GMP purification workshop workshop supporting isolation system

GMP purification workshop pharmaceutical cleanroom supporting isolation system

Isolator is a cabin, box or space that is isolated from the surrounding environment. In the pharmaceutical field, according to the process use, the purpose of using an isolator is to isolate the pollution source from the object environment that needs to be controlled and protected. The environment inside the isolator needs to meet the requirements of the process and GMP...

Text label: GMP purification pharmaceutical cleanroom plant layout, supporting isolation system

GMP purification pharmaceutical cleanroom workshop supporting isolation system

Isolator is a cabin, box or space that is isolated from the surrounding environment. In the pharmaceutical field, according to the process use, the purpose of using an isolator is to isolate the pollution source from the object environment that needs to be controlled and protected. The environment inside the isolator needs to meet the requirements of the process and GMP. These requirements may include cleanliness level, microbial control, unidirectional airflow design, pressure difference, temperature and humidity, leakage rate, light, etc.; injection production line isolators are generally related to upstream and downstream. Docking and integration of process equipment, including depyrogenation tunnel oven, filling machine, freeze dryer and its feeding and discharging system, capping machine, outer wall cleaning machine, etc.; isolator integrated vaporized hydrogen peroxide sterilization system for isolator The sterilization of the surface of the cavity and the surface of the process equipment, generally, the sterilization effect of the exposed surface can achieve a decrease of more than 6 logarithms of the high-resistance biological indicator. After the sterilization cycle, after the ventilation stage, the isolator box The hydrogen peroxide concentration is reduced below the acceptable range of the process.

For the isolation system of sterile injection production line, the airflow control system is used to provide one-way airflow protection and dynamic differential pressure control for the entire process, to ensure its dynamic isolation from the operator and the background environment. Differential pressure control is carried out by means of a fan-high-efficiency component integrated inside the isolation system. As the driving force for airflow circulation and differential pressure control, the fan system needs to be well designed, while ensuring the requirements of air volume and output pressure. The designed air volume is used to ensure the internal airflow speed, and the output pressure is used to overcome possible structural resistance. Ensure that the corresponding airflow speed is controlled at 0.36-0.54m/s; due to the small internal space of the isolator, the heat generated by the fan system should be considered for the temperature rise inside the isolator, and the fan system with the smallest heat generation should be selected as much as possible; the isolator The most commonly used high-efficiency filter is H14, with a filtration efficiency of 99.99%. Both ends of all high-efficiency filters should be equipped with a pressure difference monitoring device to characterize the pressure difference between the two ends, which is convenient for subsequent replacement after long-term use. To ensure the sealing performance of the inlet and outlet interfaces, a sealing interface is usually added outside the frame of the high-efficiency filter; the valve is used as the interface between the isolator and the background environment. In order to ensure the integrity of the isolator interior, the valve that controls the fresh air and exhaust air is usually a sealing function. Valves, mainly butterfly valves, are generally controlled by pneumatics. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for GMP purification workshops and clean workshops.

After the production is over, there may be product residues in the isolator cabin. The isolator cannot be opened directly for manual cleaning, but is cleaned by the cleaning device configured in the isolator; the isolator cabin can generally be configured with manual cleaning. For the automatic cleaning device, when the isolator is in a closed state, the operator cleans with a cleaning spray gun with gloves; during cleaning verification, it is necessary to test the cleaning coverage of the cleaning device, confirm the cleaning parameters, and verify the cleaning effect. GMP divides the clean environment into four grades: A, B, C, and D. The aseptic isolator is the core production area, and the interior is maintained at grade A. The internal environment needs to be dynamically monitored. On-line particle counters and planktonic bacteria samplers will be configured. In the core production area; the suspended particles inside the isolator are usually monitored online by a laser-type dust particle counter, and a reasonably designed particle sampling head should be arranged inside the equipment for isokinetic sampling of the air in the key process area; The environmental monitoring control valve is designed and installed outside the cabin, and is switched on and off according to the sampling process. A dust particle sensor is installed in the lower part. The laser head is used to monitor the suspended particles of different particle sizes in the air. Some sensors will not use the vacuum source for sampling. Connect the vacuum source at the back end; the pipeline at the front end of the suspended particle sensor should be clean and dust-free to prevent particles from being generated in the pipeline; the length of the pipeline should usually not exceed 1.8m, and the angle of the pipeline should not be bent. greater than 30 degrees.

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