Clean Rooms

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
  • Capsules
  • 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

Some food processing activities that requires cleanrooms are:-

  • Juices
  • Dairy Prodcuts
  • Breweries
  • Meat Processing
  • Bakeries

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:-

  • Data Centres
  • Electronics
  • Petrochemicals
  • Automobiles
  • Paintings
  • Chemicals

We design Cleanrooms achieving maximum concentration limits for range of particle sizes confirming to

  1. ISO 14644-1 Cleanroom Standards
ISO 14644-1 Cleanroom Standards
ClassificationMaximum particles/m³FED S TD 209 E Equivalent
ISO 1102.371.020.350.0830.0029 
ISO 210023.710.23.50.830.029 
ISO 31,000237102358.30.29Class 1
ISO 410,0002,3701,020350832.9Class 10
ISO 51,00,00023,70010,2003,50083029Class 100
ISO 61.0 x 102,37,0001,02,00035,0008,300290Class 1,000
ISO 71.0 x 102.37 x 1010,20,0003,50,00083,0002,900Class 10,000
ISO 81.0 x 102.37 x 101.02 x 1035,00,0008,30,00029,000Class 1,00,000
ISO 91.0 x 102.37 x 101.02 x 103,50,00,00083,00,0002,90,000ROOM Air

2. FED S TD 209 E Standards

US FED Standards 209 E Cleanroom Standards
ClassificationMaximum particles/ft³ISO 14644-1 Equivalent
1357.5310.007ISO 3
103507530100.07ISO 4
1003,5007503001000.7ISO 5
100035,0007,5003,00010007ISO 6
100003,50,00075,00030,0001000070ISO 7
1000003.5 X 10⁶7,50,0003,00,000100000700ISO 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
ClassificationMaximum particles/m³
At Rest In Operation
Class A3,52020350020
Class B3,520293,52,0002,900
Class C3,52,0002,90035,20,00029,000
Class D35,20,00029,000  

Clean Room Works

Intas Pharma - Ahmedabad
Otsuka Pharma - Ahmedabad
Harsoria Pharma - Baddi