Recently, the term “PM2.5†has been widely concerned, and PM2.5 monitoring target – dust particles (suspended particles) not only has harm to humans, but also has a great impact on production, especially for products with high cleanliness requirements. For example: medicine, semiconductor, data storage, biotechnology, aerospace, etc. Today we briefly discuss the dangers of dust particles in pharmaceutical production.
Dust particles (suspended particles) refer to tiny particles that exist in suspension in the air, and mainly include: solid particles and microorganisms. When the particle diameter is ≥20洀, it will settle under the gravity factor, while ≤0.1洀 will be attracted and diverged under the action of static electricity. Particles that are generally harmful to production and life are particles between 0.1 and 20 inches. It is important to note that bacteria (2-8 洀), inhalable particulate matter (PM10), and accessible particulate matter (PM2.5) are all within this range.
For pharmaceutical production, the damage of dust particles mainly comes from two aspects:
1. Harm to the quality of drugs, mainly including:
1. The impact on the chemical composition of the drug - the microbes in the dust particles and some of the solid particles will chemically react with the components in the drug, thereby changing the composition of the drug, causing uncontrollable changes in the drug, resulting in drug failure, mutation, and serious Lead to death of the patient.
2. Affect the stability and reliability of the drug - easily lead to shortening of the effective period of the drug;
3. Affect the purity of the drug - resulting in reduced efficacy and failure of the drug.
Second, the production process and equipment are harmful, mainly including:
1. Increasing production costs by controlling the contamination of drugs and equipment by dust particles. Such as the increase in particle monitoring and control;
2. Dust particles cause damage or even damage to the equipment itself, thereby increasing maintenance and repair costs and reducing the rate of return of the equipment;
The control of dust particle pollution in pharmaceutical production is a complex system engineering, which needs to be carried out from the design of the plant to the control of personnel. This article is only a simple introduction from the direction of control, specific reference to GMP and other relevant regulations and norms. Dust particle pollution control generally needs to be carried out in the following aspects:
1. Control the overall dust particle pollution in the plant environment, thereby reducing dust particles in the production area;
2. Control the pollution of dust particles in the production area, especially in the clean area (room), and reduce the pollution of drugs;
3. Reduce pollution directly to drugs by controlling pollution control of production equipment. Equipment selection should be as close as possible to fully sealed, high-volume, fully automatic equipment.
4. Production process design pollution control, especially to prevent secondary pollution of drugs;
5. Production personnel pollution control, reducing pollution of the production process and management of the drug due to personnel;
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