Medical Devices

Medical Devices are a vast variety of products including syringes and patches to sophisticated heart pacemakers or orthopedic implants.

Medical devices manufacturing has extremely high quality requirements and is highly regulated.

Medical Devices can be divided into two main categories: products which come in contact with the human body temporarily like syringes and surgical instruments, and products which are permanently placed inside the human body.

Medical devices of the first category are mostly produced in automatic lines, with no human contact. Critical process stages are carried our in micro-environments of cleanness conditions class 1.000 (ISO 6) or class 10.000 (ISO 7) whereas the surrounding area is maintained at cleanliness 100.000 (ISO 8). Final production stage includes sterilization.

Medical devices of the second category such as heart peacemakers, artificial heart valves, orthopedic implants etc. have a sophisticated production process and require human interference in many delicate process stages. What is more many of those products do not allow terminal sterilization. Such products are mainly produced in clean zones of class 100 (ISO 5) while the surrounding area is maintained in class 1.000 (ISO 6) or 10.000 (ISO 7). When it is feasible critical processes are carried out in isolators and working personnel can interfere through gloves. When direct contact with the product is needed critical works are taken place in special open cabinets where ultra-cleaned air produced by ULPA filtration is constantly blown to the working personnel and the whole area is maintained at cleanliness 100 (ISO 5).

Frigomech can provide solutions including cleanrooms structural materialization, ULPA filtration as well as HVAC equipment and automation control which effectively meet the high commendable requirements of Medical Devices Manufacturing.

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