In mid-January 2005, the State Food and Drug Administration's "National Drug fresh injection [2005] No. 13 document" full of natural rubber plug out of the ordinary work of adjustment: penicillin injection (sodium, potassium) and the basis of Infusion June 30, 2005 for the transition period before; rest of the large capacity injection to delay the December 31, 2005 to complete the replacement work. Blink of an eye, on June 30 is approaching the end of the world, and pharmaceutical manufacturing enterprises Dingjijiaose family-related issues to be resolved as soon as possible in order to smooth the transition period through the development of new markets.
Rational analysis of the new issues
At present, pharmaceutical packaging used in the field of halogenated butyl rubber with butyl rubber-based, the pharmaceutical industry in China generally referred to as halogenated butyl rubber butyl rubber.
China in the late 1980's was introduced in Cyprus butyl rubber production equipment and technology, after 10 years of efforts to plug the butyl rubber production, has a greater level of technical progress. Most of the products not only by domestic pharmaceutical enterprises to accept that some products have also begun to enter the international market. However, domestic pharmaceutical enterprises to use butyl rubber plug a relatively short time, lack of experience of some of the problems often occur should be rational analysis.
Transfusion products clarity passing rate has dropped to the report, different rubber plug production plant with infusion of butyl rubber plug for the packaging of different varieties of transfusion products, to speed up after testing, the product of clarity passing rate dropped significantly.
Packaging transfusion after such a situation may be the following reasons:
To carry out tests to speed up the rubber plug products, should be confirmed with the butyl rubber plug the standards. Dingjijiaosai because the standards have to clarify the test, check plug 20 (28 to the specifications of dollars), plus 400 ml of water, after the detection of sterilization. It should be noted that: The test, plug all the immersion solution, but when used with the rubber plug liquid contact area is much smaller. Butyl rubber plug before the deal can not be used natural rubber plug approach - acid, alkali treatment, and then rinse water for injection. If this way, butyl rubber plug in the rubber components will be broken network structure is damaged, the exposed filler wrapped in the water under the falling down, leading to produce insoluble solution, we can see white spots. As a result, use of appropriate cleaning methods is very important. Dingjijiaose factory has been cleaned before use, only need to clear the transport, storage in the process of friction generated by particles of plastic debris, often many times you rinse, if not to ensure that this quality, you can add the rinse water cleaner (Detergent brand, the amount of rubber plug from the supplier), after washing, using no more than 121 ℃ temperature of hot air drying.
In addition, the oil does not dissolve in water, will have a certain refractive index of small droplets, the proposed increase in the amount of oil the surface of the test plug.
In the above-mentioned items and control parameters, there are still not up to standard batch clarity, and control to meet the requirements in order to confirm the grades (formula) may not be suitable for rubber plug test solution. If the product infusion and clarity have failed because of floc, the formula may be Dingjijiaose small and medium-sized molecular weight of the polymer melting caused by filter collection methods to confirm.
Cephalosporin drugs failed to clarify the degree of this phenomenon may be caused by a number of reasons. Researchers have a variety of tests Dingjijiaosai the formula, natural rubber plug, and film (PTFE) as Dingjijiaosai control, packaging cefazolin sodium found in the original powder (various manufacturers) Is not stable, some period batches in storage, to clarify the degree of failure; some of the formula Dingjijiaose, cefazolin sodium to accelerate the time to clarify a downward trend, but still much better than natural rubber plug .
Scientific understanding of standards
In 1994 for the first time China issued a Dingjijiaosai product standards, equivalent at the time of the adoption of ISO standards.
The former State Drug Administration after the establishment of the Dingjijiaose standardization has been referred to a new level. In 2002 issued a medical CIIR Cyprus (YBB00042002), medicinal Bromobutyl rubber plug (YBB00052002) standard. These two standards, in 1994, while retaining the standard content, but also an increase of three items: first, in the light of the European Pharmacopoeia material increase in the identification of projects for pharmaceutical companies to choose varieties Dingjijiaosai provides the basis for determining methods. Second is to increase the burn residue test, to control the amount of filler in the formulation of foreign Dingjijiaose for each prescription plant has the least control over the project. The third is based on the use of drugs Dingjijiaosai the need to control particulate matter requirements, an increase of particulate matter testing, targets. Although this target after two years on a trial basis, but many of the plug, the manufacturing sector of the standard tests of understanding there is still a bias, they often resist using the results of the law, to determine the direct product of the project failed. As the general Dingjijiaosai surface coated with silicone oil, and oil do not dissolve in water, will form a small droplet, leading to the results on the high side, the United States Pharmacopoeia and Chinese Pharmacopoeia has the provisions for particulate matter up to standard indicators of the products, Microscopy should review and the results of this later. In 2005, the State Food and Drug Administration Organization 3 laboratories, 14 rubber plug on domestic production of 144 Dingjijiaose approved products for the particulate matter and burn the residue detection research and testing. According to the comprehensive test results and other interested parties on the above-mentioned criteria and the implementation of the proposed changes, the revised standards Dingjijiaose. The main criteria was the original name changes, the revised standards: Injection halogenated butyl rubber plug (YBB00042005), sterile powder for injection with halogenated butyl rubber plug (YBB00052005). The revised standards also regulate the ash (the original standard for the burn residue), particulate matter test conditions.
Three great importance to the work of
Dingjijiaose to replace the natural rubber plug is a general trend of the following three aspects should be taken seriously: the pharmaceutical companies have been hoping to find a formula Dingjijiaosai can be applied to all drugs. However, at home and abroad for drug-Dingjijiaose compatibility of the results show that there is no such a possibility. Pharmaceutical companies should plug compatibility with the drug (stability) test, with the choice of drug products that match the plug. In addition, the cleaning companies, sterilization methods, such as production equipment and technology, the pharmaceutical enterprises, even if the production of the same variety of products, rubber plug in the choice, they can not copy, but can learn from successful experiences.
Manufacturing enterprises Dingjijiaose to the stability of their product formulation system. Once selected pharmaceutical companies a formula should ensure that each batch of consistency between the formula, the main raw material in advance of the change should be to inform the user.
In addition, the crumbs off the needle has been plagued Dingjijiaosai, pharmaceutical companies, product standards have control of the project, but also an indicator of China's strict European Pharmacopoeia. Why, then, after passing the test, in use, much more than a few crumbs off the laboratory test results? The main reason may be: the use of nurses in the number of needle use (greater than 10), the puncture site duplication, acupuncture needle into the neck-side; made part of the needle puncture does not comply with the standards used to strengthen and improve the training puncture needle Quality is the solution to the problem of one of the effective ways.
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