How to choose and buy the barrier testing instrume

2022-08-09
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How should drug testing institutes choose and buy barrier testing instruments for drug packaging materials

due to the working characteristics, the author contacted many drug testing institutes that need to purchase barrier testing instruments for drug packaging materials. During the communication with them, I learned their doubts, hesitations and indecision when purchasing instruments. With these questions, the author has carefully read the "standard compilation of packaging materials and containers for drugs in direct contact with the State Food and Drug Administration (Volume VI)" (hereinafter referred to as "standard compilation (Volume VI)") published in March 2006, and has a detailed understanding of the relevant provisions on barrier testing. Combined with years of experience in barrier testing of drug packaging materials, some experience has been obtained. Now share it with readers. If you also have doubts and hesitations when purchasing barrier testing instruments, I hope you can get some information from it

generally speaking, the following points should be paid attention to when purchasing barrier testing instruments

first point: Standard

why put standard first? There are several factors

1. There are two kinds of barrier tests: the detection of gas transmission and the detection of water vapor transmission

① there are pressure difference method and electric quantity method (isobaric method) for gas transmission detection. The differential pressure gas transmission detector can detect oxygen, nitrogen, carbon dioxide, hydrogen, air and other gases, and the tested gases are not limited. Meet the requirements of YBB standard specifications. In addition, the standards for drug packaging materials

ybb and YBB also stipulate that the differential pressure method is used to detect the nitrogen transmission of materials, while the oxygen transmission test instrument of the electric method can only test the single gas of oxygen transmission, and this method is not mentioned in the 2006 "standard compilation (Volume VI)". Therefore, whether it is the quality inspection institution entrusted by the enterprise to submit for inspection 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 the first choice. In particular, quality inspection institutions, because of the variety of materials they undertake, will encounter the detection needs of a variety of 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 (isobaric method) instrument cannot do

② water vapor transmission detection methods include cup method (also known as gravimetric method), electrolysis method and infrared method. Internationally, "water vapor transmission detection cup method" is a general detection method. Standards such as ASTM E96, ASTM D1653, TAPPI t464, ISO 2528, DIN and JIS z0208 are cup methods

2. The instrument with which principle is selected depends on the standard implemented by the product to be tested, that is, the standard specifies what method to use for detection, so the equipment that conforms to the specified method of the standard should be selected. The State Food and drug administration has stipulated the material methods for detecting oxygen, nitrogen and water vapor in 19 pharmaceutical packaging materials such as pharmaceutical low-density polyethylene films and bags (Trial) in the compilation of packaging materials and containers for direct contact with drugs [Volume VI, March 2006]

among them, 19 items in the standard catalogue of pharmaceutical packaging materials, such as pharmaceutical low-density polyethylene film and bag (for Trial Implementation), have oxygen, nitrogen and water vapor detection requirements:

item 1: Pharmaceutical low-density polyethylene film and bag YBB

item 4: three-layer coextrusion infusion film (I), bag YBB

item 5: five-layer coextrusion infusion film (I), bag YBB

item 19: Pharmaceutical polyethylene/aluminum/polyethylene composite ointment tube YBB

among them, The first paragraph stipulates that the water vapor transmission shall be measured according to the first method of the water vapor transmission (YBB) cup method. The oxygen transmission is measured according to the first method of YBB, the differential pressure method

the fourth and fifth provisions: the oxygen transmission shall be measured according to the first method of the gas transmission measurement method (YBB), the differential pressure method. The permeability of nitrogen in more than 1000 graphite enterprises in China is measured according to the first method of gas permeability measurement (YBB), the differential pressure method. The water vapor penetration is determined according to the first method of the water vapor transmission (YBB) method, the cup method. The oxygen permeability tester based on electricity method cannot test the nitrogen permeability, and there are clear provisions for the nitrogen permeability test of CO extruded infusion materials in these two items

item 19 stipulates that the oxygen transmission shall not exceed 0.5cm3/m2 according to the gas transmission measurement method (YBB)? 24h? 0.1MPa (it can be seen from the quoted unit cm3/m2? 24h? 0.1MPa that this method is also the unit of differential pressure method. The unit of oxygen transmission measured by electric method is cc/M2? 24h)

in all standards on water vapor transmission at home and abroad, no matter what test method is used, the final data are corrected by the cup method water vapor transmission instrument

it is not difficult to see from the above content that for materials with barrier testing requirements, the oxygen and nitrogen permeability testing method is the differential pressure method; The water vapor transmission test is cup method

that is to say, when purchasing barrier testing instruments, the first thing to consider is whether the instruments meet the requirements of product testing standards. The simplest way is to select the appropriate instrument according to the standards implemented by the product

3. From the perspective of the pharmaceutical packaging material enterprises we have contacted, they should also strictly follow the standard requirements when purchasing instruments. Although in the process of purchasing instruments, some suppliers recommended different testing instruments to them, they finally chose the instrument that was consistent with the standard. Such instruments as Shanghai Shuangge, Shenzhen Sanjiu pharmaceutical, Zhuhai yinbulang, Sichuan Kelunda pharmaceutical, Jiangzhong pharmaceutical, Jiangsu Sihuan biopharmaceutical, Anhui Fengyuan pharmaceutical, Chengde Jingfukang, Guilin Sanjin pharmaceutical, Lizhu pharmaceutical, Jiuzhitang, etc. are selected to comply with the methods prescribed by the State Drug Administration. Other enterprises that have not purchased barrier testing instruments for the time being, when entrusting Jinan Languang barrier material laboratory to test the permeability of nitrogen, oxygen and water vapor, without exception, have chosen the differential pressure method and cup method that meet the national standard and the clamping force increases with it. The methods are different, because the data measured by different methods are not comparable. In other words, if you choose to use instruments that do not meet the standards, you will not be able to accept the requirements of commissioned testing by enterprises

4. Referring to the 2006 compilation of standards for packaging materials and containers in direct contact with drugs by the State Food and Drug Administration (Volume VI) based on the quality acceptance system of key raw and auxiliary materials, the stipulated gas transmission detection is still the first YBB method (i.e. differential pressure method), and the excessive water vapor transmission detection is still the first YBB method cup method

second point: the comprehensive strength of suppliers

after deciding which standard instrument to choose, which supplier to choose has become the second problem. The following points are used to measure the comprehensive strength of suppliers:

1 Instrument performance and brand effect. As a quality inspection institution, choosing brand products with high quality and performance should be the first choice. High quality and high performance brand products are the guarantee of data authenticity and stability. Of course, the premise of choosing brand instruments is that they must comply with national standards

our advantage is that our products fully implement national standards, and our barrier detection instruments are second to none in the world. At present, our instruments have been exported to many countries, and we have agents in 33 countries. Especially in the research field of barrier testing, Languang is the strongest enterprise with the most extensive methods

2. Nature of enterprise. It is the first choice to choose enterprises with R & D strength, which can often provide continuous technical support and perfect after-sales service. And choosing the products of dealers becomes the second choice

the advantage of LAN Guang is that we are an enterprise with a history of more than ten years, specializing in the research and production of packaging material testing instruments. LAN Guang has absolute strength to provide continuous technical support and perfect after-sales service

third point: instrument efficiency

for inspection institutions with a large amount of detection, it is essential to choose a high-efficiency and high-quality instrument

taking Labthink gas permeameter as an example, this instrument adopts the world's top sensors and components to ensure the accuracy and stability of its test, thus establishing the highest efficiency of this instrument in the differential pressure method test instrument. The most important point is that the instrument fully implements the YBB first method differential pressure method

the other three chamber gas permeameter can test three different samples each time, and its efficiency has been improved by leaps and bounds

the tsy-t3 moisture permeability tester of Labthink fully implements the YBB first method cup method, and its 12 chamber simultaneous test design determines that its test efficiency is the highest water vapor transmission detection instrument in the world

the two instruments mentioned above can work continuously 365 days a year without special supervision. What the operator needs to do is to clamp the cut sample and click the test key, so there is no need to supervise the instrument. The instrument will automatically issue the test data, which greatly improves the detection efficiency

in the face of the testing needs of the drug inspection institute, some businesses only for the purpose of sales, ignoring the requirements of product testing standards, recommend inapplicable barrier testing instruments to quality inspection institutions. For example, the detection of oxygen and nitrogen permeability is obviously not applicable if the merchant recommends the gas permeability detection instrument of electricity method. This kind of non-standard practice is obviously undesirable. If the quality inspection institutions only listen to their one-sided words and choose instruments that do not meet the requirements, then the entrusted inspection of enterprises that cannot be inspected will follow, which will also bring immeasurable losses to the units. Therefore, I hope that every person who needs to purchase barrier detection instruments will refine a pair of golden eyes and choose the most suitable one for you from many instruments

reprinted from: Languang Laboratory

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