About Us.

Qianhui Biotechnology

Zibo Qianhui Biotechnology Co., Ltd., founded in 2006 and located in Polymer Industrial Park in Zibo High-tech Zone, is a high-tech enterprise integrating scientific research, production and sales. 

The company specializes in production of pharmaceutical excipients, food and cosmetic additives that consist mainly of cyclodextrin and its derivative. Sulfobutyl ether beta cyclodextrin sodium, a new injectable excipient independently researched and developed by the company, is the first new excipient (registered as “A”) passing technical review with associated drug product and fills in the market gap in China. CDE platform - pharmaceutical excipient registration No.: F20180000620, U.S. FDA registration No.: DMF 29394. Hydroxypropyl-beta-cyclodextrin, CDE platform - pharmaceutical excipient registration No.: F20209990335 (oral administration, activated, Lu Yao Zhun Zi F2012004), F20180000146 (oral administration) and F20180000895 (injection), U.S. FDA registration No.: DMF 033403. It has been widely applied and approved in domestic and foreign markets.

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Products Display.

LEADER OF CYCLODEXTRIN

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Betadex Sulfobutylether Sodium
Betadex Sulfobutylether Sodium
Hydroxypropyl Beta Cyclodextrin
Hydroxypropyl Beta Cyclodextrin
Methyl Beta Cyclodextrin
Methyl Beta Cyclodextrin
2,6-Dimethyl Beta Cyclodextrin
2,6-Dimethyl Beta Cyclodextrin

Business Advantage

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LEADER OF CYCLODEXTRIN

The company specializes in production of pharmaceutical excipients, food and cosmetic additives that consist mainly of cyclodextrin and its derivative. Sulfobutyl ether beta cyclodextrin sodium, a new injectable excipient independently researched and developed by the company, is the first new excipient (registered as “A”) passing technical review with associated drug product and fills in the market gap in China. CDE platform - pharmaceutical excipient registration No.: F20180000620, U.S. FDA registration No.: DMF 29394. Hydroxypropyl-beta-cyclodextrin, CDE platform - pharmaceutical excipient registration No.: F20209990335 (oral administration, activated, Lu Yao Zhun Zi F2012004), F20180000146 (oral administration) and F20180000895 (injection), U.S. FDA registration No.: DMF 033403. It has been widely applied and approved in domestic and foreign markets.

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Standardized production workshop

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Professional testing equipment

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High standard specification system

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Fill the gap in the market

Technological Innovation

Adhering to the concept of treating product quality as enterprise life, the company enhances risk management and sets up and completes the quality management system as per the requirements of GMP. 

 

1. Set up a complete quality management system based on the concept of risk management to control the whole production process. 

2. Implement GMP for pharmaceutical excipients and medical products actively. 

3. Carry out validation of production process and key production equipment. 

4. Implement quality authorized person system and release products by the authorized person. 

 

Zhuangye Machine

News

09-01

2020

【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

09-02

2020

【Qianhui Sharing】Common technical problems in the research and verification of injection sterility assurance technology (4)

30. In the medium filling test, after the medium is sterilized and before filling, it is sterilized and filtered through a filter membrane to observe the aseptic effect of the filter during the sterilization and installation process. Is it feasible? Answer: The culture medium filling test is an investigation of the degree of sterility assurance in all steps including aseptic filtration. It is recommended to use the culture medium directly in the aseptic filtration and subsequent filling process after preparation. Pay attention to the actual operation Prevent insoluble particles from clogging the filter. 31. The medium filling test year is re-verified twice a year, how many batches each time? Answer: For the annual re-verification of a certain product, the usual practice is to conduct two medium filling tests every year, one batch each time. 32. The aseptic culture time of the 2005 edition of the Chinese Pharmacopoeia has changed to 14 days. Does the culture test at two temperatures after the simulated filling of the medium need to be extended? Answer: The total cultivation time should not be less than 14 days. It can be divided into two temperatures (22.5 degrees and 32.5 degrees) for at least 7 days each, or it can be cultured directly at one temperature (22.5 degrees). 33. The confidence limit of the qualification standard for the medium filling test is 95%, and the probability of infection is 0.1%. Please explain in detail which statistical method is used and how to calculate it by looking up the table. Answer: For a detailed description of the calculation formula, please refer to page 258 of the "Guidelines for Drug Production Verification (2003)" (Chemical Industry Press) compiled by the Drug Safety Supervision Department of the State Food and Drug Administration and the Drug Certification Management Center. There are two calculation methods. One is to use the approximate value calculation formula of the Poisson distribution, namely P(X>0)=1-e-Np>0.95 Among them, P is the confidence limit, N is the number of simulated bottles or batches, p=0.1% (probability of contamination) Another calculation method is the more accurate binomial calculation formula, namely P(X>0)=1-(1-X)N where P is the confidence limit, N is the number of simulated bottles or batches, X = 0.1% (probability of contamination) On page 259 of the book, there is a table of the relationship between simulated dispensing quantity, pollution quantity and pollution probability in one simulated dispensing when the credibility limit is 95%. The simulated dispensing quantity and pollution quantity can be found from this table. The corresponding value of. 34. In the film 59 on page 72 of the lecture notes, what are the differences in the process verification of powder injections, freeze-dried powder injections, and small-volume injections? , Where does it start and where does it end? Answer: For sterile powder injections, the form of medium filling has some special characteristics. For example, if you want to prepare a simulated sterile powder, use a syringe to add the liquid medium to the bottle after dispensing; or divide the sterile medium powder into the bottle. After finishing, add sterile water for injection with a syringe. But the purpose is still to investigate the degree of sterility assurance of the entire aseptic packaging process. 35. How to verify the tightness of the container? Answer: Physical and microbiological testing methods are often used to verify the tightness of containers. Physical detection has many advantages, such as high sensitivity, convenient use, rapid detection and low cost. During the validity period of the product, physical testing methods can be used to determine whether the integrity of the package meets the specified requirements. An important reason for packaging integrity testing is to ensure that sterile products are always sterile. Therefore, in the development stage of product packaging, microbial penetration tests should be considered, or physical test methods that have been verified and more effective than microbial detection should be considered to detect the integrity of product packaging. However, for the stability test of the product within the validity period, it is more difficult to carry out the microbial invasion test, so physical testing methods are recommended. The microbial invasion test is a challenging test for the integrity of the terminally sterilized container/sealing system. In the verification test, take an infusion bottle or a vial (vial), fill it with a culture medium, stopper and cap sterilize on a normal production line. Then, the sealing surface of the container is immersed in the high-concentration motility bacterial liquid, taken out, cultivated, and checked for microbial invasion to confirm the integrity of the container sealing system. At the same time, a positive control test is required to confirm the growth-promoting ability of the medium. 36. When using

09-03

2020

【Qianhui Sharing】Common technical problems in the research and verification of injection sterility assurance technology (3)

21. What is the test method of microbial contamination level and heat resistance (D value) before sterilization? Answer: The level of microbial contamination usually uses membrane filtration to retain microorganisms, and then transfer the membrane to the surface of a solid medium, cultivate and count the microorganisms. Attention should be paid to the volume of filtration and the number of retained microorganisms to ensure a sufficient detection rate (a sufficient amount of filtration) and countability (too many retained microorganisms cannot be counted). The heat resistance test performed on each batch of products is not a D value test, but a so-called boiling test-a qualitative test. Put the filter membrane that trapped microorganisms into a test tube containing the same product liquid, boil it in a water bath for 15 minutes or more, and perform a sterility test on the liquid. If it is a heat-resistant bacteria, the D value needs to be further measured. More than 99% of the inspected products are non-heat-resistant bacteria. The measurement of D value is quite complicated, please refer to the "Guidelines for Pharmaceutical Production Verification" (Blue Book, edited by the State Drug Administration), Chapter 3, Section 1, for a detailed introduction. 22. How to calculate the amount of inoculation based on the D value? Answer: Calculation of spore inoculation amount: Ni=10Do(lgNo+6)/Di where Ni is the number of heat-resistant spores inoculated as a biological indicator No is the limit of contaminating microorganisms in the intended product before sterilization Do is the maximum allowable value of D for contaminating microorganisms Di is the D value of the biological indicator heat-resistant spores in the product 23. For products that are terminally sterilized by the survival probability method, if the microbial limit is tested for each batch before sterilization, and the microbial limit detection time is 72 hours, and the actual production cycle of continuous production is much shorter than 72 hours, the test result is only Is it a reference to the sterility assurance level of the product after sterilization? Answer: Obviously, the result of the microbiological content inspection before sterilization lags far behind the production process, and its purpose is not to be used for intermediate control of the current batch of products. The inspection has two main meanings: first, it is used to evaluate the sterility assurance level of the batch of products; second, after long-term accumulation of multiple batches of pre-sterilization microbial content data, it can be The microbial contamination status of each process step is evaluated as a whole, so as to indicate whether the production system is effectively controlling the microbial contamination at a good level, whether it needs to be improved, and so on. 24. What is the method of microbial species and quantity research? What equipment is needed? If the residual probability method is adopted, is it necessary to measure the microbial level during the production process? If it is introduced, how much cost will it increase? As a large infusion manufacturer, use the residual probability Method, is it necessary to establish a special microbiology laboratory to test the microbial contamination level of the liquid medicine before sterilization? Answer: The degree of microbial contamination-that is, the quantity inspection can be carried out in accordance with the microbial limit inspection method included in the Pharmacopoeia; the type of microorganisms can be identified from the following aspects: 1) Observe the colony morphology by naked eyes; 2) Microscopically inspect the morphology and Mobility; 3) General biochemical test: Gram stain or 3% KOH test; 4) Biochemical identification (ie API test) to identify species. When the residual probability method is used, the level of microbial contamination before the product sterilization should be tested, including the boiling test of the contaminated bacteria (such as 100°C, 15 minutes) and the microbial count. Microbiology laboratory is essential for injection manufacturers. Its basic functions should include microbial limit inspection of raw materials, microbial contamination inspection before product sterilization, product sterility inspection, bacterial endotoxin inspection, and production environment dynamic inspection (air Particles, planktonic bacteria and sedimentation bacteria count). Conditional laboratories can also carry out the following tasks: microbiological identification test (it is recommended that the central laboratory of the enterprise group carry out API identification), the calibration of biological indicators (that is, the determination of the D value, it is recommended that the central laboratory of the enterprise group carry out this work) . 25. Is sterilization process verification necessary for the overkill method? What is the difference between the product development proc

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