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  • Innovation and application of detection technology for the residue on evaporation in purified water
    Innovation and application of detection technology for the residue on evaporation in purified water 2022-11-23
    ABSTRACT: The residue-on-evaporation method of purified water is to detect the quality of residue on evaporation solids obtained after 100 mL of purified water is evaporated and dried. The difficulty is that the operator needs to repeat the operation to achieve the 0.3mg constant weight value required by the Chinese Pharmacopoeia. The traditional test method has the shortcomings of low efficiency and manual duty. After long-term practice and repeated verification, it adopts an integrated automatic structure design, equipped with rapid water bath evaporation and gas balance technology, which can realize automatic feeding, water bath evaporation, blast drying and cooling balance, constant temperature weighing five-in-one automatic test. Through the repeatability experiment and gradient design experiment, the results show that: 2 rounds of weighing can reach a constant weight error value of 0.3mg, when the scalar amount is 9.4mg/100mL, the precision (RSD) is 0.73%, and the accuracy of the gradient design experiment is high. There is no deviation between parallel samples. Conclusion: After the innovation of the residue on evaporation detection technology of purified water, the test time to reach constant mass value is short, the operation is simple, and the data accuracy and precision are good. KEYWORDS: purified water; residue on evaporation; constantmass; automated test 01 Standard requirements According to the requirements of Chinese Pharmacopoeia 2020 Edition Part II "Purified Water": Take 100mL of this product, put it in an evaporating dish with constant weight at 105°C, evaporate it to dryness on a water bath, and dry it at 105°C to constant weight, and the remaining residue should not exceed 1mg. The Chinese Pharmacopoeia defines constant weight as constant weight, unless otherwise specified, refers to the weight of the test sample after two consecutive drying or igniting weighing the difference is less than 0.3mg; the second drying to constant weight and each subsequent weighing should be carried out after 1 hour of drying under the specified conditions. According to the requirements of European Pharmacopoeia 10.0 Edition, about “Purified water in containers“, Residue on evaporation: maximum 0.001 per cent. Evaporate 100 mL to dryness on a water-bath and dry in an oven at 100-105 °C. The residue weighs a maximum of 1 mg. The requirements of the Chinese Pharmacopoeia, the US Pharmacopoeia and the European Pharmacopoeia for limits of constant mass and residue on evaporation in purified water are shown in Table 1. It is worth noting that the US Pharmacopoeia does not require residue-on-evaporation items for purified water, the European Pharmacopoeia has no residue on evaporation testing items for Purified water in bulk, while Purified water in containers does not. For residue on evaporation testing items, the limit requirement is also ≤10mg/L, but there is no requirement for constant weight....
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  • Innovation and application of non-volatile detection technology in purified water
    Innovation and application of non-volatile detection technology in purified water 2022-11-18
    Summary The non-volatile matter test principle of purified water is to detect the mass of non-volatile matter solids obtained after 100mL of purified water is evaporated and dried. The difficulty is that testers need to perform repeated operations to achieve the 0.3mg constant weight value required by the Chinese Pharmacopoeia. The traditional test method has the disadvantages of low efficiency and manual on-duty. After long-term practice and repeated verification, it adopts an integrated and automated structural design, equipped with rapid water bath evaporation and gas balance technology, which can realize automatic feeding, water bath evaporation, blast drying, and cooling. Balance, constant temperature and weighing five in one fully automatic test. Through repeated experiments and gradient design experiments, the results show that: 2 rounds of weighing can reach a constant weight error of 0.3mg, and when the amount of scalar addition is 9.4mg/100mL, the precision (RSD) is 0.73%, and the accuracy of the gradient design experiment is high. There is no bias between parallel samples. Conclusion: After the innovation of the non-volatile detection technology of purified water, the constant weight time is short, the operation is simple, and the data accuracy and precision are good. Key words: purified water; non-volatile matter; constant weight; automated testing In the production of pharmaceuticals, purified water is widely used as solvents, detergents, auxiliary materials, raw materials for pure steam and water for injection, etc., from raw materials to preparations, the use of purified water runs through the entire production process. Therefore, the quality control of purified water is very important in the production management of pharmaceutical companies. The test of non-volatile matter in purified water is one of the basic inspection items. The difficulty lies in the 0.3mg constant weight value required by the Chinese Pharmacopoeia. Experimental stop condition. Traditional testing methods have disadvantages such as low efficiency, repetitive and cumbersome operations, difficulty in constant weight, and the need for manual supervision. Domestic and foreign standard requirements According to the requirements of "Purified Water" in the second part of the Chinese Pharmacopoeia 2020 edition: take 100mL of this product, put it in an evaporating dish with a constant weight at 105°C, evaporate it to dryness on a water bath, and dry it to a constant weight at 105°C. The remaining residue should not exceed 1mg. The definition of constant weight in the Chinese Pharmacopoeia is constant weight, unless otherwise specified, refers to the weight of the test sample whose weight difference is less than 0.3 mg after two consecutive dryings or igniting; the second time of drying to constant weight And every subsequent weighing should be carried out after continuing to dry for 1 hour under the specified conditions. See Table 1 for the requirements of the Chinese ...
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  • GBPI Standard Interpretation of ASTMF1249
    GBPI Standard Interpretation of ASTMF1249 2022-10-28
    Standard test method for water vapor transmission rate of plastic films and sheets using modulated infrared sensors The purpose of this test method is to obtain reliable values of WVTR for plastic films and sheets. WVTR is an important characteristic of packaging materials that is directly related to shelf life and stability of the packaged product. The data from this test method is suitable as a reference test method if the buyer and seller agree on sampling procedures, standardization procedures, test conditions and acceptance criteria. 1.1 This test method covers the procedures for determining the rate of water vapor passage through flexible barrier materials. The method applies to sheets and films up to 3 mm (0.1 in.) thick, consisting of single or multiple layers of synthetic or natural polymers and foils, including coated materials. It provides for the determination of ( 1 ) water vapor transmission rate (WVTR), ( 2 ) film permeability to water vapor, and ( 3 ) water vapor permeability coefficient for homogeneous materials. Note 1 - Water vapor permeability and water vapor permeability values must be used with caution. the inverse relationship between WVTR and thickness and the direct relationship between WVTR and water vapor partial pressure difference may not always be applicable. 1.2 This standard is not intended to address all safety issues, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory restrictions prior to use. GBPI's  Moisture Vapor Transmission Analyzer is used to test the water vapor transmission rate (WVTR) of films or sheet materials. It is suitable for testing the water vapor transmission performance of films, sheets, papers, packaging parts and many other materials in the fields of food, pharmaceuticals, medical devices, daily chemicals, photovoltaic electronics, etc. It is an ideal configuration instrument for off-line or on-line testing of the barrier performance of packaging materials by the majority of production units in the packaging industry. Testing principle W413 2.0 water vapor transmission rate tester adopts the principle of infrared method. The pre-treated specimen is fixed in the middle of the test chamber, and the test chamber is divided into high humidity side and low humidity side, compressed air flows on one side of the film, dry nitrogen (carrier gas) flows at a fixed speed on the other side, due to the existence of humidity gradient, water vapor will penetrate from the high humidity side to the low humidity side, the water vapor through the specimen is carried to the infrared sensor by the flow of dry nitrogen, and the water vapor transmission rate of the specimen is obtained by the electrical signal output from the sensor. Water vapor transmission rate of the specimen and other parameters. GBPI specializes in the production of package testing instruments, with many ...
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  •  Germany K 2022 is about to open! Welcome to the GBPI booth!
    Germany K 2022 is about to open! Welcome to the GBPI booth! 2022-10-17
    Exhibition overview The K exhibition in Germany is held every three years and is timeless, and will usher in its 22nd event in 2022. The K exhibition is currently one of the largest, highest level and most professional representative plastic industry events in the world. As a world-class rubber and plastics exhibition, K exhibition is famous not only because of its large scale, but also because of its high recognition and deep influence in the world plastics industry, no matter for the entire plastics and rubber industry, or for enterprises from various application fields, Both are important industry communication platforms, bringing new business opportunities to all areas of the industry. From October 19th to 26th, Düsseldorf, Germany, GBPI will show you a series of specialized, new, special and new equipment in Hall 13, booth 13D07. GBPI Guangzhou Standard International will display its own strength, Let global customers test the scientific and technological power of Chinese enterprises! Time and location October 19 - 26, 2022 Messe Düsseldorf, Germany
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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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