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  • Chemical injection packaging system sealing research technology guide
    Chemical injection packaging system sealing research technology guide 2022-06-17
    I. Overview A packaging system is the sum of all packaging components that contain and protect a pharmaceutical product, including packaging components that come into direct contact with the drug and secondary packaging components. This technical guide is mainly applicable to the packaging system of chemical injection. The packaging system for injectables should be able to maintain the integrity of the product contents while preventing microbial invasion. Package integrity, also known as container-closure integrity, refers to the ability of the packaging system to prevent the loss of contents, microbial invasion, and the entry of gases (oxygen, air, water vapor, etc.) or other substances to ensure that the drug continues to meet safety and quality requirements. package integrity test , or container-closure integrity test, CCIT, is a package leak test (including physicochemical or microbiological testing methods) that detects any rupture or seam, some of which can determine the size and/or location of the leak. This technical guide is drafted with reference to relevant domestic and international technical guidelines and standards, focusing on the selection and validation of sealing inspection methods for injectable packaging systems, with the aim of facilitating the research and evaluation of chemical injectables at this stage. The drafting of this technical guide is based on the current knowledge of the issue, and will be revised and improved with the continuous improvement of relevant regulations and the improvement of technical requirements of drug research. II. General considerations The main types of leaks in injection packaging systems include: 1) microbial intrusion; 2) drug escape or external liquid/solid intrusion; and 3) change in headspace volume content, e.g., headspace inert gas loss, vacuum disruption, and/or external gas entry. The sealing quality requirements of the injection packaging system can be divided into: 1) the need to maintain sterility and product component content, without maintaining the headspace volume; 2) the need to maintain sterility, product component content and headspace volume; 3) the requirement to maintain sterility of multi-dose packaging, that is, after the package is opened, to prevent microbial invasion and leakage of drugs during use. Research related to the sealing of the injection packaging system should be carried out according to the product characteristics. Injectable packaging system sealability meets the requirements, which usually means that the packaging system has passed or can pass the microbial challenge test. A broad sense means that there are no leaks that would affect the quality of the drug product. Based on scientific studies and risk assessment, the maximum allowable leakage limits should be determined taking into account the packaging composition and assembly, the product contents, and the environment to which the product may be exposed during its life cycle. A packaging system is con...
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  • Packaging inspection technology in the quality control process
    Packaging inspection technology in the quality control process 2022-04-07
    1, flexible packaging product market characteristics 2, the type and form of flexible packaging structure 3, the common testing methods and testing tools 4, the shallow media volume control process of several methods 5, the construction of the packaging laboratory points 1.flexible packaging products market characteristics 1.1, the development of flexible packaging is becoming more and more mature, rapid development, small-scale, many manufacturers, accounting for the proportion of national economic output value is rising. 2.1, packaging to the development of specialization instead of scale development, aggregation about the development of higher costs, service industry characteristics: small orders, many varieties, short delivery period, suitable for specialization. 3.1, the deep processing of agricultural and sideline products is a huge market, such as vegetables, fruit, grain, meat and poultry, eggs, in developed countries there are few farmers' markets. Farmers' markets are gradually replaced by supermarkets, and free market meat cases have evolved from frozen sales to the popular fresh sales. Fresh packaging presents a huge business opportunity for many packaging companies, which has achieved the blow molding market. In Japan today, cooking at home is a grand affair, mostly fast food, providing a market for many Chinese high-barrier film manufacturers. The accelerated pace of life, the traditional way of life is rapidly impacted, life towards convenience, clean food, fast food is the inevitable trend of development, all goods are quantitatively packaged, the development of China's packaging industry for tomorrow points the way, packaging will always be vigorous. 2.the type and form of flexible packaging structure     Today's world is short of natural resources, from the saving of resources and protection of the environment, high consumption of wood, iron, glass and other hard packaging is gradually replaced by flexible packaging, flexible packaging multi-layer composite structure and multi-layer co-extruded film provides a wide range of protective properties. Structure Performance Application NYCON/TIE/PE High strength, better barrier properties Weight packaging, liquid packaging, electronic light industry product packaging PE/TIE/NYLON/TIE/PE High strength, better barrier properties Weight packaging, milk powder, electronic light industrial product packaging PE/NYLON/PE/NYLON/PE/EVOH/PE High strength, high barrier Toothpaste tubes, preserved food, pharmaceutical packaging     The quality and technical requirements of different types of packaging films and morphological structures are very different, for example, the quality difference between cast film and blown film.     In blown film, the elongation rate is lower than that of cast film due to the process, and in blister packaging, there is a certain requirement for elongation rate, so cast film is usually used. We have customers in Zhongshan and Dongguang who...
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  • Leaders of the Ministry of Industry and Information Technology visited GBPI to guide the work
    Leaders of the Ministry of Industry and Information Technology visited GBPI to guide the work 2022-03-11
    On March 10, 2022, Shan Lipo, director of the Small and Medium Enterprise Development Promotion Center of the Ministry of Industry and Information Technology, led the team, Zhao Yi, deputy director of the Industry Promotion Center (Guangzhou) of the Small and Medium Enterprise Development Promotion Center of the Ministry of Industry and Information Technology, Cheng Yougen, deputy director of the Guangdong Provincial Bureau of Small and Medium Enterprises, Guangzhou Industry and Information Technology Co., Ltd. Ye Huadong, Director of the Small and Medium Enterprise Bureau of the Information Technology Bureau, Guo Xiong, Director of the Private Economy Division of the Guangzhou Bureau of Industry and Information Technology, Director of the Small and Medium Enterprise Department of the Guangzhou Bureau of Industry and Information Technology, Yi Huaiyu, Deputy Director of the Huangpu District Bureau of Industry and Information Technology, Huangpu Tan Jianwei, Director of the Small and Medium Enterprise Department of the District Bureau of Industry and Information Technology, and other leaders visited Guangzhou Biaoji Packaging Equipment Co., Ltd., Zhou Xuecheng, Chairman of GBPI, Zhou Xuehui, General Manager of GBPI, and company executives warmly welcomed and accompanied them throughout the process. Shan director and his party first came to the laboratory and production workshop of barrier performance testing instruments on the second floor, visited the production workshop and laboratory of water vapor transmission rate tester, gas transmission rate tester and oxygen transmission rate tester, and observed the live demonstration of IOT interoperability of products, which were highly evaluated by leaders at all levels. After that, the delegation visited the production workshop and digital laboratory of basic instruments. They learned about the components of the digital laboratory system in detail, including: connection to ERP system, automatic generation and printing of QR code based on sample information, one-click entry of sample information by scanning QR code with a code gun, automatic collection of test data, support for data screening of the same batch number, one-click generation of test reports, laboratory management functions, remote expansion support, etc. During the seminar, Mr. Zhou reported the development history of GBPI, the advantages of its products and the difficulties faced by the company at present, and the experts and leaders spoke highly of the achievements of GBPI in the industry and its digital product innovation. On the spot, he suggested GBPI to declare the qualification of National Key Specialized and New Enterprise and provided the way to declare the qualification. Director Shan pointed out that the benign development of enterprises must establish good school-enterprise cooperation, formulate a talent training plan suitable for the development of enterprises, solve the problem of supplying talents for enterprises, and...
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  • GBPI Accelerates Digital Strategy Deployment
    GBPI Accelerates Digital Strategy Deployment 2022-03-03
        On February 22, the Guangzhou Municipal Information Office held a press conference on the theme of "Guangzhou Science and Technology Innovation "14th Five-Year Plan". According to the press conference, the Guangzhou Municipal Bureau of Industry and Information Technology will focus on the implementation of the "Guangzhou Municipal  Digital Transformation Policy Measures", focusing on "one chain, one policy" to promote the digital synergy of key industrial chains, "one line, one policy" to promote the digital development of traditional industrial clusters, "one enterprise, one policy" to guide the intelligent upgrading of key enterprises with advantages, and "one park, one policy" to strengthen industrial clusters. "One enterprise, one policy" to guide the intelligent upgrading of key enterprises with advantages, "one park, one policy" to strengthen the construction of internal and external networks in industrial parks, and other four aspects.     In order to comprehensively grasp the current situation, transformation pain points and transformation needs of enterprises in Huangpu District, judge the future market scale of Huangpu District and Guangzhou City, and provide a scientific basis for formulating policies related to digital transformation of enterprises, recently, a group of leaders from the Bureau of Industry and Information Technology of Huangpu District, Guangzhou City, visited Guangzhou Biaoji to carry out special research, which was warmly received by Mr. Zhou, Chairman of Biaoji, and Mr. Wang, Manager of R&D Department. According to the introduction, GBPI digital laboratory as a benchmark demonstration project of digital transformation, the system interconnects equipment management, laboratory management, customer information management, sample information management, testing task management, comprehensive management of experimental results and intelligent evaluation and other aspects of effective digital management through the interconnection of instruments and equipment and IT systems, realizing digital laboratory data, digital product quality management and customer service facilitation.  Guangdong Province is a manufacturing province, manufacturing is the main battlefield to promote the deep integration of the digital economy and the real economy. At present, the flexible packaging testing industry is generally at the stage of digital introduction and start-up. In the future, GBPI will continue to accelerate the strategic deployment of enterprise digitalization and firmly promote the accelerated development of manufacturing industry towards digitalization, networking and intelligence.
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  • Testing program on the quality of food packaging printing
    Testing program on the quality of food packaging printing 2022-02-23
        As we all know, today's society has developed to the extent that all goods need to be packaged, where the packaging needs to be printed. Printing is the most important means of decoration and processing of product packaging, packaging without printing is almost unimaginable. Printing plays a role in the transmission of information, publicity about the product. At the same time, for some goods, printing also plays an important role in anti-counterfeiting. Today's packaging printing towards more exquisite and improve the direction of the added value of goods. Plastic flexible packaging ink is mainly divided into organic solvent-based ink, water-soluble ink, high-solid ink and non-benzene ink. Organic solvent-based ink using toluene, xylene, acetone, butanol, ethyl acetate and other low-boiling point volatile organic substances as a solvent, fast printing speed, good quality prints, lower cost, and therefore widely used.     Based on the current rapid development of China's social and economic situation, people's living standards have been greatly improved, and food safety issues are naturally being paid more and more attention to. Food packaging is not only the appearance of food to play a decorative role, but also its more important value is reflected in ensuring the safety and health of food, so the enterprises for food packaging printing technology and its safety to carry out relevant analysis, research is significant, the main direction of testing ink safety, printing ink layer firmness, ink residue and other directions. Gx-B3 Disk Stripping Tester is used for gravure printing process of plastic film and cellophane decorative printed materials (including composite film printed materials) to test the fastness of the printing ink layer bonding; it can also be used for vacuum coating, surface coating, composite and other related processes formed by the adhesion state of the surface layer test test. GX-C2 Rub Tester is suitable for testing the abrasion resistance of printing ink layer, the abrasion resistance of PS plate photosensitive layer and the abrasion resistance of the surface coating of related products; it can effectively analyze the poor abrasion resistance of printing products, the peeling off of ink layer film, the low printing resistance of PS plate and the poor coating hardness of other products. GC-9802 Gas Chromatography is suitable for detecting organic solvents, and can detect solvent residues in packaging and printing products, and also detect the purity or content of a single solvent, which is widely used in environmental protection, trace detection of pollution of the atmosphere and water sources; analysis, monitoring, and research of toxic substances; biochemistry; clinical applications; pathology and virus research; food fermentation; petrochemicals. Petroleum processing; oil analysis; geology, prospecting research; organic chemistry; synthesis research; health quarantine; publ...
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