Particles, especially the presence of dust particles directly affect the quality of drugs, endangering people's lives. A large number of clinical data show that, such as drugs contaminated by 0.7 ~ 2um dust particles, especially intravenous drugs, can lead to pyrogenic reactions, pulmonary arteritis, micro-thrombosis or foreign body granuloma, etc., serious death. The risk of particles entering the vascular system is related to the number of particles, their size and their physical and chemical properties. In addition, microbial contamination is the most important factor in the production environment and is relevant to the control of the microbial load of the final product. It has been shown that single microorganisms do not survive in the air by themselves, but they either exist in the form of colonies or have to be attached to inactive dust particles (especially particles with a diameter of more than 0.5 μm). This links the level of microorganisms in the air to the level of dust particles. The various hardware systems in a cleanroom control the number of suspended particles in the air and thus reduce the microbial contamination of the air. Therefore, GMPs require effective monitoring of dust particles in clean areas.
In order to establish routine sampling sites, the extent to which the product is in contact with or exposed to the environment must be considered. Representative sampling points reflecting the microbial content of the product must be sampled and environmentally monitored. Sources of product contact may include compressed gases, room air, production equipment, tools, critical surfaces, storage containers, conveyor belts, gloves, personnel, and water. Sources that do not come into direct contact with product may include: walls, floors, ceilings, doors, benches, chairs, test instruments, and buffer rooms. Establishing routine sampling locations should also consider whether environmental monitoring will increase product contamination. There are many factors to consider when establishing an appropriate sampling location, such as plant facilities, production line setup, validation data, manufacturing process, historical data, and testing methods. Sampling points and volumes for clean area (room) monitoring can be less than those for cleanliness confirmation, but the frequency and limits of monitoring should be determined through a formal risk analysis study and analysis of the results of the monitoring (at least 6 months of operating data should be used as the basis for analysis). At the same time, the frequency and limit of monitoring should also take into account the factors of the production process, and the monitoring limit and sampling points should be periodically reviewed and verified to ensure the effectiveness of the monitoring behavior. The following is the national standard GB/T 16292~16294-1896 "pharmaceutical industry clean room (area) suspended particles, planktonic bacteria and settled bacteria test methods in the minimum number of sampling points.
In addition to the requirement to control the level of particles in the environment, we must also focus on the level of microorganisms in the clean environment. The various hardware systems in the cleanroom control the number of suspended particles in the air, thus also reducing airborne microbial contamination.GMP stipulates that in order to assess the microbiological status of aseptic production, microorganisms should be monitored dynamically, and the methods of monitoring include the settlement bacteria method, quantitative airborne bacteria sampling and surface sampling (e.g., the swabbing method and the contact disk method).
CW-HPC600&CW-HPC600A Handheld Laser Dust Particle Counter is a highly sensitive laser dust particle counter that integrates handheld and desktop printing, which is created by Shenzhen Sainavi Environmental Technology Co. Its patent-protected design not only in the sensitivity, resolution and stability of the sensor technology is also ahead of international similar products. The unique multi-functional integrated design meets and facilitates the user's needs. It can accurately measure the number and distribution of particles in the environment in real time; various measurement parameters can be set, such as automatic real-time display, particle size selection, timing, delay and automatic repeat measurement, time, and date settings, data storage and printing, counting over the limit of the alarm light function.