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Standards, risk analysis, and energy efficiency: Steffen Röhm explains the requirements for cleanrooms used in the production of medical devices
Steffen Röhm arrives relaxed for the Technology Lunch, orders pizza with spicy salami, and treats himself to two scoops of vanilla ice cream for dessert. In conversation, he’s focused as always. He offers valuable insights into cleanroom technology for medical devices, the associated regulatory requirements, and ways to enhance energy efficiency.
Mr. Röhm, do all manufacturers of medical devices need a cleanroom?
No, but many do. For medical devices, the regulations are not as specific as they are for pharmaceutical products. That doesn’t mean there isn’t plenty to consider. Pharmaceutical products—or medicinal products—have a systemic effect and directly enter the body. They must be manufactured in accordance with the EU-GMP guidelines. The term “medical device” covers a wide range of products—from eyeglasses to pacemakers—including in-vitro diagnostics. Accordingly, the requirements for manufacturing conditions are also broadly defined.
Does that mean manufacturers themselves carry greater responsibility?
Ultimately yes. That’s because they must ensure the safety of their products and can rely less on precisely defined regulations. If something goes wrong during production and health issues arise because purity standards weren’t maintained, the responsibility falls on the manufacturer. The consequences can be far-reaching.
How can manufacturers determine the level of cleanliness required for their product?
First, they need to analyze exactly what they’re producing and what environmental conditions their product requires. It’s obvious that, from a hygiene standpoint, a pacemaker needs a different level of cleanliness than an externally fitted knee brace. This affects every step of the manufacturing process. In some cases, suppliers must also ensure the cleanliness of intermediate products and components and document compliance with the required measures.
Is that always easy and straightforward to assess?
Not really—because many factors can play a role. However, if a thorough risk analysis has been carried out, the results are clear, and the cleanroom requirements can be clearly defined. There are also standards that deal with surface cleanliness and medical devices: ISO 14644-13 and VDI 2083 Part 12.
What happens next?
Following the risk assessment for the production of the medical device, the resulting planning and construction measures for the cleanroom must be presented to the approval authorities. This includes explaining the risk assessment considerations and justifying the decisions derived from them. Manufacturers must demonstrate the risks—such as contamination—that could arise from using their medical device and what measures they are taking to eliminate or minimize those risks.
How do you support manufacturers in this process?
To avoid risks, we offer to advise manufacturers from the very beginning and accompany them in discussions with authorities on the topic of cleanrooms. With around 40 years of experience in climate control and cleanroom technology, we know where the key challenges lie and how to overcome them.
So that means you don’t just plan and build?
Consulting is one of the most crucial elements of a project like this. Asking the right questions early on helps avoid problems later—and saves money. After all, a cleanroom that doesn’t pass approval is costly—not to mention the delays in the overall project and potential production downtime.
Do you allow for generous safety margins in your planning?
No. We plan so that the design fits both the product and the process, thereby ensuring that cleanliness requirements are reliably met. Of course, we meet our customers’ specifications and draw on the expertise we’ve built over decades through participation in working groups and training programs . That sharpens our focus on details that are easily overlooked.
Do you also act as a general contractor for cleanrooms?
Yes, we design, build, and qualify cleanrooms, including personnel and material airlocks as well as furniture, illuminated workstations, and lighting. It’s convenient for our customers because everything is perfectly coordinated. And if a problem does arise, they have one number to call and a dedicated contact person who can help. That way, they avoid disputes with different subcontractors who, when in doubt, may have no answer or may blame each other.
So is that your direct phone number?
It could be mine or that of a colleague. During an ongoing project, it’s usually the project managers, and afterward, the service hotline. In any case, it’s a number from Weiss Klimatechnik. Depending on the issue, a colleague from planning, project management, or service will assess what needs to be done. Thanks to our comprehensive service network, this works quickly, smoothly, and very reliably—even in Austria and Switzerland.
Do you handle only new construction projects?
No. Especially in recent years, we’ve been increasingly active in the areas of retrofit and modernization. Many cleanrooms have simply aged, and their technology no longer delivers the required performance reliably or meets modern energy-efficiency standards. There’s plenty of work to be done.
Do older cleanrooms consume too much energy?
Many of them do. Cleanrooms inherently consume a relatively large amount of energy by nature of the process. Outdated technology, in turn, leads to high monthly costs. Replacing a 20-year-old fan that always runs at full power with a modern, speed-controlled model connected to a smart control system with night setback can quickly yield substantial energy savings. We’re happy to support our customers with that. For new cleanrooms, we ensure from the outset that all components are optimally designed for energy efficiency and operate accordingly.
Thank you for the conversation, Mr. Röhm, and enjoy your meal.
Information snippet Steffen Röhm
Graduate engineer in energy and heating technology. Steffen Röhm is enthusiastic about air conditioning technology, and it shows. He not only advises and plans, but also actively participates in standards committees to improve existing standards and develop new ones. It is important to him to work in a focused and concentrated manner. Just like in archery, which he practises with great accuracy in his spare time.
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