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Follow on Google News | Latest state of Clean Room TechnologyRavi Thakur, V.P. Marketing of GMP Technical Solution, shares latest state of clean room technology
By: Mahesh Kumar GMP Tech believes that Quality is not a singular process, but a way of life with dynamic approach. There are so many federal regulations that relate to cGMP that if they are not followed and practised, it can lead to criminal penalties. These stringent quality policies have helped distinguish GMP Tech from those who cut corners in quality. These players must understand that compromising on quality will have a cascading effect in compromising someone’s life. It all begins by doing the right thing at the first place which no doubt starts with clean rooms. Clean room providers must voluntarily take social responsibility in contributing to quality. Though the life of a clean room is approximately 8-10 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 clean rooms. 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. Clean room modular partitions are an ideal alternative to conventionally constructed civil walls; firstly because they do not shed any particles like civil walls, thus contributing less to airborne particulate matter and secondly they can be easily cleaned every day. Also the wall thickness of modular partition is less than that of a civil wall, thus providing more usable area for clean room applications. To obtain US FDA, EU GMP, MHRA-UK, TGA-Australia, WHO approvals and other recognitions at lower costs and without compromising on quality, developed countries are now seriously seeking Indian Clean room technology providers as a viable option. Trends in Clean Room technology are changing at such a fast pace that by the time you finish reading this article, you have a new technology awaiting you. Everything in the clean room is changing right from equipment to garments and in today’s era, where prices are sky-rocketing, pharmaceutical companies have to think twice before building a clean room facility especially when their product are yet to be approved. To avoid this uncertainty of going ahead with manufacturing of unapproved products, companies are now adopting modular concepts. The standard practice in the pharmaceutical industry is to maintain Class 100 (ISO Class 5, metric class M3.5) conditions in the “critical areas” and locations in which open, sterile containers are exposed to the environment. Although Class 100 conditions do not need to be maintained throughout the entire aseptic facility, it is important that they be maintained in these localized critical areas. The use of isolators is the latest means to achieve this desired cleanliness in critical areas. Isolation technology also reduces the cost of pharmaceutical/ # # # GMP Technical Solutions (GMP Tech) is an ISO 9001:2000 Certified company and is one of the largest manufacturers of Clean Room Partitioning Systems and Turnkey Solution Provider within the Indian subcontinent. End
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