Sterile Open Vials
Pyrofree® Sterile Open Vials manufactured from SCHOTT Type I Fiolax® Glass tubing, supplied with full Sterility and Endotoxin Certification.
SCHOTT Fiolax Type I Glass Vials are processed and depyrogenated under cGMP conditions to produce Pyrofree® Sterile Open Vials, which are supplied with full Sterility and Endotoxin Certification.
Pyrofree® is the only packaging process that enables the vials to be depyrogenated in their final packaging which eliminates any risk of endotoxin contamination during the oven exit or further handling.
In addition, as vials are packed under vacuum, the visible integrity of this vacuum guarantees the sterility of the vials and also provides tamper evidence.
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Your choice of Type I Glass Injection Vial is first washed with WFI (Water For Injection) then packed under vacuum into two layers of PEEK polymer, a novel polymer able to withstand the high temperatures of a depyrogenation oven.
The glass vials in the PEEK pouches are then sterilised by dry heat in a depyrogenation oven according to a validated process.
They are then vacuum packed in a third PE/EvOH/PA pouch to offer external protection.
The major benefit of using the conventional dry heat sterilisation method to process these Sterile Open Vials is that, unlike sterilisation through EtO, any trial work conducted using these vials is easily replicated on scaled up production equipment.
Please Contact Us for further information.