Quality clean room in pharmaceutical industry manufacturer and supplier: Requirements and methods of cleanliness inspection: The number of colonies in the air should be checked after disinfection, before sterile test and during operation to determine whether the aseptic room reaches the specified cleanliness, and there are often settling bacteria and floating bacteria determination methods. Regular revalidation of cleanliness: periodically (every quarter, half a year, one year) or when there is a major change in the clean room facilities, the cleanliness should be re-verified according to the national standard to ensure that the cleanliness meets the requirements, and the original verification records are kept and archived regularly. The verification results were recorded in the aseptic room use register as the original basis of the experimental environment and trend analysis data. Discover extra info on pharma clean room.
In order to ensure the cleanliness of the air necessary in the clean room, to reduce or prevent indoor dust production and growth of microorganisms, reduce or prevent the introduction of particles, microorganisms or materials that may cause cross-contamination into the clean room, Pharma clean room facility effectively removing indoor particles / microorganisms discharge. In order to achieve the ideal purification effect and reduce the purification cost, local air purification equipment is often used, including pass box, clean bench, fume hood, weighing booth,laminar flow hood,etc.
Pharmaceutical equipment includes: granulating oven, boiling dryer, wet machine, pulverizer, vibrating screen, slicer, drug frying machine, drug frying machine, tablet press, pill making machine, multi-functional extraction tank, liquid storage tank, liquid distribution tank, decompression drying oven, tilting reaction pot, capsule filling machine, bubble type packaging machine, particle packaging machine, powder packaging machine, V-type mixer, lifting feeder, etc.
In summary, maintaining the right humidity level in clean rooms is vital for ensuring their effectiveness and longevity. By understanding the normal humidity range for clean rooms (between 40% and 60% RH) and implementing proper cleanroom humidity control techniques such as using a dehumidifier, hygrometer, proper ventilation, and controlling water sources, professionals can help create a controlled environment that promotes optimal performance and safety.
The clean room workshop is also called the dust free workshop, gmp cleanroom, the industrial clean room (Clean Room) and the dust free room. It refers to the removal of pollutants such as particles, harmful air and bacteria in the air within a certain space, and the indoor temperature,cleanliness, indoor pressure, air velocity and air distribution, noise and vibration, lighting and static control. A specially designed clean room for a particular requirement. That is to say, no matter how the extemal air conditions change, the clean room can maintain the characteristics of cleanliness temperature and humidity and pressure.
For the unidirectional flow (laminar flow) clean room, the air supply volume is determined by the product of the average wind speed of the room section and the cross-sectional area, in which the measured section of the vertical unidirectional flow (laminar flow) clean room is the horizontal section 0.8m away from the ground; The horizontal unidirectional flow (laminar flow) clean room takes a vertical section 0.5m away from the air supply surface. The spacing of measuring points on the section shall not be greater than 2m, and the number of measuring points shall not be less than 10, which shall be evenly arranged. Hot bulb anemometer for instrument.
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Clean room in pharmaceutical industry wholesale provider from sz-pharma.com: Generally, the air flow distribution point on the surface of the operating table or production equipment should be located at 2/3 of the distance between the clean room space and the partition wall, so that when the operator is working, the air flow can flow from the inside of the process area to the operation area, and the The dust is taken away; if the distribution point is arranged in front of the process area, it will become an improper airflow distribution. At this time, most of the air flow will flow to the process area, and the dust caused by the operator’s operation will be brought to the back of the equipment. As a result, the platform will be polluted, and the yield rate is bound to decrease.
The clean room is generally made of foam color steel or rock wool board with a vertical wall and an independent air-conditioning air supply system. The air is filtered through high-efficiency three-stage filtration in junior high schools. The personnel and materials are equipped with an air shower room and a transfer window for clean filtration.