A look back at our webinar: An Introduction To Cleanroom Validation
On Thursday 14th November, our cleanroom validation team conducted a webinar introducing the cleanroom validation process from start to finish. They explained exactly what cleanroom validation is, the processes involved and finally how to display the results.
Thank you to everyone that managed to tune in and listen live, we hope that you enjoyed the webinar and for anyone that missed it, don’t worry, you are able to watch the replay using the link below.
The webinar consisted of a 20 minute presentation followed by 10 minutes of Q & A. For those of you that missed it, the full video is below!
Our Validation Team
Our validation engineers are independently qualified to perform cleanroom qualification testing and regularly qualify cleanrooms to comply ISO and EU GMP standards. With comprehensive training and experience, our engineers are proven to be professionally competent in their field.
Mark Jackson
Commissioning and Validation Manager
A key member of the Angstrom Technology team, Mark has over 20 years’ experience in ventilation and cleanroom validations, and has been a part of the Angstrom Technology team for all of that time!
Nick Rhodes
Commissioning and Validations Lead
Another vital member of Angstrom Technology, Nick also has over 20 years’ experience in ventilation and cleanroom validations, working on projects for NHS hospitals, universities, hotels and many more!
The Webinar
The Validations team covered a wide range of topics throughout the webinar, giving you all the information you need to truly understand cleanroom validation. The topics covered include:
- What is cleanroom qualification & why is it important
- How often should you qualify a cleanroom?
- Pre-planned tests and calibration
- How do you qualify a cleanroom?
- ISO 14644:1 2015
- Required Equipment
- Testing Locations
- Particle Counts & Classifications
- Displaying the Results
- Supporting Tests
- Pass/Fail
This webinar is aimed at anyone who:
- Works in a cleanroom facility or laboratory
- Is responsible for maintaining cleanroom compliance
- Is in the process of building a cleanroom facility
- Is looking for cleanroom validation services
Please note: The sound quality is a little echoey until 13 minutes 10 seconds in the video recording, please bear with it!
Questions & Answers
At the end of the webinar, there was time for Q&A, where the following questions were raised:
This is a rather open ended question – a bit like how long is a piece of string! It all depends on whether it is an annual validation or just interim validation checks.
The assumption from our knowledge of cleanrooms, is that this sized room to ISO class 7 would probably have between 2 and 4 filters. From that we would say an annual validation would take between 2 and 3hrs and an interim can be reduced down in time as there is no filter integrity testing to be done.
We would need more information and possibly up to date drawings to provide you with a more definite answer.
Particle count concentration limit has been exceeded – Quite simply, it has failed particle counts.
As we covered earlier within this webinar, this could be down to maintenance issues or lack of training of employees. The engineer on site should indicate to you whether this is a mechanical failure – such as fans or hepa filters failing, but they may also indicate if it is User practices that are adding to these types of failure. Pre-planned maintenance and user training, can and will, reduce all these issues.
This is an excellent and practical question, especially for industries with budget constraints.
Risk Management Vs Cost – We need to acknowledge the sometimes difficult balancing act companies face when trying to invest in achieving compliance, versus the potentially unforeseen consequences of non-compliance such as contamination of products, costly recalls of products or regulatory sanctions to ensure future compliance.
We could open up a long and drawn out debate on cost savings – what we would suggest is that the company looks for cost saving efficiencies whilst also maintaining its standards. Sometimes an external company providing a site survey can highlight these potential savings to your company and will consider things that you cannot see as you are “too close” to the action.
My final comment would be that although there are costs incurred, this is counteracted by the fact that there is a lot of value to be added when compliance is achieved and maintained.
BOOK A VALIDATION APPOINTMENT
Our cleanroom validation documentation is detailed and auditable. You will receive an interim report on the day of testing, followed by the full report within 10 working days. Reporting is aligned with ISO standards and GMP guidelines to meet your requirements and those of any nominated regulatory body, (e.g. the MHRA).
You can choose from one of our testing packages, or we can build a custom schedule based on your requirements.
REQUEST A QUOTE