Metrohm NIRS XDS RapidContent Analyzer User Manual

NIRS XDS RapidContent Analyzer Manual 8.921.8001EN / 2013-12-16

8 ▪▪▪▪▪▪▪ 2 Site Readiness Like most precision instruments, the Rapid Content Analyzer (RCA) is sensitive to environmental conditions that can affec

▪▪▪▪▪▪▪ 9 instrument detects network capability and optimizes communication speed. The computer that operates the instrument must have clear access t

10 ▪▪▪▪▪▪▪ 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 us

▪▪▪▪▪▪▪ 11 hacking or support of viruses is possible with XDS instruments. • The XDS instrument appears just like a network printer (or other periph

12 ▪▪▪▪▪▪▪ can only be entered by an authorized user, using the “two-token” method of entry. (Unique User ID and password) 3. Upon being powered up

▪▪▪▪▪▪▪ 13 3.4.1 Microsoft Windows Firewalls The Microsoft Windows® Firewall on the PC may interfere with Vision communication. To assure communicat

14 ▪▪▪▪▪▪▪ Internet Protocol (IP) and it is the first version of the protocol to be widely deployed. Together with IPv6, it is at the core of standar

▪▪▪▪▪▪▪ 15 2. Highlight “NIRSystems XDS-series Instrument Driver” as shown, then click on “Configure”. Information: At this point, Vision requests an

16 ▪▪▪▪▪▪▪ 1. Vision cannot see any instrument on the connection path. Click on the “down arrow” at the right side of the empty field to see if instr

▪▪▪▪▪▪▪ 17 • Double-click on Local Area Connection • Click on Local Area Connection Properties • Click on Internet Protocol (TCP/IP) • Click on P

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

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

20 ▪▪▪▪▪▪▪ assistance with these issues. First, verify the following: • The instrument is free-standing not connected to a network with DHCP server

▪▪▪▪▪▪▪ 21 4 Assembly of the Instrument The XDS Analyzer will be assembled and installed by a trained representative of Metrohm. This person will pe

22 ▪▪▪▪▪▪▪ 1 Load Vision Spectral Analysis Software onto the computer designated to operate the XDS instrument. 2 Place the monochromator on the lab

▪▪▪▪▪▪▪ 23 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 usi

24 ▪▪▪▪▪▪▪ 9 Lift the release handle on the monochromator and engage the module “catches” to the locking togs on the monochromator. (Module not shown

▪▪▪▪▪▪▪ 25 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 righ

26 ▪▪▪▪▪▪▪ 5 Rapid Content Module The XDS Rapid Content Analyzer is designed for sampling of many types of customer samples. This section covers use

▪▪▪▪▪▪▪ 27 2. Do not pack, unpack, or open the sample cell in the sampling chamber. This could spread sample material into the sampling chamber, whi

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 RapidContent Ana

28 ▪▪▪▪▪▪▪ A ball catch (one on each leg) is used to hold the sample cell in the correct position on the Sample Carrier. Be sure the sample cell is h

▪▪▪▪▪▪▪ 29 5.2 Use of the Sample Transport Mechanism The sample transport uses a small motor and lead screw to position the cell over the sampling w

30 ▪▪▪▪▪▪▪ self-cleaning, and requires no service of any kind. The lead screw is stainless steel, and needs no service. There are no user-serviceable

▪▪▪▪▪▪▪ 31 Installation of Iris Adapter: The Iris Adapter is used for round sample cups, beakers, vials, and other stationary samples. The Sample Car

32 ▪▪▪▪▪▪▪ The Rapid Content Analyzer may also be used for liquid analysis using the Reflectance Cell and Immersion Diffusers. These are often used f

▪▪▪▪▪▪▪ 33 The adjustment ranges from 9.5mm to 17.25mm, in adjustment steps of 0.25mm. The effective scanned sample areas at various spot sizes are

34 ▪▪▪▪▪▪▪ When using the default spot size of 17.25mm, the sample diameter should be at least 21.6mm (0.85 inch) as represented by the gray circle i

▪▪▪▪▪▪▪ 35 6 Vision Software: Connection to the Instrument This section describes communication between the computer (with Vision Software loaded) a

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

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

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

38 ▪▪▪▪▪▪▪ Next, select this DCM from the selection box. Click “OK” to connect to the instrument. Once connected, verify that the amber “Communicatio

▪▪▪▪▪▪▪ 39 7 Instrument Diagnostics Vision provides diagnostics for instrument setup, which must be performed before use of the instrument for analy

40 ▪▪▪▪▪▪▪ Instrument matching (method transferability) requires that Reference Standardization and Instrument Calibration be selected, and that Cert

▪▪▪▪▪▪▪ 41 These peak positions are not meant to be traceable, as the wavelength calibration of the instrument is done on an external standard, trace

42 ▪▪▪▪▪▪▪ enhance model transferability between instruments. A photometric standard of known reflectivity (as measured on an absolute reflectance sc

▪▪▪▪▪▪▪ 43 Vision requests the “Standard File” for the Certified Wavelength Standard. Place the mini-CD into the CD drive, and select the standard f

44 ▪▪▪▪▪▪▪ The Certified 80% Reflectance Standard is shown with the spectrum of the ceramic instrument reference. Click “OK” to plot a correction spe

▪▪▪▪▪▪▪ 45 A final spectrum (green when plotted on-screen) is plotted to verify that the corrected spectrum produces the same results as the Certifie

46 ▪▪▪▪▪▪▪ 7.1.3 Instrument Calibration Instrument Calibration uses an NIST-traceable, stable, standard, of known wavelength response, as a method t

▪▪▪▪▪▪▪ 47 Vision requests the “Standard File” for the Certified Wavelength Standard. Place the mini-CD into the CD drive, and select the standard f

▪▪▪▪▪▪▪ 3 Inhalt 1 Introduction to XDS™ Rapid Content Analyzer ... 5 2 Site Readiness ..

48 ▪▪▪▪▪▪▪ Information about the wavelength standard: The wavelength standard used is directly traceable to NIST SRM-1920a, through direct comparison

▪▪▪▪▪▪▪ 49 NOTE: The response of the WSR Wavelength Standard may vary slightly with temperature. This is typically in the range a few hundredths of a

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

▪▪▪▪▪▪▪ 51 Select the requested standard from the set. Labels on the back identify each standard. Note the mini-CD that contains the “Standards File”

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

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

54 ▪▪▪▪▪▪▪ When the reference scan is finished, insert the wavelength standard as directed. Always place the standard into the instrument in the sa

▪▪▪▪▪▪▪ 55 The first tab shows the Wavelength positions, as found. They are compared to the NIST nominal peak positions, or the empirically-determin

56 ▪▪▪▪▪▪▪ wavelength standard. These are the same peaks used during Instrument Calibration. Wavelength Certification is a verification that the peak

▪▪▪▪▪▪▪ 57 In some cases the user may see the message shown. This indicates that the instrument has passed Wavelength Certification on the NIST-defin

4 ▪▪▪▪▪▪▪ 7.2.5 Low Flux Test ... 61 8 Instrume

58 ▪▪▪▪▪▪▪ Vision requests a “Standard File”. For Photometric Test, use the RSSVxxxx.da file stored in the Vision directory. This file was created du

▪▪▪▪▪▪▪ 59 If operating in Reference Standardized mode, Vision requests the 99% standard from the set. If not operating in Reference Standardized mod

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

▪▪▪▪▪▪▪ 61 The view above shows a fairly typical Rapid Content Analyzer. The gain program sets the internal reference paddle over the sample opening

62 ▪▪▪▪▪▪▪ From the Diagnostics menu bar, select Low Flux Test. Vision asks if the user wishes to use an external sample (standard) for the test. Cl

▪▪▪▪▪▪▪ 63 Click on the tab marked “Summary” to see the summarized results as compared to acceptance specifications. Vision reports a pass or fail b

64 ▪▪▪▪▪▪▪ 8 Instrument Maintenance Instrument maintenance is quite simple on the XDS Rapid Content Analyzer. The optical enclosure is sealed to pre

▪▪▪▪▪▪▪ 65 8.2 Fan Filter Replacement The fan filter should be inspected at least monthly. (If installed in a dusty or dirty environment, it should

66 ▪▪▪▪▪▪▪ Using the new filter material, gently insert it into the filter cover. It should fit easily in any direction, as it is symmetrical. Be su

▪▪▪▪▪▪▪ 67 Turn off power at the power switch located on the back panel. Unplug the power cord. While this is not essential, it makes access easier.

▪▪▪▪▪▪▪ 5 1 Introduction to XDS™ Rapid Content Analyzer Thank you for selecting the XDS Rapid Content Analyzer, manufactured by FOSS. This instrumen

68 ▪▪▪▪▪▪▪ 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

▪▪▪▪▪▪▪ 69 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

70 ▪▪▪▪▪▪▪ 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

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

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

▪▪▪▪▪▪▪ 73 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

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

▪▪▪▪▪▪▪ 75 This screen shows entries, sorted by record number. To re-sort by another parameter, click on the column heading. 8.6 Window Cleaning Th

76 ▪▪▪▪▪▪▪ After cleaning, allow any residual alcohol to evaporate off. Then use the sample brush from the accessory kit to gently brush away any lin

▪▪▪▪▪▪▪ 77 9 Validation Tools Validation is an overriding concern in the pharmaceutical marketplace. In the United States, manufacturers must follow

6 ▪▪▪▪▪▪▪ The Rapid Content Analyzer also offers variable spot size, to focus energy on small samples. This feature is standard on the Solids Module.

78 ▪▪▪▪▪▪▪ 9.1 Hardware Validation Tools Factory Instrument Test Guide and Results Every Metrohm instrument is factory-tested, using the same batte

▪▪▪▪▪▪▪ 79 • Meets CFR 21 requirements for instrument qualification. Independent assessment, not performed by instrument user Meets independent tes

80 ▪▪▪▪▪▪▪ At over 2000 pages, this CD will satisfy your Internal Audit Staff and external regulators that Vision Software was designed from the firs

▪▪▪▪▪▪▪ 81 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

82 ▪▪▪▪▪▪▪ 10 Safety and Electrical Certification The XDS Rapid Content Analyzer and all associated components have been tested for CE (Communite Eu

▪▪▪▪▪▪▪ 83 11 Troubleshooting The XDS Rapid Content Analyzer is a dependable, trouble-free instrument, designed for many years of service in your la

84 ▪▪▪▪▪▪▪ 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 netwo

▪▪▪▪▪▪▪ 85 5 Instrument Fails Performance Test. 1. Verify that reference paddle is visible in Rapid Content Analyzer sample window when a reference s

86 ▪▪▪▪▪▪▪ 8 Instrument cooling fans are operating at maximum rate. 1. Verify that air intake on side is not blocked by other equipment. Leave at lea

▪▪▪▪▪▪▪ 87 13 Vision reports that there is no Reference Standardization or Instrument Calibration; suggests that these tests be run. 1. Usually cause

▪▪▪▪▪▪▪ 7 connection also permits remote interrogation and diagnostics checks of the instrument, if necessary and authorized. The instrument enclosur

88 ▪▪▪▪▪▪▪ 12 Lifting and transporting the Metrohm instrument: 1 Always separate the module from the monochromator (shown) before lifting or transpo

▪▪▪▪▪▪▪ 89 13 Index AC power switch ........... 83 Accessory Kit ........... 21, 27 air