Metrohm NIRS XDS RapidLiquid Analyzer Bedienungsanleitung

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Inhaltsverzeichnis

Seite 1 - XDS RapidLiquid Analyzer

NIRS XDS RapidLiquid Analyzer Manual 8.921.8005EN / 2013-12-16

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8 ▪▪▪▪▪▪▪ Alternatively, the XDS Rapid Liquid Analyzer can communicate directly with the computer by use of a UTP Crossover Cable, such as CDW #24378

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▪▪▪▪▪▪▪ 9 3 XDS Instrument Connection The XDS instrument may be connected to the host computer in one of two ways: If the XDS Instrument will be use

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10 ▪▪▪▪▪▪▪ • The XDS instrument appears just like a network printer (or other peripheral device) on the LAN system. It generates no signals, and onl

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▪▪▪▪▪▪▪ 11 3. Upon being powered up on a LAN, the XDS instrument requests a “dynamic” IP address from the DHCP server which controls the LAN. This I

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12 ▪▪▪▪▪▪▪ 3.4.1 Network Evolution Issues This document is as correct as possible at the time or writing. However, network management is an evolving

Seite 7 - 1 Introduction

▪▪▪▪▪▪▪ 13 takes the form “255.255.255.0” or something similar. This scheme is becoming obsolete, as new network management methods are being impleme

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14 ▪▪▪▪▪▪▪ 3. When Vision “finds” the instrument on the LAN, it will be shown. The dynamic IP address (assigned by the server) is shown, along with

Seite 9 - 2 Site Readiness

▪▪▪▪▪▪▪ 15 2. Vision still sees no instrument(s) after expanding the field. This indicates connection or network issues. Verify Cable Type: Verify

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16 ▪▪▪▪▪▪▪ Verify these settings: • Obtain an IP address automatically • Obtain DNS server address automatically When finished, click “OK”. Close

Seite 11 - 3 XDS Instrument Connection

▪▪▪▪▪▪▪ 17 Network Solution 2: Returning to the Local Area Connection Status dialog box, note these items for the computer: • Address Type: (should

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18 ▪▪▪▪▪▪▪ Network Solution 4: Verify that the Firewall on the computer has Vision loaded as an “exception”. This is located under “Control Panel”,

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▪▪▪▪▪▪▪ 19 3.6.2 Direct Connection Troubleshooting Overview If no XDS instrument shows as “available”, the computer may need to be configured for th

Seite 15 - 3.5 Connection in Vision

20 ▪▪▪▪▪▪▪ 4 Assembly of the Instrument The XDS Rapid Liquid Analyzer will be assembled and installed by a trained representative of Metrohm. This p

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▪▪▪▪▪▪▪ 21 1. Load Vision Spectral Analysis Software onto the computer designated to operate the XDS instrument. 2. Place the monochromator on the

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22 ▪▪▪▪▪▪▪ 5. Insert the AC power cable into the AC power block as shown. 6. Attach the RJ-45 cable to the network connector on the instrument. If

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▪▪▪▪▪▪▪ 23 9. Lift the release handle on the monochromator and engage the module “catches” to the locking togs on the monochromator. (Module not sho

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24 ▪▪▪▪▪▪▪ 13. When all the above assembly is finished, turn on the power switch on the monochromator. It is located on the lower surface, on the ri

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▪▪▪▪▪▪▪ 25 5 Rapid Liquid Module The XDS™ Rapid Liquid Analyzer is designed for sampling of many types of customer samples. This section describes i

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26 ▪▪▪▪▪▪▪ 5.3 Cuvette Types The Rapid Liquid Analyzer is preferred for samples of these types: • Non-volatile samples, run in open or capped cuvet

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▪▪▪▪▪▪▪ 27 To access the outer fittings, gently lift the black cover and peel it back. The ports are exposed as shown. Save the cover as a light-bloc

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Metrohm AG CH-9100 Herisau Switzerland Phone +41 71 353 85 85 Fax +41 71 353 89 01 [email protected] www.metrohm.com NIRS XDS RapidLiquid Anal

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28 ▪▪▪▪▪▪▪ • If scanning at an elevated temperature using the controller, be sure samples are not already above that temperature from prior processi

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▪▪▪▪▪▪▪ 29 The spectra show pure water and 99.5% pure 2-propanol, taken in 1mm pathlength cuvettes. Water absorbs strongly between 1350-1600nm and 1

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30 ▪▪▪▪▪▪▪ 6 Vision Software: Connection to the Instrument This section describes communication between the computer (with Vision Software loaded) a

Seite 27 - 5 Rapid Liquid Module

▪▪▪▪▪▪▪ 31 Vision asks if the default directory location is acceptable. Click on “Yes”. Vision creates a directory for the project as shown. Vision

Seite 28 - 5.4 Flow-Through Fittings

32 ▪▪▪▪▪▪▪ described in section 7.1.3 of this manual. If so, this option must be set in Project Options. To do so, cancel out of Data Acquisition, an

Seite 29 - 5.6 Cuvette Spacers

▪▪▪▪▪▪▪ 33 A Data Collection Method (DCM) must be established to communicate with the instrument. There are no Data Collection Methods available upon

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34 ▪▪▪▪▪▪▪ are accomplished on only 16 grating cycles, and are very rapid. Click “OK” when finished. The user may check test parameters, Click the “T

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▪▪▪▪▪▪▪ 35 7 Instrument Diagnostics Vision provides diagnostics for instrument setup, which must be performed before use of the instrument for analy

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36 ▪▪▪▪▪▪▪ Use Instrument Calibration (XDS only) This is a method to adjust the instrument wavelength profile to an external, traceable wavelength st

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▪▪▪▪▪▪▪ 37 Wavelength Linearization uses an internal wavelength standard set to determine a set of internal, arbitrary peak positions that the instru

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Teachware Metrohm AG CH-9100 Herisau [email protected] This documentation is protected by copyright. All rights reserved. Although all

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38 ▪▪▪▪▪▪▪ The results screen shown above is typical. Peak positions for the reference materials are located using a peak-finding algorithm. These “

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▪▪▪▪▪▪▪ 39 The menu selection for Blank Correction is available when the option is selection in This Project’s Options, and the Data Collection Metho

Seite 37 - 7 Instrument Diagnostics

40 ▪▪▪▪▪▪▪ The black spectrum is SRM-2035. The gray spectrum is XC-1300, which is used to calibrate the wavelength scale of the XDS Rapid Liquid Ana

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▪▪▪▪▪▪▪ 41 To assure transferability of models between similar instrument models, one more step is taken as part of Instrument Calibration. The wavel

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42 ▪▪▪▪▪▪▪ Vision takes an instrument reference, which takes about 20 seconds. This dialog box is displayed. Next a sample scan is taken, and this

Seite 40 - 7.1.3 Blank Correction

▪▪▪▪▪▪▪ 43 Following Wavelength Linearization, the user is asked to select a standard file. This is provided on the mini-CD found in the standards bo

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44 ▪▪▪▪▪▪▪ These will be measured later in Wavelength Certification, as a test of how well the instrument is maintaining the settings established in

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▪▪▪▪▪▪▪ 45 Vision requests a “Standard File”. This is provided on a mini-CD, packed in the wooden box with the standards. Insert this diskette into t

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46 ▪▪▪▪▪▪▪ 7.2 Evaluation Diagnostics Evaluation Diagnostics are used to verify that the instrument is operating within allowable parameters. These

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▪▪▪▪▪▪▪ 47 When instructed, insert the WST3xxxx standard into the sample drawer. The label should face the user when inserting the standard. Place

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▪▪▪▪▪▪▪ 3 Table of contents 1 Introduction ...

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48 ▪▪▪▪▪▪▪ page titled “Instrument Calibration Verification”. These peaks are used to set the “Instrument Wavelength Profile,” and one peak is used f

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▪▪▪▪▪▪▪ 49 for future recall. See the Vision manual for a full explanation. If the instrument passes the NIST-type peaks (page 1 of the report), but

Seite 48 - 7.2 Evaluation Diagnostics

50 ▪▪▪▪▪▪▪ At the end of Performance Test, all measured values are compared with acceptance criteria stored in Vision. If all results meet acceptanc

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▪▪▪▪▪▪▪ 51 Noise Summary displayed using the OpQual tab. The OpQual tab brings up the display shown. This shows results of the Noise Test for each o

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52 ▪▪▪▪▪▪▪ Photometric Test provides a method to verify ongoing photometric performance of the instrument. This is a requirement for pharmaceutical u

Seite 51 - 7.2.2 Performance Test

▪▪▪▪▪▪▪ 53 Vision requests a tolerance file. The tolerance file was loaded in the C:\Vision directory, and is an “XDA” formatted file. Select this fi

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54 ▪▪▪▪▪▪▪ Select the requested standard from the set. Labels on the top of each standard identify the number of the standard. Approximate transmissi

Seite 53 - 7.2.3 Photometric Test

▪▪▪▪▪▪▪ 55 After each standard is run, Vision plots the comparison for each wavelength area as shown. Tolerances are automatically applied, and a “Pa

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56 ▪▪▪▪▪▪▪ NIR and Visible regions. Gain Factor is a measure of signal amplification. In the NIR region (1100-2500nm) it occurs in steps of 1, 2, 4,

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▪▪▪▪▪▪▪ 57 XC-1310 Transmission Standard Set contains a 10% transmission standard (T033xxxx) which may be used for this test, if desired. The T03 tra

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4 ▪▪▪▪▪▪▪ 7.2.2 Performance Test ... 49 7.2.3 Photome

Seite 57 - 7.2.4 Gain Test

58 ▪▪▪▪▪▪▪ specifications. Vision reports a pass or fail based upon successful test completion. Results are stored in the Diagnostic Database for lat

Seite 58 - 7.2.5 Low Flux Test

▪▪▪▪▪▪▪ 59 samples up to the set point temperature. This is located in the Data Collection Method (DCM) as shown in the next illustration. The Equili

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60 ▪▪▪▪▪▪▪ 8 Instrument Maintenance Instrument maintenance is quite simple on the XDS Rapid Liquid Analyzer. The optical enclosure is sealed to prev

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▪▪▪▪▪▪▪ 61 Turn off power at the power switch located on the back panel. The power cord may be removed for easier access to the filter, if desired. T

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62 ▪▪▪▪▪▪▪ Be sure the filter material is positioned correctly, and is not wrinkled or folded. There should be no gaps at the edges. Starting at the

Seite 62 - 8 Instrument Maintenance

▪▪▪▪▪▪▪ 63 Unplug the power cord. While this is not essential, it makes access easier. Remove the communications cable too. Loosen the six (6) capti

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64 ▪▪▪▪▪▪▪ This orientation photo shows the area inside the back cover. The lamp box is at the lower left. The fan and heat sinks, shown to the right

Seite 64 - 8.3 Lamp Replacement

▪▪▪▪▪▪▪ 65 Gently grasp the corners of the lamp mounting plate. Push in about 1mm, then rotate clock-wise (to the right) about 5 mm. The lamp mountin

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66 ▪▪▪▪▪▪▪ Position the lamp with the black arrow up as shown. Gently insert the lamp and mounting plate into the lamp housing as shown. Engage the h

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▪▪▪▪▪▪▪ 67 Carefully re-install the back cover, lining up the captive screws with the mating threaded holes. Tighten gently by hand. Do not over-tig

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▪▪▪▪▪▪▪ 5 1 Introduction Thank you for selecting the XDS™ Rapid Liquid Analyzer, manufactured by FOSS. This instrument is the third generation in a

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68 ▪▪▪▪▪▪▪ Perform tests as specified in the prior sections of this manual. These normally include the following: • Wavelength Linearization • Perf

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▪▪▪▪▪▪▪ 69 Remove the power cord for access to the fuse. Use a tool (such as an Allen wrench) to pull the housing open. There is a small slot, unde

Seite 70 - 8.4 Fuse Replacement

70 ▪▪▪▪▪▪▪ When finished, re-install the power cord. Turn on AC power and re-establish instrument communication. 8.5 Maintenance Log Vision provide

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▪▪▪▪▪▪▪ 71 This screen shows entries, sorted by record number. To re-sort by another parameter, click on the column heading.

Seite 72 - 8.5 Maintenance Log

72 ▪▪▪▪▪▪▪ 9 Validation Tools Validation is an overriding concern in the pharmaceutical marketplace. In the United States, manufacturers must follow

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▪▪▪▪▪▪▪ 73 customer testing. Included with your instrument are results from Instrument Noise, Bandwidth, Wavelength Accuracy, Photometric Certificati

Seite 74 - 9 Validation Tools

74 ▪▪▪▪▪▪▪ • Independent assessment, not performed by instrument user Meets independent test requirements of CFR 21 and most auditing methods. • Fu

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▪▪▪▪▪▪▪ 75 At several thousand pages, this CD will satisfy your Internal Audit Staff and external regulators that Vision Software was designed from t

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76 ▪▪▪▪▪▪▪ This screen shows many of the setup items to be set by the System Manager for 21 CFR Part 11 Compliance. To access this screen, click on C

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▪▪▪▪▪▪▪ 77 10 Safety and Electrical Certification The XDS Rapid Liquid Analyzer and all associated components have been tested for CE (Communite Eur

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6 ▪▪▪▪▪▪▪ Green when stable operating temperature is reached Green when module is properly attached Vision Software™ offers an easy user interface,

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78 ▪▪▪▪▪▪▪ 11 Troubleshooting The XDS Rapid Liquid Analyzer is a dependable, trouble-free instrument, designed for many years of service in your lab

Seite 80 - 11 Troubleshooting

▪▪▪▪▪▪▪ 79 2 No communication between Vision and the instrument. 1. Verify that the RJ-45 cable is plugged in at both the instrument and at the netw

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80 ▪▪▪▪▪▪▪ 5 Instrument Fails Performance Test. 1. Verify that the sample drawer is not jammed or impeded in any way. It should be free to open and

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▪▪▪▪▪▪▪ 81 8 Instrument cooling fans are operating at maximum rate. 1. Verify that air intake on side is not blocked by other equipment. Leave at le

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82 ▪▪▪▪▪▪▪ 12 Lifting and transporting the Metrohm instrument 1 Always separate the module from the monochromator (shown) before lifting or transpor

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▪▪▪▪▪▪▪ 83 13 Index Accessory Kit .... 20 Assembly..... 2

Seite 85 - 13 Index

▪▪▪▪▪▪▪ 7 2 Site Readiness Like most precision instruments, the Rapid Liquid Analyzer is sensitive to environmental conditions that can affect its p

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