Duran Pure glass bottle range for pharmaceutical packaging

The Duran Pure glass bottle is covered with a dust cover during the production process to avoid contamination of the inner surface of the glass bottle during transportation. Glass properties are type I according to USP <660>, EP 3.2.1 and JP 7.01 Method 1.

The Duran Pure line consists of Schott bottles (from 500 - 20.000 mL), dust cover, premium screw cap Stericlin and a validation package. The primary packaging system is gas tight with a cap and liner made of material conforming to USP class VI, USP <87>, <88> and ISO 10993-5; the silicone liner has a PTFE coating that is catalytically platinum cured. All materials conform to FDA CFR 21 §177.1550 and CFR §177.2600. Components are temperature resistant up to 260°C, the only contact while filling of the bottle is with glass and PTFE.

Duran Pure is a packaging solution for the pharmaceutical industry. Regulatory authority requirements of the pharmaceutical industry require comprehensive documentation. Fulfilling all requirements, the new product line, Duran Pure, comprehensively makes available regulatory information for a company. Such an example would be for the use of products in processes like adjuvant production for vaccines.

The Duran Pure range offers solutions that cover the increased industry demands certification for BSE/TSE, food safety, biocompatibility, conformity approval (USP, EP, JP), audits, batch-specific delivery for product and supplier qualification and for validation by regulatory authorities.

The validation package offers all kinds of information for product and supplier qualification needed by the pharmaceutical industry and required by regulatory authorities. It contains information about the Duran Group, quality management, production process, product specification, article drawings, certificates, samples and explanation regarding labelling and batch certificate, distribution channels, batch certificate with certificate of analysis, conformity certificates (USP, EP, JP), REACH, RoHS, BSE/TSE, food safety and biocompatibility.

The Duran Pure solution primary packaging material conforms to the current Pharmacopeia standards, is free of plasticisers and needs no extractable and leachable studies because glass is practically inert.

For further information contact Schott Australia for your nearest distributor.