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China: manufacturers unaware of new IV infusion bottle standards

The latest set of Chinese standards for intravenous (IV) infusion glass bottles is intended to bring bottle production more in line with international standards, but an insider told Interfax on 27 Jun…

The latest set of Chinese standards for intravenous (IV) infusion glass bottles is intended to bring bottle production more in line with international standards, but an insider told Interfax on 27 June 2008 of his fears that Chinese companies will continue to produce bottles to their own specifications. The standards, formulated by the China Pharmaceutical Packaging Industry Association (CNPPA), comprise specifications for the size and quality of glass bottles used in IV infusion kits, and were released for public comment earlier in June 2008. “This move to standardize IV bottle specifications is intended to bring to an end the inconsistencies that characterize the market for IV infusion glass bottles”, said Dong Xiaoxing, a CNPPC commissioner and an engineer at Nantong Yaorong Glass Co. Ltd. In the 1980s, the General Administration of Quality Supervision, Inspection and Quarantine released a standard for glass IV infusion bottles (GB 2639-90) that was enforced throughout the country. However, in 2000, the State Food and Drug Administration (SFDA) released a revision to the standards aimed at improving the safety of the bottles, though these standards contained only non-binding size specifications. As a result, manufacturers began producing bottles in various sizes, according to customer preferences. “As these latest standards are non-binding too, few manufacturers are likely to adhere to them”, Dong said. Enquiries by Interfax revealed that the majority of glass bottle manufacturers are unaware of the latest standards.

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