In the pharmaceutical industry, the planktonic bacteria sampler is crucial. It is not an optional auxiliary equipment, but a key production process directly related to drug safety and legal compliance.
For pharmaceutical companies, sampling of planktonic bacteria is a mandatory compliance requirement. The Chinese Good Manufacturing Practice (GMP) and international standards (such as ISO 14698) explicitly require monitoring of airborne microorganisms (planktonic bacteria) in clean rooms. It is the intuitive basis for proving the continuous compliance of the production environment. Whether it is sterile filling areas, clean corridors, or critical operating points, regular testing of planktonic bacteria is required to evaluate environmental cleanliness.



Sampling process of planktonic bacteria
1. Sampling preparation
Operators need to wear corresponding clean clothes according to the clean area changing process (such as sterile changing in Class A/Class B areas) to avoid the introduction of pollutants such as cosmetics and jewelry.
Confirm that the sampling area has been cleaned and disinfected, and the production environment is in a stable state. The HVAC system should run for at least 30 minutes to ensure stable airflow.
Check the cleanliness of the appearance of the planktonic bacteria sampler, confirm that the equipment is regularly calibrated according to SOP, and record it within the calibration validity period. Prepare sterilized sampling medium using soy casein agar SCDA to confirm the sterilization effectiveness of the medium and within its validity period.



Prepare sterile sampling dishes and select the appropriate diameter based on the sampling volume. The commonly used size is 90mm. Before use, the lid should be opened in the biosafety cabinet to avoid contamination.
According to the monitoring purpose, daily monitoring, dynamic monitoring, verification, etc., the sampling point, sampling time, and sampling volume are determined and set according to the cleanliness level. A and B levels usually sample 1000L per time, C level 500L, and D level 100L. The sampling head, airflow channel, and other parts of the sampler that come into contact with the sample are sterilized using methods such as wet heat sterilization and ethylene oxide sterilization.
In a biosafety cabinet or clean bench, place the sterilized culture medium petri dish steadily on the sampler tray, ensuring that the dish cover is fully open and avoiding touching the surface of the culture medium.



2. Sampling process
Please refer to regulations such as the Chinese Pharmacopoeia, GBT16293, ISO14644 for specific labeling. Confirm that the device flow rate is stable, usually at 28.3L/min or 100L/min, and should be consistent with the calibrated flow rate of the device. Set according to the preset sampling point order for easy data traceability.
Place the sampler at the preset sampling point, usually at a height of 0.8-1.5m above the ground, consistent with the operating surface or product exposure height, to avoid direct placement in areas with abnormal airflow such as return air vents and equipment vents.



Start the sampling program to ensure stable operation of the equipment during the sampling process, without any abnormal vibration or noise. During the sampling period, operators need to maintain a distance to avoid interfering with the airflow.
After the single point sampling is completed, close the sampler, cover the petri dish lid in the biosafety cabinet, and mark the sampling point number, time, operator, and other information.
When changing sampling points, the surface of the sampling head should be disinfected and wiped with 75% sterile alcohol to avoid cross contamination. If the sampler needs to move in areas of different cleanliness levels, it must be cleaned and disinfected in the lower level area before entering the higher level area.





3. Sampling analysis
After sampling is completed, the culture medium petri dish should be sent to the microbiology laboratory within the specified time, usually ≤ 4 hours, and cultured under standard conditions at 30-35 ℃ for 5 days. Fungi need to be cultured at 20-25 ℃ for 7 days.



Record the cultivation conditions and time to ensure compliance with testing standards. After the sampling is completed, clean and disinfect the surface and sampling head of the sampler, and remove them from the clean area according to the prescribed procedures.
During non use, the equipment should be stored in a clean and dry environment, regularly maintained, and the sampling information should be fully recorded, including sampling point, time, flow rate, volume, culture medium batch, operator, equipment number, etc.
Monitoring data should be promptly entered into the system and associated with environmental monitoring trend analysis to ensure data traceability. Abnormal data should be handled according to deviation procedures.



Regularly calibrate the flow accuracy and timing accuracy of the sampler, and archive the calibration records for future reference. The operation process needs to be standardized and documented, and operators must be trained and qualified before they can take up their posts to ensure compliance with drug regulatory audit requirements. Through standardized operating procedures, the planktonic bacteria sampler 3080 can accurately capture microorganisms in clean environments, providing reliable data support for clean area management in the pharmaceutical industry.