Sterile and pyrogen-free products
Pyrogen-free products are required in areas such as pharmaceuticals, medical technology, food production, biomedical research and blood banks. They prevent pyrogens, which can cause fever or adverse reactions, from entering the human body by injection.
We wash, sterilise and depyrogenate vials and caps and pack them. I can customise the vial, cap and packaging unit to meet your individual requirements.
Sterile & depyrogenated vials and closures according to customer specifications
Choose a vial and cap from our comprehensive range. We clean, sterilise and depyrogenate the vials and caps and deliver them to you double-sealed with a certificate.
Our processes are fully validated and our devices are all IQ / OQ qualified. We only use trained personnel. Our products only leave our clean room after a 100% visual inspection. Each product in a production batch is analysed for sterility and BET (bacterial endotoxin test) by an external accredited laboratory. The detection of the BET test is <0.001 EU / ml.
WASH
Your vials and caps are cleaned in our specially configured laboratory dishwasher
STERILIZATION / DEPYROGENATION
The vials and caps are sterilized and depyrogenated by means of hot air, in an autoclave by means of an e-beam.
INDIVIDUAL PACKING
Custom packaging of vials and caps in the product protection workbench (LAF)
QUALITY CONTROL & CERTIFICATE
Sterility and freedom from pyrogens are tested in an accredited laboratory and confirmed accordingly by the issue of a certificate.