Clean workshop environment inspection training

Spotless, excellent quality - clean workshop environment testing training to create a new benchmark for aseptic pharmaceuticals

First, the importance of clean workshop environmental testing

• Core indicators: Clean workshop dust particle number monitoring is one of the core indicators of clean environment, is an important factor to judge whether the clean environment is qualified.

• Aseptic requirements: In the production of sterile drugs, the environmental control of clean workshops is directly related to product quality and patient safety.

2. Clean workshop environment testing project

• Dust particle count: The number of dust particles in the air of the clean workshop is monitored by the dust particle counter to evaluate the cleanliness level.

• Microbial monitoring: including the monitoring of settling bacteria, floating bacteria, surface microorganisms, etc., to ensure that the number of microorganisms in the workshop is controlled within the specified range.

• Physical parameters: such as temperature, humidity, wind speed, pressure difference, etc., these parameters have an important impact on the environmental stability and product quality of clean workshops.

Third, clean workshop environment testing process

1. Preparatory phase

• Equipment calibration: Ensure that detection equipment such as dust particle counters are calibrated and in working order.

• Clean up the environment: clean up the debris in the clean workshop, ensure that there is no personnel walking and operating activities in the monitoring area, and maintain a stable environment.

2. Sampling point arrangement

• According to the area, structure and air flow distribution of the clean workshop, the sampling points are rationally arranged. The number and location of sampling points shall comply with relevant standards and requirements.

3. Detection operation

• Place the test device in the clean space to be tested and set the appropriate test parameters (such as sampling time and sampling flow rate).

• Start the detection equipment for air sampling. During the test, ensure that the testing equipment is not interfered with by external interference.

4. Data recording and analysis

• After sampling, turn off the detection device and record the test results. The test results of each sampling point are recorded in table or chart form for easy analysis and comparison.

• According to the monitoring data, the cleanliness level of the clean workshop is analyzed to determine whether it meets the cleanliness level requirements.

  

4. Precautions

• Avoid interference: During the monitoring process, the impact of personnel movement and operational activities on the monitoring results should be avoided.

• Equipment maintenance: Regularly calibrate and maintain the testing equipment to ensure its accuracy and reliability.

• Safe operation: During operation, comply with relevant safety regulations to prevent equipment damage and personal injury.

V. Case analysis

• Through the actual case analysis, let the students understand the common problems and solutions in the clean workshop environment detection, and improve the students' coping ability and actual combat ability.

6. Relevant laws, regulations and standards

• Introduce the laws, regulations and standards related to clean workshop environmental testing, such as GMP, ISO 14644, etc., to help students understand the industry norms and requirements.

In summary, the training content of clean workshop environment testing covers the importance of testing, testing items, testing process, precautions, case analysis and relevant laws and regulations. Through systematic training, students' cognition and ability of clean workshop environment testing can be improved, providing a strong guarantee for the production of sterile drugs.