Interview with Frank Panofen, Life Science Marketing Manager at Particle Measuring Systems
How do we solve cleanroom contamination control issues when face to face discussions and in-person visits are not an option?
In this interview, Dr. Frank Panofen of Particle Measuring Systems (PMS) explains how PMS advisors tackled travel restrictions and the inability to visit customers:
The cleanroom contamination control advisory service is mainly required where there are problems to be solved or gaps to be filled. Traditionally this type of work is based on the visit of the site, on the interaction with different professional figures, on the careful observation of the physical characteristics of the production premises and the personnel behavior, on the review of procedures and other documentation in place to determine whether the regulatory requests are met and possibly propose solutions or alternatives”.
“We had to change our mindset and approach to the customer completely”
We take into account pharmaceutical companies that have motivated personnel, eager to emerge and see in the Advisory service a possibility of growth. Compared to a traditional project, the client is much more involved in gathering information and critically reviewing the process. Therefore, the transfer of knowledge from the consultant to the client is much higher. For this reason, it is essential to identify within the company a reference person who has the time to be actively involved, generally, a motivated junior figure who can see a return of investment.
Another big advantage our customer’s achieve during a remote consultancy is that they can schedule the meetings over several weeks. In a face to face consultancy our team arrives on site for a limited amount of time and everything must move quickly.
Particle Measuring Systems is carrying out several environmental monitoring risk assessment projects to define the sampling points and several projects for defining a cleaning and sanitization strategy for production departments. In all cases, the customer was requested to produce photographic and video material for the description of the premises and machines, furnishings, monitoring sampling points; the customer was asked to share on the virtual platform the layout of the premises and the flows of material and personnel, and to perform with the advisor a critical review of the procedures in place.
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Three Core Events to Establish Environmental Contamination Control – Per EU GMP Annex 1
Potential Cleanroom Sampling Points per Annex 1 Draft (Part 4 of 5)