.

Speak to us today about environmental monitoring, microbial identification, and other microbiological advice.

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