Introducing the DURAN® PURE DEVELOPED FOR PHARMA

DURAN® PURE is a range of high-quality bottles and closures developed for the needs of the pharmaceutical industry. DURAN® PURE meets the requirements of the international pharmacopeias and is available with the certificates required by the regulatory authorities.

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.
 

DURAN® PURE, 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). 

For more information, please contact us at sales@sentori.com.my