Sterile and depyrogenated vials & closures from the clean room

Available processes

• Purified water rinse (de-ionised / de-mineralised water)
• Packing in low-particle environment
• Steam sterilisation
• Hot air sterilisation
• Hot air depyrogenation
• E-Beam sterilisation in co-operation with contract partners
• Individual pack sizes
• Individual combination of products per unit
• Production of small, medium or large quantities

Quality control

• Validated process
• Skilled staff
• IQ/OQ - equipment qualification, rotative PQ
• Visual inspection for visual defects of 100 % of the finished products
• Analysis for sterility and BET test (bacterial endotoxin-test) carried out by an independent microbiology laboratory
• Detection limit BET: <0.001 EU/ml
• Particle counting according to USP 788