Policy changes how butyl rubber stopper enterprises steer the helm
2005 will be a year for both butyl rubber stopper manufacturers and some pharmaceutical manufacturers to find that Chinese enterprises have the talent to produce their own plastic extrusion machinery by themselves. In the middle of January, the "gsyjz  No. 13 document" of the State Food and drug administration made adjustments to the overall elimination of ordinary natural rubber plugs: penicillin for injection (sodium salt, potassium salt) and basic infusion before June 30, 2005 is the transition period; The replacement of other large volume injections was postponed to December 31st, 2005. This means that natural rubber, which was originally scheduled to be completely eliminated by the end of 2004, will be given a "suspended sentence" for one year
so, does this also mean that those pharmaceutical companies that are not well prepared can breathe a sigh of relief, or the butyl rubber stopper enterprises that have been warming up for a long time have to wait another year? This is not the case. As fengguoping, assistant inspector of the registration department of the State Food and drug administration, said, "although the replacement of some varieties has been delayed, there is not much time left. In this half a year to one year, butyl rubber stopper enterprises and pharmaceutical factories still have a lot of work to do, such as the implementation of the revised rubber stopper product standard, the compatibility test between rubber stopper and some infusion products, and so on."
for butyl rubber stopper manufacturers, although they encountered variables in the final breakthrough, in any case, it is a foregone conclusion that the country will completely eliminate natural rubber stopper. At the same time, after ten years of accumulation, the industry has also been greatly developed in terms of market and technology, which can be said to be smooth sailing. However, how to stabilize the use of heading pressure testing machine is very extensive, which undoubtedly becomes the key to the development of the industry. A few days ago, China Pharmaceutical Packaging Association held a professional meeting to discuss the revision of product standards, industry self-discipline, product prices and other issues in depth
although there are disputes over the revision of product standards, the competent departments try to ensure product quality with new standards based on the principle of "high standards and strict requirements"
last year, when some pharmaceutical enterprises proposed to suspend the use of butyl rubber plugs for some drugs, they said that the operability of butyl rubber plugs was not ideal, and the compatibility between domestic butyl rubber plugs and some drugs was not satisfactory, especially affecting the insoluble particles and clarity in infusion. To this end, on January 6 this year, China Pharmaceutical Packaging Association took the lead in holding a seminar on butyl rubber stopper product standards in Shanghai. After that, the clamping methods of different tensile testing machine clamps of the national food and Drug Administration Jinan assaying were also different. Three testing institutions, such as the pharmaceutical packaging materials inspection center of the State Administration of food and Drug Administration and the Shanghai food and drug packaging materials testing institute, tested 144 batches of butyl rubber stopper products sent by 13 butyl rubber stopper manufacturers, and put forward suggestions for revising the standards of insoluble particles and ignition residues (ash) of rubber stopper on this basis
Feng Jianping, deputy general manager of SHENGRI Qianzhou rubber and plastic (Suzhou) Co., Ltd., believes that setting the ash standard too rigid is a bottleneck for the production of powder injection rubber plugs. This restriction will also have a certain impact on the progressiveness of the production process. These views have also been recognized by Ma Dongfeng, general manager of Zhengzhou soaring pharmaceutical packaging Co., Ltd. He told that China's national and international standards are generally formulated according to the use of products, while YBB standard is divided by materials (medicinal chlorinated butyl rubber plug and brominated butyl rubber plug), which not only limits the application of domestic butyl rubber, but also limits the application of new materials (such as thermoplastic elastomers that have been applied abroad). Duan Chaoyang, general manager of Hubei Huaqiang Technology Co., Ltd., is also worried about this: "this is higher than the international standard. On the one hand, many enterprises are difficult to achieve, on the other hand, it also makes it more difficult to promote butyl rubber plugs. Pharmaceutical companies will refuse to use them on the grounds of not reaching the standard."
the testing organization that proposed the revision has fully explained these standards. Cai Rong, deputy director of Shanghai food and drug packaging materials testing institute, said that after testing 144 batches of products submitted by 13 enterprises through random sampling, this standard is fully based. In particular, insoluble particles, from the verification results, the problem is not as serious as expected. Feng Guoping also pointed out that because the use, storage, transportation and other environments of rubber plugs when applied to drugs are uncontrollable, the determination of relevant indicators should be as close to the use situation as possible in the inspection method, so that the drugs are less affected by packaging materials and other factors within the validity period. In addition, higher standards are not a bad thing for enterprises. To a certain extent, it can make the product quality better and the development space of enterprises larger
at present, the finalization of these two standards is still in full swing and is expected to be released and implemented in the near future. According to Feng Guoping, based on the opinions and suggestions of the enterprise and the changes in the requirements of the 2005 pharmacopoeia for infusion plugs, the final standard may be slightly looser in form than the original recommended standard, but its detection methods and indicators will be more scientific and reasonable. He said that after the natural rubber plugs are completely replaced, the regulatory authorities will strengthen supervision in two aspects: first, check whether the pharmaceutical companies are still using natural rubber plugs; Second, urge butyl rubber stopper enterprises to produce in strict accordance with quality standards
overcapacity and intensified competition cause market chaos, which is bound to affect the development of the industry. At present, the voice of industry self-discipline is rising, and enterprises are sensitive to prices and related factors
it is understood that at present, the number of butyl rubber stopper manufacturers registered by the State Food and drug administration has rapidly increased from 27 last year to 37, and there are also fiveorsix foreign-funded enterprises registered. Overcapacity is an unavoidable fact. Although the national development and Reform Commission has listed butyl rubber plugs as a restricted industry, there are still many new enterprises continuing to start