Clean laboratory safety and environmental monitoring requirements
Clean laboratory safety and environmental monitoring requirements
The equipment and environmental conditions of the clean laboratory must not only meet the requirements of the relevant specifications, but also meet the requirements of the normal operation of the precision instruments, so as to avoid affecting the quality or accuracy of the structure and the normal service life of the instruments and equipment, which is to ensure the pharma machinery Powerful measures for safe operation...
Text label: clean laboratory environment requirements, safety and monitoring, Zhongjing Global Purification
Clean Safety and Environmental Monitoring Requirements
The equipment and environmental conditions of the clean laboratory must not only meet the requirements of the relevant specifications, but also meet the requirements of the normal operation of the precision instruments, so as to avoid affecting the quality or accuracy of the structure and the normal service life of the instruments and equipment, which is to ensure the laboratory Powerful measures for safe operation; the laboratory should abide by the restrictive conditions and meet the relevant technical requirements, and at the same time, it should meet the requirements for the environmental conditions of the instruments and equipment and meet the requirements for ensuring the safety and health of operators, such as biosafety laboratories, genetic laboratories and strict Fire-proof laboratories, etc.; laboratories should establish a daily safety inspection system, and establish emergency measures and emergency procedures.
When facilities and environmental conditions have an impact on the quality of testing and calibration results, they should have the ability to monitor and control environmental conditions, monitor and understand the impact of changes in environmental conditions on the quality of results, and timely detect and regulate fluctuations in environmental conditions , to avoid affecting the quality of the test and calibration results due to these fluctuations; attention should also be paid to whether the environmental conditions of temporary or mobile facilities other than fixed sites meet the requirements; the monitoring and control of environmental conditions should have true and timely records , This kind of record is information reflecting changes in environmental conditions, a reference factor for analyzing data changes, and an important condition to ensure that the detection and calibration work can be reproduced under the same conditions. Sampling is performed in temporary or movable implementation sites other than fixed sites , When testing, special attention should be paid to the impact on environmental conditions, and at the same time, the environmental conditions affecting the testing and calibration work should be effectively monitored and recorded; in addition to the facilities and environmental conditions of the clean laboratory, effective monitoring, control and In addition to the records, some sophisticated analytical instruments and equipment should also have special monitoring records, which should be archived together with the use records of related instruments and equipment, such as mass spectrometry detection instruments, high-precision electronic balances, and biosafety experimental areas. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for clean laboratories and sterile laboratories.
facilities used for inspection and calibration, including but not limited to energy, lighting and environmental conditions, shall be conducive to the correct implementation of inspection and calibration; relevant specifications, methods and procedures require, or have a negative impact on the quality of the structure When affected, the laboratory shall monitor, control and record environmental conditions, paying attention to factors such as biological disinfection, dust, electromagnetic interference, radiation, humidity, temperature, power supply, sound and vibration levels, etc., to adapt them to relevant technical activities ; Adjacent areas of incompatible activities should be effectively isolated and measures should be taken to prevent cross-contamination; access to and use of areas that affect the quality of testing and calibration should be controlled, and the degree of control should be determined according to their specific circumstances; laboratories should Prepare thermometers, hygrometers, vibrometers and other facilities as needed; verify the temperature and attach a calibration status mark; the operating environment of the micro-Vickers hardness tester, the temperature is 13-25 °C, the relative humidity is ≤65%, no Dust, no vibration and no corrosive gas; the use environment for special measuring tools, the temperature is 15-25°C, and the change per hour is not more than 0.5°C; the use environment for universal energy tools, the temperature is 15-25°C; the use environment for tooth thickness calipers, the temperature is 12-28 ℃; Electro-optical analytical balance use environment, temperature 13-23 ℃. Soundproofing and anti-vibration measures should be taken for laboratories that experience large vibrations during calibration and testing to effectively isolate them from other parts. For experiments that generate oil fume and harmful gases during measurement, ventilation systems should be installed to prevent cross-contamination. ; Strictly separate the detection area from the non-detection area, and effectively control the detection area to prevent irrelevant personnel from entering and using the detection area; configure the necessary fire-fighting equipment to ensure that the detection area is clean and comfortable.
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