It is based on ultra-modern cleanroom technology, automated production cells, automated camera inspection, and a unique validated washing process. All facilities aligned with the FirstLine® manufacturing standard are specially designed and operated under a zero-defect philosophy. The entire facility incorporates rational and lean production flows in accordance with the Six Sigma methodology. Our FirstLine® standard is used to produce our most complex elastomer components. Furthermore, our highly specialized fluoropolymer spray coated components are manufactured exclusively with this standard.
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Highest level of innovation, quality, and safety.
To offer best-in-class processes, our most advanced manufacturing standard, FirstLine®, is characterized by numerous components to guarantee the highest level of quality and safety.
These manufacturing processes are based on our ultra-modern zoning concept. Each zone has been meticulously designed and constructed to prevent bio-contamination. Each zone 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 another zone of even higher cleanliness. The process flow, gowning protocols, personnel and material flow, as well as cutting-edge automation processes all result in the lowest endotoxin, bioburden, particulate, and defect levels available in the industry. To not only guarantee a trouble-free environment but also a high surveillance of the process itself, we use a sophisticated, independent monitoring system. It helps us monitor every critical element of the FirstLine® manufacturing process, from particle measurement to air temperature and moisture levels.
All of those factors are continuously monitored by an independent monitoring system. Our validated camera inspection system scans the entire surface of all serum and lyo stoppers for the presence of visual defects while checking, at the same time, for dimensional correctness and consistency. Each individual closure also passes through an integrated metal detection system. Therefore, our new cleanroom incorporates the latest generation in camera inspection techniques, guaranteeing all items are camera inspected in a closed environment immediately prior to packaging, thus preventing any possible bio-contamination.
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An ongoing commitment to quality
An ongoing commitment to quality
in processing and coating.
At the FirstLine® manufacturing level, packaging is performed under unidirectional airflow compliant with ISO class 5 requirements as per ISO 14644-1. This is equivalent to a “Guidance for Industry – Sterile Drug Products Produced by Aseptic Processing – cGMP” class 100 environment as defined by the FDA. At FirstLine®, our most complex elastomer components are coated with our proprietary fluoropolymer spray coating. This high-end product is exclusively manufactured in facilities incorporating this standard. Furthermore, thanks to chlorination and siliconization, we preserve the integrity of products requiring even the most sensitive processing environment.
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Opening of the FirstLine®
Opening of the FirstLine®
plant in Middletown, USA.
With the opening of the FirstLine® plant in Middletown, Delaware, USA, we emphasize the importance of our most advanced manufacturing concept for high-quality elastomer components for the fast-growing global biotech and pharmaceutical markets and expand our worldwide FirstLine® offering.
With the existing FirstLine® capacities in Belgium and the recently expanded FirstLine® capacities in India, we will be able to serve customers in the three most important economic regions, namely the USA, Europe, and Asia, with locally produced FirstLine® components. The new production capacity will enable us to increase our global FirstLine® volume by 50% by end of 2020 and accelerate profitable growth. Thanks to this fact, we offer our customers optimized process efficiency and total cost management with our FirstLine® production on a global scale while providing the industry benchmark in closure components.
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Video
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Our pioneering manufacturing concept.
The Datwyler FirstLine® standard is an advanced manufacturing concept for high-quality elastomer components for the health care industry with state-of-the-art clean room technology, automatic production cells, fully automatic camera inspection and a unique washing process.
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