What Mrs. Müller does not want to experience during the next audit

It is a Tuesday morning. Mrs. Müller, responsible for quality assurance at Pharma GmbH, opens the current monitoring report and notices increased microbial counts in Zone B. The value is once again above the threshold. Not the first time this quarter.

During the last audit, the inspector made a comment about the gowning process. Nothing written down, no official finding. But it’s annoying because the topic was recently on the agenda, yet it remained an issue.

A monitoring value that is still within the green zone but raises questions. Three new employees, whose onboarding was shorter than planned due to the hectic daily routine. None of these points alone would be cause for concern. Taken together, they paint a picture that cannot be ignored. The issue of cleanroom training lands on Mrs. Müller’s desk.

Three Ways to Train

Mrs. Müller considers her options. A purely online training would be quick, the cheapest, and would provide a participation certificate. But it would be completely disconnected from her own operation, from the processes, from her own cleanroom. For a workforce where ingrained behavioral routines are the real problem, that’s hardly sufficient.

The second option: sending the three new colleagues to an external seminar provider. Sounds manageable, but it’s not. With travel, they are on the road for three days, plus seminar costs, travel expenses, hotel. And the course is necessarily general, because participants come from very different companies. What applies to Pharma GmbH remains uncertain.

The third option is in-house training. Mrs. Müller initially thought it would be the most expensive option. After the first conversation, her view changes. No travel costs, no lost production days, no hotel. The training takes place where the work is done, and the organizational effort is manageable. And the total costs are significantly lower than she feared for the scope of services.

In-house — but with which provider?

She researches and finds several providers. Among them cleaning service providers, dealers, and laundries offering training as part of a package. Closer inspection leaves many things vague: Who will conduct the training specifically, and what experience does the person bring? Are the contents tailored individually, or is it a standard training? And can a company mainly offering cleaning services, consumables, or clothing and leasing truly evaluate what makes sense for Pharma GmbH objectively?

The question that preoccupies Mrs. Müller the whole time: Will my team actually do things differently after this training? You get a certificate of participation everywhere. What she’s looking for is a concept that addresses her operation. What finally convinces her is not a glossy brochure. It’s a sentence: We will come one day beforehand. Not for a preliminary video call, but to infiltrate, experience the operation in practice, identify deviations that could be discussed at the next audit. So that on the training day, it’s not abstract standards being explained, but situations from her own operation. And expert feedback — that has significant added value for her.

How the training project is implemented

About four weeks before the training, a detailed online workshop is held for planning. It turns out that a total of 25 people are to be trained. When Mrs. Müller mentions that three cleaning staff also work in the cleanroom, the recommendation is clear: They should definitely participate. Cleaning staff significantly contribute to contamination control, and a heightened awareness of their tasks is just as important as that of production personnel. In the end, it’s 28 people.

A single training for everyone would not have been feasible organizationally. So, the concept is adjusted: An online session a few days before the in-person training discusses the theoretical basics, cleanroom technology fundamentals, contamination sources, and behavioral rules. The recording is also made available. The on-site sessions are divided into three groups, each lasting 3–4 hours. This considers operational needs and allows production to continue. At the same time, there is enough time to understand and practice the topics.

The trainer arrives one day before the actual training. He infiltrates and reviews the areas that will be the focus the next day: behavior, equipment, gowning process, cleanroom clothing, cleaning, and disinfection. What he observes is documented with photos and notes: points where daily routines deviate from SOPs, routines that have crept in, issues that could be noticed during the next audit.

On the training day, the focus can be on practical application, since the basics were already covered in the online session:

- Review of photos and feedback from the walkthrough
- Hand hygiene including practical exercise
- Cleanroom clothing: step-by-step order and practical exercise for correct gowning
- Material ingress and surface cleaning including practical exercise
- Disinfection
- Fundamentals and practice of cleanroom cleaning — especially for cleaning staff

All content is aligned with the SOPs of Pharma GmbH and conveyed practically — based on relevant standards: ISO 14644, VDI 2083, GMP, Annex 1, and ApoBetrO, depending on the application.

After the training

A few days later, everyone completes an online test and finally receives their certificate. Mrs. Müller has the documentation she needs for the next audit.

What surprises her most is the feedback from the groups. The participants expected a training that is somehow endured. Nothing new, just particle limits, ISO classes, and airflow. What they received was direct, straightforward, tailored to their work. Some understood for the first time why certain rules in the cleanroom are what they are. Not because the norm says so, but because they saw what happens if they don’t follow them during the training day.

In a follow-up discussion, observations from the walkthrough are reviewed, and some changes are now being implemented: process optimizations, adjustments to the clothing concept, and savings potentials in consumables, which together amount to more than the cost of the training.

Mrs. Müller not only has the documentation for the next audit. She also now knows where her cleanroom truly stands.