Pay attention to filter leak test and create a clean production environment

Pharmaceutical production puts forward strict requirements for environmental cleanliness Generally speaking, clean rooms are divided into different levels According to different requirements of each process, different air cleanliness levels are used in pharmaceutical production In order to meet the standards, some pharmaceutical companies will use filters to purify the air in the clean room In fact, the filter is the key equipment to achieve high cleanliness and air purification It can supplement the particle dust and suspended matter below 0.5um, and it can also be used as the end filtration of various filtration systems The filter is a favorable equipment for air purification If there is leakage in the process of installation, replacement or commissioning, it will bring pollution to the clean production of medical products Therefore, it is necessary to test the filter for leakage, so as to ensure the clean environment of the workshop So, how to do the leak test? Shanghai Sujing Industry Co., Ltd related personnel made a specific introduction The staff said that the dust particle counter can be used to detect whether there is leakage in the filter Specifically, the dust particle counter needs to be wiped and disinfected with water for injection and 75% alcohol first, then exposed to ultraviolet for half an hour, and then transferred to the clean area Secondly, place the dust particle counter horizontally on the table, and connect the measuring plastic pipe port to the street mouth of the filter Then turn on the power supply After TL inspection and option, pull out the measuring plastic pipe After Zui, it is necessary to slowly scan along the inner frame and the middle of the filter during detection It should be noted that each filter should be tested at least 5 points to observe the data In addition, the dust particle counter is used to detect whether the filter has leakage, and DOP leak detection method is also used According to the introduction, the Pao generator is usually used to detect the leakage of the filter, and the photometer is used to detect the concentration of the aerosol upstream and downstream of the filter to determine whether it is leaking If only particle counter is used, it is difficult to find out the leakage delusion, so we need to supplement the dust to judge it easily The DOP leak detection method can effectively detect whether there is leakage DOP leak detection requires the following materials and instruments, including dust source (PAO solvent), aerosol generator and aerosol photometer Simply speaking, three steps should be done, that is, introducing Pao aerosol on the upstream side of the filter to be tested; then initializing the aerosol photometer, setting 100% and 0% reference standard values; after Zui, carry out scanning leak detection In addition, there are differences in different standards for the determination of filter leak detection results For example, in China, it is stipulated to use atmospheric dust or other aerosols, and the penetration rate of leakage concentration measured by the example counter shall not be more than twice of the qualified penetration rate In the United States, the on-site leakage detection transmissivity of class C and D filters is 0.3um, and the scanning leakage detection method of breadth meter is 0.01 Relevant experts said that the filter leakage rate standard of less than or equal to 0.01% does not affect the actual detection of leakage The leakage detection of the filter can not only detect whether there is leakage, but also understand the service life of the filter According to some manufacturers, if the air supply volume drops to 70%, the filter needs to be replaced in time in case of air leakage; if any abnormality is found during the verification according to the air conditioning purification system, the equipment needs to be replaced in time; if the pressure difference is unqualified and the air supply volume cannot be felt, the cause should be analyzed in time; if it is a filter problem, a new filter should be configured It is recommended by some manufacturers for the leakage test of the filter that the drug companies should conduct the leakage test at least once a year If there is any problem, the leakage shall be stopped or the equipment shall be replaced in time If the filter is repaired or replaced, the leakage test shall be carried out Only by doing these work well, can we ensure the filter to play the real value of equipment, can we ensure the cleanliness of pharmaceutical production, and ensure the efficacy of pharmaceutical products In addition, the pharmaceutical enterprises should also pay attention to the leak test of the filter, and make documents for the replacement cycle of the equipment to ensure a clean pharmaceutical production environment.