Drug package barrier testing must implement national unified method standards

In the field of quality inspection, the test results of the same indicator according to different inspection standards (different test methods) are inconsistent in many cases. If you do not pay attention, it will lead to confusion in the data system, which will seriously affect product quality. It is a good way to cure this phenomenon. At present, there are some cases where the implementation of testing standards is not uniform in the testing of some indicators of pharmaceutical packaging in China, and the most prominent is the barrier testing of packaging materials.

1. The barrier test method in the standard system of China's pharmaceutical package The barrier performance of packaging materials is one of the most prominent features of its functionality. The use of packaging materials with excellent barrier performance can not only provide more for the storage environment and shelf life of items Convenient, it can also improve the storage quality of products, especially suitable for pharmaceutical packaging with extremely high storage quality requirements. Therefore, barrier packaging materials have been very quickly promoted in pharmaceutical packaging. However, for the Chinese market, barrier testing is a relatively new test item. There are many test methods in the world. Although there is a certain understanding of the data relationship between various test methods, it can be used in a variety of ways. The data system of the test method has not yet been formed, so the data measured by different test methods is not yet comparable.
Considering that pharmaceutical packaging companies need a unified test method when purchasing packaging materials and comparing performance, China Food and Drug Administration formulated YBB00082003 "Gas Permeability Measurement Method" and YBB00092003 "Water Vapor Permeability Measurement" in 2003. The "Law" provides guidance for pharmaceutical package companies to reasonably select pharmaceutical packaging materials and testing equipment. The air permeability test methods in the YBB00082003 "Gas Permeability Measurement Method" standard include the differential pressure method and the electricity analysis method, of which the electricity analysis method is rarely used, and it is only used by 2 standards in the currently implemented pharmaceutical packaging container (material) standard Adopted, however, these two standards also use the pressure difference method to measure the permeability of the material; the moisture permeability test methods in the YBB00092003 "Water Vapor Permeability Measurement" standard include the cup method and the electrolytic analysis method, of which the cup method is applied Extensive, only two standards use electrolytic analysis.
The test methods adopted by China's drug package testing standards follow the principles of international standards, otherwise it will increase the difficulty of the actual promotion of the standard, and the difference from the national standards is not conducive to the unified testing method and the establishment of a unified in the entire packaging field Data system. The test methods developed in accordance with the national standard requirements in the drug package standards are the differential pressure method and the cup method. They were first used in the 1970s. The relevant testing equipment has been widely used in China and is also the current standard for pharmaceutical packaging containers (materials) The most widely used test method for air permeability and moisture permeability (except for individual materials, almost all require the use of these two test methods for testing).

2. The economic loss caused by the chaotic application of standards and the chaotic industry quality Although China's packaging industry started late, but China's inspection technology has advanced rapidly, and according to China's current industrial level, it is possible to manufacture inspection equipment that meets the requirements of international standards. . However, due to the low level of implementation of the barrier test standards for drug packs, and the fact that some enterprises engaged in export trade are affected by the testing requirements of foreign buyers, the choice of barrier test methods is often different from the national standard and the standard of drug packs. The barrier test equipment purchased by the company is different from other domestic companies and quality inspection institutions in terms of test methods, and the self-test data of these companies is not comparable to the test data of other domestic institutions.
The particularity of medicines puts forward higher requirements on the barrier properties of pharmaceutical packaging materials, but the different barrier test methods will cause the original material test data that meets the requirements to fail to meet the standard or the originally unqualified material test data to enter the qualified range. This is not only a detection error, but also leads to the scrapping of a batch of finished packaging products, and it will make the drugs invalid in advance. If such invalid drugs are used, the consequences will be unimaginable. The reason is that the current barrier test data system is chaotic. In theory, it should be a test method corresponding to a data system. However, when multiple test methods are applied but the corresponding data system is not clear, Confusion has arisen, and at the same time it has brought hidden dangers to the quality of industry products.
Barrier property testing is different from general material physical property testing. The principle is complex, and the equipment price is relatively high, ranging from a few hundred thousand to as many as hundreds of thousands. To purchase a complete series of barrier testing equipment including various barrier testing methods, at least one million yuan is required. China is a developing country. Even if some manufacturers can afford the high cost of testing equipment, it is not conducive to the development of their own production level. With the further improvement of China's standard system and the full-scale development of industry certification, the promotion of national standards and drug pack standards will be greatly strengthened. Any testing equipment that does not meet the standards may not be able to be put into quality inspection and enterprise self-test applications in the future. in. Therefore, it is necessary to be cautious in the selection of barrier testing equipment, otherwise it is likely that a batch of expensive testing equipment will be idle or scrapped due to the improper selection of testing methods. The selection of test equipment in accordance with the standard of the drug package is conducive to unifying the barrier test method in the field of the drug package. On the one hand, it can greatly reduce the false purchase of detection equipment due to the conflict of test standards, saving enterprises money, on the other hand, it is conducive to promoting the industry The internal coordinated development improves the overall detection level of the material barrier performance of China's pharmaceutical industry.

3. The package barrier test needs to implement a unified test standard. China ’s standards are divided by competent authorities (including recommended standards and mandatory standards). The highest level is the national level. Currently, about half of China ’s national standards are directly It adopts international standards or is indirectly derived from international standards. Industry standards are the second-level standards in China's standard system, local standards are the third-level standards, and enterprise standards constitute the fourth-level (that is, the lowest-level) standards in China's standard system. . Generally, after national standards or industry standards are formulated, enterprise standards should be abolished or revised with reference to the latest national standards and industry standards.
At present, in the field of pharmaceutical packaging in China, there is a lack of unified understanding of the selection of barrier testing standards and test methods for materials. Therefore, there is a strong randomness when purchasing barrier equipment. This phenomenon is fundamentally due to the fact that manufacturers have not paid enough attention to the standard of medicine packages, and still adopt the enterprise standard or the standard used by the purchaser. As mentioned above, this development will inevitably lead to repeated investment in enterprise quality inspection equipment and possible product quality decline. Therefore, pharmaceutical package companies should timely adjust their inspection processes with reference to the latest national standards or industry standards, and abolish enterprise standards or Relevant aspects of enterprise standards shall be revised in accordance with the latest national standards and industry standards, but they shall not conflict with national standards and industry standards on basic principles (such as test principles, test methods, and testing environment, etc.). In short, the standards implemented in the field of barrier testing in the pharmaceutical package need to be unified, and according to the current testing situation, this need is very urgent.

4. Summarize that in the past, China's standards once emphasized the formulation rather than the promotion, but the standards have not been effectively implemented after the formulation. However, with the intensification of international competition after China's accession to the WTO, the formulation and implementation of standards have greatly increased, accelerating the pace of standard unification. Drug packaging is directly related to people's medical safety, and quality assurance should be greatly strengthened. Implementing uniform testing standards is an effective way to improve overall quality.