First Line Quality
An ongoing commitment to quality
Datwyler is dedicated to guaranteeing the highest levels of quality and safety and continues to make investments aimed at meeting the ever-stricter regulatory requirements. Our latest 6000m² First Line production facility in Alken, Belgium is part of that ongoing commitment and has been designed and equipped to meet the very latest good manufacturing practices (gmp).
Each zone has been meticulously designed and constructed with a view to preventing bio-contamination. Each is equipped with material airlocks. State-of-the-art pass-through washing equipment has its automatic loading side in one one and its automatic unloading side in a zone of still higher cleanliness. The new clean room also incorporates the latest generation in camera inspection techniques. The entire facility as a whole incorporates rational and lean production flows in accordance with the Six Sigma methodology.
All critical processes and equipment, furthermore, are subject to multiple validation procedures. Boasting an ISO 15378 certified quality system, the Alken facility has set the new benchmark for the manufacture of primary packaging components for parenterals.