Cleanroom equipment has an efficient as well as cost-effective impact on optimum utilization of man, material and machines, thus helping pharmaceutical companies to enhance productivity and profitability, say industry experts.
Says Ravi Thakur, Vice President -Marketing, GMP Technical Solutions Pvt. Ltd. “The clean room equipment is advantageous from cost point of view as well as plays an important role when it comes to achieving GMP standards. For instance, pass boxes can reduce man intervention in clean rooms to a large extent, thus maintaining least contamination level in clean rooms. Also during manufacturing of potent drugs, large-scale clean rooms can be replaced by multiple smaller rooms with the help of isolation techniques”.
- By adopting automated method within an isolator for moving the products in-and-out, isolation technology also remarkably reduces the number of people required in the clean room. Wherever class 100 is to be achieved, the entire ceiling of clean room is required to have High Efficiency Particulate Air (HEPA) filter which is exorbitantly expensive. As all clean room equipment are built to provide class 100 environment, they can be utilized in such places, thus reducing the cost of HEPA filters” , he adds.
Right from wooden pass-boxes, Laminar Air Flows (LAFs) and glove-boxes used in the past, till the latest galvanized iron and stainless steel made pass boxes, LAFs and isolators respectively, the pharmaceutical industry has seen many trends that are changing clean room equipments’ requirements. Formerly, India used to import them from various European and American companies in order to benefit from the advantages of metallic clean room equipments. But seeing the growing demand, all the clean room equipment were manufactured in India. Today India not only manufactures cleanroom equipments to fulfil its domestic demand, but also exports to the world and accounts for an accountable market share, he says.
With the advent of global pharmaceutical giants arriving in India, it has become imperative for Indian clean room technology providers to abide by international standards. In an attempt to make India a global manufacturing hub for clean room products, GMP Tech has pushed through a big indigenisation effort with the help of its dedicated team of professionals who have more than 30 years of experience in the pharmaceutical industry. By understanding the clients’ perceptions and helping them set baselines and benchmarks the company was highly successful in placing their products in various competitive landscapes. GMP Tech has already made its mark in the export market by tying up with various international vendors for indigenisation and delivering competitive products, he points out.
Though the life of a cleanroom is approximately 10-12 years, pharmaceutical manufacturers are regularly upgrading their facilities in order to cope up with the advancement in medical discovery and growing demands for medicines. This eventually leads to a growing demand for cleanrooms. Having understood the commercial viability of clean room technology products and their impact on national economy, Indian companies are now diverting their technical, financial and human resources towards clean room operations.
According to him,after the electronics market sector, the biotechnology & pharmaceutical sector is the second largest consumer of clean room products with a global market of $ 4.7 billion. Demands for Indian pharmaceutical machinery and equipment market for higher-grade clean rooms has intensified with the progress of precision/ultra precision machining technology. In addition to it, the need for clean rooms is also being realized in industrial fields where clean rooms have not been used so far. As the Indian pharmaceutical industry which is presently a US $15 billion market is estimated to reach US $ 35 billion in 2015, he foresees huge growth prospects in this sector.
However he points out that the lack of adequate knowledge of regulatory standards results in hapless choice of clean room products. The cleanroom technology sector is highly unorganized and many small players have further worsened this scenario. Precise technical knowledge with an edge to quality is the need of the hour.
In order to reduce costs, many pharmaceutical manufacturers opt for inexpensive and inferior imported clean room products. This would impact the end products since most of these are life-saving drugs. Hence, the government should impose additional duties such as anti-dumping duty and countervailing duty on such imported products, he adds.
The primary purpose of cleanrooms is to ensure production of a product with high quality standards. As the market always leans towards quality, pharma and biotech companies should strive to achieve the same. There is a common consensus on the fact that commercial success of a company will largely be dependent on initiatives like cleanroom implementation.
Cleanrooms are absolutely important to atmospheric air. This will include material weighing for batch processing, and manufacturing area till primary packing.
Cleanrooms are contamination-free environments where high-tech manufacturing and assembly take place. Cleanrooms range from very small chambers, called microenvironments, to large-scale rooms, called ballrooms. Cleanroom technology is used in a wide range of industries including semiconductor assembly, biotechnology, pharmaceutical, aerospace, food, medical devices and hospitals.
There are a number of important aspects to consider while determining which cleanroom type fits the needed application. This includes the cleanliness class, fabrication type, and special features such as ESD control, pass throughs, and a gowning area. Cleanliness class is a standard determined by the contamination control industry.
Amidst stringent regulatory requirements pharma and biotech companies have been forced to upgrade their product quality and standards. Cleanrooms help them in a great way to achieve this particular goal. In biotech and pharma industries, cleanrooms are used when it is necessary to ensure an environment free of bacteria, viruses, or other pathogens. In addition, the temperature and humidity may be controlled. GMP provides its customers all such data and information at the conceptual stage of the project.
According one of the experts,the cleanroom design should be based on the cGMP, for e.g. type of product, process requirements, like temperature humidity, class of air filtration (HVAC), equipment, room dimensions, etc. by following User Requirement specifications (URS). The cleanroom design specifications should be prepared for example, functional specifications, technical specifications, drawings of all components etc.
The design specifications should be documented and qualified (DQ). The cleanroom erection should be executed according to DQ with proper monitoring and control during the period. The cleanroom should be installed according to DQ. It should be qualified for installation with the details documented (IQ). It should be qualified for operations (OQ) by ensuring that all required operating parameters of all equipment, systems, including HVAC, are operating within acceptable limits as required by process. The OQ should be documented.
According to another expert in the field, the only way to control contamination is to control the total environment. Air flow rates and direction, temperature, humidity and specialised filtration all need to be tightly controlled. And the sources of these particles need to controlled or eliminated whenever possible.
As the cost of cleanroom operations increases, management of this space becomes a critical task. The state of cleanliness can only be maintained through a deliberate programme of training, personnel monitoring, proper gowning, cleaning and sanitisation, process controls and environmental monitoring, he adds.