Pall Corporation's Pyrofree vials product range provides filling processes with ready-to-use glass vials depyrogenated and sterilised according to industrial operations methods applied in vaccines, biotechnology, pharmaceuticals and in hospitals.
The packaging is specifically for the processing of small batches such as clinical and technical lots, orphan drugs or personalised medicines.
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 crucial 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 the properties and stability of the drug. In this case, sterilisation of primary packaging (e.g. by ethylene oxide sterilisation) represents a risk of introducing chemical agents into drug substances.
The Pyrofree vials allow sterilisation 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 2ml, 5ml, 10ml and 20ml, supplied with grey stoppers of 13mm and 20mm diameters, made of bromobutyl with Flurotec coating.