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China’s infusion manufacturers advised to pay particular attention to packaging safety

By Grace Zhang, Asia Manufacturing Pharma
Monday, 07 July 2008

Packaging is an important factor that may impact the safety of infusions, said Cai Hong, vice president of the China Pharmaceutical Packing Association. The association’s 2008 Infusion Packaging Development Forum was held in Qingdao, Shandong province, China on June 25, with the aim of helping infusion producers eliminate safety risks associated with infusion packaging.

Infusion is widely used in clinical applications to provide water, electrolyte and nutritious ingredients necessary for patients, and serves as a medium to administer a pharmaceutical compound through veins. Packaging specifications, including inside and outside diameters of bottle mouths, as well as the thickness of bottle walls, have a close relation with the quality of infusions and the safety of patients, according to Cai.

Today, China’s infusion manufacturers primarily work with three packaging formats, glass bottles, plastic bottles and flexible plastic bags. Due to the impact of procurement and fixed pricing policies for drugs, the profitability of infusion makers continues to show a marked decline. As packaging accounts for a significant share of an infusion maker’s costs, some infusion

producers are seeking to lower their manufacturing costs by reducing diameters of bottle mouths, or by using rubber stoppers with a smaller size or low-cost glass specifications, which may lead to potential safety risks for infusion products.

Statistics show that China’s infusion market has experienced explosive growth since 1995. The production capacity of infusion products has increased to 7.1 billion bottles/bags in 2007 from approximately 1.4 billion bottles/bags in 1995. The country’s oversight authorities, including the State Food and Drug Administration, have put in place a series of measures to upgrade the management of infusion products. Those measures have actually imposed higher requirements on infusion packaging, said Cai. Higher sterilization temperatures and extended sterilization time, for example, require enhanced durability of infusion packaging, Cai added. In addition, evaluation and registration are required for some infusion packing, forcing infusion manufacturers to redefine their packaging strategies.

As packaging accounts for a significant share of an infusion maker’s costs, some infusion producers are seeking to lower their manufacturing costs by reducing diameters of bottle mouths, or by using rubber stoppers with a smaller size or low-cost glass specifications,

which may lead to potential safety risks for infusion products.

Statistics show that China’s infusion market has experienced explosive growth since 1995. The production capacity of infusion products has increased to 7.1 billion bottles/bags in 2007 from approximately 1.4 billion bottles/bags in 1995. The country’s oversight authorities, including the State Food and Drug Administration, have put in place a series of measures to upgrade the management of infusion products. Those measures have actually imposed higher requirements on infusion packaging, said Cai. Higher sterilization temperatures and extended sterilization time, for example, require enhanced durability of infusion packaging, Cai added. In addition, evaluation and registration are required for some infusion packing, forcing infusion manufacturers to redefine their packaging strategies.

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