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  • Testing for Migratory Substances in Pacifiers
    Testing for Migratory Substances in Pacifiers 2022-10-14
    In the production process of rubber, plastic and other products, in order to prolong the service life of the product and have good anti-oxidation, smoothness, flexibility and other properties, antioxidants, anti-blocking agents, plasticizers and other additives are often mixed. In addition to this, it is difficult to completely react the individual monomers used to prepare the product. Experiments have shown that these additives and residual monomers will slowly migrate outward in rubber, plastic and other products. When rubber and plastic products are in direct contact with food and medicine in packaging or other forms, these substances are likely to migrate. In food and medicine, food safety incidents such as "liquor plasticizer incident" and "toxic plastic wrap incident" are all related to the migration of harmful substances in packaging. Monitoring of Migratory Substances in Articles. Pacifiers are mostly used by infants and are in direct contact with the milk powder and oral cavity. The functional development of various organs of infants is not perfect. There are more migratory substances in the pacifier, which is more harmful to the baby. The total amount of control to ensure the safety of infant food intake. Each country has national standards, such as Thailand Thailand mandates TIS 1025-2562 (2019) as a new standard for pacifiers. This will take effect on December 13, 2021. On June 16, 2021, the Ministry of Industry of Thailand published a regulation in the Government Gazette requiring TIS 1025-2562 (2019) as a standard for pacifiers (the regulation). This industry standard is mainly based on EN 1400:2013+A1:2014 and contains requirements related to the materials, construction, performance, packaging and product information of such products. It is built with reference to information from the manufacturer, the user and the following documents: EN 1400:2013+A1:2014 "Children's use and care articles - Pacifiers for infants and young children - Safety requirements and test methods" EN 71-3:2013+A2:2017 'Safety of toys - Part 3 "Migration of certain elements" EN 12868:2017 'Children's use and care articles - Method for determination of the release of N-nitrosamines and N-nitroso substances from elastomer or rubber teats and pacifiers DIN 53160-1:2010 "Determination of colour fastness of commonly used articles - Part 1: Artificial saliva test" ISO 105-A03:1993 'Textiles - Tests for colour fastness - Part A03: Grey scales for assessing dyeing' Ministry of Health Circular (No. 369) BE 2558 (2015) Re: Bottles and Containers for Infants and Young Children. TIS 1025-2562 (2019) also requires certain nipple materials/components to comply with certain chemicals/tests involving: Migration of 17 elements Release of N-nitrosamines and N-nitroso species 2-mercaptobenzothiazole release Antioxidant release formaldehyde release Bisphenol A (BPA) release Color fastness Volatile compound content Test methods and instruments The AUTO ZF3600 total migration and ...
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  • GBPI Will attend K2022 exihibition
  • Welcome to visit GBPI booth at 2022 K SHOW exhibition
    Welcome to visit GBPI booth at 2022 K SHOW exhibition 2022-08-30
    Circularity will be in the spotlight at K 2022, the world’s largest plastics trade show.  K SHOW 2022 The World’s No.1 Trade Fair for Plastics & Rubber Location: Germany Booth No:13D07 Time: 19-26 Oct. 2022    we look forward to seeing you there! K is the world's largest trade fair for the plastics and rubber industry. It gathers the most important supplier of plastics and rubber machinery, raw and auxiliary materials and semi-finished products, technical parts and reinforced plastic products under one roof. It is an ideal platform to showcase products and innovations and to make business contacts. K will be followed by a special exhibition under the theme "Visions in Polymers", that presents the trends and innovations of the industry. Special consideration is given to the subjects of energy efficiency and resource conservation.
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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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