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By B. Bhattacharjee
Director, Bhabha Atomic Research Centre
Mumbai
B. Bhattacharjee is a chemical engineer with a masterís degree and a post-graduate training programme in Nuclear Science and Technology. A member of the Atomic Energy Commission, he was conferred the National Award ìPadma Shriî for his contributions to Nuclear Science and Technology.
The technologies involved in air cleaning and clean rooms play an important role in almost all the major activities in the nuclear fuel cycle, starting from fuel fabrication at the front-end to the nuclear reactor and then to the reprocessing and waste management facilities at the back-end. This technology is just as important in pharmacy/ radio-pharmacy, bio-safety, healthcare, electronics and for special applications in other sectors like defence, research and space technology.
The concept of clean environment and its management was first proposed about a century ago in the medical facilities when doctors felt the need for controlling infections of wounds due to bacteria and other micro-organisms. Although pioneer microbiologists and surgeons of those days tried to formulate the outline of a clean zone concept, it was not until the early sixties when the first serious attempt to develop an organised clean room with controlled environmental conditions in respect of temperature, humidity, air borne particles count, air changes per hour, illumination levels etc. was made.
The role of artificial dynamic ventilation was studied for the first time by the famous American engineer Willis Whitfield and his team at the Sandia Laboratories, who realized the concept of uni-dimensional or laminar air flow to create the so-called Piston Effect of Aerodynamics, for quick and effective removal of micro contaminants from clean space. The maturity of HEPA filters technology at around the same time made it possible to realize this concept and these filters quickly made their way into the air cleaning and clean room technology.
Clean rooms have come a long way since then and today we see diverse requirements of modern clean rooms in many spheres of activities, as we advance both in R&D and in the commercial sector. Their role in advanced technological areas like bio and genetic engineering, space and nuclear applications, advanced material sciences etc., is extremely important. In fact, clean rooms and air cleaning are almost mandatory in pharma, food and agro, micro-electronics and semi-conductors and healthcare segments.
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The perception of clean rooms have seen a sea change since the first clean room standards were formulated in the early sixties. While the class of cleanliness levels of Class 1,000 or Class 100 were thought to be stringent in those times, today Class 10 or even Class 1 is a practical proposition, with the latest standards specifying classes better than Class 1. The gradual degradation of our atmosphere by way of pollutions on one hand and the stringent quality control requirements on the other have put a great burden on engineers to build and maintain high class modern clean rooms. In fact, additional parameters like the levels of noise and vibration, ionising and electromagnetic radiation, etc., have also been included for controlled environment in clean rooms for certain special applications in the areas of material science, nuclear and space applications, etc.
The latest International Standards Organisation (ISO) standard on clean rooms is a step in this direction, which gives guidelines for classification of ultra pure clean rooms. International Standards Organisation has introduced ISO classification numbers for clean rooms from ISO-1 to ISO-9 and has released 2 standards ISO-14644-1 and ISO-14644- 2, wherein the objectives has been, to combine the best features of the different base documents available from Europe, Japan and the USA and this is a very welcome measure from the point of view of standardization.
These standards have also clearly spelt out the mandatory tests along with the optional tests that are necessary to demonstrate the continuing compliance of clean room standards.
Before we proceed further, it would be appropriate at this stage to have a look at the five means (5 P’s) that are available for the control of air borne particulate matter.
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There have been a series of major technological developments that have greatly assisted in achieving the daunting challenges posed to clean room industries for realization of their ever-increasing goals.
HEPA filters
Development of HEPA filters (high efficiency particulate air filters) in the
1940s, which formed the heart of the clean rooms, in filtering the air borne
particle contamination to levels of 0.3 microns at 99.97% efficiency, were originally
developed for nuclear applications, which were later on considered as an industry
accepted standard.
Test procedures were formulated using forward light scattering photometer for measuring performance of the HEPA filters after installation. As 0.3 micron size range were the most difficult to remove from the air stream at that time, this size of the particle was taken as the base for formulating the standards.
ULPA filters
Growing market demand from advanced science and technology calls for improved
efficiencies and that led to a new term in the clean room industry, i.e., ULPA
filters (ultra low penetration air filters) which provide a minimum of 99.999%
efficiency (0.001% maximum penetration) on 0.3 micron particles for achieving
better cleanliness classes and cleaner working environments. These are used
for ultra-clean rooms, where contamination levels have to be controlled at levels
better than that which can be achieved with conventional HEPA filters.

Boron free ULPA filters / Metal free HEPA
Boron free ULPA filters of 99.9997% efficiency for particles down to 0.12 micron
size for Class 10 and Class1 clean rooms are specially used in electronic/semiconductors/
wafer manufacturing industries, where tolerance to contamination level above
0.12 micron is also very critical and not permitted. These are special filters
specifically manufactured depending on the application and which are rated for
much higher efficiencies to avoid product contamination.
Similarly, metal free HEPA filters were developed by this centre for application in ultra trace analysis of materials.
Minipleat separatorless HEPA/ULPA filters
A separatorless filter pack made up of folds (or pleats) of micro glass fibre
media supported by micro fibre glass ribbons has been introduced in the late
90s, specially for Class 10 and better clean rooms, which has several advantages
over conventional HEPA filters, such as:
These filters are slowly finding their place in many critical applications replacing the conventional HEPA filters.
VLSI laser tested filters
As a result of the need for super clean environments, a new standard of air
cleanliness has emerged. The traditional standard of defining classes of clean
rooms in terms of 0.5 microns particles is no longer satisfactory. Particles
as small as 1,200 Angstroms (0.12 microns) must be removed with an efficiency
of 99.99995% to provide clean rooms of the proper class to mass produce VLSI
(very large scale integrated circuits) with minimum rejection, in the manufacturing
of silicon wafers, micro chips, disc drives and other semi-conductor industries.
A laser spectrometer that measures the upstream and downstream particulate concentration
with computer calibration has been in use to measure accurately particles of
this size.
Advances in materials and sub-systems for Clean Rooms
In parallel, lots of advances have been made in construction materials, clean
room fittings and subsystems for new generation of clean rooms that are being
presently built. Some salient advances are worth mentioning.
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Non-laminar and laminar flow clean rooms (both horizontal and vertical) have been built, generally as per specific requirements from users. However, vertical laminar flow clean rooms have become very popular for most of the critical and specific applications in view of their following advantages:
The clean room market has seen considerable growth in India during the past 10-15 years and this demand will remain so, as more and more industries and R&D centres will have prime requirement for this technology in future.
Today, clean rooms in India are not only concerned about particulate and microbial contamination control, but also about a complete environmental regime conducive to the process requirements, in which various parameters are systematically regulated and controlled. Over the years, we have also realised the importance of education and motivation while dealing with the operation and maintenance of clean rooms.
Efforts to develop indigenous technology for production of the basic borosilicate glass fibre, that are needed for manufacture of high efficiency particulate intermedium, have started yielding results by way of production of such fibres on a bench scale at CGCRI, Kolkata. Other developments worth noting are:
However, it is the maintenance of clean rooms during their prolonged use, which is more challenging than design and construction of the same. I observe from the list of topics of the special lectures, that this aspect is not covered in detail. I am sure, this will be taken care of during the proceedings. However, we have complete programmes in place with protocols that are well defined for implementation, routine safety norms and follow up procedures, which are very important for the successful operation of clean rooms.
About two decades back there were a very limited number of suppliers who carried out the job of building clean rooms in India. Generally, air conditioning contractors used to take up this job as a part of their total contract. Specialized and skilled personnel were generally not available and expertise available was limited. Most of the components for better-than Class 100 clean rooms had to be imported. For example, HEPA filters with efficiencies of 99.97% down to 0.3 micron (particle size) only were available. The filter media was fully imported and sometimes the entire filter had to be imported. In addition to the above, full scale testing facilities as per standards were not available and had not been set up by the manufacturers. Third party validation of clean rooms could not be carried out in the absence of suitable agencies. Last but not least, the cost of construction was very high.
Today, a considerable number of indigenous vendors are available to do the job for conventional clean rooms of Class 100 and above. Specialised and skilled personnel are available now and expertise for design and construction is available indigenously. Only a few components of better-than Class 100 clean rooms have to be imported and remaining are being developed in-house and manufactured indigenously. Both HEPA as well as ULPA filters with higher efficiencies are being produced in India and a few suppliers are available to manufacture as per customer’s requirements. Separatorless mini-pleat HEPA filters which are being widely used in clean room applications are produced indigenously in glass fibre and ceramic fibre media. Full fledged filter testing facilities are available with many of our manufacturers, both at their factories and for site testing. Agencies are now available indigenously for carrying out third party validation and testing at site with portable instruments. However, they are yet to be formalized. Nowadays, the cost of construction is competitive and comparable with imported units.
However, the quality of the components and the workmanship of the indigenously manufactured items for clean rooms have much scope for improvement in comparison with the imported components and materials.
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| ISO 144644 Parts 1 & 2 | ||||||
|---|---|---|---|---|---|---|
| Maximum Concentration Limits (particles/m3 of air) of size > | ||||||
| Class | 0.1 µm | 0.2 µm | 0.3 µm | 0.5 µm | 1 µm | 5 µm |
| ISO 1 ISO 2 ISO 3 ISO 4 ISO 5 ISO 6 ISO 7 ISO 8 ISO 9 |
10 100 1000 10000 100000 1000000 |
2 24 237 2370 23700 237000 |
10 102 1020 10200 102000 |
4 35 352 3520 35200 352000 3520000 35200000 |
8 83 832 8320 83200 832000 8320000 |
29 293 2930 29300 293000 |
| Schedule of mandatory tests to demonstrate continuing compliance: | |||
|---|---|---|---|
| Test Parameter | Class | Max.Time Interval | Test Procedure |
| Particle Count ΔP Airflow |
< ISO 5 > ISO 5 All All |
6 months 12 months 12 months 12 months |
ISO 14644-1 Annex-A ISO 14644-1 Annex-A ISO 14644-1 Annex B5 ISO 14644-1 Annex B4 |
| Schedule of optional tests to demonstrate continuing compliance: | |||
|---|---|---|---|
| Test Parameter | Class | Max.Time Interval | Test Procedure |
| Installed Filter leak Containment leak Recovery Airflow Visualisation |
All All All All |
24 months 24 months 24 months 24 months |
ISO 14644-3 Annex B6 ISO 14644-3 Annex B4 ISO 14644-3 Annex B13 ISO 14644-1 Annex B4 |
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Looking into the future of clean rooms, one important aspect that dominates our mind is the economic viability of building high quality clean rooms. Having been personally associated with clean rooms, I feel the need to sincerely address this issue, if we are serious to ensure sustained growth of clean room technology in India. High constructional and operating costs must be reduced so that small manufacturers and entrepreneurs could also gain access to this technology.
This would need detailed studies of the basic process to be carried out inside the clean spaces by a specialized group/ consultants along with studies on, aero-dynamic flow contours vis-a-vis the process activities, particle generation sources and their dispersion paths, containment at source, improved architectural concepts to reduce air movements leading to reduced air volumes, etc.
This also calls for concerted efforts for development and availability of cheaper finishing materials for modular clean rooms. It is only through such detailed studies of all these factors, coupled with the control of effective operation and safety, can we bring down the cost. I feel this is the need of the hour and a challenge to the Indian clean room industry today.
Another aspect I would like to dwell upon is the need to constitute a national body, which shall be responsible for providing guidance for various needs and quality assurance programme for the clean room industry in India. This body could work in various areas like formulation of local codes and standards to suit user requirements, broad-based design specifications, implementation procedures, operation methodologies, maintenance and validation procedures, training and certification of manpower specialized to take up these jobs, conducting regular courses and lectures for various levels of management and overall consultancy to users and manufacturers in this area.
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