Pall launches pyrofree sterile, ready-to-use glass vials

The packaging has been specifically designed for the processing of small batches such as clinical and technical lots, orphan drugs or personalized medicines.

The Pyrofree vials product range is a unique solution providing filling processes with ready-to-use glass vials depyrogenated and sterilized according to industrial operations methods applied in vaccines, biotechnology, and pharmaceutical industries, and in hospitals. The packaging has been specifically designed for the processing of small batches such as clinical and technical lots, orphan drugs or personalized medicines. The Pyrofree vials product range offers a unique opportunity to simplify, facilitate and accelerate the filling of these products.

A pyrogen is defined as any substance that can cause a fever, such as endotoxins. The injection of endotoxins into the blood can cause severe hazard to a patient and in worst case, lead to septic shock. Depyrogenation, or the removal of pyrogens, is therefore a crucial need in the aseptic filling process of parenteral drugs. Primary packaging of injectable drugs is particularly controlled for the absence of pyrogens and any chemical agent which may alter drug substances properties and stability. In this case, sterilization of primary packaging (e.g., by ethylene oxide sterilization) represents a risk of introducing chemical agents into drug substances.

The Pyrofree vials product range addresses these needs thanks to its unique packaging technology, allowing sterilization and depyrogenation of the vials by dry heat in their primary packaging under vacuum. The Pyrofree process results in ready-to-use vials which can be used for the filling of injectable drugs without using washing and depyrogenation equipment from the filling line.

The Pyrofree vials product range consists of Type I clear glass vials of 2 mL, 5 mL, 10 mL and 20 mL, supplied with grey stoppers of 13 mm and 20 mm diameters, made of bromobutyl with Flurotec coating.