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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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  • Comparative analysis of water vapor transmission rate testing methods for packaging plastic films
    Comparative analysis of water vapor transmission rate testing methods for packaging plastic films 2022-05-06
    Packaging plastic films refer to films made of polyvinyl chloride, polyethylene, polypropylene, polystyrene and other resins for packaging, as well as for use as a laminating layer. The share of plastic packaging and plastic packaging products in the market is increasing, especially the composite plastic flexible packaging, has been widely used in food, medicine, chemical and other fields, among which the largest proportion of food packaging, such as beverage packaging, frozen food packaging, steamed food packaging, fast food packaging, etc. These products have brought great convenience to people's lives. In order to ensure the effectiveness of packaging products, it is required to have good barrier performance, which is measured by an important indicator is the water vapor transmission rate (amount). There are many testing standards on water vapor transmission rate (amount) at home and abroad, of which the following are the common testing standard methods. ISO 15106-2 - Plastics -- Film and sheeting -- Determination of water vapour transmission rate -- Part 2: Infrared detection sensor method ASTM F1249 - Standard Test Method for Water Vapor Transmission Rate Through Plastic Film and Sheeting Using a Modulated Infrared Sensor TAPPI T557 - Water vapor transmission rate through plastic films and sheeting using a modulated infrared sensor ISO 2528 - Sheet materials -- Determination of water vapour transmission rate -- Gravimetric (dish) method ASTM E96 - Standard Test Methods for Water Vapor Transmission of Materials ASTM D1653 - Standard Test Methods for Water Vapor Transmission of Organic Coating Films TAPPI T464 - Water Vapor Transmission Rate of Paper and Paperboard at High Temperature and Humidity ISO 15106-3 - Plastics -- Film and sheeting -- Determination of water vapour transmission rate -- Part 3: Electrolytic detection sensor method W900 Gravimetric Method Vapor Transmission Rate Tester 1.Analysis from the principle of the test method Visible film water vapor transmission rate (amount) detection methods are mainly divided into two categories, respectively, the gravimetric method and the sensor method. The gravimetric method (also known as cup method) is divided into two types of weight gain method and weight loss method, which detects the weight change of the moisture vapor transmission cup. Electrolysis analysis method and infrared detector method belongs to the sensor method, which, the principle of electrolysis method refers to the electrolysis of water vapor encountered electrodes for hydrogen and oxygen, through the electrolysis current to calculate a certain period of time through the unit area of the sample water vapor transmission rate (amount); infrared method is the principle of water vapor from the high humidity cavity through the sample penetration to the low humidity cavity, the electrical signal generated by the carrier gas transmitted to the infrared detector to calculate the water vapor permeation rate (amount). W203 ...
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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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  • Warmly welcome the leaders of Guangdong University of Technology to visit GBPI
    Warmly welcome the leaders of Guangdong University of Technology to visit GBPI 2022-04-01
    On March 31, Xiong Xiaoming, President of Guangdong University of Technology, led a group of five key teachers from the College to visit Guangzhou BSI, and Zhou Xue Cheng, General Manager of the company and various technical backbones attended the exchange meeting. General Manager Zhou led President Xiong and his party to visit the CNAS laboratory , introduced the qualification capability and testing scope of CANS laboratory, and focused on the industrial digitalization construction results of the digital laboratory. Manager Huang introduced to President Xiong the development history, strategic direction and core advantages of Biaoji. The two sides then had an in-depth discussion and exchange on strengthening school-enterprise cooperation, mutual support, complementary advantages and resource sharing between schools and enterprises. President Xiong said at the meeting that the college and GBPI can start a comprehensive cooperation, hoping to take the opportunity of today's visit to establish a close contact with GBPI through the school-enterprise cooperation platform, so as to directly understand the development needs of enterprises on the one hand, and effectively improve the relevance and applicability of the college's personnel training on the other. GBPI has always been committed to promoting the win-win model of school-enterprise cooperation, deepening communication and cooperation with universities and research institutions, building bridges for talent mining and training, and concentrating efforts to promote the technical development of the industry. In the future, GBPI will continue to plow deeper and strive for innovation to lead the development of the industry.
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  • Welcome the leaders of Southern Metropolis News to visit GBPI
    Welcome the leaders of Southern Metropolis News to visit GBPI 2022-03-23
    On March 22, 2022, a group of leaders from Southern Metropolis Daily visited GBPI headquarters to conduct special research on "Specialized and New" enterprises, and was received by the management team, including General Manager Zhou Xuehui. It is reported that this series of research activities is to promote and appeal to the relevant departments to pay attention to the development problems of the specialized and small giant enterprises and remove obstacles for the development of the specialized and small giant enterprises. During the investigation and research, accompanied by our company's general manager Zhou, the crowd visited the production workshop of various instruments, CNAS laboratory and digital laboratory. During the seminar, Mr. Zhou expressed a warm welcome to the research and guidance team and introduced the development history of GBPI over the past 20 years, as well as its current strategic direction, core advantageous products and the newly launched digital laboratory business, and truthfully reported the challenges faced by the enterprise in the process of development, such as the overall situation and relevant initiatives in recruiting talents, retaining talents and using talents well. Afterwards, the guests and hosts exchanged the current development status of the packaging testing industry, analyzed the problems in the development of GBPI, and discussed the enterprise cases with reference significance. Finally, Mr. Zhou said that GBPI, as one of the first high-tech enterprises rooted in Huangpu Development Zone, has been continuously increasing its investment in technology research and development, striving for a new journey and building a new era, making the enterprise bigger and stronger while contributing its share of strength in environmental protection, food and pharmaceutical industries with more advanced testing technology.
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