The cleanroom industry , which is vital for pharma and biotechnology sectors , is all set to boom in India if the manufacturers take up cost - effective and indigenously designed systems to suit the requirements of the industry.
With more and more entrepreneurs setting up newer industries and regulatory bodies insisting on stringent standards to ensure safety and quality of products, it has become imperative for all the critical and high value product manufacturers in India to install advanced cleanroom equipment to have a safe and fool proof contamination free environment of their premises. The growth of cleanrooms will get a further boost if manufacturers offer more cost-effective technologies that are indigenously designed, opine industry experts.
Especially with respect pharma and biotechnology industry, the role of clean rooms is regarded vital in complying with the good manufacturing practices (GMP) and good laboratory practices insisted by regulatory bodies across the globe.
India being reckoned as one of the leading exporter of high quality generic medicines to the world, it has become imperative for the manufacturers to comply with global regulatory norms and quality standards. As our competitors are continuously moulding in accordance with global standards, the pharma and biotechnology product manufactures in India should spruce up the technologies according to the need of the day.
In the pharma and biotechnology industries which are highly regulated, there is an increasing need to continuously monitor their manufacturing and laboratory environments and install highly sophisticated and advanced cleanroom technologies to be free from microbial and dust contamination.
In fact the bio/pharmaceutical industry is the second largest consumer of clean room equipment. “The demand for cleanrooms and air filters is growing in India; the clean room equipment industry is probably growing at 20-25 per cent every year. With more awareness and more restrictive regulations by the authorities insisting on quality and higher standards, we can foresee a bright future for the industry,” says P.S.R.K Prasad, Managing Director, Cary Air Systems, Hyderabad.
Need for cleanrooms in pharma industry
As pharma industry is highly regulated and quality conscious sector, the need for cleanrooms to ensure clean environs is highly significant. The cause of concern in the pharmaceutical industry is of contamination, wherein the biological activity of viable particles such as bacteria and viruses may cause the final pharmaceutical product such as tablets, capsules, packaged liquids and parenterals etc to have unintended side-effects.
Many pharmaceutical products cannot be subjected to a final, ‘terminal’ sterilization step because they are not heat stable. These products must be produced using an aseptic filling process, in which the separate components of the product are sterilized in individually appropriate ways and assembled under conditions approximating sterility as closely as possible.
In Hyderabad there are around 150 companies manufacturing various kinds of cleanroom equipment. Many firms are even exporting their products to various parts of the world and earning huge revenues.
While giving insights into the growing demand for cleanroom equipment within the country, Gouse, a spokes person of Cary Air system said, “The demand for cleanroom equipment within the country has increased many folds during the past few years; we are constantly getting a lot of orders from across different states, particularly from the pharma and biotechnology firms.”
Environmental monitoring of cleanrooms and isolators has been subject to a significant rise in regulatory requirements recently, as contaminations can harm product, slow the product’s time to market, and even result in recalls. This critical need for effective environmental monitoring processes has made the equipment used for microbial monitoring increasingly important. Pharmaceutical companies and their suppliers have therefore been working to assess and improve the products used to test surfaces and ambient air in critical pharmaceutical environments.
Indigenization of cleanrooms in India
In India, though the importance of cleanroom technology is realized long back, the industry is yet to install it at all levels due to huge costs involved. In view of this, many Indian pharma and biotechnology manufacturers are looking towards indigenization of cleanrooms thereby reducing costs without compromising on the quality.
More over as the pharma research is moving into more target-oriented molecules that have a higher therapeutic activity per unit weight than earlier molecules; it requires better containment solutions and cleanrooms are a part of these needs as well.
In fact the cleanroom service providers have been successful in meeting most of the demands in the form of better containment solutions like indigenous isolators for highly active pharmaceutical ingredient (HAPIs) and other industries, better HVAC designs including specialized filtration equipment like bag in-bag out (BIBO) filters, better control systems for temperature, pressure and relative humidity, automation of heating, ventilation and air conditioning (HVAC) systems, access controls including biometrics, better materials of construction for clean rooms including thermoplastic materials etc.
A number of service providers for HVAC, utility providers, and modular clean rooms do meet the international requirements and even export their solutions to many other countries.
“In India it is observed that while at the macro level, Indian systems and the facilities do meet and even exceed the regulatory and client requirements, the attention to detail is unsatisfactory. For example, while the overall finish of the modular clean rooms may be at par with any other available worldwide at first sight, the defects become visible on closer scrutiny. A lot of indigenisation needs to take place in containment solutions, sanitation technologies, single use disposables, decontamination technologies tailored for specific products etc,” say industry experts.
Cleanroom technologies HEPA
Among the various cleanroom technologies the High-efficiency particulate air (HEPA) filtration system is usually preferred more in the pharmaceutical industry. But of late the researchers have found some distinct challenges with this system. In this system ducts connect the individual HEPA filters to the air handling system, is the most common choice for Class 1000-100000 clean rooms. It is critical that the ducting does not contain any acoustic lining that could harbour microbial growth.
The filters meeting the HEPA standard have many applications, including use in medical facilities, automobiles, aircraft, and homes. The filter must satisfy certain standards of efficiency such as those set by the United States Department of Energy (DOE). To qualify as HEPA by the US government standards, an air filter must remove 99.97 per cent of all particles greater than 0.3 micrometer from the air that passes through.
Isolation technology
The use of isolation technology can reduce the cost of cleanrooms in a variety of industries such that large-scale cleanrooms can be replaced by rooms with various areas utilizing isolation techniques. Isolation technology is now being applied in production facilities at pharmaceutical companies.
The flow pattern within the volume of the isolator demands very careful consideration. It may need to be laminar in some specialized applications where high particle burdens are generated but, in general, turbulent flow will provide the desired conditions - although there is an argument that laminar flow will remove the need to sterilize the isolator. The important factor is that the flow should purge the entire volume, leaving no dead spaces, so that particles are steadily swept away to the exhaust filter. For fast transfer of items to and from an isolator, the special rapid transfer port solves the problem of waiting while items are sterilized on the way in, or decontaminated on the way out.
Aseptic work is probably the largest single application of isolation technology and thus the sterilization of the interior of isolators and their contents is critical. Most sterile processes will need to be validated before products can be marketed, and thus isolator users must be able to demonstrate reliable and reproducible sterilization cycle results.
Cleanrooms in biotechnology industry
Biotechnology is the fastest growing segment of the industry and there is a great deal of potential growth in clean room sales to this sector. This industry requires cleanrooms not only to protect the product, but also to protect the worker. For example, approximately five per cent of biotechnology plants currently utilize cells or products known to be pathogenic or derived from genetic engineering techniques. In this sector, it needs to have safety cabinets, benches and complete clean rooms.
Applications for isolator technology in biopharmaceutical manufacturing include maintenance of cell culture banks and the initial steps of seed culture expansion. Isolator systems can also be used for fermentation operations done at working volumes of only a few litres.