Injection

• The injection is carried out in an ISO 7 clean room.
• An automatic feeding system supplies most of the injection molding machines with raw materials.

Medical tubes Extrusion

• The extrusion of our medical tubes is carried out in an ISO 7 clean room with a MAILLEFER extrusion line including a diameter controller from ZUMBACH: 
  • Tube diameter range: 1.5 to 12mm
  • Tolerances on I.D and O.D: ± 0.05 mm

Infusion Sets Assembly

• Assembly is made in an ISO 7 clean room.
• Flexible Unit for assembling of infusion sets, transfusion sets, extension lines, Chemio lines and other products. The customer requirements are considered when making the choice of the components for each type of infusion line.

Packaging

• Packaging is carried in an ISO 7 clean room and complies with ISO 11607 requirements.
• Packing machines can handle soft and rigid films and are equiped by flexo printers to print paper with customers requirements.

Sterilization

• Sterilization done with Ethylen Oxide according in full compliance with ISO 11135-1 requirements.
• Two sterilization plants, conform to EN 1422 and fully automated, are available:
  • Chamber 1: 10 m3 for 4 pallets
  • Chamber 2 from STERIMED, Switzerland: 34 m3 for 12 pallets

Quality controls & bioburden Tests

• In process control lab
• Accredited control lab
  • At reception
  • Physical controls
  • Chemical controls
  • Microbiological controls
• Strict application of the normative requirements for each medical device
• Initial Bioburden measurement