Highest manufacturing standard: First Line

Datwyler’s state-of-the-art solutions for drug packaging and medical devices are built on over 100 years of knowledge. Our experts are constantly researching and developing the most advanced standards to ensure the highest available purity and compatibility of our products. A global strategic approach with a local presence is a key success factor in the pharmaceutical market. Datwyler’s manufacturing set-up guarantees identical quality standards on a global level. Due to the most advanced quality standard identically produced in three different continents, we can provide our customers with flexible supply chains to improve time-to-market risk mitigation plans to ensure business continuity.

Ongoing commitment to quality

Datwyler offers best-in-class packaging solutions for the pharmaceutical and bio-
tech markets. To ensure patient safety, our priority is to deliver safe and effective sealing solutions for drug packaging to our customers. Our most advanced manufacturing standard, First Line, is specially designed to manufacture pharmaceutical rubber components for high-end pharmaceutical and biotech markets in a fully integrated cleanroom environment conforming to the highest industry standards. The First Line manufacturing concept is based on ultra-modern cleanroom technology, automated production cells, fully automated camera inspection, and a unique validated washing process. All facilities aligned with the First Line manufacturing standard are specially designed and operated under a zero-defect philosophy.

Ultra-modern zoning concept

Each zone has been accurately designed and constructed in order to prevent bio-contamination and is equipped with material airlocks. State-of-the-art pass-through washing equipment has its automatic loading side in one zone and its automatic unloading side in a zone of even higher cleanliness. The process flow, gowning protocols, personnel and material flow, as well as state-of-the-art automation processes all result in the lowest endotoxin, bioburden, particulate, and defect levels available in the industry – both visible and subvisible. This innovative approach to manufacturing exceeds the most stringent quality standards of the European and US regulatory authorities and is certified to ISO 15378. The health care industry benefits from the high-quality standards, especially regarding rational test and lean production flows, which are uniform in all First Line facilities. In addition, every element, such as particle measurement, air temperature and moisture levels, is independently monitored. In this way, Datwyler is shaping the future of the global health care industry and stays by its vision to improve patients’ lives.