In recent years, quality requirements in the pharmaceutical industry have continuously been rising. This development is driven by a growing number of highly sensitive biotech products, increasing demands from regulatory authorities, tighter international guidelines and other factors.
Primary packaging which gets in direct contact with active pharmaceutical ingredients (APIs) is an important part of (bio)pharmaceutical products. Packaging materials must meet high requirements. Apart from protecting the product, it is critical to avoid interactions between the active ingredient and the packaging material. This is in particular demanding for biotech products consisting of complex molecules which are – due to their nature – very sensitive towards contact materials.
Qualification and validation processes of primary packaging systems at companies in the pharmaceutical and biotech industry include extractables and leachables testing as well as stability studies to prove suitability of use for a specific (bio)pharmaceutical product. This assessment involves use of significant resources and high cost. Objective is to assure efficacy and safety of the product for patients.
Glass is particularly suitable for primary packaging because this material is chemically and thermally very durable and inert. The highest quality standards are fulfilled by Type I borosilicate glass which shows due to its chemical composition excellent hydrolytic resistance.
The product portfolio is a range of high-quality glass bottles and plastic closures for storage and transport of APIs, intermediates, excipients and media. The main application area is in sterile manufacturing of pharmaceutical and biotech products according to Good Manufacturing Practice (GMP).
This product line includes a series of bottles manufactured from DURAN® glass (Type I borosilicate glass 3.3) with DWK Life Sciences' long-standing expertise in glass molding technology.
DURAN® PURE Bottles are offered in a size range from 25 ml – 20 l for the neck sizes GL 25, GL 45 and from 500 ml – 20 l for the wide neck design GLS 80®. All bottles are closed with protective covers which are assembled onto the bottles directly at the manufacturing line. This prevents contamination of the glass surface inside the bottles during storage and transport.
Since a number of pharmaceutical and biotech products is light sensitive, DWK Life Sciences offers DURAN® PURE Bottles also in amber colored version. For this purpose, DWK Life Sciences utilizes an amber coloring process on the outer surface of clear glass bottles. The contact material of the active ingredient on the interior glass surface is the same as in the case of clear glass bottles. Amber colored DURAN® PURE Bottles comply with a light transmission rate below 10% in the wave length range from 290–450 nm as stipulated by international pharmacopoeias.
DURAN® PURE Bottles are manufactured with additional personal at the line, undergo 100% visual inspection and enhanced in-process control (IPC) to warrant highest quality standards.
DWK Life Sciences delivers DURAN® PURE Bottles as single batches to the customers. The retrace code (batch number) which is included in the print of the bottles ensures 100% traceability of data from all manufacturing steps. DURAN® PURE batch certificates are issued as Certificates of Analysis (CoA) including data on hydrolytic resistance according to EP, USP and JP measured for the individual batch. Based on these data, DWK Life Sciences confirms compliance with the requirements of Type I glass. Certificates of Analysis are available for download on the DWK Life Sciences homepage and will upon request be forwarded to the customer.
The DURAN® PURE Bottle line is covered by change control management. This means customers will be informed in advance about any changes of products or processes.
Comprehensive quality documentation of DURAN® PURE Bottles including product specifications, statements on BSE TSE, food contact and more is available for download on the DWK Life Sciences homepage and will be forwarded on request. In addition, an extractables report is provided to support customers in DOE (design of experiments) of own extractables and leachables studies.
DWK Life Sciences has submitted a Drug Master File (DMF) Type III for DURAN® PURE Bottles. Customers can reference the DMF in case of marketing applications for new drugs, biotech products, biosimilars and generics.
DWK Life Sciences' range of high-quality closures consist of the DURAN® PURE Premium Screw Caps GL 25 und GL 45 made from PFA (fluoropolymer) and the DURAN® PURE GLS 80® Screw Cap from PSU (polyarylsulfone). These closures include pre-assembled, PTFE coated silicone seals and are ideally suited for the DURAN® PURE bottle series with GL 25, GL 45 and GLS 80® neck sizes.
In addition, DWK Life Sciences offers the DURAN® PURE Premium Lip Seal Cap (GL 45) which has in the cap design an integrated lip seal. This product is an alternative closure for DURAN® PURE GL 45 bottles.
DURAN® PURE Screw Caps are chemically and thermally very inert, compatible with autoclaving and other common sterilization methods. They are manufactured and packaged in clean rooms, come with the DURAN® PURE features and services. These are single-batch delivery, batch certificates (Certificates of Analysis) and 100% traceability of all manufacturing and assembly steps. The retrace codes are marked on the products. Change control management, a full set of quality documents including statements on elemental impurities (ICH Q3D) and residual solvents (ICH Q3C) are available. DWK Life Sciences has also submitted Drug Master Files (DMF) Type III for DURAN® PURE Screw Caps.
The batch certificates (Certificates of Analysis) of DURAN® PURE Screw Caps include dimensional values and results of visual inspection for the individual batch. In addition, compliance with pharmacopoeias and other international standards is confirmed. Extractables profiles assist in evaluation of the products and planning of extractables & leachables studies by the customer.
The DURAN® PURE Premium Pouring Ring GL 45 from PFA complements the DURAN PURE line as a solution for easy pouring of liquids during the drug manufacturing process. The product is manufactured and packaged in a clean room, delivered as single-batch with batch certificate (Certificate of Analysis) and 100% traceability. Quality documentation and change control management are part of the offering.
DWK Life Sciences fully supports the qualification and validation process at the customer. This starts with DURAN® PURE samples for first product evaluation, goes through quality documentation and supplier questionnaires up to supplier site audits, regulatory support and technical service.
The DURAN® PURE product line is due to its features and quality attributes a container closure system of choice for the pharmaceutical and biotech manufacturing process.
