Clean Room Classification Pharma Industry

Modular Clean room in Pharmaceutical Manufacturing Facility

Modular clean room are the solution where higher degree of cleanness is required in some places like pharmaceutical manufacturing and in healthcare and Space and computer chip manufacturing places. Particle contaminants are not just particles but they harbor bacterial as well as fungal and viral contaminants, therefore it is important to eliminate the particles from air in the core manufacturing area, Sterile injections are required to have almost no viable microbial and viral or fungal count in the filling and manufacturing area.

Such clean environments are achieved by filtering air going into a room through High efficiency particulate air filter, filtered air is then conditioning the air with respect to temperature and humidity.

Air is forced inside the clean room with pressure from ceiling top, at the top of ceiling of a clean room at the point where air inlet in clean room is provided, these inlets are fixed with High efficiency particulate air filter, these filters filter almost 99.997 % of the air, and removes all particles of size greater than 0.3 micron from circulating air, while particles are removed from air bacterial and viral fungal contaminants which is mainly there over the particles also get filtered out and the air can be made free of bacterial and fungal contaminants, class 100 in pharmaceutical manufacturing is such area which is considered free from bacterial and fungal contaminants, in addition such areas are provided with laminar air flow which ensures that the particles are swept away from the area and prevents contamination of exposed sterile product. Also see efficiency of HEPA filter efficiency of HEPA filter.

Construction of Modular Clean Room in Pharmaceutical Industry 

Modular panels with smooth surface are available, some modular panels consist of fireproof puff inside the panels which is preferred where the product handled is flammable or where there is a risk of fire, fire proof modular puf panels are used, puff panels of thickness of 80 mm and 60 mm are available depending on the strength roof side panels are selected. Advantage of modular panels is they are easy to install, provide smooth surface, edges can be rounded and almost airtight fitment can be achieved.

Another big advantage of puf panels is they are cheaper in cost as compared to other materials which might be required to provide similar performance quality.

Surface is smooth and easily cleanable, disinfection and electric fittings also can be done easily, the look is very nice, and are recommended for sterile dosage form manufacturing areas. Modular view panels can be fitted with static or dynamic pass boxes as required, AHU ducts supplying the air into the clean room can be fitted easily, with grills.

Raisers air the ducts through which air is going out returning to the Air handling unit, these are fitted with 3 microns, or 10 micron return air filters, which helps to eliminate contamination of air with product contaminants.

Moulded puf panels are fabricated in a manner that one does not require to fit a raiser for return air, the sidewall panel itself is fabricated hollow and cut and a inside the panel return air duct is formed, which gives seamless look to clean room

Types of Clean Room 

There are following types or Classification of Clean room in pharma industry, Class A , Class B, Class C, Class D.

Class 100, Class 1000, Class 10000, Class 100000

Does Surrounding environment of a Clean room affect the quality of Air or cleanliness?

Surrounding environment of a pharma company does affect the level of contaminants in the air is dependent on the environment surrounding a pharmaceutical company.   

It should be surrounded by greenery or the land should be planted and grass lawns should be prepared over empty land so that the dust is not generated. Even vehicular traffic and their emissions do affect the environment condition and it will have an impact on the clean room in pharmaceutical companies if it is situated near a heavy traffic area, or in a city.

Can AHU be installed in an open area out of a pharmaceutical manufacturing unit.

Therefore, it is required by Pharmaceutical GMP guidelines that air handling units ( AHU ) should be installed inside a closed area where the environmental ventilation is available to cater the fresh air needs of AHU and intern clean room.

Classification of Clean room is provided over here

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