"For infusion preparations, packaging is an important factor influencing their safety. The purpose of hosting this forum is to help infusion companies remove insecurities from infusion packaging," said Cai Hong, vice president of the China Pharmaceutical Packaging Association.
Cai Hong emphasized that as the public attaches greater importance to drug safety, relevant state departments have increased the management of injections and raised the threshold for entry of injections. Infusion manufacturers should pay more attention to the safety of infusion packaging and ensure that the infusion products are safe and effective.
Hidden danger
Infusion preparations are one of the five commonly used preparations in clinical practice. They provide the required moisture, electrolytes and nutrients for patients, and they can also be used as vehicles for intravenous administration of pharmaceuticals.
According to Huang Xiaolong, an expert from the Center for Drug Evaluation of the State Food and Drug Administration, infusion has the following four characteristics: it does not pass through the inherent protective barrier of the human body, and it directly enters the bloodstream; it has quick effects and high safety requirements; the liquid volume is large, Generally greater than 50 ml; must be a sterile product.
There have been many cases of history of patient deaths caused by infusion contamination. From 1970 to 1975, more than 400 septicemias were caused by infusion contamination in the United States, and the problem products passed sterility inspection when they were shipped from the factory. This typical case has led people to pay more attention to infusion packaging that may pose potential safety hazards that may cause later contamination.
“The size of the inner and outer diameter of the bottle mouth and the thickness of the bottle wall (film) are related to the quality of medicines and the safety of public drugs. There is no potential safety hazard in the infusion products from production to filling, and even to the entire transportation process.†Cai Hong stressed.
At present, there are three types of packaging used for infusion production in China: glass bottles, plastic bottles, and plastic soft bags. Soft plastic bags are divided into PVC (polyvinyl chloride) bags and non-PVC soft bags.
Cai Hong said that due to many factors such as bidding and procurement, policy drug prices, and other factors, the profits of large infusion companies plummeted. Since the infusion packaging cost is one of the important components of the infusion production cost, in order to reduce the cost, some infusion companies have actually used the idea of ​​infusion packaging to cut corners. If you change the mouth of a small infusion bottle, use a correspondingly smaller size rubber stopper and a low-cost glass formula to reduce the wall thickness of the bottle. Even the plastic bottles and soft bags that are used for infusions have changed their mouths, reducing the tendency of bottle wall thickness and film thickness.
"We do not mean that infusion packaging must not be changed, but emphasize that for such a relatively complicated process change, infusion production enterprises should be based on sufficient scientific and reasonable verification work." Cai Hong said.
It is reported that in order to strengthen the management of infusion products, in the second half of 2007, the Center for Drug Evaluation of the State Food and Drug Administration issued the “Requirements for the Research and Evaluation of Sterile Aseptic Infusion Processesâ€, emphasizing that the value of F0 must be greater than or equal to that of large infusions. 8; On January 10, 2008, the State Food and Drug Administration issued the "Notice on Issuing Basic Technical Requirements for Injections of Chemical Injections and Multicomponent Biochemical Injections" (Order No. 7) to further refine the improvement of infusion products. Bacteria requirements.
"This actually puts higher requirements on infusion packaging." Cai Hong said, "For example, the increase in sterilization temperature and the extension of sterilization time directly require infusion packaging to be more tolerable. Some regulations are also The infusion production companies are required to review and register certain infusion packagings. Based on these circumstances, infusion manufacturers need a new understanding of infusion packaging.â€
Solve the right way
According to statistics, since the "Ninth Five-Year Plan" period, China's infusion industry has developed rapidly, with production increasing from 1.38 billion bottles (bags) in 1995 to 2.91 billion bottles (bags) in 2001, an average annual increase of 16.1%; the infusion market in 2003. Capacity reached 3.5 billion bottles (bags).
According to the data released by the China Chemical Pharmaceutical Industry Association, a total of 7.1 billion bottles (bags) were produced in 2007, an increase of more than 10% from 2006. It can be imagined that once quality problems occur in infusion products, the consequences can be disastrous.So, how to ensure the infusion product is sterilized? Huang Xiaolong said that in order to ensure the quality of infusion products, one must study and design products that meet the requirements of asepsis, and the second should strictly follow the research and verification process. When designing aseptic products, it is necessary to consider suitable dosage forms, sterilization processes, and packaging materials.
Huang Xiaolong pointed out that in the choice of packaging materials, infusion companies should follow the following three basic principles: First, according to a specific prescription, should choose the best sterilization method, and then select the appropriate packaging materials; Second, the packaging material is not hot Stabilization cannot be used as a reason to reduce the aseptic production process requirements; in the end, any commercial considerations should not be used as a reason for not using the final sterilization method with the highest level of aseptic assurance.
He further suggested that infusion companies should consider four major issues in the choice of packaging materials: First, whether the material can withstand the corresponding sterilization temperature, that is, according to the aseptic requirements of drugs, to ensure the sterilization effect; Second, How the compatibility of the material with the drug solution is in the end, whether it can ensure the quality and safety of the drug; third is how the tightness of the container can guarantee the aseptic performance of the drug within the validity period; fourth is whether it is convenient to transport and use Wait.
“Infusion manufacturers must adhere to the principle of quality first and safe use of drugs first, and do not increase product safety risks and corporate operating risks and management costs in order to reduce the cost of a few cents of packaging.†Huang Xiaolong said.
An industry source pointed out that "Shuanghe, Minsheng and other manufacturing companies are very strict in the choice of infusion packaging materials. Although the use of high-quality packaging will substantially increase the cost, but they still insist on the needs of infusion products, choose excellent quality Packaging material. This practice should be respected in the industry."
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