Injection Consistency Evaluation Series: Pre-potted syringe technical standards and industry competitive situation

Wenzhulikou431the evaluation of the consistency of generic drugs is an integral part of the ongoing reform of the pharmaceutical system in China, and it is also an important work that affects the safety and efficacy of drug use in patientsChina is a big pharmaceutical country, but not a pharmaceutical power, to carry out the conformity evaluation of generic drugs, on the one hand, can improve the quality of drugs, reduce the cost of drug use, on the other hand, by raising the overall level of the pharmaceutical industry, can promote the internationalization of China's pharmaceutical industrystarting in 2016, the curtain of generic consistency evaluation officially slowly opened, the generic drug consistency evaluation started with oral solid preparationsAt present, the evaluation of the consistency of generic drugs of solid oral preparations has been on the right trackDecember 22, 2017 and March 14, 2018, the Drug Review Center (CDE) of the State Administration of Food and Drug Administration issued a notice on the Technical Requirements for Conformity Evaluation of Listed Chemical Recombinationdrugs (Injections) and technical guidance on the development of pharmaceutical injections, but this work has been delayedIn October 2019, the State Drug Administration issued the Technical Requirements for the Conformity Evaluation of The Quality and Efficacy of Chemical Injection Siubos (Draft for Comments), and the Reporting Requirements for the Conformity Evaluation of Drug InjectionS on the Market (Draft for Comments), and the evaluation of the consistency of injections has finally been significantly advancedAs of May 14, 2020, 266 products had passed the consistency evaluation, including 32 injection products, according to data queried by insight databaseMay 14, 2020, NMPA issued the Announcement of the National Drug Administration on the Quality and Efficacy Consistency Evaluation of Chemical Injection Siubo (No62 of 2020), which provides new technical guidance and regulatory basis for this workinjection products compared to oral solid preparations, the quality risk is higher, in addition to the product's own characteristics and production process, packaging materials and accessories are more affecting its quality and safety factorsThis series of articles mainly introduces the application and progress of packaging materials commonly used in injection consistency evaluation and the auxiliary materials used in injectionsin this paper mainly discusses the main technical standards and manufacturers of pre-filled syringes, as well as related industry development sitThe Technical Requirements for the Evaluation of Conformity of Chemical Injection Siuca Siugenerics (Draft for Comments) provide detailed requirements for packaging materials and containers that come into direct contact with pharmaceuticals: "The packaging materials and containers used in direct contact with the drug for injections shall meet the packaging standards promulgated by the National Bureau, or the requirements of USP, EP, JP; Technical Guidelines for Sexual Research (Trial), Technical Guidelines for Research on the Compatibility of Chemical Injections and Pharmaceutical Glass Packaging Containers (Trial), Technical Guidelines for The Study of The Compatibility of Chemical sofories and Elastomer Seals (Trial) and other relevant technical guidelines to conduct research on the compatibility of packaging materials and containers; To comprehensively study the compatibility of contents with sealing components such as glue plugsThe quality and performance of the packaging materials and containers used in the injection shall not be less than that of the reference preparation to ensure that the quality of the drug is consistent with the reference preparation"
pre-potted syringe is a new type of drug package developed in recent years, it is not a medical device, but an integral part of the pharmaceutical packaging system, with the storage of drugs and ordinary injection two effects, the world's first pre-potted syringe was born in 1984 in the United States BD company, and since then, gradually familiar with and accepted for the United States, European marketsPre-potted syringes are mainly used for vaccines, biological products, biochemical products, anti-thrombosis drugs, beauty products and other high-value products packaging, but also can be used for ophthalmology, ear, orthopaedics, gynecology and other surgical flushingIn 2019, the global market for pre-filled syringes reached $4.6 billion, the fastest growing of all forms of packaging containersDomestic pre-filled syringe research started late, China's first glass pre-potted syringe was born in 2005 in Shandong Weigao Grouppre-potted syringes are generally divided into glass pre-potted syringes and plastic pre-potted syringes, products are mainly divided into injection needles and not injection needles two categories, glass product specifications are 0.5 ml-20 ml, plastic product specifications have 5 ml-50mlPre-potted syringes are generally combined and consist mainly of casings, pistons, pushrods, tapered heads and capsNeedle with needle embedded, consisting of needle tube, needle cap, piston and pushrod, without needle divided into tapered head and spiral head type, tapered head type consists of needle tube, cone head cap, piston and pushrod, spiral head consisting of needle tube, spiral head cap, spiral head, piston and pushrodpre-potted syringe needles are generally stainless steel materials, the rest of the material solely using high-quality glass, plastic and rubber, to ensure the safety and reliability of the product, on the other hand, pre-potted syringes to eliminate the transfer of drugs from packaging to syringes, effectively reduce the waste caused by adsorption and avoid cross-contamination of drugs and secondary pollution;pre-potted syringe sits with separate standards (e.gboron glass needle YBB00062012 for pre-potted syringes, stainless steel injection needle YBB10072012 with pre-potted syringeY10072012, pre-potted syringe yBB30012012, pre-potted syringe with bromine butyl piston YBB3022012, Pre-potted syringe with polyisoprene rubber needle cap YBB30032012 and so on), pre-potted syringe combination of domestic implementation of the standard for YBB00112004-2015, the main technical indicators are the following:1- pre-potted syringe body dense pre-potted syringe body density directly affect its use and adaptability performance, is one of the indicators of the production enterprises focus on the use of the production enterprises2-Pre-potted syringe stress value glass pre-potted syringe production process to go through the process of annealing, pre-potted syringe stress once exceeded the standard, there will be occasional self-explosion and slight external force induction is the possibility of rupture, to the use of a great safety hazardScientific detection of stress in pre-filled syringes can help enterprises to analyze and improve the internal stress index of products, and effectively reduce market risk3-Pre-potted syringe piston sliding piston sliding is an important detection index to detect pre-potted syringe, because when pushing the piston, the piston and glass needle inner wall will produce a certain resistance, in the actual use of the medium force value is too large will cause injection difficulties, the force value is too small injection too fast to cause danger4-Pre-potted syringe injection needle steel test project stainless steel needle in the application process, requires that it has a certain degree of rigidity, to ensure that the steel needle in the process of use is not easy to bend, reduce the possibility of medical accidentsin addition, the international pre-potted syringe also has ISO11040 series standards, such as ISO11040-4 (pre-potted syringe with glass needle tube), ISO11040-5 (pre-potted syringe piston), ISO11 1040-6 (Plastic needle for pre-potted syringes), ISO11040-7 (packaging system for pre-potted syringe assembly), ISO11040-8 (requirements and testmethods for pre-potted syringe assembly)after the author's search, found that the pre-potted syringe accessories manufacturers are numerous, so this article mainly introduces the manufacturer of pre-potted syringe components the current rapid development of vaccines, bio-recombinant genes, monoantigens, microspheres and blood products, pre-potted products market development space is huge, the national pre-potted syringe slot about 350 million units of market space, according to the National Drug Administration CDE original auxiliary package registration information data, pre-filled syringe combinations are: BD, GerresheimerBuende GmbH, SCH Pre-filled syringe combination synthes of domestic production enterprises are: Shandong Weigao Group Medical Polymer Products Co., Ltd., Shandong Weigao Puri Pharmaceutical Packaging Co., Ltd., Shandong Zibo Minkang Pharmaceutical Packaging Co., Ltd., Shandong Pharmaceutical Glass Co., Ltd., Shandong Yongju Pharmaceutical Technology Co., Ltd., Ningbo Zhengli Pharmaceutical Packaging Co., Ltd There are two types of preliminary review and approval results for pre-potted syringes and preparations : raw materials/excipients/bags (A) approved for use in listed formulations, raw materials/excipients/packs (I) that have not been approved for joint review and approval of the preparation (See Table 1) Table 1CDE Pre-potted syringe registration information statistical table
BD is a global medical technology company, is also the world's first manufacturer of pre-potted syringes, currently has glass pre-potted syringes and plastic pre-potted syringe production line, as well as syringes or needles and other series of components, can provide semi-finished, finished products full of specifications of pre-filled syringes BD is the world leader in pre-potted syringes, accounting for about 70% of the global market share, and is one of the leading market leaders in the pre-filled sealing market and one of the leading framers of industry standards Most biopharmaceutical companies work with BD, which has successfully provided or customized pre-potted syringe combinations for a wide range of biotech drugs, chronic disease treatment drugs, vaccine products, etc In 2016, bD pharmaceutical system pre-filled syringe production line started construction in Suzhou Weigao Group Pharmaceutical Packaging Products Co., Ltd and Shandong Weigao Pre Pharmaceutical Packaging Co., Ltd are affiliated with The Weegaard Group Medical Polymer Products Co., Ltd., is China's first pre-potted syringe (pre-charged syringe) manufacturer to obtain a registration certificate, is also the leading enterprise of the domestic pre-filled syringe, its product variety covers the entire pre-filled syringe (pre-filled) specifications Shandong Zibo Minkang Pharmaceutical Packaging Co., Ltd., founded in 2004, the company has Asia's first, the world's fourth complete pre-potted syringe production line, not only to fill the domestic gap, and break the monopoly of foreign products The company's leading products for 1.0ml, 2.25ml, 3.0ml pre-potted syringe, the company was approved by the Shandong Provincial Science and Technology Department as a "pre-filled syringe research and development center." Shandong Pharmaceutical Glass is currently Asia's largest pharmaceutical glass packaging products and butyl plug products production base, is the domestic pharmaceutical glass products industry segment of the leading, traditional products have been firmly occupied the absolute dominant position in the domestic market, the company in 2011 was issued by the State Food and Drug Administration "pre-filled syringe combination" registration certificate, and built a complete pre-potted syringe product production line Description: This article does not constitute value judgment and investment advice