According to the announcement of the National Medical Products Administration and the National Health Commission on the promulgation of the 2025 edition of the Pharmacopoeia of the People's Republic of China (No. 29 of 2025), the 2025 edition of the Pharmacopoeia will come into effect on October 1, 2025. This edition of the Pharmacopoeia is the result of multiple rounds of coordination between China and ICH, and is the most "international" edition of the Chinese Pharmacopoeia in history.Among them, the aseptic and microbiological limit test method for drug packaging materials and the onion Burkholderia test method are newly added chapters in this edition of the pharmacopoeia.Today, I will take stock of the requirements and operations of these chapters with everyone.

Sterility testing and microbiological limit testing of drug packaging materials both require method suitability testing.

Aseptic drug packaging materials shall be sampled according to the relevant requirements of medical equipment in the aseptic inspection method, and the inner and outer surfaces shall be subjected to aseptic inspection. Among them, pre filled syringes, eye drops bottles, ointment tubes, seals and other test samples are directly inoculated (if necessary, chopped); Take a specified quantity of test samples such as plastic bottles and soft bags, thoroughly rinse the inner and outer surfaces of the test samples with flushing solution, combine the flushing solutions, and perform sterile testing using membrane filtration method.

The inspection quantity for non sterile drug packaging materials such as containers and solid materials is generally not less than 5, and the inspection quantity for sheet materials is generally not less than 500cm²(Calculated on one side), take 5 equal parts, each part is 100cm²Containers are used to pour eluent into the inner cavity and shake for elution; Solid and sheet materials are placed in sterile containers containing a certain volume of rinsing solution, and the test sample is thoroughly shaken and washed to obtain the test solution. The risk analysis of the test solution was conducted using direct inoculation or membrane filtration methods for limit testing.

Note: When the eluent volume is large, the membrane filtration method can obtain more accurate results.

Tailin sterile testing series products are also suitable for pharmaceuticalspackageAseptic inspection of materials. Products such as self sealing homogeneous bags (suitable for sheet materials) and sterile water collection bags (suitable for solid materials) are suitable for shaking and washing of pharmaceutical packaging materials, and are used in conjunction with microbiological detection systems to assist pharmaceutical companies in improving microbiological detection of pharmaceutical packaging materials.

Self sealing homogeneous bag

Aseptic water bag

Burkholderia cepacia, also known as onion Burkholderia cepacia

Complex (Bcc) is currently a typical unacceptable microorganism, and pharmaceutical companies need to confirm whether raw materials, intermediates, and products require this inspection based on risk analysis. It is recommended to conduct microbiological testing on pharmaceutical water, and the specific implementation process is as follows:

Conduct a suitability test on the selective culture medium of Burkholderia cepacia: The growth promoting ability and indicator characteristics of the culture medium need to be inoculated with onion Burkholderia cepacia CMCC (B) 23005, new onion Burkholderia cepacia CMCC (B) 23006, and mysterious Burkholderia cepacia CMCC (B) 23010, respectively, at a temperature of 30-35 ℃ for no more than 48 hours, and compared with the control medium to confirm their colony size and indicator characteristics; The inhibition effect experiment requires inoculation with no less than 100 cfu of Pseudomonas aeruginosa and Staphylococcus aureus, and cultivation at 30 ℃ -35 ℃ for no less than 72 hours to ensure sterile growth.

Conduct method suitability test: Prepare the test sample as the test solution, add the test solution and onion Burkholderia cepacia CMCC (B) 23005, new onion Burkholderia cepacia CMCC (B) 23006, and mysterious Burkholderia cepacia CMCC (B) 23010 with a concentration of no more than 100 cfu to the bacterial culture medium, and incubate at 30-35 ℃ for 48-72 hours; If membrane filtration is used to treat the test solution, add bacteria to the final rinse solution, inject it into the incubator or remove the filter membrane and inoculate it into the culture medium. Incubate at 30-35 ℃ for 48-72 hours. Then take the culture medium and streak it on the selective culture medium of Burkholderia cepacia. Incubate at 30-35 ℃ for 48-72 hours to observe whether suspicious colonies are detected, and select suspicious colonies for identification. If there is no suspicious bacterial growth and it is confirmed that the test solution does not inhibit bacteria, consider using ten fold diluted TSB for bacterial enrichment culture. It is recommended to use membrane filtration method to treat sufficient water samples for pharmaceutical use, and then use ten fold diluted TSB for bacterial culture.

Sample inspection: Conduct according to the applicability process of the method, and extend the incubation and selective cultivation time to 48-72 hours. The laboratory needs to determine the frequency of positive controls based on the laboratory evaluation results (the newly established method recommends conducting at least 3 consecutive batches of inspections per batch). The positive control bacteria selected are Burkholderia cepacia CMCC (B) 23005, Burkholderia cepacia CMCC (B) 23006, and Burkholderia mirabilis CMCC (B) 23010, one of which is sufficient. The applicability test of the same method should be conducted with the addition of bacteria.

To assist enterprises in conducting onion Burkholderia testing, Tailin has launched a set of quality control strains that contain both negative and positive bacterial strains required for validation. The bacterial content is appropriate and can be dissolved and used immediately. Applicable to the suitability of culture media, method suitability, and positive control in daily examinations. Tailin's microbial detection series products can be directly used for membrane filtration method to detect Burkholderia cepacia in onions.HEALT

The above newly added chapters have raised the requirements of pharmaceutical companies for microbial control. Customers are advised to pay attention to and make adjustments in a timely manner. Zhejiang Tailin Life Science Co., Ltd. has been focusing on aseptic testing for over 30 years, providing a complete set of solutions for aseptic testing. We provide supporting products such as bacterial collectors, bacterial culture equipment, quality control strains, enzymes, and oscillating instruments to help customers solve problems during the pharmacopoeia conversion stage, and continuously provide high-quality products and comprehensive technical services.