Conversion of glass packaging to neutral borosilicate glass
november 8, the beginning of winter. The seminar on the impact of pharmaceutical glass packaging on drug quality and market (hereinafter referred to as the Seminar) hosted by China Pharmaceutical Packaging Association was held in Cangzhou, Hebei Province. In addition to a few experts in pharmaceutical packaging materials, more than 160 participants were all from more than 60 pharmaceutical enterprises
it is rare for pharmaceutical enterprises to be so concerned about the dynamics and progress in the packaging material field of upstream suppliers. In the view of the representatives of pharmaceutical enterprises present at the meeting, it was very normal. Behind the "rare" and "normal" is an impending event in the pharmaceutical industry: the related approval of excipients, packaging materials and drugs
the opinions of the State Council on the reform of the review and approval system for drugs and medical devices (GF  No. 44) clearly stipulates that the examination and approval of drugs, pharmaceutical packaging materials and pharmaceutical excipients shall be carried out in association, and the examination and approval of pharmaceutical packaging materials and pharmaceutical excipients shall be changed from the separate examination and approval to the examination and approval of drug registration applications. At the same time, the main body of the applicant shall be implemented
with document No. 44 as the endorsement, drug manufacturers, especially high-risk injection manufacturers and glass packaging manufacturers, should strengthen interaction and pay attention to the packaging technology market
the advantages of medium boron are fully displayed.
"we were very strict in inspecting and auditing the suppliers at the beginning. We determined that the neutral vials made of four-star glass have not been changed since then. Now the annual consumption is about 10million. The appropriate packaging material is an important factor for the stability of the quality of our injections." Wusidan, general manager of Jilin Cornell Pharmaceutical Co., Ltd., told me during the seminar
the neutral vial used by Cornell pharmaceutical is made of neutral borosilicate glass (neutral glass for short). The consensus of drug packaging materials experts has long been that neutral glass is especially suitable for acid, alkali and pH sensitive drugs because of its good chemical stability, low alkali leaching amount and first-class water resistance. Therefore, neutral glass is widely used in injection packaging in developed countries, and Russia, India and other countries are also vigorously promoting it. However, in China, most injection glass packaging is still low borosilicate glass. According to the data provided by yuanchunmei, senior engineer of Beijing Institute of pharmaceutical packaging materials inspection, only 1% of the more than 600 injection packaging bottle registration certificates in China are produced with neutral glass tubes. The resulting injection safety risks have long been valued by the drug regulatory authorities and the industry
2012, the former Beijing food and Drug Administration sampled 111 batches of pharmaceutical glass packaging materials for injection and found that "the inspection data of water resistance on the inner surface of a few glass packaging materials and water resistance by 121 ℃ particle method are close to the standard critical value; the inspection results of breaking force of a few glass ampoules are close to the standard critical value, and there are potential quality hazards"
insiders pointed out that the situation in Beijing is actually widespread throughout the country. It has been found that some glass bottled injections may lose their activity within the validity period, and may also be prone to flakes and white spots within the validity period. After direct injection into the blood, it will cause problems such as capillary blockage, swelling of the meat that can store and process the experimental results. In severe cases, the debris may even be embedded in the blood vessels of the brain, endangering life. These glass bottles are made of low borosilicate glass or lower end soda lime glass
under this background, on November 8, 2012, the former State Food and Drug Administration issued the "notice on strengthening the supervision and administration of drugs for pharmaceutical glass packaging injections" (132). The notice requires that pharmaceutical glass or other suitable packaging materials with 121 ℃ particle method water resistance of grade 1 and internal surface water resistance of grade HC1 shall be selected for biological products, acid and alkali and pH sensitive injections. Neutral glass is the medical glass that meets the above requirements
3 years have passed, and the promotion of medicinal neutral glass has made breakthroughs, but it is far from becoming the mainstream of injection packaging. The low-end packaging materials still frequently appear behind the injection quality problems: in July this year, dobutamine hydrochloride injection, which was sold by Liuzhou pharmaceutical and produced by Zhejiang Ruixin pharmaceutical, contained glass debris and was identified as inferior by Liuzhou Food and Drug Administration of Guangxi; In October this year, amendment pharmaceutical was also punished by Chengdu food and Drug Administration for using the unqualified drug packaging material "low borosilicate glass controlled oral liquid bottle"
market knots to be solved
price is a major reason why pharmaceutical enterprises are unwilling to complete packaging upgrading as soon as possible. It is understood that at present, the main manufacturer of neutral glass in foreign countries is Schott, with a price of about 27000 yuan per ton; The main domestic producers of neutral glass include Cangzhou Sixing, Shandong lino and Shandong Pharmaceutical glass, with a price of about 12000 yuan per ton. Among them, Cangzhou four star has the largest production capacity in China, with an annual output of 20000 tons of neutral borosilicate glass tubes, 2billion neutral glass vials and ampoules. Experts say that even if the domestic neutral glass is used, the packaging cost will also double. At present, the tearing and cutting direction should be the same as the rolling direction 1. In the provincial drug centralized bidding procurement dominated by low price, the injection packaged with neutral glass is difficult to gain competitive advantage
Zhaoting, general manager of Shandong Fangming Pharmaceutical Group Co., Ltd., pointed out that 95% of the glass packaging injections in China use low borosilicate glass or sodium calcium glass, while 95% of the small volume injections in clinical use cost only 10 to 20 cents per unit. If the packaging is changed to medium borosilicate glass, the cost will basically double. There are many manufacturers of small volume injections, and the competition is very fierce. "Unless it is recognized in the drug bidding, and the injection packaged with neutral glass can gain a price advantage in the market access, the good currency will be expelled.". He also put forward specific suggestions on the conversion of injection packaging from low boron to medium boron: the State formulates policies and the industry advances step by step, such as first specifying that the injection with a certain pH value should be converted first; Each province shall also give a certain proportion of price increase rights to pharmaceutical enterprises using neutral glass packaging. "The policies of various management departments should cooperate with each other, so that the use of neutral glass can be implemented and the quality and safety level of injection can be improved." Zhao Ting emphasized
in fact, the development achievements of neutral glass in China are commendable. Hebei Cangzhou Four Star Glass Co., Ltd. is determined to develop neutral glass. Since 2006, the company has adopted the advanced, energy-saving and environment-friendly "all electric melting Vero method" pipe drawing technology and independently developed the first-class water resistance 5. 0 neutral borosilicate glass tube has obtained the national invention patent, filled the domestic blank, and the product quality is stable, breaking the situation that China's pharmaceutical neutral borosilicate glass tube is completely dependent on imports. As a key support project for strategic emerging industries in the 12th Five Year Plan of the national development and Reform Commission, the technology upgrading of domestic neutral glass tubes has received the support of the innovation fund of the Ministry of science and technology and special subsidies from the national and Hebei Development and Reform Commission. In 2014, Cangzhou Sixing successfully developed the first glass tube automatic packaging and transmission system in China, and all tube drawing processes have realized intelligent production
large scale production can reduce the cost, and neutral glass is no exception. Wanghuanyi, chairman of Cangzhou four stars, introduced that the production cost per ton of neutral glass is about 3000 yuan, with an output of 100000 tons and an output of 10000 tons. "We have been trying to provide suitable packaging materials for pharmaceutical enterprises by increasing scale and technological progress to reduce costs."
it is compatible with drugs, with reasonable cost performance and policy coordination support. In the process of glass to medium boron conversion of low boron drugs, none of them can be omitted. Representatives of pharmaceutical enterprises also pointed out that under the situation of medical insurance fee control, how to explain that using more expensive packaging materials can bring greater benefits is a difficult problem for pharmaceutical enterprises and pharmaceutical packaging materials enterprises
reform promotes transformation
in addition to market, price and other factors, another factor restricting pharmaceutical enterprises from upgrading pharmaceutical packaging materials is that they do not understand and worry about the approval
like many previous seminars, China Pharmaceutical Packaging Association actively builds a platform for tripartite communication among pharmaceutical enterprises, packaging materials enterprises and drug regulatory agencies, and invites authoritative people to answer questions and solve doubts for enterprises. "What is a preparation? A preparation is an active ingredient + excipients + packaging materials. We hope that enterprises will pay attention to the drug registration reform, including the approval of cleaning the surface dust. After the reform, the pressure of pharmaceutical enterprises will inevitably increase. Packaging materials will affect the stability of drug quality. Although some injections pass the factory test, they are actually unqualified within the validity period because of the interaction between the drug solution and glass. If neutral glass is really considered to be superior to low boron drugs Bo, then pharmaceutical companies should start early and change early. " A drug administration official suggested the enterprise at the meeting. Caihong, Secretary General of the Pharmaceutical Packaging Association, pointed out that in the "13th five year plan", the association hopes to make its normal operation of water needle glass packaging change from low boron to medium boron, because the first reason is that liquid preparations are high-risk products, and the second reason is that strong acid and strong alkali biological products are sensitive. To promote the smooth transformation from low boron glass to neutral glass, on the one hand, we should strive for policy support; On the other hand, enterprises should have less wait-and-see hesitation, more wisdom, more voices and more suggestions
as the only Chinese member of the packaging, storage and Transportation Committee of the United States Pharmacopoeia Commission, Gao Yonghua, Deputy Secretary General of the Pharmaceutical Packaging Association, introduced the requirements and standards of the U.S. regulatory agencies for pharmaceutical packaging materials, as well as the key points and methods of pharmaceutical enterprises' auditing suppliers. She suggested that at the moment of the reform of the drug review and approval system, pharmaceutical enterprises will become the main body of drug quality. They should have an in-depth understanding of the characteristics and production process of packaging materials as soon as possible, carry out research on extractable substances and compatibility tests, and select packaging suitable for specific drugs (1 to 1); Formulate appropriate agreement (contract) standards (refer to Chinese Pharmacopoeia, YBB, ISO and association standards) on the basis of compliance with national mandatory standards; In order to meet the requirements that the drug quality must be safe and reliable, it is recommended to use neutral borosilicate glass for water injection; The pharmaceutical enterprises have properly audited the packaging material suppliers, fully communicated with the suppliers, and handled the changes to ensure that the packaging products that meet the quality requirements are continuously obtained
global glass () Department