Cleanroom filling and assembly 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 processed in a controlled environment where the presence of particles, microorganisms and contamination is kept to a minimum. Only in this way 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 services. In our controlled environment, we safely handle sensitive liquids, gels and reagents before they are packaged or incorporated into diagnostic kits. We combine our packaging expertise with a production process that meets the highest quality and hygiene standards.
Waarom DaklaPack?
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Expertise in medical packaging and diagnostic kits
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Cleanroom assembly and filling in accordance with strict protocols
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Minimal risk of contamination thanks to separate 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 one needed?
A cleanroom environment is a production environment in which the levels of dust particles, microorganisms and other airborne contaminants are controlled. Special air filters, controlled airflows and strict operating procedures are used to prevent sensitive products from coming into contact with unwanted particles.
Cleanroom production is used when product quality and reliability are heavily dependent on a clean working environment. This is the case, for example, with medical products, diagnostic reagents and buffer solutions that will subsequently come into contact with medical samples. By carrying out production, assembly and filling in a cleanroom environment, the risk of contamination with 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 strict hygiene and quality standards. Our hard-wall cleanrooms are built in accordance with ISO Class 6 guidelines, whereby air is continuously filtered and circulated to minimise the number of particles in the environment. This creates a stable production environment for sensitive products.
For added protection, we use laminar airflow cabinets (LAF). These cabinets create an even cleaner working zone in which products can be safely processed or filled. When not in use, this working zone achieves ISO Class 5, whilst during production a controlled environment at ISO Class 7 level is maintained. This combination enables us to process 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. Take, for example, medical tubes that are filled with a buffer solution. The buffer solution ensures that human tissue, DNA or bodily fluids remain stable for longer, for analysis or transport.
In our cleanrooms, liquids can be filled accurately and fully automatically into various types of packaging, such as vials, tubes, sachets, stand-up pouches, jars, bottles or other medical packaging formats. After filling, closures are applied automatically and products can be labelled or coded immediately. This creates 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 assembled with precision. In our cleanroom, we assemble and package, in accordance with strict protocols, items such as medical disposables and complete kits for diagnostic tests or sample collection.
Depending on the product, various packaging formats can be used, such as barrier pouches, blister packs or other medical packaging. Products are assembled, labelled and coded in the cleanroom before being processed further down the supply chain. We can develop our own production lines for specific assembly steps. This ensures that components are assembled efficiently and without error under controlled conditions.
Packaging and labelling in the cleanroom
Following 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 various packaging formats, such as vials, tubes, sachets or other types of medical packaging. Products can be fitted with closures, labels and coding in the cleanroom, so that they are ready for further processing or distribution.
For applications requiring low temperatures, products can be stored temporarily under refrigerated conditions at DaklaPack following assembly or filling. In combination with our diagnostic kits and medical components we can safely packaged for transport to laboratories, research institutions or distribution points.
Quality control in cleanroom manufacturing
Working in a cleanroom requires strict protocols and continuous quality control. During production, various checks are carried out to ensure that products are processed under the correct conditions. These include monitoring air quality, checking processes and carrying out interim quality checks.
Our staff are specifically trained to work in accordance with the guidelines. Furthermore, only one product is processed at a time in each cleanroom. This reduces the risk of cross-contamination and ensures a controlled and consistent production environment. Through a combination of protocols, training and monitoring, medical products and diagnostic components can be reliably assembled, filled and packaged.
Frequently asked questions
Your cleanroom partner for manufacturing and assembly
Cleanroom manufacturing requires a partner who understands processes, monitors quality and can offer flexible solutions. DaklaPack supports customers with the cleanroom assembly, filling and packaging of medical products or complete kits. We ensure a controlled process that meets the specific requirements of your product.
Please contact our team for advice on cleanroom assembly and filling by calling +31 (0)320 277 900, emailing info@daklapack.com or using the form on this page to hire a cleanroom. Our filling specialists are on hand to answer your questions.
