Quality and safety
We at Datwyler ensure quality and safety with industry-leading processes and procedures. All of our products are produced in the most advanced manufacturing environment, assuring commitment to the highest level of quality. ISO-standard cleanrooms with state-of-the-art automated production cells, camera inspection capabilities, and a unique washing process pay tribute to our zero-defect philosophy.
Reliable combination.
Plungers & Combiseals.
Plungers are a core mechanism of cartridge delivery systems. These elastomer components are frequently used as closure solutions and must perform a wide variety of functions. They are in permanent contact with the liquid pharmaceuticals and must not cause any impurities or chemical reactions.
Our plungers are made of specialized butyl-based formulations with all the physical, chemical, and mechanical properties essential for the safe and easy administration of the drug product. The rubber components also offer an optimized extractable and leachable profile to secure the integrity and safety of the customers' drug – even the long-term contact between drug and seal is not a problem, and Plunger Barrel Seal Integrity (PBSI) is guaranteed.
For highly sensitive drugs, we also offer our customers components coated with our proprietary fluoropolymer spray coating technology. Both barrier properties and the elimination of the closure as a source of silicone oil-based particles can be ensured.
With our combiseals, we complete our unique sealing solution for cartridge applications. Our plungers combined with rubber-lined aluminum combiseals enable us to ensure the system integrity of the cartridge. In addition, our components are multifunctional: after multiple piercings with pen needles, our combiseals still protect the contents of the cartridge. Furthermore, our products offer our customers a superior usability with combiseals that feature a dual compound elastomeric liner inside the aluminum cap.
Pioneer using unique materials and technologies
In accordance with our mission to “Improve patients’ lives,” we are always striving to enhance our products and processes. Our latest development is the DuraCoat™ combiseal: the optimal solution for high-end cartridge applications. Datwyler's DuraCoat™ combiseal combines an industry-leading aluminum lamination with a high-quality alloy. This proprietary technology proves our competence: we supply a lamination that provides a protective barrier against external forces and reduces the risk of abrasion during manufacturing and handling.
In short, DuraCoat™ combiseals are currently the ideal solution for cartridge applications in the pharmaceutical and biotech markets.
With continuous and rigorous testing, expertise, proprietary technologies, and the most advanced manufacturing processes for the highest chemical cleanliness, we at Datwyler make sure that our plungers and combiseals are an effective packaging solution for cartridges. As a solutions partner, we support our customers in mastering all the changes and challenges of the global healthcare system and advise them on exploring the opportunities offered by new therapies.
Bringing value to our customers by enhancing efficiency in drug filling and packaging
Datwyler offers combiseals ready-for-sterilization to take the burden off drug manufacturers to prep packaging components for sterilization, saving time and cost while complying with FDA and EU regulations. Prior to arriving at the sterile drug manufacturer, the RFS combiseals undergo Datwyler’s own Water-for-Injection washing process and are packed in steam sterilizable (RFS) bags, optionally also suitable for isolators connection, to ensure a controlled state of microbiological cleanliness. This enables immediate sterilization of the combiseals.
RFS combiseals are 100% camera inspected and follow a regulatory compliant washing program contributing directly to fewer visual defects and fewer rejects on production lines, lowering the cost of operation for our customers. The washing validation information process will be filed in Datwyler’s DMF so that our customers can easily reference the same for drug submissions to the FDA by using RFS combiseals.
Resources
Resources at your fingertips
Looking to learn more about the complex process behind packaging injectable pharmaceutical products? Visit Datwyler's Resources page to discover how our parenteral packaging solutions can elevate your injectable pharmaceutical products to the next level.
