In the in-house controlled zone we wash, sterilise and depyrogenise vials, bottles and closures to customer specifications.

Sterile and depyrogenated vials & closures from the controlled zone

Available processes

  • Purified water rinse (de-ionised / de-mineralised water)
  • Packing in low-particle environment
  • 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 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 accredited microbiology laboratory
  • Detection limit BET: <0.001 EU/ml
  • Long term objective: GMP accreditation