What are the cleanliness standards for production facilities that comply with GMP requirements for medical devices of classes I–III? 

As you know, the medical device industry is divided into three categories:

The first class is low-risk products whose safety and effectiveness can be ensured through normal control measures. For example: blood pressure monitors, percussion hammers, oxygen bags, sterilizers, etc.

The second category is medium-risk medical devices that require strict controls to ensure safety and effectiveness. These include medical products whose safety and effectiveness are subject to control, for example: electronic thermometers, electroencephalographs or electrocardiographs, ultrasound machines, gastroscopes, dental equipment, masks, etc.

The third category is high-risk medical devices that require special measures and strict controls to ensure their safety and effectiveness. These are medical devices that are implanted into the human body to support and preserve life; pose a potential hazard to humans and require strict monitoring of safety and effectiveness. For example: disposable sterile medical devices, orthopedic implants, implantable medical devices, corneal corrective lenses, neonatal incubators, hollow fiber dialyzers, etc.

What are the standards for GMP-compliant manufacturing facilities for various categories of medical devices?

01. The production of medical devices intended for implantation and insertion into blood vessels must be carried out in clean rooms with a cleanliness level of at least 10,000. For example: vascular stents, artificial vessels, venous catheters, intravascular catheters, etc.

02. The production of medical products that come into contact with damaged human skin surfaces and mucous membranes must be carried out in clean rooms with a cleanliness level of at least 300,000. For example: medical cotton swab, intrauterine device, endotracheal tube, etc.

03. Medical devices implanted into human body tissue, as well as directly or indirectly in contact with blood, bone cavity or unnatural cavities, must be produced in clean rooms with a cleanliness level of at least 100,000. For example: pacemakers, blood filters, venous needles, artificial bones, etc.

04. The production of primary packaging that does not come into direct contact with the surfaces of sterile medical devices must be carried out in clean rooms with a cleanliness level of at least 300,000. For example: materials for primary packaging of catheters, dispensers, syringes, infusion systems.

05. In the absence of special requirements for the production process, the temperature in clean rooms (zones) with air cleanliness class 100 and 10,000 should be 20–24 °C, and relative humidity — 45–65%; the temperature in clean rooms (areas) with air cleanliness class 100,000 and 300,000 should be 18–26 °C, and relative humidity — 45–65%. If there are special requirements, these indicators must be determined in accordance with technological requirements.

06. Manufacturing requiring special requirements or sterile processing operations should be carried out in local cleanliness class 100 zones and in cleanrooms class 10,000. Such operations include, for example, compression and drug coating of vascular stents, as well as the filling of anticoagulants and preservative solutions in the production of blood bags.

07. The temperature in rooms for personnel disinfection should be 16–20 °C in winter and 26–30 °C in summer.

08. To avoid cross-contamination, it is necessary to equip rooms for the disinfection of personnel, materials, tools, a laundry room, a temporary storage room, a room for cleaning work tools, etc. Each of these rooms must be independent to ensure the rational movement of people and materials.