The Cleanroom is an environment built and used to minimize the introduction, generation and retention of airborne particles inside it. The Cleanrooms are made according to the “dynamic containment” technique, according to which the atmosphere of the rooms is kept in constant overpressure in order to avoid the introduction of potentially polluting reverse flows.
Differential pressures are monitored continuously by pressure gauges.
The Cleanroom is an environment where relevant parameters are monitored such as: temperature, humidity, number of particles, differential pressures between the rooms. In all operating conditions, the filtered air ventilation must maintain a positive pressure with respect to the surrounding areas of a lower class and guarantee an effective exchange of air.
The Cleanroom must meet cleaning standards, so those that define class verification. The subdivision of the classes is generally represented by Classes A and B “sterile“, C and D “controlled“. Production must take place in environments where personnel, material and equipment are accessed through airtight compartments, which must be kept clean and ventilated appropriately.
All cleaning material that is introduced in cleanrooms must be cleaned in two operations:
The material that at this point is introduced in the clean room must be kept in appropriate closets in the clean room itself.
Specifically, an example of dressing to do before accessing at the Clean Room:
• enter the locker room (after an air shower if present) with general work clothing; remove shoes and clothes; wear sterile gloves (according to the classification of the clean room, in agreement with the client)
• start at the bench which separates the gray area from the white area, remove disposable gown, gloves and headgear, wear new gloves, cap and sterile overalls;
•access the Clean Room.
• sit on the bench, put a footwear and pass the corresponding leg in the white area; operate in the same way with the other shoe and pass completely in the white area;
• take the sterile garments in sealed bags and go into the gray area;
• wear an undersuit or a disposable gown, headgear, wear slippers or clogs,
• remove watches, rings, bracelets, chains, etc; remove any cosmetic products from face and hands and wash hands thoroughly with disinfectant soap;