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近紅外應(yīng)用模型為什么需要定期校準(zhǔn)維護(hù)

 昵稱37581541 2017-08-05




NIR Calibrations are based on mathematical models, based onspectral and reference data, and these data sources changes with time due to the following facts: 

近紅外定標(biāo)是基于數(shù)學(xué)模型,包含光譜和參考值,并且這些數(shù)據(jù)來(lái)源會(huì)隨著下列因素而發(fā)生變化:


naturalbiological substances changes by season, weather,origin (continents, country), pollution, evolution of species, geneticallychanges, related especially to: Food & Feed

自然生物成分隨著季節(jié)、氣候、起源(洲、國(guó)家)、污染、物種進(jìn)化、基因改變而發(fā)生變化,尤其涉及到食物和飼料


§ product production processes changeby improvements, process parameters, timing, physical properties, environment,changed raw material variations, different suppliers, related especially to:Pharmacy, Chemistry, Process Analytical Technology (PAT), Quality by Design(QbD)

產(chǎn)品生產(chǎn)過(guò)程隨著加工參數(shù)、時(shí)間、物理性質(zhì)、環(huán)境、原材料變化、不同供應(yīng)商而發(fā)生變化,尤其涉及到藥劑學(xué)、化學(xué)、過(guò)程分析技術(shù)(PAT),質(zhì)量設(shè)計(jì)(QbD


§ sampling process changessample selection, see Theory of Sampling (TOS)

取樣過(guò)程變化,包括樣品選擇,見(jiàn)取樣原理(TOS


§ sample preparation changeschopping, grinding, milling, mixing (homogeneous), sieving, numerous effects ofvariable particle sizes, heating/freezing temperature program (ramp, hold),wet, dry, pressure and density, thickness, aging and contamination of samplesbetween NIR and Lab measurement, air-tight transport cell, weight or volume,see NIR Sample Preparation

樣品準(zhǔn)備過(guò)程變化,包括截?cái)?、研磨、粉碎、混合(均質(zhì))、篩分、顆粒度變化、升溫和降溫過(guò)程、潮濕、干燥、壓力和密度、厚度、在近紅外與實(shí)驗(yàn)室分析時(shí)的時(shí)效和污染情況、密封實(shí)施、重量或體積,見(jiàn)近紅外樣品準(zhǔn)備。


§ sample measurement changesmeasurement cell cleaning, container, glasses, petri glasses, cuvettes, plasticcoverage, auto sampler adjustments and sampling plan, positioning, measurementarea, fixed vs. moving spot, sample temperature, spectral resolution,apodization method (FT-NIR), number of scans, measurement repeats, averagingwith/out outliers

樣品檢測(cè)方式發(fā)生變化,包括測(cè)量室的清潔、容器、玻璃、培養(yǎng)皿、比色皿、塑料蓋、自動(dòng)進(jìn)樣調(diào)整和抽樣方案、定位、測(cè)量區(qū)域、固定、移動(dòng)、樣品溫度、光譜分辨率、切趾法(FT-NIR)、掃描頻率、重復(fù)測(cè)量、平均值或離群值。


§ reference method changesdifferent method types, different Labs, refinements

參比方法變化,包括不同類(lèi)型方法、不同實(shí)驗(yàn)室、方法改良。


§ SOP changes QA/QC procedures

SOP變化,包括QA/QC規(guī)程


§ instrument / spectrometer changesdrifts by temperature and aging of electronic components, aging and defilement(dirt) of reference substances, wavelength accuracy, signal to noise ratio

儀器/光譜儀發(fā)生變化,包括溫度變化、電子組件的老化、參比物的老化和污染、波長(zhǎng)準(zhǔn)確性、信噪比變化。


§ new NIR data iscollected continuously and should be used to extend the calibration, fill thematrix gaps, to increase robustness, and in some cases the older data can befaded out.

不斷收集新的近紅外數(shù)據(jù),用于定標(biāo)的擴(kuò)展,補(bǔ)充矩陣間隙,增加定標(biāo)穩(wěn)定性,并且在某些情況下可以去除舊的數(shù)據(jù)。



Because of all these changes, NIR Spectroscopy requires extensiveapplication calibration and validation on an ongoing basis

由于上述因素發(fā)生變化,近紅外光譜需要廣泛應(yīng)用定標(biāo)和持續(xù)數(shù)據(jù)驗(yàn)證

It’slike the weather forecast models, everything is changing and sothe models need to be adjusted. Thankfully for NIR the period is longer thanfor the weather. But there is an interval, that means the models can not be held frozen and constant if the measurementresults should be reliable. NIR require speriodic


像氣象預(yù)測(cè)模型一樣,許多因素發(fā)生變化,因此模型需要調(diào)整。還好有一點(diǎn),近紅外的調(diào)整要比天氣變化還長(zhǎng)。但是近紅外具有間隔性,是指即使檢測(cè)結(jié)果比較可靠也不能保持模型固定不變。近紅外需要不定期的改變完善。





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