Intelligent bacterial collection device is a core equipment in the field of microbial detection, mainly used for safety verification of sterile products such as injections and ophthalmic preparations. By simulating the human infusion path, it efficiently enriches microorganisms in the drug solution and provides key data for drug quality control.Mastering its standardized operating methods is the foundation for ensuring the accuracy of test results.

　　1、 Preparation before operation: Details determine success or failure

Three core preparations need to be completed before use:

1. Environment and instrument sterilization: The operating environment must meet the cleanliness requirements. Components that come into contact with the drug solution, such as the bacterial culture incubator (including filter membrane), tubing, and culture medium bottle, must be sterilized by moist heat or irradiation to avoid external contamination.

2. Instrument status check: After connecting the power, confirm that the host is running smoothly without any abnormal noise, the peristaltic pump speed adjustment function is normal, and there is no leakage at the pipeline connection.

3. Consumable installation: Install the sterilized bacterial culture incubator on a fixed bracket, with the filter membrane facing upwards. Connect the inlet end to the test sample pipeline, and the outlet end to the culture medium bottle through a conduit to ensure good sealing of the entire system.

　　2、 Standard operating procedure: Complete microbial enrichment in four steps

1. Pre rinsing: Start the intelligent bacterial collection instrument and run it at low speed (10-15rpm) for 1-2 minutes. Rinse the pipeline with an appropriate amount of sterile physiological saline to remove residual bubbles and impurities, avoiding interference with subsequent testing.

2. Injection of test substance: Inject the test drug solution into the bacterial culture device at a constant speed through a dedicated syringe or infusion pump. The injection speed should match the rotational speed of the peristaltic pump to ensure that the drug solution fully contacts the filter membrane.

3. Microbial interception: Maintain stable operation of the instrument, effectively intercept microorganisms in the liquid through the filter membrane, and allow the liquid to enter the waste collection bottle through the filter membrane.

4. Rinse and transfer of culture medium: Backwash the filter membrane with an appropriate amount of rinsing solution (100-200mL) to remove the inhibitory effects of the drug components. Then inject the culture medium into the culture medium bottle through a catheter, infiltrate the filter membrane, and reverse osmosis to provide a nutrient environment for the intercepted microorganisms.

　　3、 Key considerations: Standardize and ensure reliable results

1. Speed control: Adjust the speed according to the viscosity of the medicine, but ensure sufficient flow rate to allow microorganisms to fully contact the filter membrane.

2. Aseptic operation: Wear sterile gloves throughout the process to avoid hand contact with consumable interfaces; If there is a pause midway, sterile film should be used to cover the opening of the pipeline to prevent contamination.

3. Subsequent cultivation: After completing the transfer, place the culture medium bottle under the specified conditions for cultivation, and observe daily for turbidity or colony growth.

The standardized operation of intelligent microbial collectors requires strict adherence to the "preparation injection retention culture" process, ensuring the sensitivity and accuracy of microbial detection through detail control and parameter optimization, and building the first line of defense for drug safety.