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06-22

The Betadex Sulfobutyl Ether Sodium obtained CEP certificate

Recently,we received the European Pharmacopoeia certification(hereinafter referred to as "CEP certificate") for the suitability of Betadex Sulfobutyl Ether Sodium as a pharmaceutical excipient, which issued by the European Directorate for Quality Medicines (EDQM).
06-11

Good news || High quality Betadex Sulfobutyl Ether Sodium prompt the approval and marketing of Voriconazole for injection

Nowadays Voriconazole for injection by Poly Pharm has been approved by the NMPA officially.
06-11

Research guide || Research group on Zibo high quality development of pharmaceutical industry visited Qianhui

Research group on Zibo high quality development of pharmaceutical industry visited Qianhui.
06-11

Mrs. Liping Wang, chairman of Zibo Qianhui Biological Technology Co., Ltd, was appointed as the supervisor of optimizing the business environment of Zibo "No.1 Reform Project"

Mrs. Liping Wang, chairman of Zibo Qianhui Biological Technology Co., Ltd, was appointed as the supervisor of optimizing the business environment of Zibo "No.1 Reform Project".
05-31

【Qianhui Sharing】Solubilization of lead ions in soil by hydroxypropyl-β-cyclodextrin

As a heavy metal chemical element, lead has a large amount of storage in soil, and its chemical properties are stable and difficult to be decomposed. It is a potential threat to human health. Phytoremediation is one of the main methods to restore lead-contaminated soil. Total lead accumulation in plants depends on the concentration of soluble lead in soil.
09-01

【Qianhui Sharing】Common technical problems in the research and verification of injection sterility assurance technology (5)

40. Does the container tightness test have to be completed in all injection forms such as ampoules and vials? Answer: The container tightness test must be carried out in all injection forms such as ampoules and vials. However, the methods used are not the same. Ampoules generally use physical testing methods, and vials use physical and microbiological testing methods. 41. What is the current level of sterile filtration verification that domestic manufacturers can achieve? Which level is recognized by the country? Answer: According to the "Basic Technical Requirements for Chemical Injections (Trial)" issued by the Drug Registration Department of the State Administration on January 10, 2008 (2) the requirements for freeze-dried powder injections in point 4 of the preparation process, the sterilization filtration system is adapted to The performance verification test includes the compatibility test of the filtration system, the integrity test of the filtration membrane before and after filtration, and the microbial retention test of the filtration membrane when necessary. The verification of the sterilization process is currently in the process of advancement. The above are the phased requirements based on the current understanding, and will continue to be improved with the understanding of this issue. 42. Does the microbiological challenge test of the filter membrane need to be carried out for each specific product? Since this part of the test is carried out by the manufacturer, is there any requirement for the qualification of the manufacturer? That is, how to determine whether the test report provided to me by the supplier is Effective? Answer: If different products have different effects on the permeability of the filter, resulting in different retention efficiency, the microbiological challenge test should be carried out separately, otherwise it is not necessary. At present, there are no legal requirements for the qualification of filter manufacturers. It is recommended to choose manufacturers that have passed industry certification and whose products are widely used in international and domestic, with guaranteed quality and high creditworthiness. Whether the selected filter supplier is credible is based on the pharmaceutical manufacturer's knowledge of the products to be produced and the understanding of the filtering process. Whether the filter manufacturer is legally qualified is not the most important thing. The most important thing is whether the pharmaceutical manufacturer knows that the filter of its choice is suitable for the product it produces, whether the material of the filter meets the safety requirements and meets the requirements of pharmaceuticals. Does the pharmaceutical manufacturer know whether the filtration process developed by itself is effective? In other words, only if you truly understand the professional knowledge of filtering, and understand the product and process, can you determine the validity of the supplier's inspection report. In addition, you can also go to the filter supplier to see the inspection process with your own eyes and conduct quality audits on the supplier, which also helps to enhance the accuracy of judgment. 43. Two filter elements are used in series for sterilization filtration. Is the pore size the same? If it affects the ingredients of the main medicine, how to solve it? Answer: The pore size of the two sterile filters connected in series should be the same. It is better if the two sterile filter cartridges in series are of different production batch numbers. If the filter membrane has an impact on the main ingredients, filter membranes of other materials should be selected according to the results of the compatibility test of the filter system so that it has no effect on the main drug ingredients. 44. Please introduce the test method of filter integrity test in detail, such as "diffusion flow test". Answer: The test method of filter integrity test should refer to the method provided by the supplier's manual. If the diffusion flow method is adopted, please use the specified medium to wet the filter according to the supplier's instructions, and then connect it to the special instrument and pressure gas (compressed air or nitrogen) of the diffusion flow method, and provide the filter with the pressure determined by the supplier's instructions , The dedicated instrument will automatically print out the test results, indicating that the test passed or failed. 45. Which filter verification must be carried out by the manufacturer? Which is provided by the supplier? Some teachers mentioned in the lecture that the "microbial challenge test is done by the supplier to avoid contamination of the product", and some teachers mentioned in the lecture that the sterile filter microbial challenge test should be verified under actual production parameters. And the microbial retention test must be carried out in the drug solution, which seems to be done only
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