Clean room is an enclosed clean work space employing control over the particulate matter in the air with temperature, humidity and pressure control. All clean rooms must not exceed a particulate count as specified in the air.

We are all aware that the times are changing in Indian industries in all sectors have to gear up to meet the new challenges of changing time. The manufacturing practices of the past are no longer considered good enough. The quality standards are being revised constantly to meet Indoor Air Quality (IAQ)
The laminar air flow principle was introduced in clean room technology. This was considered to be the biggest revolution in clean room design engineering to maintain IAQ.
BATS built Clean rooms are compliances with:
|
: |
Global standards for cleanliness levels and associated controlled environment |
|
: |
For Current Good Manufacturing Products (CGMP) |
|
: |
American society of heating, refrigeration and Air conditioning Engineers. |
|
: |
American conference for Governmental industrial Hygienists. |
|
: |
Code of practice for Air distribution duct work |
GENERAL REQUIREMENTS
- Clean rooms to be built and operate in an area where particle generation levels are minimum.
- Environmental control
- Clean room air pressure
- Air changes rate of air flow
- Temperature range
- Humidity range
- Noise level
- Vibration levels
- Microbial contamination
- Other factors like lighting, internal equipment load, occupancy, electromagnetic radiation, radioactive particles, gases, vapors.
CLEAN ROOM DESIGN REQUIREMENTS
- Area to be defined to built clean room space.
- Entry ways
- Ante rooms , change rooms
- Air handling system with filtration
- Air-conditioning equipment
- Clean room furniture’s, equipments
- Clean room lighting and fire protection
- Desired level of cleanliness.
AIR CLEANLINESS CLASSIFICATIONS:
CLASS AS PER IS 14644 |
NUMBER OF PARTICLES PERMISSIBLE |
CLASS AS PER FED STD 209 E |
|||||
0.1 Micron |
0.2 Micron |
0.3 Micron |
0.5 Micron |
1.0 Micron |
5.0 Micron |
||
ISO1 |
10 |
2 |
- |
- |
- |
- |
- |
ISO2 |
100 |
24 |
10 |
4 |
- |
- |
- |
ISO3 |
1000 |
237 |
102 |
35 |
8 |
|
Class 1 |
ISO4 |
10000 |
2370 |
1020 |
352 |
83 |
|
Class10 |
ISO5 |
100000 |
23700 |
10200 |
3520 |
832 |
29 |
Class 100 |
ISO6 |
1000000 |
237000 |
102000 |
35200 |
8320 |
293 |
Class 1000 |
ISO7 |
- |
- |
- |
352000 |
83200 |
2930 |
Class 10000 |
ISO8 |
- |
- |
- |
3520000 |
832000 |
29300 |
Class 100000 |
ISO9 |
- |
- |
- |
35200000 |
8320000 |
293000 |
- |
Note: particle counts generally carried out at rest for cleanliness level test.
MODULAR CLEAN ROOM |
As IAQ is a major concern in the clean room engineering to meet the desired class conditions, today, the Modular clean rooms of pre fabricated panels system are more popular for the following advantages |
|
CLEAN ROOM EQUIPMENTS
BATS also manufactures clean room equipments using a combination of GI powder coated with SS construction & all SS construction to meet class 100 cleanliness level and in line with GMP. These equipments are generally used in manufacturing process of pharmaceutical & surgical / medical products, research laboratories, bio technology, precision engineering industries, hospitals & Diagnostic laboratories.
The following are the clean room equipments manufactured by BATS under standard / non standard size and designs depending upon the applications.
- Horizontal / vertical laminar flow benches
- Static & dynamic pass boxes
- Garments racks & cross over benches
- Sampling & dispensing booths
- Bio safety cabinet
- Fume cupboards.
- Glove boxes, HEPA filter modules.
- Entry air showers.
- Lab tables, SS storage racks.