Exceptional clean room production standards

Raising the standard in high-quality packaging components !

 

Datwyler’s Firstline™ production facility in Alken, Belgium incorporates the very latest state-of-the art equipment and techniques to eliminate every possible form of bio-contamination.

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  • FirstLine 
  • Fully certified and validated procedures
  • Monitoring
  • Quality Management

FirstLine

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 FirstLine 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).

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Fully certified and validated procedures

Each step of the production process has its own specific, stringent air classification.

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.

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Monitoring

Sophisticated, independent monitoring system

Every critical element of the FirstLine manufacturing process from particle measurement to air temperature and moisture levels is subject to continuous monitoring by an independent monitoring system.

 

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Quality Management

The new benchmark in closure components

Certified under the latest ISO 15378 standards, Datwyler’s products set a new standard for quality and reliability throughout the industry. The ISO 15378 standard goes a lot further than ISO9001 : 2000, incorporating all relevant GMPs for the design, manufacture and supply of primary packaging materials for medicinal products.

Visual inspection

Datwyler’s 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.  All items are camera inspected in a closed environment immediately prior to packaging, thus preventing any possible bio-contamination.

Omniflex Coating

Preserving the integrity of even the most sensitive product

For highly sensitive applications, Datwyler offers a range of innovative coatings offering the lowest possible extractables and leachables profile without compromising on seal integrity.

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Chlorination of polyisoprene rubber products

Chlorination is a process where rubber articles, particularly of polyisoprene, are treated with chlorine in an aqueous environment.

The chlorine is either added in molecular form as a gas or is generated in situ by acidification of an hypochlorite solution. The contact of the chlorine gas with the rubber article under appropriate conditions leads to a superficial oxidation of the elastomer.

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SILICONISATION & WASHING CYCLES

Siliconization - Enhanced lubrication, greater machineability

Datwyler’s advanced, proprietary siliconization process was developed specifically to improve the machineability of components on filling and assembly lines. For the majority of processes, Datwyler uses an advanced, silicon oil with a high viscosity (30 000 cst) which meets all requirements of the usp monograph ‘dimethicone’ and of pharm. eur. 3.1.8 ‘silicone oil used as a lubricant.’

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RfS (Ready-for-Sterilization)

Optimizing process efficiency and total cost management

By taking responsibility for the washing and siliconization process, Datwyler’s ready-for-sterilization (RFS) components give you the freedom to focus on your core manufacturing and filling processes.

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RTU (Ready To Use)

Greater process efficiency, reduced cost

Datwyler prides itself on providing customers with total solutions that help boost efficiency and reduce costs. By eliminating the need for sterilization, we let you focus on your core business: manufacturing and filling your product.

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