“Climate technology is both my hobby and my profession - and is always fascinating.”
Casual in manner, clear in facts: Steffen Röhm briefly considers tarte flambée and rib-eye steak before deciding on the latter. He then makes it clear that he is passionate about climate technology and is familiar with the details of standards, regulations and legal requirements.
Mr. Röhm, can climate technology be fun?
For me, definitely. I've been in the industry for more than 30 years, and it continues to excite me. The technical possibilities, the regulatory requirements, and the development of custom solutions are all highly fascinating.
But there are always new regulations to consider?
Yes, and that's partly a good thing. On the one hand, it standardizes technical solutions and makes them safer. On the other hand, standards - such as norms and guidelines - ensure that requirements such as temperature consistency, air quality and measurement procedures are standardized. This makes it easier for operators or users to understand what they are getting. They specify how a system should be designed and built, and what values should be measured where and when. There are fewer gray areas, and customers have more clarity. For example, important changes have been made to Annex 1 of the EU GMP Guide. Some issues that were previously open to interpretation are now more clearly defined. This simplifies planning, implementation, and operation, and provides more safety for the operator as well.
How does Annex 1 increase safety?
Take, for example, the airlock concept for clean rooms. It was previously specified that no zone should be skipped. However, many details were unclear, and everyone developed their own solution. Annex 1 now specifies that there should be separate airlocks for entering and exiting between Clean room Class A and B. At Weiss Klimatechnik, we've long recommended this approach as it reduces the risk of contamination. Now everyone has a clear understanding of it, which increases safety. There are also a number of other topics, which are set out in more detail in Annex 1.
What does this mean for existing systems?
It depends on the individual case. In principle, however, there is no protection of the status quo when it comes to making changes. If I convert a clean room, a qualification must be carried out. However, there may be technical or structural conditions that prevent implementation as described in Annex 1, or that make the changes uneconomical. In such cases, it is necessary to consider whether organizational measures can still achieve the goal stated in Annex 1.
Does this mean that there is no longer any room for interpretation with Annex 1?
There is still room for interpretation. Although the EU-GMP guidelines, including Annex 1, apply across the entire EU, there are still differences in interpretation and implementation. Each national authority interprets the guidelines according to its own understanding. The German authorities responsible for implementation may interpret the details slightly differently. However, this interpretation must always fall within the framework defined by the guidelines. And that framework is as narrow as possible.
But isn't this hard for many companies to understand?
Definitely. Anyone planning a clean room today typically seeks the assistance of a consultant who has experience in the regulated environment for pharmaceutical manufacturers. At Weiss Klimatechnik, we are not GMP consultants, but we do provide comprehensive advice on the planning and implementation of climate technology. This includes airflow design, air handling, zone concepts, material flow, airlock concepts and monitoring. Through our sister company, Weiss Pharmatechnik, we also provide consulting on isolators, workbenches, and other clean room equipment.
You also participate in standardization committees. How does that work?
For more than 20 years I have been active in the VDI's guideline work, trying to implement national and international standards, best practices, generally accepted rules of technology and guidelines. And in such a way that they can be applied.
Isn't this a pretty dry job?
Quite the opposite. It's very exciting. After all, it’s about the application of climate technology, in my case, for clean rooms and measurement rooms. I'm also involved in the Clean room Technology Committee at the VDI, where we focus solely on guidelines for clean rooms. Depending on the topic, we work in a committee of up to 20 people from various fields and companies. These include planners, plant builders, institutes, clean room operators, as well as government representatives.
Sounds like a lot of work, right?
It depends. Sometimes it's just about adapting an existing guideline to a technical innovation, extending it, or complementing it. In other cases, a completely new guideline needs to be developed and harmonized. This is time-consuming and can take a while, from the first draft to the adopted guideline.
What does your employer, Weiss Klimatechnik, gain from this work?
Designing and building clean rooms is a big responsibility. That's why Weiss Klimatechnik is committed to developing the best possible standards and creating sensible solutions. I’m glad that the work I, and other colleagues, do at the VDI is so highly valued within the company.
Is this your only area of responsibility?
No, it's just a small part. As Technical Consultant I am the contact person for all companies of the weisstechnik group for questions regarding special climate technology, such as clean rooms, dry rooms and measuring rooms. I also support my colleagues in the design of components and systems with high technical requirements and in the technical approval of projects.
Thank you for the conversation, Mr. Röhm, and enjoy your meal.
Some facts about Steffen Röhm
Steffen Röhm was introduced to building technology at an early age by his father. He went on to study energy and thermal engineering. After working in various positions for plant manufacturers, trade companies and service providers in the field of refrigeration, air conditioning and clean room technology - including in service - Steffen Röhm returned to Weiss Klimatechnik more than seven years ago, where he is now a technical consultant. Since he turned his hobby into a career, there's no reason for him to take a break. If he does, it's through 3D archery.