Glass Delamination

Considering the world of commercial transparent polymers, Daikyo Crystal Zenith® cyclic olefin polymer (COP) clearly stands out – having very good resistance to oxygen/water and compatibility with drug product (it comprises only carbon and hydrogen). Other transparent polymers may suffer limitations, in one or more ways. For example, poly(vinylidene chloride) has outstanding resistance to oxygen/water, but lacks compatibility; sterilization can result in release of HCl. For parenteral drug products, polymer-based containment/delivery systems have many advantages compared to glass.

Cell therapies offer a powerful new approach to treat cancer and other serious conditions. The manufacture and supply of these therapies is complex – to address the short shelf lives of such living products, storage and shipping is done at cryogenic temperatures (liquid nitrogen, approximately -180^oC). A challenge is selecting the right container system.

As global healthcare systems become more heavily reliant on radiopharmaceuticals for diagnostics and treatment, ensuring that the radioactive drug is safely contained for the duration of its shelf life has never been more vital.

To reduce and detect particulate matter is a shared responsibility between Container Closure component suppliers and the pharmaceutical industry. Keeping the patient´s safety in mind, lively discussions about particle inspection were held in the panel session at the PDA Conference on Freeze Drying Technologies.

Diane Paskiet, Director, Scientific Affairs, serves as co-chair for the 2014 PDA Packaging Conference: Pharmaceutical Packaging Systems – Current and Emerging Practices, Technologies and Materials, which will be held at the Washington Marriott Wardman Park, Washington, D.C. on May 20-21, 2014.

Even though glass syringes are predominantly used for primary containment of parenterals, the (bio)pharmaceutical industry continues to cope with certain limitations associated with glass containment systems. This is especially true when the drug is administered via prefilled drug-delivery systems such as auto-injectors or pens where glass cracks and breakage can be a serious risk for patients.