| By Daisy Zhang, Asia Manufacturing Pharma |
| Friday, 23 May 2008 |
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The China Pharmaceutical Packing Association (CPPA) recently held a seminar with rubber stopper producers to discuss the issues concerning specifications for infusion bottle mouths and safety of drugs. |
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The attendees reached a consensus on standards for the size of butyl rubber stopper for medical use and barrier to entry into the market, among others.
Industry insiders said rubber stopper makers have agreed in principle that for infusion bottles with a volume of 250ml and above, the external diameter of bottle mouth can also be |
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26mm in addition to the current 32mm and 28mm, laying a significantfoundation for the establishment of standards concerning glass bottles and rubber stoppers for medical use. Pharmaceutical companies, however, are required to carry out a risk assessment before they choose to use such a small rubber stopper.
Too small a diameter for the rubber stopper would inevitably affect the safety of infusion products, said an executive at a bottle stopper manufacturer. Despite challenges brought about by the soaring prices and supply shortages of raw materials, rubber stopper producers should not make profits at the expense of quality, the executive
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noted.
Other issues discussed at the seminar included the current oversupply of rubber stoppers used for infusions in the market.
Data from the
CPPA show that there are now 50 companies engaged in the manufacturing of butyl rubber stoppers in China, with a total production capacity far exceeding market demand.
In addition, the CPPA called on the relevant oversight authorities to encourage China’s domestic companies to bring the production of the raw materials for butyl rubber stoppers in house, lowering the overall costs by reducing dependence on exports. |
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