Certified according to EN ISO 14644-1 classes 7 to 8

Our cleanrooms are located at Sainte Hélène du Lac in the heart of the French Alps. The cleanrooms are and certified according to EN ISO 14644-1:

  • The cleanroom for bag production and assembly are certified ISO 7
  • The cleanroom for the injection moulding is certified ISO 8. An ISO 7 environment is created with a FFU placed over the machine where the parts are produced.
Our Quality Management System ensures strict compliance with standards and internal procedures in the maintenance and operation of the cleanrooms and the equipment used in this environment.