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Our Bureau, Bengaluru May 30 , 2016
Amanta Healthcare Ltd., a manufacturer of sterile dosages covering critical care, fluid therapy, respiratory care and eye care products, has now pumped in Rs.80 crore for the design and development of SteriPort which is a new generation IV fluid system.

Global standards such as Pharmaceutical Inspection Cooperation Scheme (PIC/s) and European Pharmacopoeia (EP) have emphasized a lot on container integrity. Some of the most critical aspects are sterility, transparency and closure system. Amongst others world over sterilization of container at 121 degrees C is a norm and a necessary condition to meet most of regulatory guidelines. 90 per cent of IV fluids bottles in India do not comply. The other critical aspect is a closure system to ensure leak-free IV administration and supplementary medication without breaching the container integrity. The container has to be transparent so that any contamination in it can be detected before administrating.

However, the fact is that 85 per cent – 90 per cent% of IV containers are neither meeting sterility requirement nor have necessary closure system and are, at best, translucent, said Bhavesh Patel, MD, Amanta Healthcare.

SteriPort is a novel packaging concept. It has high sterility assurance level (sterilized at 121 degrees C), and is as transparent as a glass container and has two port closure systems. Moreover, the product and the process meet the global standards like Pharmaceutical Inspection Cooperation Scheme and European Pharmacopoeia on critical aspects like container integrity, drug delivery compliances and drug compatibility. Its unique feature is that it is compatible with most of the oncology products for IV administration, which is not the case with polyethylene (PE) bottles.

“Innovation and adopting new concepts comes naturally. SteriPort – is made of Random Co-Polymer (RCPP). This polymer resists temperature up to 125 degree C. It has superior tensile strength, optical and barrier property.

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