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pharmaniaga small volume injectables (svi) facility - pharmaceutical technology

pharmaniaga small volume injectables (svi) facility - pharmaceutical technology

The Puchong factory will carry out SVI fill and finish contract manufacturing for both regional and global companies. Built at a cost of RM149m, the plant has a production capacity of 40 million units a year.

The new facility is compliant with the good manufacturing practices (GMP) of the European Union, US Food and Drug Administration (FDA) and Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S).

Pharmaniaga constructed the SVI facility to expand its manufacturing base and accommodate future manufacturing capabilities. As a long term strategy, Pharmaniaga plans to relocate its entire manufacturing operations to the new site.

The Puchong factory is equipped with European processing equipment such as a solution preparation line, ampoule filling line, terminal and parts autoclave, external washer and inspection machine, leak tester machine and a purified water system.

OLSA supplied the solution preparation machine, Bausch and Strobel supplied the ampoule filling line, Fedegari the autoclave sterlisation systems, Seideneder external washing and inspection systems and Bonfiglioli supplied the leak testing machine.

The new SVI plant help the company participate in the RM400m market for SVIs in the country. Pharmaniaga has 15-year concession up to 2019 to supply medical products to government hospitals. The contract was renewed in 2010.

Pharmaniaga aims to become a world-class SVI fill and finish contract manufacturing company. It has identified Europe and South East Asian regions as priority markets. The Puchong facilitys compliance with international GMP will enable Pharmaniaga to export products to developed regions such as the US and Europe.

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