The importance of clean production facilities in pharmaceuticals is difficult to overestimate because the production of high quality medicine is impossible without a cleanroom. This room is a kind of barrier that prevents the penetration of contaminants: particles of dirt, dust, microorganisms, bacteria in the air.
The design of clean room provides protection against pollution and allows decontaminating not only the product, but the entire production process, as well as everything that comes into contact with it: personnel, technical outfit, etc. We create a completely controlled environment where not only the quantity of suspended particles per cubic meter, but also its properties such as temperature, humidity, lighting level, heat loss can be monitored. Clean rooms for pharmaceutical industry used for the production of infusion and injection preparations, creams, emulsions, drops, antibiotics and other medicine. Moreover, the packaging must be carried out exclusively in a clean room.
PHARMACEUTICAL CLEANROOMS: CLASSIFICATION
In accordance with GMP, which is one of the main regulatory documents governing the construction, premises for pharmaceutical production are separated into the following areas (by purity zones)
Zone A. It is a local clean zone where the most important production processes are located and risk of contamination is not allowed. Such processes include filling, opening, sealing ampoules and others. Regulations for the cleanliness of airspace in this zone are the highest, therefore within its limits there is a laminar air down flow r, the speed is from 0.36 to 0.54 m/ s.
Zone B is a local zone surrounding zone A, designed for aseptic production and preparation. Requirements for cleanliness of the airspace in such a room is not so high, it is allowed up to 3520 particles sized 0.5 microns in the equipped state and 352,000 in the operated one.
Zone C and Zone D are the premises used for less critical stages of pharmaceutical production of sterile products. Zone C is used for the manufacture of liquid medicines, so the requirements for the purity of space are higher compared to zone D used for solid preparations, since water is a favorable medium for the development of microorganisms.
Despite the fact that the GMP regulations do not establish specific requirements for air purity for the manufacture of non-sterile medicinal products, clean rooms for their production are also used to increase best before date and prevent infection of the drug with bacteria. The production of clean rooms in SanBela company is carried out with full consideration of existing norms and international standards: GOST, ISO, GMP. After the installation is finished, the finished object passes the appropriate certification and validation.
PHARMACEUTICAL PRODUCTION: PURITY PROTECTION MECHANISMS
Monitoring suspended fragments in clean rooms air is carried out in different ways. In general, the main emphasis is on preventing the entry of substances from outside, as well as their generation:
- Solutions related to equipment;
- Special fencing around technological elements;
- Use special clothing by operator and personnel;
- Capture of dust and other contaminants directly at the site of their formation.
After the above actions are provided, the following approaches are used to control the level of air contamination in clean rooms: air purification with HEPA filters, airflow corresponding to the appropriate room class, ensuring the required differential pressure between rooms. Pressure differences creates the effect of a barrier that does not allow contamination from one room to permeate into another. The pressure difference between adjacent rooms should be 10-15 Pa.
PRODUCTION OF PHARMACEUTICAL PREMISES FROM SANBELA
SanBela has been presenting its products for more than 11 years, offering a full range of design, construction, installation and maintenance of cleanrooms. Designs are carried out in accordance with GMP and the international standard ISO 14664-1. We always guarantee production in time. If You still have questions about the premises for pharmaceutical production, we are ready to provide you with all the essential information. Send us inquiry, by e-mail, call or use the feedback form.