The hottest infusion bottles and other drug packag

Infusion bottles and other drug packaging materials have been effectively supervised

"for infusion preparations, packaging is an important factor affecting the safety of fine screw pair transmission. The purpose of hosting this forum is to help infusion enterprises eliminate unsafe factors in infusion packaging." Caihong, vice president of China Pharmaceutical Packaging Association, said. Cai Hong stressed that with the increasing public attention to drug safety, relevant national departments have increased the management of injections and raised the entry threshold of injections, with a moisture content of ≤ 0.10%. Infusion production enterprises should pay more attention to the safety of infusion packaging to ensure the safety and effectiveness of infusion products

hidden dangers remain

infusion preparations are one of the five commonly used clinical preparations, which provide patients with water, electrolytes and nutrients, and can also be used as a carrier for intravenous drug delivery

according to Huang Xiaolong, an expert from the drug evaluation center of the State Food and drug administration, infusion has the following four characteristics: it directly enters the blood without passing through the inherent protective barrier of the human body; Fast onset and high safety requirements; The volume of liquid medicine is large, generally greater than 50 ml; It must be sterile

there have been many cases of patients' death caused by infusion pollution in history. From 1970 to 1975, there were more than 400 cases of septicemia caused by infusion pollution in the United States, and all the problematic products passed the sterility test when leaving the factory. This typical case makes people pay more attention to the infusion packaging that has potential safety hazards and may cause later pollution

"the internal and external diameter of the bottle mouth and the thickness of the bottle wall (film) are related to the quality of drugs and the safety of public medication. There should be no potential safety hazards in the production, filling and even the whole transportation process of infusion products." Caihong emphasized

at present, there are three kinds of packaging forms used in infusion production in China, namely glass bottles, plastic bottles and plastic soft bag packaging, of which plastic soft bag packaging is divided into PVC (polyvinyl chloride) bags and non PVC soft bag packaging

Caihong said that due to the influence of many factors such as bidding procurement and price reduction of policy drugs, the profits of large infusion enterprises have plummeted. As the cost of infusion packaging is one of the important components of infusion production costs, in order to reduce costs, some infusion enterprises have even started the idea of cutting corners in infusion packaging. If the mouth of a small infusion bottle is changed, the corresponding smaller size rubber stopper and low-cost glass formula are used to reduce the wall thickness of the bottle. Even plastic bottles and soft bags for infusion packaging have the trend of reducing the bottle mouth and the thickness of the bottle wall and film

"we do not mean that the infusion packaging must not be changed, but emphasize that for such a complex process change, the infusion production enterprise should be based on sufficient scientific and reasonable verification work." Caihong said

it is reported that in order to strengthen the management of infusion products, in the second half of 2007, the drug evaluation center of the State Food and Drug Administration issued the "principles and requirements for the research and evaluation of injection sterility assurance process", emphasizing that the F0 value of large infusion must be greater than or equal to 8; On January 10, 2008, the State Food and Drug Administration issued the notice on Issuing the basic technical requirements for chemical drug injections and multi-component biochemical drug injections (order 7), which further refined and improved the sterility requirements of infusion products

"this actually puts forward higher requirements for infusion packaging." Caihong said, "for example, the increase of sterilization temperature and the extension of sterilization time directly require infusion packaging to have higher tolerance. And some regulations also require infusion production enterprises to review and register some infusion packaging. Based on these circumstances, infusion production enterprises need to have a new understanding of infusion packaging."

solution Youdao

the data shows that since the "Ninth Five Year Plan", China's infusion industry has developed rapidly, and the output has increased from 13% in 1995. 800 million bottles (bags) increased to 29 in 2001. 100million bottles (bags), with an average annual growth of 16. 1%； In 2003, the market volume of infusion reached 3.5 billion bottles (bags)

according to the data released by the China Chemical Pharmaceutical Industry Association, the national large-scale infusion production in 2007 totaled 7.1 billion bottles (bags), an increase of more than 10% over 2006. It is conceivable that once the infusion products have quality problems, the consequences will be unimaginable

then, how to ensure the sterility of infusion products? Huang Xiaolong said that to ensure the quality of infusion products, first, we should study and design products that meet the sterility requirements, and second, we should strictly follow the process after research and verification. The design of sterile products must consider the appropriate dosage form, sterilization process and packaging materials

Huang Xiaolong pointed out that in the selection of packaging materials, infusion enterprises should follow the following three basic principles: first, according to the specific prescription, choose the best sterilization method, and then choose the appropriate packaging materials; Secondly, the thermal instability of packaging materials cannot be used as a reason to reduce the requirements of aseptic production process; Finally, no commercial consideration can be taken as a reason not to use the final sterilization method with the highest sterility assurance level

he further suggested that infusion enterprises should consider four major issues in the selection of packaging materials: first, whether the material can withstand the corresponding sterilization temperature, that is, whether the sterilization effect can be guaranteed according to the requirements of drugs for sterility; The second is how compatible the material is with the liquid medicine, and whether the quality, safety and effectiveness of the medicine can be guaranteed; Third, how airtight the container is, and whether it can ensure the sterility of drugs within the period of validity; Fourth, whether it is convenient for transportation and use

"infusion production enterprises must adhere to the principle of leading quality and safe medication, and do not increase product safety risks and enterprise operation risks and management costs in order to reduce the packaging cost of a few cents." Huang Xiaolong said

one industry insider pointed out, "production enterprises such as Shuanghe and Minsheng are very strict in the selection of infusion packaging materials. Although the use of high-quality packaging will significantly increase the cost, they still insist on selecting high-quality packaging materials according to the needs of infusion products. This practice should be respected by the industry."