With continuous improvement, Indian clean room products are getting more and more competitive particularly in modular clean room technology as almost all clean room accessories are available in the country. Moreover the constant indigenous upgradation of technology has made it more cost effective say experts in the field.
According to P Narendran,General Manager (Isobuild),Beardsell Ltd,Bangalore,Indian clean room providers have helped in indigenization that at one time was the sole domain of international clean room providers. This has helped the users of clean rooms to compete in the international market and produce products as per global standards and helped its users obtain US FDA, MCA & WHO approvals and recognition with lower costs and on par with the western world.
Though earlier technologically mature overseas pharma companies used to easily outshine Indian pharma companies, today Indian pharma industry's flexible approach towards accepting concepts like cleanroom technology has strengthened their credibility in the global market, he added.
Biotech companies are also moving from the small pilot-type facility to large production facilities with substantial clean rooms. Many global pharma majors are outsource manufacturing to Indian companies due to much lower costs (both capital and recurring) than their western counterparts, he pointed out.
Many Indian companies have made their plants cGMP-compliant. India also has the largest number of USFDA-approved plants outside the US. The role of cleanroom suppliers is crucial in making the facilities cGMP compliant and ensuring adherence to USFDA and other stringent regulatory requirements.
Cleanroom Service providers in India have done a remarkable job in the manufacturing of AHUs and cleanroom equipment of international standards. This has enabled Indian companies to set up manufacturing plants at a minimum level project cost than in the western world and at the same time to meet international standards, he added.
Cleanroom service providers can and do go beyond providing robust cleanrooms with energy wise operating system. They are perfectly capable of providing the necessary certification and validation documents in order to meet various cGMP regulatory requirements.
In addition they need to cooperate with the user in keeping the system in validated mode by maintaining and certifying the system on regular basis. It's well established that sterile dosage forms became commercially viable due to Klenzaid's introduction of Laminar Flow and Depyrogenation technologies. That put India on the international map.
Cleanroom providers have helped provide these affordable and fully supportable technologies to Indian companies who have been able to consequently produce products at lower costs and on par with the western world Says Frank Schaefer, Managing Director of Becker Technologies Pvt. Ltd, “from our point of view the Indian market will continue to grow for quite sometime. There will be a huge export market for our Indian customers, which forces them to use best quality and energy efficiency equipment & facilities”.
Commenting on the future of the cleanroom industry in India , he said “we do foresee quite a good future of the cleanroom industry in India and we are determined to serve our India customers with our continuing technological upgradation programmes their needs of energy efficient & cost effective cleanroom facilities”
Despite the bright prospects for this sector, there are many constraints for growth. Says Narendran,the stringent protocols for clean room operations formulated by FDA (Food & Drug agencies-USA), has made difficult to Indian customers to adopt. Managing clean rooms is not an easy task. Slight irregularity in monitoring this vastly technical science could well be a matter of life or death for the end user. There are many dos and don'ts that will decide clean room technology like cost of implementation, its efficiency, the level of clean room requirement in a particular project etc.
More importantly , continuous maintenance and keeping the classification intact for a longer period is difficult unless constant upgradation is made which is difficult for small scale unit.
According to him the Govt should come forward to assist small scale units to implement clean room technology so that they are equally competitive for both national and international business participation effectively.
Talking on the latest trends in clean room technology , he said modular clean room is the latest technogloy where steel sandwich insulated panels of different core material and cladding materials are used for room construction instead of cement-mortar construction which helps in time saving, power saving due to insulation of rooms and shifting of one unit to another depending upon viability and inter-shifting of cleanroom in same plant also. Even for air filtration and airhanding lot of new products have come into the market both indigenously and combined with overseas accessories, he added.
A clean room is an environment, typically used in manufacturing or scientific research, that has a low level of environmental pollutants such as dust, airborne microbes, aerosol particles and chemical vapours. More accurately, a cleanroom has a controlled level of contamination that is specified by the number of particles per cubic meter at a specified particle size. The ambient air outside in a typical urban environment contains 35,000,000 particles per cubic meter, 0.5 µm and larger in diameter, corresponding to an ISO 9 cleanroom.
The role of clean rooms in core segments like pharmaceuticals, biotechnology and microelectronics is of vital significance. Since these industries require the perfect environment to operate and function, clean rooms need to subscribe to the most stringent quality norms and display consistent performance and long term utility.
As the pharmaceutical and biotechnology players are increasingly making their presence in the global arena,delivering products of a consistently high quality and credibility is becoming all the more imperative. As a result quality control and quality assurance has become a must have for the pharmaceutical and biotechnology industries.
As organisations like the US Food and Drug Administration (FDA) are formulating very stringent protocols for cleanroom operations, implementation of cleanroom technology is getting primacy among the many initiatives that pharma industry is taking to comply with all international norms. Hence cleanroom technology is gaining more importance than ever.
Clean room technology is a very vast field. Other than pharmaceutical and electronic industry, it is applicable in medical facilities such as operation theatres, pharmaceutical packaging industries and certain industrial applications where cleanliness is of utmost importance.