How does EM sampling work?
- Jan-Hendrik Scheerlinck
- Project Engineer
At Advipro, as a Junior Project Engineer, you will follow a comprehensive training programme. You will have the opportunity to gain practical experience in cleanroom qualification, among other things. This practical experience complements the theoretical basis provided. Jan-Hendrik, junior project engineer, takes you through his first experience with environmental monitoring (EM) sampling gained during his training programme.
What is environmental monitoring?
Environmental monitoring is part of the qualification of the cleanroom before it can be used in operations. In this way, uncertainties that could have an impact on production are maximally eliminated and product quality can be guaranteed.
What preceded
During my training programme, my Business Manager (BM) asked if I was interested in gaining practical experience in cleanroom qualification. Of course I was very interested in this! With great pleasure, I assisted Joris and Hanne from MoVE in an 'at rest' EM of a new cleanroom at MSD's Innovax project in De Bilt (Utrecht, the Netherlands).
In preparation for the EM, I went through the necessary work instructions (WIs) and standard operating procedures (SOPs). These documents served as a starting point for our sample preparations.
The process of EM sampling
To gain access to grade B, we first had to go through a mandatory gowning training (changing procedure). After this, we could start sampling in these strictly categorised rooms. We proceeded systematically (from high to low grade) and meticulously (touching or moving over the plates as little as possible) in the order of priority established with the customer.
We took 3 different types of samples on site:
- Active air samples
We had an airsampler grade dependent suck in several litres of air, over an agar-filled petri plate, to capture potential contaminants (such as bacteria and fungi). The more stringent the grade, the more litres should be sucked in.
- Contact samples
We took the contact samples by pushing agar contact plates against the surface to be sampled. After taking the contact print, we cleaned this surface with IPA in a figure-of-eight motion to avoid leaving any agar behind.
- Passive air samples (sedimentation plates)
We laid plates on the ground, open to the environment, for a minimum of 2 hours and a maximum of 4 hours, with all contaminants settling on the agar plate during that period.
We then sent all these packed microbial plates to the lab for incubation. Colony-forming units (CFUs) were then counted, reported and, if necessary, the germs identified.
My experience
During Advipro's training programme, I have already been trained in cleanroom behaviour and gowning procedures. Advipro shares its cleanroom expertise through a practical workshop on the use of testing equipment, cleanroom gowning, good cleanroom practices and so much more.
Through this EM project, I learned how cleanroom gowning can differ between companies, and discovered how to work in a cleanroom environment to minimise contamination, i.e. no unnecessary movements and touches, regular decontamination,... . Taking microbial samples was also done according to protocol in order to avoid contamination, which was also an instructive experience!
In short, I am very happy to have had this experience. My admiration is very high for people who have to perform long-term work in grade B as it can get very hot in the suit with goggles. In addition, it was a learning experience regarding working in clean room environment. This experience will definitely come in handy on future projects!
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