Cleanrooms are perhaps one of the most crucial parts of the lifesciences sector, given that regulatory agencies are upping the ante when it comes to monitoring good manufacturing practices (GMP)
Cleanrooms are perhaps one of the most crucial parts of the lifesciences sector, given that regulatory agencies are upping the ante when it comes to monitoring good manufacturing practices (GMP). There is also increasing concern for safety of working personnel as well as the outside environment. Increasing environmental contamination has also increased the importance of these technologies. Manufacturers of cleanrooms are thus expected to provide an ever escalating number protective features yet at affordable costs, with energy efficiency built into the design.
With India striving to remain an important part of the global pharma supply chain, it cannot afford to be hauled up for faulty GMP. Thus, it is a given that demand for cleanroom technologies is only set to rise in India. Express Pharma has therefore put together a selection of interviews and articles cataloging trends in lifesciences cleanroom technologies in this supplement.
The lead article, ‘Changing Dimensions’ (see story on pages 5-8), explores how the cleanroom industry has come of age in India, with pharma companies demanding and willing to pay more for better designed cleanroom facilities. Basic cleanroom panels have given way to more advanced construction materials, as well as modular and flexible designs. Cleanrooms are also better designed today, incorporating energy efficiency aspects and integrating into the overall manufacturing plant’s associated engineering requirements like the HVAC systems, etc.
These demands are being met by local manufacturers. Aasif Khan, Managing Director, Fabtech Technologies, out their strategy saying, “Our aim is to imbibe the best from the west so that our customers get future-tech at affordable prices.” (See interview on page 9). Competition is fierce in this industry, with Prashant Kavale, Director, GMP Technical Solutions vowing that, ‘We develop plans to correct any issues that are uncovered”. (See his interview on page 10)
To share with us global insights on innovations in cleanrooms and environmental monitoring, we have Dr Tim Sandle, Head, Microbiology at Bio Products Laboratory and visiting tutor at the Department of Microbiology, University of Manchester, UK. His article touches on some innovations relating to cleanroom and clean device operations, together with personnel control and environmental monitoring. The article emphasises the importance of ensuing that good cleanroom design factors necessary for ensuring contamination control are met. (See pages 12-16)
But the strong demand for cleanroom technologies could possibly be hampered by access to skilled cleanroom operators in the future, points out Guy Tiene, MA, Director of Strategic Content, That’s Nice LLC / Nice Insight. (See pages 16-18).
Pharma companies as well as cleanroom technology providers in India should take serious note of this warning and plan now to create a pool of specialist cleanroom operators. The most expensive and advanced technologies in the world would be a waste if we do not also educate and train staff to use them effectively as per global GMP standards.
Besides a lack of skilled manpower, the high cost of setting up and maintenance will also restrain growth of the global cleanroom market. In India, financial resources will also always be a constraint. Smaller companies will see cleanrooms as a cost, while larger companies would be in a better position to reap the return on investment.
Even given these constraints, the cleanroom technology market, projected to be globally worth $3,761.9 million by 2019, is set to grow at a higher CAGR in India and the APAC region (8 per cent compared to 5.5 per cent in the US, EU and other more matured markets). As global cleanroom tech players look at India and APAC for growth, here’s hoping that competition will make cleanroom tech more affordable.