With the aim to provide to the Clients a service, as comprehensive as possible, Midial S.p.A has an extremely well equipped laboratory for chemical-biological analysis, which is subject to the Company’s quality system as well.
It is for this reason that Midial S.p.A., from the services point of view, is in the position to offer its Clients a complete assistance, from the formulation of the validation protocols concerning the verification of the “clean rooms”, to the sterilization process and the performance of the analysis required.
For the companies operating in the medical device sector, tests to determine the amounts of ethylene oxide residue are carried out, in conformity to the Normative UNI EN ISO 10993-7, pyrogen analysis (LAL test).
The microbiology laboratory can perform controls on the products, as well as in the production areas.
As well as other tests carried out are: :
- Bioburden determination (F.U.I. X ed., ISO 11737-1)
- Medical Devices Sterility (F.U.I. X ed. ISO 11737-2)
- Air particles contamination (EN ISO 14644-1 FED-STD 206)
- Air Microbiological contamination (F.U.I. IX Ed.)
- Surfaces Microbiological contamination (F.U.I. IX Ed.)
The quality system developed and applied by MIDIAL S.p.A. is in compliance to ISO 13485 and ISO 9001 , as certified by the TÜV of Monaco (certification number Q2 97 10 31125 001).