Full Analysis of the Standard Operating Procedure for Settling Bacteria Testing in Pharmaceutical Plant Purification Workshops

As Guangzhou Cleanroom Construction Co., Ltd., which is dedicated to the production of purification equipment, we are well aware of the significance of the environment in pharmaceutical plant purification workshops for drug quality. Settling bacteria testing is a crucial part of evaluating the microbial contamination status in purification workshops. Today, we will introduce the standard operating procedure in detail.

Pre - operation Preparation

1. Personnel Preparation: Operators must undergo professional training, be familiar with the settling bacteria testing process and relevant microbiological knowledge. They should wear clean clothes, masks, hats, and gloves that meet the requirements of the purification workshop to avoid the interference of microorganisms carried by themselves on the test results.

2. Instrument and Reagent Preparation: Prepare calibrated Petri dishes to ensure they are sterile and undamaged. Prepare corresponding culture media, such as Soybean - Casein Digest Agar Medium, etc., and prepare and sterilize them according to the specified methods. At the same time, prepare tools for marking and recording, such as marker pens, record forms, etc.

3. Environmental Preparation: Before the test, ensure that the purification system in the purification workshop has been operating normally for a sufficient time to make the environmental parameters such as air flow, temperature, and humidity in the workshop reach a stable state. Turn off unnecessary equipment, doors, and windows, and reduce personnel movement to avoid the influence of external factors on the test environment.

Specific Operation Steps

1. Sampling Point Layout: According to the area of the pharmaceutical plant purification workshop, the division of functional areas, and relevant standard requirements, reasonably determine the sampling points. Generally, set sampling points at the four corners, the center of the workshop, and near key production equipment to ensure that the microbial distribution in the workshop can be comprehensively reflected.

2. Placing Petri Dishes: Place the prepared Petri dishes horizontally at the sampling points, open the Petri dish lids, expose the surface of the culture medium to the air, and start timing. The exposure time is determined according to relevant standards and actual situations, usually ranging from 30 minutes to 4 hours.

3. Recovering Petri Dishes: After the specified exposure time ends, quickly cover the Petri dish lids and recover the Petri dishes in sequence according to the sampling points. Pay attention to avoiding collisions and contamination of the Petri dishes during the recovery process.

4. Cultivation: Put the recovered Petri dishes into a constant - temperature incubator in a timely manner. Set appropriate culture temperature and time according to the characteristics of the culture medium and relevant standard requirements, generally cultivate at 30 - 35°C for 48 hours.

5. Counting and Recording: After the cultivation is completed, count the colonies in the Petri dishes in a sterile environment. Adopt appropriate counting methods, such as direct visual counting or with the help of colony counters and other tools. Accurately record the number of colonies at each sampling point and fill it in the pre - prepared record form.

Precautions

1. Aseptic Operation: The entire testing process must strictly follow the aseptic operation principle to avoid introducing new microbial contamination during the operation.

2. Environmental Monitoring: During the test, monitor and record the environmental parameters such as temperature, humidity, and pressure difference in the purification workshop at the same time for reference when analyzing the test results later.

3. Data Processing: Statistically analyze the number of colonies obtained from the test to determine whether it meets the settling bacteria standard requirements of the pharmaceutical plant purification workshop. If abnormal data is found, find the reasons in time and conduct a review.

Mastering the standard operating procedure for settling bacteria testing in pharmaceutical plant purification workshops is an important measure to ensure that the drug production environment meets the requirements. Guangzhou Cleanroom Construction Co., Ltd. is always committed to providing high - quality purification equipment and technical support for pharmaceutical factories and other customers, helping the pharmaceutical production industry create a high - quality production environment. If you have any questions or needs regarding settling bacteria testing or purification workshop construction, please feel free to contact us at any time!