Clean Room
If packaging of finished products is a secondary stage at the majority of other plants and factories, at the ABM Technology Medical Product Plant this is an integral part of manufacturing process. Really, we are performing not simple, but a sterile packaging of our products with very strict quality criteria. The sterile packaging of medical instruments carried out at our ABM Technology Medical Product Plant is divided into the intermediate and final ones.
The tasks solved at the stage of intermediate sterile packaging of medical instruments are as follows:
• preservation of high-grade of chemical purity of their contact surfaces reached at the stage of ultrasonic cleaning (washing);
• their preparedness for bactericidal radiation sterilization and final sterile packaging before sending to the customer
There is a special manufacturing area named “clean room” arranged at our enterprise for the intermediate sterile packaging of medical instruments. It is fully consistent with ISO 7 European Specialized Standard as confirmed by the relevant Certificate and systematic laboratory research (verification inspections).
To assure required sterility of works, a strict mode of cleanliness is organized and maintained in our “clean room”, which list of measures includes the following:
• reliable isolation from the environmental contact (outdoor air and neighbouring manufacturing facilities);
• reliable cleaning (filtering) of incoming and circulating air with the help of high-efficiency HEPA filters assuring retention of up to 99.995 % of all airborne finely dispersed particles;
• periodic thorough sanitization of the premise with a focus on bactericidal treatment of all surfaces;
• control of pass and access of the employees and officials of the enterprise;
• regular medical examinations of the employees;
• work with treated (packaged) products exclusively wearing insulated clothing (overalls and gloves) and only with the use of hand tools in order to exclude the contact of sterile surface of manufactured products with the hand skin of packers.
The result of treatment in the “clean room” is an intermediate sterile packaging of medical products in boxes with the full preservation of chemically pure condition of their surfaces reached at the stage of ultrasonic washing. In this state, some of our products, namely the prosthetic implants, are ready for forwarding to the final technological stage of bactericidal radiation sterilization with their final sterile packaging.