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.
Read more about :
- Fully certified and validated procedures
- Quality Management
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).
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.
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.
Strict gowning procedures, together with personnel air locks in each clean room, prevent any form of bio-contamination.
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.
Designed in accordance with the latest European and US regulatory requirements, the system is built to automatically shut down operation systems whenever a critical alarm is sounded while the Supervisory Control & Data Acquisition system (SCADA) provides an overview of all alarms and trend curves.
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.
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.
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.
The challenge of compatibility
For applications involving long-term contact with parenterals, Datwyler always uses the most advanced compounds exhibiting extremely little to no interaction with the contents. for some pharmaceutical applications, however, such as biotech drugs administered in very small quantities per dose, there is no margin at all for absorption or any kind of interaction on the part of the vial stopper or syringe plunger. In such cases, Datwyler offers a range of state-of-the-art coatings to ensure 100% integrity of your product.
Superior protection for your product
Datwyler’s state-of-the-art coatings offer several advantages over other alternatives available on the market. Firstly, our coatings cover the entire product surface and not just the contact zone, guaranteeing the maximum integrity of the fluoropolymer layer itself and a more effective barrier between the rubber component and your product. The coating prevents the leaching of compounds from the stopper into the drug and vice versa, which, in combination with the inert characteristics of fluoropolymers leads to better stopper/drug compatibility. the non-sticky surface of Datwyler coatings and their high level of elasticity also eliminate the need for siliconization without compromising the integrity of the container seal.
The Omniflex family
Datwyler’s advanced omniflexplus coating offers even lower levels of residual stickiness, greater safety and improved functional performance. Launched in 2008, the latest generation Omniflex 3G coating offers the same advantages combined with even greater elasticity and a low extractables profile. Omniflex 3G is offered in combination with a limited number of product designs, incorporating dimensional features that yield greater safety margins in terms of closure/vial seal integrity.
The entire Omniflex family is exclusively produced in our FirstLine plant.
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.
As a result, the skin of the product becomes somewhat harder. Thereby the stickiness of the products is significantly reduced, and so is their coefficient of friction. Machineability of chlorinated polyisoprene rubber products is far superior to that of non-chlorinated parts.
Datwyler avails of a modern facility for chlorination of polyisoprene rubber products.
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.’
Guaranteed cleanliness via validated washing processes
Washing is the final step in the elastomeric closure manufacturing process before packaging. for Datwyler’s uncoated closures, washing is combined with siliconization for better machineability during filling and/or assembly. coated components do not require siliconization.
Washing ensures a well defined and controlled state of microbiological and particulate cleanliness for all closure components. Datwyler uses a variety of state-of-the-art washing and siliconization processes. Datwyler's firstline products are washed using specially developed washing processes. these processes are subject to validation and revalidation. They also constitute part of Datwyler's drug master file with the FDA in the USA.
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.
All RfS components are rinsed with WFI and siliconized before being packaged in sterilizable bags. All RfS components guarantee a very high standard of particulate and biological cleanliness and as such are ready for either steam or EtO sterilization without the need for any form of pre-treatment.
Ready-for-sterilization products are packaged in specially designed bags which are precisely that: ready for sterilization and fully compatible with steam sterilization processes. Datwyler’s rfs bags consist of a tyvek layer on one side and a high-density polyethylene layer (HDPE) on the other. While tyvek is permeable to air and steam – enabling both steam sterilization and ethylene oxide sterilization – it is impermeable to microbiological contamination, thus preserving the sterility of its contents and preventing re-contamination after sterilization. The HDPE layer is impermeable both to steam and microbiological contamination
Flexible, efficient concept
Datwyler’s flexible RfS concept helps you simplify your stock management and operational planning. The end result is faster turn-around times coupled with reduced risk and labour costs associated with washing and siliconization procedures.
Optimized supply chain solutions
RfS bags are available in a variety of sizes and can be delivered from multiple locations, including our FirstLine™ facility in Alken, maximizing the flexibility and efficiency of your supply chain even further. For isolator and RABS applications, RfS components can also be supplied in Rapid Transfer Ports packaging.
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.
Flexible, ready-to-use solutions
Datwyler’s validated RTU concept comprises a wide variety of sterile rubber stoppers and aluminium seals ready for immediate use straight from the warehouse. Ready-to-use components not only simplify stock management and operational planning by eliminating cleaning and sterilization procedures. The increased efficiency, flexibility and security of your supply chain will also result in faster lead times and a reduction in risk and labour costs. For isolator and rabs applications, sterile rubber and aluminium components can be supplied in rapid transfer port packaging, to boost your process efficiency even further.
Secure packaging, instant validation
All Datwyler RTU rubber and aluminium closures are double packed for easy introduction into aseptic filling areas. Our vacuum packaging technique between the outer bags also makes it easy to check for sterility at the point of use. This tamper-evident packaging also greatly simplifies the process of validating components for transportation.
All Datwyler RTU solutions are supplied with a validated sterility assurance level of 10-6 in compliance with iso 11137, as well as an extensive validation package indicating the shelf life.