3M Cuno have set up an advanced validation centre at an investment of Rs 3 crore. The centre which spans over an area of 5,000 sq ft is located at the Electronic City in Bangalore and it is expected to cater to the needs of the pharma-biotech companies.

The filter validation lab, is one of four such labs in the world set up by Cuno which is a global major in the design, manufacture and marketing of filtration products. The lab has dedicated areas for application process development, filter integrity and compatibility testing, microbiology and bacterial retention testing with a separate lab to only handle cytotoxic drugs.

It will have a dedicated service team of scientists and technical experts to carry out filter validation services, filterability and compatibility tests and filter sizing studies. From the current capacity of 40 projects a year, the lab can scale-up to handle over 100 projects at optimum capacity.

Filtration and sterilization processes are extremely important components of drug manufacturing process and under the surveillance of the national and international regulatory authorities. The US FDA has mandated the sterile drug products produced by aseptic processing - current Good Manufacturing Practice (cGMP) norms since September 2004 for manufacture of sterile drug and biological products using aseptic processing.

"We opened the facility in India based on the growing opportunities and expansions chalked out by domestic bulk drug and formulation drug manufacturers. Our Validation Support Services will now make regulatory compliance less cumbersome by providing well designed, properly executed and completely documented test protocols," stated Antony Doina, vice president, APAC region, Cuno.

Further, the validation centre adheres to the PDR-26 \(Parentral Drug Report) which streamlines filter regulatory compliance, said Cyril D'Souza, general manager, CUNO Filtration Division, M Electro & Communication India Pvt. Ltd.

The India lab has the broadest range of advanced process systems. The company has a group of four families of products: BioAssure is a robust sterilizing grade polythersulfone membrane filter. Microfluor II PTFE Membrane is a high air flow filtration solution. SterAssure is a filter cartridge and capsule. Betafine XL is an advanced pleat technology for extra long life and reduced total filtration costs.

Among Cuno's global customers are Biogen, Amgen, Biomarin, Abbott to name a few. In India it will focus on the large API and formulation companies. The size of the validating market in India is estimated at $ 150 million and pharmaceutical business generated will be valued at around 450 million, said D'Souza.

The need for filtration in the healthcare industry is estimated at nearly $3 billion worldwide, and filtration markets are currently growing at a rate of 7 to 8 percent annually. "We see a huge opportunity for our products and services in India. Filtration is one of the core processes in the manufacture of drugs," stated Ramesh Ramadurai, director, Industrial Business, 3M India Limited. While Bangalore has three validation centres namely Millipore, Pall Life Sciences, Sartorius, 3MCuno is the fourth centre in the city.

The global slowdown has seen signification investments in the emerging markets which includes India. The advanced manufacturing effort has opened up opportunities for validation services. There is also major shift from re-useable technologies to disposables, said Cuno.