Standard for ABCD classification of clean area of pharmaceutical factory - clean room related
The clean area of the pharmaceutical factory is divided into ABCD. The clean room and clean area of the pharmaceutical industry are mainly controlled by particles and microorganisms. At the same time, the environmental temperature, humidity, pressure difference, illuminance, noise, etc. should be specified. 01 The clean area of the pharmaceutical factory is divided into ABCD grade A: high-risk operation areas, such as: filling areas, areas for placing rubber stoppers, open ampoules, open vials, and areas for aseptic assembly or connection operations. A laminar flow stage (hood) is usually used to maintain the environmental conditions of the zone. The laminar flow system must supply air evenly in its working area, with a wind speed of 0.36-0.54 m/s (guidance value). There should be data to prove the state of the laminar flow and be verified. In a closed isolated operator or glove box, unidirectional flow or lower wind speeds can be used. Class B: refers to the background area where the high-risk operations such as aseptic preparation and filling are located in the Class A area. Class C and Class D: refer to the less important clean operation areas in the production of sterile drugs. Class A corresponds to the dynamic class 100, that is, it should still be class 100 under dynamic conditions. Class B corresponds to the static class 100, that is, it can meet the class 100 standard under static conditions, and it can meet the class 10,000 standard under dynamic conditions. (There is no so-called thousand-grade in GMP.) C-grade corresponds to ten-thousand-grade, which meets the ten-thousand-grade standard under static conditions and D-grade standard under dynamic conditions, that is, one hundred thousand grades. Level D corresponds to level 100,000. 02 Environmental requirements of the ABCD clean area of the pharmaceutical factory The air temperature in the operation area of the Class A clean area should be 20-24°C The relative humidity of the air in the operation area should be 45%-60% Wind speed in the operation area: horizontal wind speed ≥ 0.54m/s Vertical wind speed Leak detection of ≥0.36m/s high-efficiency filter is greater than 99.97% Illumination: >300lx-600lx Noise: ≤75db (dynamic test) The air temperature in the operating area of the Class B clean area should be 20-24 °C The relative humidity of the air in the operating area should be For 45%-60% room ventilation times: ≥25 times/h Pressure difference: B-level area relative to outdoor ≥10Pa (different areas of the same level should maintain a certain pressure difference according to the airflow direction.) The leak detection of the high-efficiency filter is greater than 99.97% illuminance: >300lx-600lx Noise: ≤75db (dynamic test) The air temperature in the operation area of the C-level clean area should be 20-24℃ The relative humidity of the air in the operation area should be 45%-60% Room ventilation times: ≥ 25 times/h pressure difference: C-level area is ≥10Pa relative to outdoor (different areas of the same level should maintain a certain pressure difference according to the airflow direction.) The leak detection of the high-efficiency filter is greater than 99.97% Illumination: >300lx-600lx Noise: ≤75db (Dynamic test) The air temperature in the operation area of the Class D clean area should be 18-26°C, and the relative humidity of the air in the operation area should be 45%-60%. The number of air changes in the room: ≥15 times/h Differential pressure: 100,000 class area Relative to outdoor ≥10Pa high-efficiency filter, the leak detection is greater than 99.97%. Illumination: >300lx-600lx Noise: ≤75db (dynamic test) • Execution standard for the pharmaceutical industry: 1. 'Code for Design of Clean Plants in Pharmaceutical Industry' GB 50457-2008 Code for Design of Pharmaceutical Industry Cleanroom2, 'Good Manufacturing Practice for Pharmaceuticals' GMP 2010 Good Manufacturing Practice for Pharmaceuticals3, Guidelines for Good Manufacturing Practice and On-site Inspection for Medical Device Manufacturing 2020 © Copyright Notice: The content of this article is from the Internet, subject to changes, the copyright belongs to the original author , if there is any infringement, please contact us in time, we will delete it within 24 hours
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