One hundred thousand high clean workshop: refers to the clean level, which can be understood as a dust-free room, but the dust-free room also needs to be ventilated. The air changed into it needs to be purified by the purification room and then sent to the dust-free room. 100000 (100,000) level requires 15-19 air changes per hour, and the air purification time after complete air change is not more than 40 minutes.
Cleanliness level of purification workshop:
Hundred grade > thousand grade > ten thousand grade > one hundred thousand grade > three hundred thousand grade
In fact, the cleanliness level of the purification workshop is that the smaller the value, the higher the purification level, the higher the cleanliness and the higher the cost. One hundred thousand level purification workshop refers to the clean workshop with one hundred thousand level air cleanliness, that is, the particles per cubic meter in the workshop are controlled within 10W, and the food workshop should reach one hundred thousand level.
01, one hundred thousand grade purification workshop standard
Standard 1 of 100000 class purification workshop: The number of particles with the maximum allowable number of dust particles ≥ microns shall not exceed 3.5 million, and the number of particles ≥5 microns shall not exceed 20,000.
Standard 2: Maximum allowable number of microorganisms, the number of planktonic bacteria is not more than 500 /m; The number of settling bacteria should not exceed 10 / Petri dish.
One hundred thousand grade purification workshop standard three: differential pressure. The pressure difference of clean rooms with the same cleanliness level should be the same. The pressure difference between adjacent clean rooms with different cleanliness levels should be ≥5Pa, and the pressure difference between clean rooms and non-clean rooms should be ≥10Pa (mainly to ensure that air flows from clean areas to non-clean areas and avoid airflow backflow).
02, purification workshop principle
Generally after the first effect filter, in effect filter, high efficiency filter and other three segments and airflow to effect at the beginning of purification, humidification section - heating section - table hot section to table cooling section, the effect of purifying - fan air - pipe to efficiently purify tuyere, blow into the room to go at the beginning of the dust particles such as bacteria - return air shutters - effective purification, repeat the above process can achieve purification.
03. How to detect whether the 100,000 grade purification workshop reaches the standard?
Sedimentation bacteria determination method:
Settling bacteria refers to the bacteria carried by dust that falls on the ground or surface of objects. With the aseptic operating table open, a number of sterile Petri dishes with an inner diameter of 90 mm were taken, and more than 15 ml of nutrient AGAR medium melted and cooled to 45℃ was injected into the aseptic operation respectively, and then placed upside down in the 30-35 ℃ incubator for 48 hours to prove the sterility and for future use.
Place the petri dish covered with nutrient AGAR medium at a specified place about 1 meter from the ground in the designated area (generally, one plate is placed per 10 square meters), expose it to air for 30 minutes, collect settling bacteria, cover the plate, and incubate it in an incubator at 30-35℃ for 48 hours, take it out and count it. It should be in the operation state in the workshop. Test the number of sedimentation bacteria, each dish is less than or equal to 10, can reach the standard of 100000 purification workshop.
In general, sedimentation bacteria monitoring once a month can be done. Purification workshop engineering commonly used instruments include temperature and humidity meter, hygrometer, digital anemometer, infrared thermometer, differential pressure meter, multifunctional sound level meter, particle counter, air meter, etc. They are conventional real-time detection equipment, to help detect whether to meet the standard of 100,000-level purification workshop.
04. Documents and records required for verification of 100000 grade purification workshop