FLUKE972B温湿度检测仪在医药洁净度检测时的应用
FLUKE972B温湿度检测仪在医药洁净度检测时的应用,文章来源于福禄克。随测随看,工业设计,巡检必备。温度和湿度是室内空气舒适度、环境检测的两项至关重要的检测项目。 Fluke972系列温湿度检测仪可以快速、方便地获取准确的湿度和温度数据。流线型工业设计易于持握,精简的操作按钮无需更多复杂操作,精选的高精度传感器确保数据可靠。对于设备维护和工程技术人员、HVAC 服务承包商、研发及生产人员、以及从事室内空气质量 (IAQ) 评估的专家来说,Fluke 972 系列是好用的的环境监测工具。
FLUKE972B Temperature and Humidity Tester for Pharmaceutical Cleanliness Inspection article from Fluke. Measure as you go, industrial design, inspection must-have. Temperature and humidity are two critical tests for indoor air comfort and environmental testing. The Fluke 972 Series Humidity and Temperature Detectors provide quick and easy access to accurate humidity and temperature data. The streamlined industrial design is easy to hold, streamlined operation buttons eliminate the need for more complex operations, and a selection of high-precision sensors ensure reliable data. The Fluke 972 Series is an indispensable environmental monitoring tool for facility maintenance and engineering technicians, HVAC service contractors, research and development and manufacturing personnel, and specialists in indoor air quality (IAQ) assessment.
1、应用对象 application object
公司:江苏某药品检验所
Company: Jiangsu a drug testing center
部门:化药检验
Department: chemical drug testing
受访人:徐工
Interviewee: Xu Gong |
2、应用背景 Application Background
参照国家标准GB/T 16294-2010、GB50591-2010、GB50073-2013及YY 0033-2000 无菌医疗器具生产管理规范规定,医药相关的洁净室、洁净车间等需要对多种环境参数进行控制,确保洁净室环境达标。如温湿度(45%-65%)、照度(≥150LUX)、悬浮粒子数(≥0.5μm悬浮粒子每立方米不超过350000个)、换气次数(每小时不低于20次)等,都是需要严格进行控制的,所以在洁净度检测时这些参数都会列为检测必要指标。其中温湿度超过标准容易导致物料变质,所以在温湿度的检测中需要用到高精度的检测仪进行多点检测。
Referring to the national standards GB/T 16294-2010, GB50591-2010, GB50073-2013 and YY 0033-2000 Aseptic Medical Apparatus Production Management Specification, pharmaceutical-related clean rooms and clean workshops need to control a variety of environmental parameters to ensure that the clean room environment meets the standards. Such as temperature and humidity (45%-65%), illumination (≥150LUX), suspended particles (≥0.5μm suspended particles per cubic meter not more than 350,000), the number of air exchanges (not less than 20 times per hour) and so on, are all need to be strictly controlled, so in the cleanliness test these parameters are listed as the necessary indicators for testing. Temperature and humidity exceed the standard easily lead to material deterioration, so in the temperature and humidity of the test need to use high-precision detector for multi-point detection.
03 应用目标 application objective
在洁净度检测中,需要测量以下几个地方的温湿度:
In cleanliness testing, temperature and humidity need to be measured in the following places:
01 洁净室进出口处 clean room entry/exit point
作为出入洁净室的地方,这个位置的监测不能被忽略。需要测量温湿度以确保洁净室内外的温度差异不会影响生产过程。As a place to enter and exit the cleanroom, monitoring of this location cannot be ignored. Temperature and humidity measurements are needed to ensure that temperature differences between the inside and outside of the cleanroom do not affect the production process.
02 工作区域 work area
工作区域整体生产或实验过程中最重要的地方,一旦温湿度出现允许范围内的变化,就会导致生产的质量或实验结果受到影响。因此需要测量工作区域的温湿度以确保生产的质量和效率,保证良好的稳定性。The work area is the most important place in the overall production or experimental process, once the temperature and humidity changes within the permissible range, it will lead to the quality of production or experimental results affected. Therefore, it is necessary to measure the temperature and humidity of the work area to ensure the quality and efficiency of production and to ensure good stability.
03 空气处理设备 Air handling equipment
空气处理设备是维持洁净室温湿度的关键设备,如空调、风机、烘干机等。在工作中需要测量空气处理设备的温湿度以确保它们正常工作,保证温湿度在设定范围内,帮助确保洁净室是适合进行生产操作的环境。Air handling equipment is key to maintaining the temperature and humidity of a cleanroom, such as air conditioners, fans, dryers, etc. The temperature and humidity of air handling equipment needs to be measured during operation to ensure that they are working properly, and to ensure that the temperature and humidity are within the set range to help ensure that the cleanroom is a suitable environment for manufacturing operations.
|
4、温湿度检测仪具有以下特性 The detector has the following characteristics
可选标配或选配外置探头,灵活应对空间限制;精度±0.4℃, ±3%RH, 应对工业级测试需求。Optional standard or optional external probe, flexible response to space constraints; accuracy of ± 0.4 ℃, ± 3% RH, to cope with the needs of industrial-grade testing.
1、温度湿度测量。Temperature and humidity measurement.
2、内置外置传感器可选。Built-in external sensor optional.
3、99组存储数据(仅限972B)。99 groups of stored data (only 972B).
2、内置外置传感器可选。Built-in external sensor optional.
3、99组存储数据(仅限972B)。99 groups of stored data (only 972B).
4、露点和湿球温度(仅限972B)。dew point and wet bulb temperature (only 972B)
5、应用效果 Application effects
在进行洁净室验收的时候,会根据不同洁净室的等级执行不同的检验标准。以万级洁净室为例,需要对噪声、空气质量、温度湿度等参数进行检测。其中温度需要控制在18-28℃范围内,湿度要控制在45%-65%,照度也需要≥300lx,在洁净室检测的过程中这些都是SOP内规定需要进行检测并记录的参数。在对室内温湿度进行检验的时候,使用FLUKE972B就非常方便,可以即测即读,快速记录各关键位置的温湿度,还有数据记录的功能,方便对关键点记录的数据进行复核。如果遇到温湿度检测时正在进行其他试验的情况,如室内培养皿已经开始沉降菌的检测,可以使用972B的外置探头,伸入检测区域测量温湿度,十分方便,减少对其他检测造成影响。When conducting cleanroom acceptance, different inspection standards will be implemented according to the level of different cleanrooms. To ten thousand clean room, for example, the need for noise, air quality, temperature and humidity and other parameters to be tested. The temperature needs to be controlled in the range of 18-28 ℃, humidity should be controlled at 45% -65%, illuminance also needs to be ≥ 300lx, in the process of clean room inspection, these are SOP provisions need to be tested and recorded parameters. In the indoor temperature and humidity inspection, the use of FLUKE972B is very convenient, can be measured that is read, and quickly record the temperature and humidity of the key positions, and data logging function, easy to review the data recorded at key points. If you encounter temperature and humidity testing when other tests are being conducted, such as indoor petri dishes have begun to settle bacteria detection, you can use the 972B external probe, reach into the test area to measure the temperature and humidity, very convenient, to reduce the impact on other tests.
6、用户证言 user testimony
FLUKE972B使用起来比较方便,操作很简单上手就会用了,出去做检验的时候装在小包里也不占地方。我比较喜欢外置探头这个设计,比较灵活,像高一点的位置或者边边角角的地方不用把主机直接靠过去,用外置探头探过去就能测了,总体来说还是减少了很多麻烦的。而且传感器保护壳很厚实,用的时候不用束手束脚担心弄坏,这个点我也很喜欢。FLUKE972B is relatively easy to use, the operation is very simple to get started on the use, go out to do the inspection when mounted in a small bag does not take up space. I prefer the external probe design, more flexible, like a higher position or corner places do not have to put the host directly against the past, with the external probe probe over to the test, overall still reduces a lot of trouble. And the sensor protective shell is very thick, when used without having to tie hands and feet worried about getting broken, this point I also like.
深圳银飞电子有售FLUKE972B温湿度检测仪
深圳银飞电子有售FLUKE972B温湿度检测仪