GEA Pharma Systems has opened a new chapter in its Indian marketing activities with a recent order from Alpa Laboratories for its new FlexStream™ granulation technology. This is the first time GEA Pharma Systems has sold a FlexStream™ fluid bed system that was manufactured wholly in India to European-standard specifications. The new technology offers Alpa Laboratories European-quality manufacturing at a price performance level that is affordable in its local market.
Alpa Laboratories Limited from Indore in Madhya Pradesh is a company specialising in pharmaceutical manufacturing and exports and listed on National Stock Exchange of India and Mumbai Stock Exchange. The order demonstrates a progressive attitude by Alpa Labs to invest in leading edge capital equipment to enhance its manufacturing facility. It also opens up the market in India for GEA to include smaller niche manufacturers within its sales and marketing plans.
Alpa Laboratories has been operating since the 1960s and ranks around 150th in the listings of India’s pharmaceutical manufacturers. Alpa is venturing into regulated markets of Europe and North America with its range of products from the new manufacturing facility. Until it received this order, GEA Pharma Systems was working on the assumption that its high level technology would appeal only to the top 20 companies in the market. The forward-thinking vision of Alpa has changed its mind.
The company invested in GEA’s FlexStream™ technology to manufacture granules for hormone production. Previously the intention of ALPA Labs was to handle this highly toxic material using conventional isolators, however by investing in FlexStream™ Alpa has, at a stroke, improved containment within the factory, improved the quality and consistency of its product, and significantly improved productivity. By investing in the FlexStream™ technology ALPA Labs has ensured that it is in the top league of modern manufacturing facilities of the world.
The system also provides 10-bar explosion protection, so if an incident occurred, all the API (Active Pharmaceutical Ingredients) would be retained within the machine thereby reducing the risk of exposure to operators and avoiding releases to the atmosphere. An automated cleaning regime provides significantly reduced cleaning cycle times.
FlexStream™ is the latest in fluid bed technology, providing granulation, drying and coating all in a single process. Features such as automatic side discharge were important to Alpa Labs as it facilitates contained transfer to the next process. FlexStream™ also prevents the uncontrolled over-wetting of particles by using a protective air stream taken from the normal process air. As no compressed air is required, fewer particles are destroyed in the process and the system is more energy efficient. The system is also easy to switch between use as a dryer, a granulator or a coater. Impressive test data proves that, in addition to those commercial benefits, FlexStream™ gives superior product quality when compared with conventional top-spray granulation.
Mr. Paresh Chawla (Director) from Alpa Labs explained the benefits of using FlexStream™ from his point of view. He said that, for product quality to be maintained it was important for the equipment used in manufacture to reproduce the original formulation accurately. “Using the GEA equipment means that our quality will not be compromised. It gives us an increased security of outcome with better homogeneity and consistency. This latest 10 bar fluid bed technology also inherently addresses containment and explosion risk at source, unlike conventional vented systems”
GEA is delighted with the order which represents the first of its kind for FlexStream™ equipment manufactured solely in its Indian factory. Navin Lakhanpaul, Regional Manager for GEA Pharma Systems in India, was also pleased that a niche manufacturer such as Alpa had appreciated the benefits of its advanced engineering. “We thought we were only targeting the top 20 companies in India. This order has opened up a whole new market segment for us. It shows that we can supply European-quality equipment, manufactured in and serviced from India, at a price performance level that is affordable across a larger Indian pharmaceutical customer base. It’s very exciting.” It has, of course, opened up new markets for Alpa too. “We now have the opportunity to supply our products and offer our manufacturing facilities to the European market. That would certainly have been more challenging with our old manufacturing systems.”
This latest FlexStream™ technology manufactured by GEA will be displayed on the GEA Pharma Systems stand at the P-MEC India exhibition ((hall 6, stand A1) in Mumbai 1st to 3rd Dec. For more information about P-MEC India and GEA Pharma Systems please visit our website: http://www.gea-pharma.in/
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Notes:
FlexStream (Patent Pending) - Granulation, Drying and Coating in One Process with built in linear Scale-up
The Aeromatic-Fielder™ FlexStream™ Fluid Bed is a new Multi-Purpose Processor from GEA Pharma Systems that uses proven fluid bed technology to achieve granulation, drying and pellet coating (or tablet coating) in ONE processor.
Advantages of FlexStream™:
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Only ONE product container for all unit operations
Fluid Bed Granulator - Fluid Bed Dryer - Fluid Bed Coater, ALL in 1 container
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Only one design/height for all unit operations
Reduced building envelope in both height and footprint
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Built in linear scale up
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Ready for fully contained loading and unloading
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Superior product homogeneity both for LOD and PSD
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Enabling PAT: in-line measurement of particle growth