| The quality of medicines is related to the lives of patients, and it is related to the national economy and people's livelihood. It is understood that the pharmaceutical packaging material is an inseparable component of the drug, which is directly related to the quality of the drug throughout the entire process of drug production, circulation and use. Therefore, improving the quality of pharmaceutical packaging materials and strengthening the standardized management of pharmaceutical packaging materials are valued by various pharmaceutical companies, pharmaceutical packaging materials manufacturers and quality inspection organizations.
Strengthening the research and development of drug packaging materials testing instruments to improve the quality of drug packaging materials
The detection of drug packaging materials mainly refers to the detection of the barrier properties of the drug packaging materials (gas permeability test and water vapor transmission test) by means of testing instruments. In order to ensure the safety of drug use, China has successively promulgated relevant laws and regulations, and listed the quality inspection of pharmaceutical packaging and packaging materials as one of the key tasks that pharmaceutical companies must carry out. Strengthening the quality inspection of pharmaceutical packaging materials is one of the important aspects of drug quality assurance. It is particularly important to strengthen the innovative research and development of related pharmaceutical packaging materials testing instruments.
With the continuous advancement of technology, China's pharmaceutical packaging materials testing equipment is also more and more advanced. For example, the instruments for detecting the puncture force of pharmaceutical packaging materials are now emerging in a variety of new devices. For example, the CCY-02 equipment developed by a company adopts large liquid crystal display test process and PVC operation panel, which is convenient for the experimenter to operate, greatly improving the work efficiency; professional computer software operating system, convenient for users to connect to the computer for data storage, Analysis and printing; using imported sensor system, the test accuracy is high, and the accuracy of the test result is effectively guaranteed; the speed of the screw drive system is adjusted freely to ensure the test speed and displacement accuracy.
Another example is the borosilicate glass ampoules, which have strong water resistance, acid resistance, alkali resistance, thermal shock resistance and high mechanical strength. They are mainly used for holding water needle injections, biological vaccines and blood products. Available in 1ml, 2ml, 3ml, 5ml, 10ml, 20ml, 25ml. Nowadays, with the expansion of the use of borosilicate glass ampoules, the pharmaceutical packaging inspection institute has also increased the quality control of glass ampoules. The author was informed that an enterprise has continuously strengthened its technological innovation and produced a number of instruments and equipment required to meet the requirements of YBB00322005-2-2015 "Borrosilicate Glass Ampoule". The ampoule breaking force tester ZDY-01, round Bounce tester YTD-80, polarized stress meter YLY-03, particle water resistance device milled and 杵NB-C.
The inspection of pharmaceutical packaging materials includes various aspects such as tensile strength and elongation testing, peel strength testing, heat sealing strength testing, heat shrinkage testing, puncture retention testing, suspension testing, and the like. The related pharmaceutical packaging materials testing equipment manufacturers need to be based on various characteristics, customer needs, from the actual, continue to innovate, and promote the advanced technology of pharmaceutical packaging materials testing equipment to better meet various needs.
Pharmaceutical packaging materials manufacturers should strictly follow the regulations to ensure product quality
In the process of supervision of pharmaceutical packaging materials production enterprises, it is often found that some pharmaceutical drug packaging materials manufacturers still have problems such as management confusion, insufficient quality inspection capability, and illegal operation, and the product safety risks are relatively high. Strengthening the supervision and supervision of pharmaceutical packaging materials is only one of the means to ensure the quality of products, but to fundamentally improve the quality of pharmaceutical packaging materials, it is also necessary for production enterprises to produce according to regulations and improve the production quality of products.
In the production process, the enterprise shall organize the production and quality inspection of the pharmaceutical packaging materials according to the regulations, and prompt the production process of the enterprise to meet the production requirements of the pharmaceutical packaging materials, and ensure that the pharmaceutical packaging materials production enterprises meet the production sites, personnel composition, equipment settings, production management, etc. Specification requirements, etc. From the details, grasp every detail to ensure the safe production of pharmaceutical packaging materials.
Some insiders said that pharmaceutical packaging materials manufacturers should strictly follow the requirements of the "Administrative Measures for Packaging Materials and Containers Directly in Contact with Medicines". For example, the pharmaceutical packaging materials produced in the clean area should be opened. The workshop should open the purification system to ensure that the air supply volume and the number of air changes and dust particles meet the requirements. The layout of the workshop for registration and re-registration of the pharmaceutical packaging materials shall not be changed at will; the production shall be carried out according to the process of registration of the applied medicine packaging materials, and the formula and process parameters shall not be changed arbitrarily, for example, the filling masterbatch shall not be added without authorization. |
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