Our quality commitment :
Quality management has been the central value our corporate culture for more than 20 years, that’s what each manufacturing has is dedicated quality department.
Our quality standards : ISO 9001, ISO 13485 and GMP (Good Manufacturing Practices), allows to guarantee the conformity of ours products and ensure healthy and safety products.
Our clean rooms :
- 6 clean rooms in overpressure to dust control class ISO 8
- 1 clean room in controlled atmosphere overpressure class ISO 7
Our controls for thermoformed packaging :
- Annual qualification of the clean room and its airlock by an approved laboratory.
- Mirage workplace
- Bioburden Test : at least at the beginning and end of production.
- Piece aspect : distribution and material aspect ; absence of waves, folds and breaks; absence of foreign body
- Sealing range: flatness, absence of marks, impacts and foreign bodies.
- Cutting : centering, non-cutting fastening points, no burrs, cutting of eyelets and functional openings.
- Sealing sachets and double sachets: absence of chimney and folds against welding; absence of bubbles and waves around the weld, absence of foreign matter; traceability label stuck on first bag protected from damage.
- Functionality of the piece : tailor made according to functionality and for exemple : closing/opening, sharpness of clipping, folding hinges, tests with medical device client in conditions use.
- Specific control: according to realization and customer request, indicated on quality documents systematically present in production and created for each product belonging to the customer.
Our controls for flexible bag :
- Control services for pockets (routine): Tensile testing on welds, regular monitoring of residual weld thicknesses, airtightness tests (destructive), suspension filling test (destructive), tube holding test.
- Additional services (for pockets): unitary or statistical tightness test with specific testers (non-destructive), achievement for customers of product-specific usage test, aging test, monitoring of product contamination rate, taken in charge of the complete sterilization validation of the customer product (OE or Gamma) with all related ancillary services (analysis laboratories)
- All of our production processes related to the medical activity, are qualified according to the standards in force (welding, gluing, sealing sterilization bag (ISO 11607-2) and leak test with tester)