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Medicines are special products that are closely related […]
Medicines are special products that are closely related to people's health. Their quality must be guaranteed. The ultimate goal of the GMP purification workshop in the pharmaceutical industry is to ensure that every needle and every medicine produced is safe and effective. GMP purification workshops for environmental control, while focusing on particulates and microorganisms, should not neglect any other pollutants that may affect the quality of the drug. GMP purification workshops require a clean environment.
The pharmaceutical industry has high requirements for air cleanliness. The GMP purification workshop requires the highest level of Class A, which is the 100-level purification we often talk about. Air conditioning units are highly demanding in terms of air leakage and filtration. The pressure difference in each area of the GMP purification workshop is strictly controlled to avoid cross-contamination between drugs. This requires that the AHU air volume must be stable, otherwise the pressure difference will not be guaranteed. The GMP purification workshop also requires strict constant temperature and humidity requirements, and the performance requirements for components such as the air cooler are very high.
Test method for temperature and humidity of GMP purification workshop
The temperature test confirms the temperature control capability of the air treatment facility. The temperature test should be commissioned in the GMP purification workshop, the airflow uniformity test is completed, and the air conditioning system is continuously operated for more than 24H. The temperature test of the GMP purification workshop has a functional temperature test and a general temperature test. The functional temperature test is mainly used when the temperature accuracy is strictly controlled or when the builder requires testing in "static" or "dynamic"; the general temperature test is mainly used in the "empty" temperature test.
GMP purification workshop temperature test: The clean work area should be divided into equal-area grids, each of which has a grid area of no more than 100 square meters or negotiated with the construction party. Each grid has more than one measuring point, and each room is measured. At least two. The test height shall be the height of the working face. The distance from the ceiling, wall and ground shall not be less than 300MM. The influence of heat source shall be considered. The measurement time shall be at least 1H and measured at least 6min. Record the reading after it is stable. The measuring point of the general temperature test of the GMP purification workshop, one measuring point in each temperature control area or each room, the height of the test point should be the working surface height, the measuring time should be at least 1H, and the measurement time should be at least 6min. recording.
GMP purification workshop humidity test: humidity test can be used ventilated dry and wet bulb hygrometer, capacitive hygrometer, digital hygrometer, hair type humidity instrument. The measurement point, test frequency and time of the relative humidity test are the same as the temperature test time, and should be tested together.
In the GMP verification phase, the pharmaceutical company usually runs continuously for up to one year, and the actual production is also continuous for a long time. It is a very strict test for the stability and life of the unit. The GMP purification workshop of the pharmaceutical company usually introduces fresh air of 10-40%. The performance of the cold coil of the fresh air must be reliable. Otherwise, the temperature and humidity of the air-conditioned room are a serious threat. In order to prevent bacterial contamination of drugs, the GMP purification workshop includes air conditioning systems for regular cleaning and disinfection. This requires the air conditioning unit to be clean, easy to clean and resistant to corrosion by disinfectants.
Any effective pollution control technology should include the two inseparable preconditions of the necessary hardware conditions and rigorous software management. Nothing can be achieved with any aspect of abandonment or partial waste. The GMP purification workshop is strict, standardized, and scientifically managed, laying the foundation for pollution control.