How to choose barrier testing instrument for drug packaging materials

Due to the working characteristics, the author has contacted many drug inspection institutes that need to purchase drug packaging barrier tester In the communication with them, I learned their doubts, hesitations and hesitations in purchasing instruments With these problems, the author carefully read the "national food and Drug Administration of packaging materials and containers for drugs in direct contact with the standard collection (the Sixth Series)" (hereinafter referred to as the "standard collection (the Sixth Series)" published in March 2006, and detailed understanding of the relevant provisions of the barrier test Combined with many years of experience in barrier test of drug packaging materials, some experience was gained Now share it with the readers If you have doubts and hesitations when purchasing barrier test instruments, I hope you can get some information from it Generally speaking, the following points need to be paid attention to when purchasing barrier testing instruments * point: why does the standard put the standard in the * position? There are several factors 1 There are two types of barrier test: gas transmission test and water vapor transmission test ① There are two methods to measure the gas transmission: differential pressure method and electric quantity method (equal pressure method) The instrument can detect oxygen, nitrogen, carbon dioxide, hydrogen, air and other gases The tested gases are not limited Meet the requirements of ybb00082003 In addition, the standards ybb00102005 and ybb00112005 for drug packaging materials also stipulate that the permeability of nitrogen in materials can be measured by the differential pressure method, while the oxygen permeability test instrument of the electricity method can only test the oxygen permeability, which is a single gas, and this method was not mentioned in the "standard collection (Volume VI)" in 2006 Therefore, whether it is the quality inspection organization entrusted by the enterprise or the enterprise that controls the product quality through self inspection, the gas transmission detection instrument based on the principle of differential pressure method should be Especially for the quality inspection organization, because of the large number of materials it undertakes, it will meet the detection requirements of various gas sources in the detection of gas transmission The gas transmission detector with differential pressure method can meet the detection requirements of nitrogen, oxygen, carbon dioxide and other different gases But this is what the electric quantity method (equal pressure method) instrument can't do ② The detection methods of water vapor transmission include cup method, electrolysis method and infrared method In the international scope, "water vapor transmission detection cup method" is a general detection method Standards such as ASTM e66, ASTM D1653, TAPPI t464, ISO 2528, DIN 53122-1 and JIS z0208 are all cup methods 2 The selection of the principle of the instrument depends on the standard to be tested, that is, the standard specifies the method to be used for testing, so the equipment that meets the method specified in the standard shall be selected In the compilation of standards for packaging materials and containers in direct contact with drugs [Volume 6, March 2006], the State Food and drug administration has made corresponding regulations on the material methods for detecting oxygen, nitrogen and water vapor in 19 pharmaceutical packaging materials, such as medical low-density polyethylene film and bag (Trial) Among them, the requirements for oxygen, nitrogen and water vapor detection in 19 drug packaging material standard catalogues such as medical low-density polyethylene film and bag (Trial) are: * item: Medical low-density polyethylene film, bag YBB 00072005 item 4: three-layer co extrusion infusion film (I), bag YBB 00102005 item 5: five-layer Co extrusion infusion film (I), bag YBB 00112005 Item 19: Medical polyethylene / aluminum / polyethylene composite ointment tube YBB 00252005, wherein, item * stipulates that the water vapor transmission shall be determined by the method of cup method (ybb00092003) The oxygen transmission shall be measured according to the gas transmission measurement method (ybb00082003) and the differential pressure method The fourth and fifth provisions: the oxygen transmission shall be determined according to the method of gas transmission measurement (YBB 00082003) * differential pressure method The nitrogen transmission shall be determined according to the gas transmission measurement method (YBB 00082003) and the differential pressure method The water vapor permeation is determined according to the method of measuring the water vapor permeation (YBB 00092003) * cup method It is impossible to test the nitrogen transmission with the oxygen transmission tester of the electricity method, and there are clear provisions in these two items for the nitrogen transmission test of the coextrusion infusion materials Item 19: the oxygen transmission shall be determined according to the gas transmission measurement method (YBB 00082003) The oxygen transmission shall not exceed 0.5cm 3 / M 2 · 24h · 0.1MPa (as can be seen from the cited unit cm3 / m2 · 24h · 0.1MPa, this method is also the unit of differential pressure method The unit of oxygen transmission measured by electricity method is CC / M 2 · 24h) In all the standards of water vapor transmission at home and abroad, no matter what kind of test method is used, the final data of Zui is calibrated by the cup type water vapor transmission instrument It is not difficult to see from the above content that for materials with barrier detection requirements, the detection method of oxygen and nitrogen transmission is differential pressure method; the detection method of water vapor transmission is cup method In other words, the first thing to consider when purchasing barrier testing instruments is whether the instruments meet the requirements of product testing standards The simple method of Zui is to select the right instrument according to the standards of the product 3 From the perspective of the pharmaceutical packaging material enterprises we contact, they should also strictly follow the standard requirements when purchasing instruments Although in the process of purchasing instruments, there are also suppliers who recommend different methods of testing instruments to them, but they choose the instruments that are consistent with the standard For example, Shanghai Shuangge, Shenzhen Sanjiu pharmaceutical, Zhuhai yinbrown, Sichuan Kelun pharmaceutical, Jiangzhong pharmaceutical, Jiangsu Sihuan biopharmaceutical, Anhui Fengyuan pharmaceutical, Chengde Jingfukang, Guilin Sanjin pharmaceutical, Lizhu pharmaceutical, Jiuzhitang, etc are all instruments that meet the methods specified by the State Drug Administration While other enterprises that do not purchase barrier testing instruments temporarily entrust Jinan Languang barrier material laboratory to test the penetration of nitrogen, oxygen and water vapor, without exception, they all choose the air permeability method of pressure difference and cup method that meet the national standards The methods are different, because the data measured by different methods are not comparable In other words, if you choose to use non-conforming instruments, you will not be able to accept the requirements of enterprise commissioned testing 4 Referring to the 2006 National Food and Drug Administration's standard collection of packaging materials and containers for direct contact with drugs (Part 6), the gas transmission test is still in accordance with YBB 00082003 * method (i.e differential pressure method), and the water vapor transmission test is still in accordance with YBB 00092003 * method Second point: after the comprehensive strength of the supplier decides which standard instrument to choose, which supplier to choose will become the next question There are several points to measure the comprehensive strength of suppliers: 1 instrument performance and brand effect As a quality inspection organization, the choice of high-quality, high-performance brand products should be Brand products with high quality and performance are the guarantee of data authenticity and stability Of course, the premise of selecting brand instruments is to meet the national standards Our advantage lies in that our products are in full compliance with national standards, and our barrier testing instruments are all in the world At present, our instruments have been sold to many countries, and there are agents in 33 countries Especially in the research field of barrier testing, Languang is an enterprise with strong strength and wide range of methods 2 Nature of the enterprise The choice of enterprises with R & D strength is that such enterprises are often able to provide continuous and perfect after-sales services And the product that chooses dealer becomes second choice The advantages of Languang are: we are a company with a history of more than ten years, specializing in the research and production of packaging material testing instruments Languang has the strength to provide continuous and perfect after-sales service The third point: the efficiency of the instrument is essential for the inspection organization with large amount of testing It is necessary to choose a high-quality instrument with high rate Taking Labthink gas permeameter as an example, this instrument adopts sensors and components of Zui * all over the world to ensure the accuracy and stability of its test, thus establishing the high position of this instrument in the efficiency Zui of differential pressure test instrument It is important for Zui that the instrument fully implements the YBB 00082003 * differential pressure method In addition, the efficiency of the gas permeameter with three chambers, which can test three different samples at a time, is obviously improved The tsy-t3 moisture permeability tester of Labthink fully implements the YBB 00092003 * method cup method, and its 12 chamber simultaneous test design determines that its test efficiency is the world's Zui high water vapor penetration test instrument The two instruments mentioned above can work continuously 365 days a year without special personnel What the operator needs to do is: hold the cut sample well, and click the test key, then there is no need to supervise the instrument The instrument can automatically produce test data, which greatly improves the detection efficiency In the face of the testing needs of the drug testing institute, there are some businesses only for the purpose of sales, ignoring the requirements of product testing standards to recommend unsuitable barrier testing instruments to the quality inspection agency For example, if the seller recommends the gas penetration detection instrument of electricity method for the detection of oxygen and nitrogen penetration, it is obviously not applicable It is obviously not advisable to adopt this kind of practice without standards If the quality inspection agency only listens to their one-sided words and chooses unqualified instruments, then it will bring inestimable losses to the unit as well as the entrusted inspection of the enterprise that cannot undertake the inspection Therefore, we hope that everyone who needs to purchase barrier testing instruments will have a pair of eyes, and choose the Zui suitable for your use from many instruments! This information is released by Liu Jun, Sales Department of lambhink Languang Guangzhou Branch For more information, please call