DURAN® PURE Bottles
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.