(1) Maintain the positive pressure of the air-conditioned room. If the negative pressure or positive pressure in the room is lower than that in the adjacent room, the air in the outdoor and surrounding rooms will infiltrate through the door and window cracks, especially in the purification air conditioning system, the purification level is higher than that in other rooms. The cleanliness of pharmaceutical design is at least 10 Pa higher than that of non-clean area, and between different cleanliness is more than 10 Pa.
(2) To ensure the rationality of air distribution in air-conditioned rooms. If the air distribution is destroyed, not only the indoor temperature distribution is affected, but also the dirty air near the corner and the ground diffuses to the indoor working area because of the excessive spiral flow. Therefore, the rationality of air distribution should be taken into account in the layout of workbench and equipment in air conditioning room. The equipment
can't block the return air outlet. The shutters of the return air outlet are strictly forbidden to move in disorder.
(3) Cleaning rooms must ensure that there are three levels of filtration: crude, medium and efficient. It is necessary to strengthen the management of clean air conditioning. Staff members should abide by the rules and operating procedures to ensure that indoor hygiene meets the requirements of purification.
(4) Clean and replace air filters regularly or on schedule, and plastic filters should be cleaned regularly. When the final resistance of the effective filter is twice the initial resistance or the limit value, it should be cleaned. When the resistance of high efficiency filter is too large, it should be replaced. Foam plastic filters should be tested after cleaning.
(5) Keep the air-conditioning treatment equipment and the air-conditioning room clean.
(6) Measure indoor dust content and positive pressure regularly. In accordance with the fourth part of the Chinese Pharmacopoeia 2015 edition and the Standards for the Quality Control of Pharmaceutical Production (2010 Revision) (GMP), non-unidirectional flow is adopted for Class B, C and D clean rooms. The H14 high efficiency filter with 99.995%-99.999% filtration efficiency is adopted at the end, which ensures 55 air exchange times in class B, 25 times in class C and 15 times in class D. We use clean air to dilute the air in the room in order to meet the corresponding cleanliness requirements.
For Class A clean room, unidirectional flow is adopted, and H14 high efficiency filter with filtration efficiency of 99.995% - 99.999% is adopted at the end. The surface wind speed is guaranteed to be 0.36 - 0.54m/s. Then the particulate matter in the air is compressed vertically and blown away from the working area to ensure the cleanliness requirement of Class A in the working area.
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