Specific requirements
Controlled, clean and pure production conditions are extremely important for the manufacturing of medical technology products and primary packaging, and the legal and customer-specific requirements on cleanroom technology are correspondingly high. Our cleanroom technology offers our customers the highest level of safety and maximum protection against contamination. This is especially important in the medical technology sector with its stringent requirements. For example, the production and acceptance of stents, implants and primary packaging should take place under cleanroom conditions.
Solutions
Tailor-made cleanrooms
Setting up a GMP*-compliant cleanroom requires close cooperation between the client, specialist planner, manufacturer and responsible regulatory authority from the very first planning step. We ensure smooth cooperation from the concept to the handover of the turnkey, qualified cleanroom. As a specialist in air-conditioning technology, we also ensure the air-conditioning of cleanrooms. Our units are precisely matched to the system concept and offer advantages by saving energy and reducing operating costs.
Experience
In recent years, we have successfully planned and executed numerous customised cleanroom projects in accordance with nationally and internationally applicable standards and regulations. These included cleanrooms for the manufacture of products in risk classes III, II A and II B (according to Annex IX of EU Directive 93/42/EEC) such as eye implants and corrective lenses, orthopaedic implants or test equipment for medical laboratory applications. In addition, we have also realised clean rooms for the measurement of medical technology products. Thanks to our consistent improvement management, we ensure that we always meet the technical and economic requirements of our customers in the best possible way. This of course also applies to our cleanrooms for new processes such as additive manufacturing in 3D and 4D printing, for example for artificial blood vessels.
Monitoring, qualification and requalification
Cleanrooms have to be reliably clean – always and everywhere. For this reason, the qualification of systems and rooms is mandatory and a central component. With our innovative measuring technology we record, monitor and document the critical parameters for cleanroom operation. For this purpose, particulate measuring devices count and identify the tiniest particulate matter contaminations. To avoid risks and secure the qualified status of the system long-term, our service experts service and test all the relevant points at regular intervals. Together with our qualification team, they also ensure that the cleanroom is operated in compliance with all legal regulations.
Solutions
As experienced specialists in cleanroom technology, we have been serving pharmacies and pharmaceutical production facilities as well as laboratories for many years. We know the legal requirements, the practical demands and also the economic aspects very well. Which means we can classify and incorporate these three criteria and implement them in line with requirements and processes.
Our range includes systems for complete cleanrooms as well as components: functional and comfortable cleanroom cabins, class 2 safety workbenches, laminar flow cabinets and isolators. The scope of services ranges from the room concept to the technology to monitoring and beyond. We accompany the entire project from the planning phase through to day-to-day practice: with consultation, planning, qualification, implementation and after-sales service.
The route to a turnkey cleanroom laboratory
Optimum room layout
The first important planning factor is the spatial conditions on site. Taking the desired production capacities and the product portfolio into account, we develop a concept for the future standard-compliant laboratory or cleanroom area together with our customers. First of all, a room layout is drawn up. This covers the areas of personnel and material locks, preparation, mixing and production. In compliance with the cleanliness classes and pressure levels, these are coordinated with the personnel and material flow. Subsequently, the locations for safety workbenches, laminar flow systems or isolators, airlocks and laboratory furniture and equipment, for example, are determined.
GMP-compliant products:
- Microbiological workbenches
- Cleanroom personnel and material locks
- Cleanroom wall, ceiling and floor systems incl. cleanroom-compatible lighting
- Air-conditioning units and refrigeration technology
- Laminar flow systems
- Cleanroom monitoring systems
The pharmaceutical industry demands rigorous cleanroom conditions to ensure product purity and safety. Our company offers tailored cleanroom solutions that meet the highest industry standards. We collaborate closely with clients to design and implement GMP-compliant cleanrooms, from initial planning to final handover. Our expertise in air conditioning technology ensures optimal environmental control, while our monitoring systems guarantee consistent cleanroom performance.
We provide a comprehensive range of cleanroom solutions for the pharmaceutical industry, including complete cleanrooms and individual components. Our experienced team assists clients in designing efficient laboratory layouts and selecting appropriate equipment, such as safety workbenches, laminar flow cabinets, and isolators. We offer a full suite of services, from initial consultation to ongoing maintenance, ensuring the long-term performance and compliance of cleanroom facilities.
The pharmaceutical industry demands rigorous cleanroom conditions to ensure product purity and safety. Our company offers tailored cleanroom solutions that meet the highest industry standards. We collaborate closely with clients to design and implement GMP-compliant cleanrooms, from initial planning to final handover. Our expertise in air conditioning technology ensures optimal environmental control, while our monitoring systems guarantee consistent cleanroom performance.
We provide a comprehensive range of cleanroom solutions for the pharmaceutical industry, including complete cleanrooms and individual components. Our experienced team assists clients in designing efficient laboratory layouts and selecting appropriate equipment, such as safety workbenches, laminar flow cabinets, and isolators. We offer a full suite of services, from initial consultation to ongoing maintenance, ensuring the long-term performance and compliance of cleanroom facilities.
