FT IR-4000和FT IR 6000系列FTIR仪器验证软件

智能文字提取功能测试中

在受控或受监管的实验室中使用分析仪器时，通常需要对仪器进行某种形式的性能评估，以确保其按照规定的规范运行。FT/IR-4000/6000仪器配有“验证”软件包，作为Spectra Manager II软件包的一部分。该验证软件提供了各种性能测试，可用于评估FT-IR仪器的持续性能。Spectra Manager II软件包括一个仪器验证包，可用于评估FT/IR-4000/6000紫外-可见光谱仪器的性能。用户可以根据需要选择和执行这些性能测试，以确保FT/IR-4000/6000仪器的最佳性能。Application Note 2/4FT/IR-4000/6000 Series Instrument Validation Software USGO FT/IR-4000/6000 Series Instrumen t Validation Software I n troduction When utilizing analytical instruments i n a controlled or regulated laboratory， i t is usually required to perform some manner of performance evaluation of the instrument to ensure that it is operating to stated specifications. The FT/IR-4000/6000 i ns t ruments are provided with a ‘Validation' software package as par t of the Spectra Manager II software package. This Validation sof t ware provides various performance tests that can be used to evaluate the continued performance of an F T -IR i ns t rumen t . When utilizing an FT-IR spectrometer， i t is often desi r ed to obtain a con f irmation of the i nstrument performance by conducting instrument qualification tests. The FT/IR-4000/6000 Ins t rument Validation software contained within th e Spec t ra Manager Il softwa r e provides a set o f packaged analysis functions to ver i fy that the ins t rument is performing to design spec i fications . The ‘Pass/Fail' cr i teria are established for each i nstrument in the FT/IR-4000/6000 series， based on the performance specifications for each instrument. This software uti l izes a majority o f tests that compare current performance vs. h i storical data as well as external standards，with performance speci f ications which are traceable to NIST or some oth e r recognized authority. Figure 1 outline s the various performance tests that can be selected within t he software. The majority of these t e sts compare the current instrument performance against data collected short l y after i nstallation. Other tests uti l ize the Polystyrene film that i s included with the i n strument. In addition， a NIST traceable polystyrene f i lm can be used for some of the performance te s ts. The qualification tests that do not require external standards have been checked within t he displayed software dialog. The unchecked qualification tests require other external standards such as a glass standard (P/N 6713-F429A) which can be obtained from Jasco. The Li n earity'test requires user -established linear i ty standards， such as a solution or other q u ant i tative standards.Spec i fic tests required to conform to sta n dards established by US Pharmacopeia (USP)， the European Pharmacopeia (EP)， the Japanese Pharmacopeia (JP) or Japan I ndustrial Standards (JIS) can be selected， or ，individua l tests can be selected from the l i st by the user performing the validation tests. Application Note The tests are easily performed and the only required user i nput is the col l ection of the original historical data soon after i nstrument installation (Figure 2). Al l other performance tests have specified values applied according to t he i nstrumen t type and the required i nstrument parameters are specified dependent upon the individual test procedure (Figure 3). When t he tests are initiat e d， the software performs each test， telling the user when to insert the specific standards for the performance tests. At the end of the q u al i fication tests，a detailed report can be saved in an electronic format and also pri n ted out for inclusion in the instrument notebook (Figure 4). Although it d epend s upon i nternal protocol procedures established by the laboratory，Jasco generally recommends performing t hese tests on at least a quarterly or semi-yearly basis. Conclusion The Spectra Manager II software includes an instrumen t Validation package that can be used to evaluate the performance of a FT/IR-4000/6000 UV-Vis instrument . These performance tests can be selected and performed as needed by a user to ensure opt i mum performance of the FT/IR-4000/6000 instrument . Fi g ur e 1： Availabl e p erforman ce e val u at i on tests i n t h e Vali d ation software. Unchecked i tems require external sta n dards that are n o t i ncluded wit h the standard i nstrument. Application Note Figure 2： The Polystyrene Sub t raction t est . The 'Standard data (po l ystyrene)' can be measured af t er t h e i nst r ument in stallation， or，imported f rom a collection of a standard po l ystyrene spect r um. Fi gure 3： The E n erg y Subtract i on (ES) performance dialo g usi ng a previousl y collected Energ y (Ba ck gr ound) s pectrum. I n this dialog，t h e historical dat a is also collected or imported by t he user. 司 70 Fig ure 4： I n st r ument Validation res u lts for sp ecified tests that do not r equi r e the external standards . All tests have ‘Passed and the r esults can be saved elect r on i call y a nd/or pr i nted to an attac h ed pri n ter .