Services

Packaging

  1. Packaging in blisters (multilayer foil + medical paper)

Gas sterilization

  1. According to the following parameters
    • sterilisation medium – ETO
    • hypertensive sterilization up to 2.5 bars
    • according to EN ISO 11135-1 standard
  2. Chamber dimensions
    • height 1950 mm
    • width 1200 mm
    • volume 26 m3
    • 10 Euro pallets

Process validation

  1. Validation of packagin
    • installation qualification
    • operational qualification
    • process qualification
  2. Validation of sterilisation
    • installation qualification
    • operational qualification
    • process qualification with microbiological testing