Cleanrooms are Controlled environments required for contamination sensitive industrial activities. We design cleanroom HVAC systems to keep low level of pollutants such as dust, airborne microbes, aerosol particles and chemical vapors. At Comfonomics we do an in-depth study of all the factors required fr a proper functioning Cleanroom.
Different industries require ail filtration and purification to suit their specific needs and we provide the combination of solid, gases filtration and sterilisation as required.
We undertake holistic Cleanroom HVAC Design approach taking into account various factors like :-
Contamination Source and Generation, Air Change per Hour, Air Pressure, Temperature, Humidity, Air Flow, System Architecture, Automation, Measuring Systems, Feedback Controls, Electrostatic discharges, and Future Proofing to cater to specific needs of your application for Solid, Gases, and Air borne disease causing living organisms.
Sterilised Environment is essential in pharmaceutical manufacturing to ensure non presence of any particles in the manufacturing space which may reduce the sterility of the product being manufactured by introducing bacteria in the space.
Major Pharma Activities which require Cleanrooms are-
- External Drugs
- Internal Oral Drugs
- Betelactum Drugs
- Powder and Tablets
- Salines and Injections (Intravenous drugs)
Since the source of bacterial contamination are also the personnel present inside the manufacturing zone, we focus actively on real time contamination monitoring and maintaining effective and efficient feedback loop for contamination reduction. Also depending on the criticality of various processes cleanroom zoning is done to optimize the Cleanroom system performance.
Requirement for food and Beverages clean room is dependent on the type of food product being manufactured. Also with increasing awareness amongst consumers about the healthiness of food and beverages they eat and drink, manufacturers have also started incorporating clean rooms for their processes.
Cleanroom helps in preventing the spread of bacteria, yeasts and molds that can grow in moist conditions of the process areas leading to
- Air conditioning equipment atop a modern building
- Germ contamination of foodstuffs
- Limitation of shelf life
- Reduced Freshness
- Reduced Yield
There is a need to limit the number and size of any form of particle inside with the manufacturing facilities to avoid particulate contamination which lead to reduced reliability and durability of machines, machine failures, poor product quality, defects, etc.
We design cleanrooms with both laminar and turbulent air streams depending on specific applications and ensure efficient energy use in the running of the cleanrooms to provide better return on investments.
Industries requiring cleanrooms are:-
We design Cleanrooms achieving maximum concentration limits for range of particle sizes confirming to
- ISO 14644-1 Cleanroom Standards
|ISO 14644-1 Cleanroom Standards|
|Classification||Maximum particles/m³||FED S TD 209 E Equivalent|
|ISO 3||1,000||237||102||35||8.3||0.29||Class 1|
|ISO 4||10,000||2,370||1,020||350||83||2.9||Class 10|
|ISO 5||1,00,000||23,700||10,200||3,500||830||29||Class 100|
|ISO 6||1.0 x 10⁶||2,37,000||1,02,000||35,000||8,300||290||Class 1,000|
|ISO 7||1.0 x 10⁷||2.37 x 10⁷||10,20,000||3,50,000||83,000||2,900||Class 10,000|
|ISO 8||1.0 x 10⁸||2.37 x 10⁷||1.02 x 10⁷||35,00,000||8,30,000||29,000||Class 1,00,000|
|ISO 9||1.0 x 10⁹||2.37 x 10⁷||1.02 x 10⁷||3,50,00,000||83,00,000||2,90,000||ROOM Air|
2. FED S TD 209 E Standards
|US FED Standards 209 E Cleanroom Standards|
|Classification||Maximum particles/ft³||ISO 14644-1 Equivalent|
|100000||3.5 X 10⁶||7,50,000||3,00,000||100000||700||ISO 8|
|US Fed. Standard 209E was officially cancelled by the General Services Administration of the US Dept. of Commerce November 29, 2001, but is still widely used.|
3. GMP EU Classification
|GMP EU Classification|
|At Rest||In Operation|