Pharmig Best Practices in Environmental Monitoring Conference
By Hamish Hogg
The ‘Best Practices in Environmental Monitoring’ Pharmig conference was held on the 13th February 2019 at Nailcote Hall Hotel, Golf & Country Club, Warwickshire. I attended with Andrew Barrow our Sales Manager, not only to aid as an exhibitor, but also attending as a delegate. I was excited and nervous as it was my first event with Cherwell Laboratories and with my background as a Biomedical Scientist in the NHS and then a Product Specialist in the medical device industry, it was challenging to keep up with the information and aid in discussion in an area I have never really experienced. However, I thoroughly enjoyed my time at the event not only as a learning experience, but interacting, networking and creating discussions with industry individuals.
Edel Fitzmaurice – The Environmental Monitoring Programme
Edel was the opening speaker, getting straight into the nitty gritty of creating an EM programme. She mentioned historically that not much has changed in EM, in relation to monitoring the environment with agar and technical methods such as air sampling. What we do know now is more of an understanding of the environment and how that will relate to your EM monitoring.
Edel commented on the use of methods for the EM programme including particulate monitoring, air samplers, settle plates, contacts and swabs. The controversy per se on contact plates is how to apply them to a surface and if it should be standardised with an applicator. However, all that is really needed in my opinion is to have the technique documented, trained staff and to be repeatable. For those hard to reach areas swabs are useful for sampling.
There was mention of being aware of rapid microbiology methods and that it is part of the GMP to keep up to date with advances in technology. If rapid microbiology is part of your EM programme you need to ensure it complies with regulations and will need validation, which can be an extensive process. In my opinion agar still has its place alongside current RMM.
With all these tools, it is then an assessment of risk on sampling location and frequency. That a level of effort has been made to commensurate areas that put product at risk, the EM programme is able to detect a change in trends, be well documented, compliant with regulations and flexible using all the range of applications to monitor the environment.
Mapping of the room is essential to assess risk and place appropriate EM techniques and frequency around critical processes, staff movements and equipment.
The industry practice is to review your EM programme once a year. However, your test programme needs to be dynamic in order to avoid a false sense of security and to allow reaction to changes and trends. So, if your EM programme needs reviewing earlier then do it earlier.
Of course, all cleanrooms are different, so the emphasis was in to creating your programme to the needs of your facility and basing it on RISK.
Tim Sandle – Risk Management and EM
This led nicely into Tim Sandle’s presentation on risk. He outlined that risk needed to be put into context, to give risk definition that leads to the probability of occurrence of harm and severity of that harm. The ICHQ9 gives a regulatory outline for risk assessment in microbiology and outlines methods for assessing risk e.g. HACCP, FMEA, etc.
The way I interpreted this information was that EM programming should be based on risk. The risk factors for contamination in a cleanroom are: equipment; air filtration; air direction; air movement (pressure); with the biggest sources of contamination being staff and water. Programming appropriately for that cleanroom allows for the best observations of the environment and management of risk to the product. This information can then be shown to auditors to demonstrate what you are doing for your EM and especially why.
Biocontamination control strategy has become a buzzword within the industry. It takes into account developing plans to minimise microbial contamination for pharmaceutical operations and understanding that manufacturing, quality and contamination control are all interconnected.
Tim Sandle – Incubation strategies for EM
Incubation strategy was an interesting discussion, taking into consideration that during active and passive air sampling, settle plates and contact plates only have a 50% recovery rate. With swabs, it is worse, at around 20% recovery (this can be improved with flock swabs providing 40-60% recovery). Not only are we worried about the statistics for recovery, but between 70-90% of microorganisms in the environment are ‘viable but non-culturable’.
Already accurate EM seems to be a struggle, then it comes to the debate on 1 or 2 sets of media, one for bacteria and one for fungi. There is no overall single fantastic, spangled banner culture media that will detect all culturable organisms, if there was, I would be selling it! What is known in the industry is that TSA is good for growing bacteria and SDA for growing moulds and fungi.
What if you only use TSA as your detection media? Do you dual incubate and which way round? 20-25ºC first for moulds and fungi then 30-35ºC for bacteria or visa versa? Decisions, decisions, the evidence currently out there showed pros and cons for both, but nothing statistically significant stood out. It all depends on the justification of the Microbiologist to state why they use a certain incubation strategy.
Interesting was that we touched on the Human Microbiome Project, completely mapping the microorganisms growing on individuals, showing an expansive range of micro flora. My thought was would this then influence media choice in the EM programming regarding testing of personnel, or upon an alert limit being reached and the investigation yields a gram-negative rod, is it then bad to assume that it can only have come from water contamination and potentially it’s coming from an individual?
Anna Lovatt – Environmental Identification Strategy
Anna was coming from GSK as an industry specialist and had some great input on when and how far you ID an organism for your environmental monitoring. The ID of an organism is defined as presumptive (genus) or confirmed (species) and the level you go to depends on micro-organism source, level recovered, criticality of identification and Pharmacopoeia regulation.
She stated interestingly to be aware if you need to ID the organism as if you give it a name, you need to investigate and define why it is there in the first place. This can be time consuming and expensive if you keep doing it for every organism. She included if you do ID an organism you don’t always need to go to species level.
There are several identification devices (of which from my laboratory days I could recognise and understand) and the considerations needed to help the Microbiologist decide on the best choice for them.
After lunch we were asked by some BPL individuals to attempt, in our table groups, to perform a practical where we are asked to place EM locations on maps for a Grade A filling line, surrounded by Grade B cleanroom and then a Grade C cleanroom. Grey matter now struggling to condense and utilise the 5 weeks on the job training and the morning lectures, I attempted the exercise with the only remaining individual on my table. I found that even with limited knowledge we got some of the locations correct, but as we went around the tables people had placed EM differently and had their own justifications. There was no right or wrong answer, only allowing for an understanding of the techniques used, the critical process, then environment itself and justifying your actions.
When discussing what BPL put for their testing, they mentioned testing the compressed air found in the grade C cleanroom. This led to pointing out Cherwell Laboratories supplies the Pinocchio for compressed air testing and further correspondence during the break with 2 cosmetic industry microbiologists.
It was a good and interesting exercise to applying the knowledge we learned, even though Andrew asked me if I passed and based on the actual BPL EM I would have to say…..no! But I will next time!
Sinead Cowman – Data Strategies and Environmental Monitoring
Sinead from Lonza provided a lecture on what is currently considered a hot topic. She talked about the ability to trend data to indicate a level of control over your environment. This can be shown through changing cleaning patterns that correspond to the changes in environment due to season.
She stated there is no defined way of trending data and most labs go on ‘Tribal Knowledge’ that I was taught by this person who was taught by that person. Educating yourself on what software to use and how to use it allows for better data handling. Then you can ask the questions, what data do I need to trend? What data do I need to capture? How do we audit this data? How do I access this information for investigations? (Biggie).
This was not really suited to my role at Cherwell Laboratories as Microbiology Product Specialist. However, it was interesting on bringing data capture forward as EM data information is mostly in seen in hindsight, and with the adaptation of software to allow insight to trending data and hopefully in the future to use this information for foresight on environment of the cleanroom.
Edel Fitzmaurice – Microbial Data Deviations
Final presentation of the day on deviations was a struggle as the mind was beginning to fail me. This involves making sure you have the correct alert and action limits against the data you are producing for each environment. It is pointless to set these levels too low and perform an investigation every other day or too high and never perform an investigation. It was made clear that an SOP needed to be formulated to aid investigation.
An interesting note was that we touched on the Human Microbiome Project again and that it allows for ID of organisms to be interpreted differently, potentially leading to new possibilities for root cause away from standard areas of investigation. For instance, not assuming that a gram-negative rod is coming directly from a water source, it may be coming from a staff member.
All in all, it was a great day, reinforcing learning over the past number of weeks in my new role in Cherwell Laboratories, ranging on all aspects for EM in sterile and non-sterile industries. It pushed me out of my comfort zone to approach and interact with industry individuals and work towards potential positive correspondence. It was also good to get a feel for what questions and needs the industry requires for cleanroom solutions. I look forward to going to my next event….as long as Andrew keeps driving there.
The Environmental Monitoring Processes and Validation Guide
Understand the key changes and challenges of the EU GMP Annex 1 draft revision.
What will it mean for your environmental monitoring processes?