Pharmaceutical and medical device manufacturing imposes stricter requirements than most other industries. The right cleanroom is crucial for quality, safety, and regulatory approval.
A cleanroom for pharmaceutical and medical device manufacturing must be based on the correct ISO and GMP class, materials that can withstand frequent disinfection, and a modular system design that can accommodate future changes. If you delay making these decisions, production risks costly retrofits and revalidation down the line.
Strictly regulated standards such as ISO 14644-1 and EU-GMP govern manufacturing in the pharmaceutical and medical device industries. Classifications such as ISO 7 or ISO 8 are common, but for particularly sensitive products, the requirements can be as high as ISO 5.
Pharmaceutical manufacturers often use GMP grades (A–D), where, for example, filling zones require a Grade A environment. In addition, quality management systems in accordance with ISO 13485 govern the requirements for medical device manufacturing, which entails clear procedures for both processes and documentation.
“We often see that the choice of cleanliness class is made too late in the process. If it’s decided early on, along with how production will actually flow, you can avoid costly redesigns later on,” says Albin Olén, project manager at Octanorm Cleanroom.
The cleanroom class determines how many particles the air may contain and how the airflow should be designed. An ISO 7 environment allows a maximum of 352,000 particles of 0.5 µm per cubic meter of air, while an ISO 5 cleanroom allows only 3,520.
In pharmaceutical and medical device manufacturing, classification affects everything from ventilation systems to the selection of filters, pressure zones, and material surfaces. By determining early on which class your production requires, you can avoid unnecessary modifications and costly validations.
In the pharmaceutical and medical device manufacturing industries, the choice of materials is crucial. Surfaces must be smooth, non-porous, and easy to clean, while also withstanding frequent disinfection. Aluminum profiles with recessed painted panels made of steel or stainless steel are common, as are block walls—both for hygiene and durability.
Octanorm Cleanrooms’ modular cleanroom components make it possible to build flexible cleanrooms that you can customize and expand as needed. You can combine doors, ceilings, airlocks, and windows in a modular way and integrate them with existing buildings without compromising on airtightness or airflow control — for example, with:
The choice of materials is rarely just a matter of hygiene. A wrong choice early on often results in maintenance costs that you end up paying for over several years, says Marcus Maciejec, CEO of Octanorm Cleanroom.
Answering these questions early on is crucial for an effective and sustainable investment.
The pharmaceutical and medical device manufacturing industries are changing rapidly. New materials, shorter development cycles, and stricter regulatory requirements therefore place higher demands on cleanrooms that you can adapt over time.
If you choose a modular solution in which walls, ceilings, and airlocks are integrated, you’ll get a cleanroom that not only meets today’s requirements but also those of tomorrow. When building cleanrooms for pharmaceutical and medical device manufacturing, patient safety is ultimately what matters most—a well-planned solution reduces the risk of operational disruptions, lowers energy costs, and meets regulatory requirements from the start.
The right cleanroom isn't an expense—it's a long-term investment in quality, efficiency, and trust.
The cleanroom class depends on the product and process—simpler assembly can take place in an ISO 8 cleanroom, while sterile products require an ISO 5 or GMP Grade A cleanroom.
The most common are ISO 14644-1 for cleanrooms and ISO 13485 for medical device quality, as well as the EU GMP Directive for pharmaceuticals.
Smooth, chemical-resistant, seamless, and impervious surfaces such as painted aluminum, steel, or stainless steel that are easy to clean and disinfect.
The validation interval depends on the classification and type of operation, but a common rule of thumb is that GMP zones classified as Class A/B are revalidated every six months and Class C/D zones once a year. The same principle often applies to ISO-classified cleanrooms: ISO 5 or cleaner every six months, ISO 6–8 once a year. In addition to the regular cycle, the cleanroom should always be revalidated following major changes—such as filter replacement, remodeling, or a process change.
Do you need advice for your next cleanroom project? We’ll help you choose the right system solution for pharmaceutical and medical device manufacturing—from planning to final installation.
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Every cleanroom is as unique as the task performed in it. Flexibility in cleanrooms is important, as requirements can change quickly. We are happy to explain how this can be achieved.