Cleanroom assembly and filling for medical applications
For many medical and diagnostic products, a standard production environment is not sufficient. Reagents, buffer solutions and other sensitive components must be handled in a controlled setting where particles, micro-organisms and contamination are kept to an absolute minimum. Only then can the product’s properties be preserved and the reliability of analyses or applications be guaranteed.
As a specialist in packaging solutions for medical and diagnostic applications, DaklaPack also offers cleanroom assembly and filling. In our controlled environment, we process sensitive liquids, gels and reagents safely before they are packaged or integrated into diagnostic kits. We combine our packaging expertise with a production process that meets the highest quality and hygiene standards.
Why DaklaPack?
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Expertise in medical packaging and diagnostic kits
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Cleanroom assembly and filling to strict protocols
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Minimal contamination risk via dedicated production areas
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Integration of assembly, filling, packaging and labelling
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Controlled facilities for medical applications
What is a cleanroom and when is it needed?
A cleanroom environment is a controlled production area in which the level of dust particles, micro-organisms and other airborne contaminants is carefully managed. Using specialised air filtration, controlled airflow and strict working procedures, sensitive products are prevented from coming into contact with unwanted particles.
Cleanroom production is used when product quality and reliability depend heavily on a clean working environment. This is the case, for example, for medical products, diagnostic reagents and buffer solutions that will later come into contact with medical samples. By carrying out production, assembly and filling in a cleanroom environment, the risk of contamination from dust or bacteria is significantly reduced, and products remain stable, reliable and suitable for medical and laboratory applications.
Certified cleanroom facilities
DaklaPack’s cleanrooms are designed to meet stringent hygiene and quality standards. Our hard-wall cleanrooms are built in line with ISO class 6 guidelines, with air continuously filtered and circulated to keep particle levels in the environment to an absolute minimum. This creates a stable production setting for sensitive products.
For additional protection, we use laminar airflow (LAF) cabinets. These create an even cleaner working zone in which products can be processed or filled safely. When idle, this zone achieves ISO class 5, while during production a controlled environment at ISO class 7 level is maintained. This combination enables us to handle sensitive liquids, reagents and other medical components under strict conditions.
Cleanroom filling of liquids, gels and powders
In medical and diagnostic applications, products are filled under controlled conditions. Think, for example, of medical tubes that are filled with a buffer solution. This buffer helps keep human tissue, DNA or bodily fluids stable for longer, for analysis or transport.
In our cleanrooms, liquids can be filled accurately and fully automatically into a wide range of packaging formats, such as tubes, sachets, stand-up pouches, jars, bottles and other medical packaging types. After filling, closures are applied automatically and products can be labelled or coded straight away. The result is a controlled and efficient process in which product quality and traceability are central.
Cleanroom assembly of diagnostic kits
Many medical products consist of multiple components that must be brought together with precision. In our cleanroom, we assemble and package medical disposables and complete kits for diagnostic testing or sample collection, following strict protocols.
Depending on the product, various packaging formats can be used, such as barrier pouches, blisters or other medical packaging. Products are assembled, labelled and coded in the cleanroom before moving further through the supply chain. For specific assembly steps, we can develop dedicated production lines, enabling components to be combined efficiently and error-free under controlled conditions.
Packaging and labelling in the cleanroom
After assembly or filling, products can be packaged and labelled directly in the cleanroom. Combining assembly, filling and packaging within a single process ensures an efficient workflow and consistent product quality, with minimal risk of contamination.
Depending on the product and application, we use a range of packaging formats, such as tubes, sachets or other types of medical packaging. Products can be fitted with closures and provided with labels and codes in the cleanroom, so they are ready for further processing or distribution.
For applications where low temperatures are required, products can be stored temporarily under refrigerated conditions at DaklaPack after assembly or filling. Combined with our in-house dry ice solutions, diagnostic kits and medical components can then be packaged safely for transport to laboratories, research institutions or distribution points.
Quality control during cleanroom production
Working in a cleanroom requires strict protocols and continuous quality monitoring. During production, various checks are carried out to ensure products are processed under the right conditions. This includes monitoring air quality, verifying processes and performing in-process quality checks.
Our employees are specifically trained to work in line with the guidelines. In addition, only one product is processed at a time in each cleanroom area. This reduces the risk of cross-contamination and ensures a controlled, consistent production environment. With this combination of protocols, training and monitoring, medical products and diagnostic components can be assembled, filled and packaged reliably.
Frequently asked questions
Your cleanroom partner for production and assembly
Cleanroom production calls for a partner who understands processes, safeguards quality and can think flexibly alongside you. DaklaPack supports customers with cleanroom assembly, filling and packaging of medical products or complete kits. We provide a controlled process that aligns with the specific requirements of your product.
Contact our team for advice on cleanroom assembly and filling on (201) 630-6480, e-mail info@daklapack.us, or use the form on this page to hire a cleanroom. Our filling specialists are ready to answer your questions.
