[确认&验证]检验仪器再确认的疑问。
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[确认&验证]
检验仪器再确认的疑问。
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发表于 2015-11-27 13:52:27
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实验室的一些仪器，例如，PH计，分析天平，干燥箱等，如果每年都定期进行了校验，还有必要再定期进行确认吗？不知道这个再确认周期怎么定？再确认内容又该怎么定？
求大神解答。
谢谢。
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发表于 2015-11-27 14:09:12
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这个美国USP的分类，好像是分为5类，简单的直接计量了事，视乎是这样，hongwei2000老师比较专业，我召唤大神吧。@hongwei2000
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hongwei2000
分类不是最关键的
最关键的还是你的用途
例如天平和干燥箱
至于说做不做确认、检定是否可以代替确认要看情况
最起码老外不太认可国内的检定
而不认可国内的检定主要原因有几方面：
1）没有方案或方案没有经过
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发表于 2015-11-27 16:44
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发表于 2015-11-27 14:11:20
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INSTRUMENT CATEGORIES
Modern laboratories typically include a suite of instruments and equipment varying from simple nitrogen evaporators to complex automated instruments. Therefore, applying a single set of principles to qualifying such dissimilar instruments would be scientifically inappropriate. Users are most capable of establishing the level of qualification needed for an instrument. On the basis of the level needed, it is convenient to categorize instruments into three groups: A, B, and C, as defined below. Examples of instruments in each group are provided. Note that the list of instruments provided here is for illustration only and is not meant to be exhaustive. It does not provide the exact category for an instrument at a user site. That category should be determined by users for their specific instruments or applications.
The exact grouping of an instrument must be determined by users for their specific requirements. Depending on individual user requirements, the same instrument may appropriately fall into one group for one user and another group for another user. Therefore, a careful selection of groups by users is highly encouraged.
Group A
Group A includes standard equipment with no measurement capability or usual requirement for calibration, where the manufacturer's specification of basic functionality is accepted as user requirements. Conformance of Group A equipment with user requirements may be verified and documented through visual observation of its operation. Examples of equipment in this group are nitrogen evaporators, magnetic stirrers, vortex mixers, and centrifuges.
Group B
Group B includes standard equipment and instruments providing measured values as well as equipment controlling physical parameters (such as temperature, pressure, or flow) that need calibration, where the user requirements are typically the same as the manufacturer's specification of functionality and operational limits. Conformance of Group B instruments or equipment to user requirements is determined according to the standard operating procedures for the instrument or equipment, and documented during IQ and OQ. Examples of instruments in this group are balances, melting point apparatus, light microscopes, pH meters, variable pipets, refractometers, thermometers, titrators, and viscosimeters. Examples of equipment in this group are muffle furnaces, ovens, refrigerator-freezers, water baths, pumps, and dilutors.
Group C
Group C includes instruments and computerized analytical systems, where user requirements for functionality, operational, and performance limits are specific for the analytical application. Conformance of Group C instruments to user requirements is determined by specific function tests and performance tests. Installing these instruments can be a complicated undertaking and may require the assistance of specialists. A full qualification process, as outlined in this document, should apply to these instruments. Examples of instruments in this group include the following:
atomic absorption spectrometers
differential scanning calorimeters
dissolution apparatus
electron microscopes
flame absorption spectrometers
high-pressure liquid chromatographs
mass spectrometers
microplate readers
thermal gravimetric analyzers
X-ray fluorescence spectrometers
X-ray powder diffractometers
densitometers
diode-array detectors
elemental analyzers
gas chromatographs
IR spectrometers
near-IR spectrometers
Raman spectrometers
UV/Vis spectrometers
inductively coupled plasma-emission spectrometers
摘自USP35 《1058》 ANALYTICAL INSTRUMENT QUALIFICATION
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发表于 2015-11-27 16:44:55
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工作QQ 发表于 2015-11-27 14:09
这个美国USP的分类，好像是分为5类，简单的直接计量了事，视乎是这样，hongwei2000老师比较专业，我召唤大 ...
分类不是最关键的
最关键的还是你的用途
例如天平和干燥箱
至于说做不做确认、检定是否可以代替确认要看情况
最起码老外不太认可国内的检定
而不认可国内的检定主要原因有几方面：
1）没有方案或方案没有经过质量部门的审核和批准；
2）没有原始数据；
3）没有经过审批的报告。
而且有些设备也不可能使用检定
例如干燥箱计量限所能做的只是表的检定
做不了mapping
而mapping对于用于生产和检验的设备来说是一个关键的内容
但对于pH计、电导率仪这种一般检定是可以的
但对于老外来说并不是是“接受”这个词
而是人家关注的是你日期使用的校准
对于再确认来说
一般实验室仪器建议不超过一年
对于易波动的或使用频率非常高的可以加大频率
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5#
发表于 2015-11-27 16:49:05
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工作QQ 发表于 2015-11-27 14:11
INSTRUMENT CATEGORIES
Modern laboratories typically include a suite of instruments and equipment va ...
太牛了，点赞
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发表于 2015-11-27 16:51:56
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jim嘉熙 发表于 2015-11-27 16:49
太牛了，点赞
楼上那位 @hongwei2000才是大神。
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