Cleanroom Technology Conference 2021

By Hamish Hogg

Cleanroom Technology Conference 2021 was, for the first time, combined with their sister company Manufacturing Chemist to form a hybrid event, held both in-person and virtually, setting a new way forward for the foreseeable future.

This was the first conference attended in-person by Cherwell staff for over 18 months. So how did it go? The phrase of the event was ‘it’s good to be back.’ A considerable number of exhibitors attended, bringing a surprisingly relaxed and positive feeling to the conference and despite a few initial reservations, it generally was good to be back.

Considering the challenging times, we have been through and are progressively coming out of, we were cautious enough not to hold high expectations for turnout. However, delegates from across the pharmaceutical industry did attend and we had considerable conversations on how things are progressing.

Conversations ranged from discussing EM and sterility testing requirements with new customers, to catching up with current customers and obtaining feedback on the performance of our product, which was reported as doing well especially over the turbulent times of not only COVID, but also leaving the EU, which we are 9 months down the road.

There were also conversations with customers around their considerations for the implementation of Annex 1, where continuous monitoring rises as a theme. With Cherwell supplying the ImpactAir-90 and ISO-90 ranges, which are Annex 1 ready, to aid in this regulatory requirement, we were happy to offer advice.

The majority of those we discussed this with stated that they are performing a gap analysis to ensure they capture any change requirements once the new draft is implemented. It was interesting to hear how companies will transition from what they do currently to the definite future.

We attended a few seminars to keep abreast of any developments within the industry. I attended the ‘Regulatory compliance: Trends, qualifications and guidance for microbiological monitoring.’ The seminar provided additional information of the regulatory requirement BS EN 17141:2020 replacing BS EN ISO 14698-1:2003 and BS EN ISO 14698-2:2003. The emphasis was on continuing to understand the environment where you work and to apply appropriate risk assessment. The most interesting component was the questions at the end of the seminar. Delegates queried the monitoring required in supporting areas and found that good EM in these areas can lead to capturing levels of contamination that could lead to greater issues in the main facility. The advice provided for a Gene and Cell Therapy manufacturer, was to ensure a more robust approach to micro monitoring and essential monitoring at critical points, as there is a viable organism involved in the process. The use of outside perspectives from regulators or outsourced consultants would be an invaluable tool to protect your facility from potential contamination.

It was positive to know that the industry has in no means stood still, providing relevant and probing questions that allow for a great sharing of knowledge.

All in all, the event was a pleasant surprise, yes it may not have been attended to the level it was 2 years ago. However, attending a conference was a welcomed change of pace and what can be considered almost normal play has been resumed.

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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?

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