On the 21st – 22nd May 2019 the annual Cleanroom Technology Conference was held at the NCC, Birmingham. The conference aimed to bring together leaders and innovators within the cleanroom and contamination control industry, to take a closer look at industry trends, standards and future of cleanroom design and technologies.
With presentations highlighting best practice and regulations affecting both cleanroom design and cleanroom operation, and 69 exhibitors showing all manner of cleanroom design, equipment, PPE and environmental monitoring solutions; there was plenty of information and advice available.
The morning started well setting up the stand before delegates arrived for the welcome address from the chairman, Gordon Farquharson. I had a look at the agenda for the first day and I picked a few presentations to sit in, to keep myself abreast of the industry’s development. The first talk was about the ‘GMP waiting on annex 1’ and then ‘Real-time Microbiological Air Sampling in Cleanrooms’ followed.
There’s more to GMP than waiting for Annex 1
The first presentation outlined information we already know, that GMP is 5 years behind best practice and 10 years behind state of the art. It also does not help that there were 6,200 comments on the first draft of annex 1 for the committee to consider and that there was a change in the rapporteur. There is no time frame for annex 1, but the hope is for the end of 2019.
Gordon Farquharson was good at instilling that even though annex 1 is still in draft, you can still make investment today to head in the right direction for the future. For instance, the term ‘contamination control strategy’ was mentioned 19 times in the new annex 1, aiming the pharma microbiologist to document and outline how to achieve an ideal assured sterility and reducing risk, during production.
Looking at the purpose of the cleanroom in relation to design, procedures, monitoring and putting up against a benchmark, then to try and move towards that benchmark level of sterility and reduced risk. This can be achieved by simple, common approaches including assessing EM location, access and techniques. It is not completely necessary to install RABS/Isolators or even an entire robotic filling line, even though it seems that this is where the future is headed.
Useful information is coming from other sources to help guide professionals while annex 1 is still in draft! Like the Blogs from MHRA, providing updated activity and information. Industry associations bridging the gap from GMP to manufacturing. Another interesting way to keep ahead of annex 1 is to disassemble myths, fables, fantasies and traditions that may be implemented in your own area of work and asking are these reasonable answers?
Real-time microbiological air sampling in cleanrooms
A presentation then followed on the TSI product, the BioTrak, by Simon Tebb. This is a real time microorganism air sampler. Combining the particle counter with laser induced fluorescence (LIF), with algorithm development and particle library to indicate organic material present. It helps continuous throughput process, minimising the amount of product quarantined, benefit to production with real time information to assist in any root cause investigation. However, it does ask the question is the organism detected viable or not? Will the organism if viable grow on the media used for that cleanroom’s EM? Simon stated there was no correlation between a signal from the BioTrak and CFU. Then what would be deemed an out of limit to regulators leading to an investigation? Would every signal need investigation, causing even more work than intended?
After this presentation I joined our MD, Andy on our stand. Being my first conference, it was exciting to talk to the delegates and gauging their needs and how we can work with them to aid in their EM. Conversation ranged from air samplers to the supply of specific formula media and packaging variants. The industry delegates ranged from toiletries to Pharma industries and all needs were different and varied, which made for interesting discussion.
When delegates attended the presentations, we had the opportunity to talk to other exhibitors and how they fitted into the Cleanroom scope. I talked to Assured Microbiology who offer a wide range of services to test companies EM, who subsequently use our media. Pharmig - a non-profit making professional organisation, networking people who have a microbiology interest within the industry and aiding continuous professional development with courses, conferences and forums. VWR and Trafalgar Scientific as catalogue companies supplying a range of products. Exhibitors came from a range of areas that are involved in the building, personnel clothing and monitoring of cleanrooms.
Rapid microbiology method
I then headed to the final speaker, Les Dodd, for his talk on Rapid micro testing through oxygen. EMS Technology have designed a rapid detection method using swabs. The swab/contact debate is a constant debate in EM monitoring on best practice as each have pros and cons. But rather than get into that debate, I will talk about the SurCapt product and that it works by detecting depletion of O₂ for the presence of organisms. It starts by using a flock swab on a surface which is placed into the SurCapt tube with Tryptic Soy Broth. This is then placed in an analyser that incubates and reads O₂ depletion on a phosphorescent signal. It is non-destructive towards the organism allowing it to be tested for identification. The instrument reads every 2 mins and gives early detection of growth. The talk was to the point and informative, the technology simple and effective. It was an interesting presentation on the use of a rapid microbiology testing for cleanrooms. However, Les did state it should be supplemented with traditional methods, so there is still a requirement for growth promoting media.
Day 2 was more basing myself in the exhibitor’s area and gaining experience in this environment, engaging more with the delegates and developing a greater understanding of the needs of the industry we are based in. It was a great arena to develop skills for my role as a product specialist.
The Cleanroom Technology conference; still in its infancy, running for only their third year - are already thinking of expanding into a bigger venue and joining it with their sister magazine, Manufacturing Chemistry, that has many crossovers in the industry.
The event was worth attending, with leaders and innovators talking about the future and relevant topics for the cleanroom and contamination control industry and bringing together industry providers…allowing an opportunity to scope out the competition! It was great to exhibit at the conference and Cherwell Laboratories Ltd will be definitely attending next year.