SCIEX PA 800 Plus System Overview Manual
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SCIEX PA 800 Plus System Overview Manual

Pharmaceutical analysis system
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PA 800 Plus Pharmaceutical Analysis
System
System Overview Guide
RUO-IDV-05-5521-A
January 2018

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Summary of Contents for SCIEX PA 800 Plus

  • Page 1 PA 800 Plus Pharmaceutical Analysis System System Overview Guide RUO-IDV-05-5521-A January 2018...
  • Page 2 This document is provided to customers who have purchased SCIEX equipment to use in the operation of such SCIEX equipment. This document is copyright protected and any reproduction of this document or any part of this document is strictly prohibited, except as SCIEX may authorize in writing.

  • Page 3: Table Of Contents

    Fluid Delivery, Power Supply, and Interlocks, 18 Syringe Pump, 18 High Voltage Power Supply, 18 Indicators, 18 Cartridge and Sample Cover Interlocks, 18 UV Detector Optics, 19 System Overview Guide PA 800 Plus Pharmaceutical Analysis System RUO-IDV-05-5521-A | A51963AE 3 / 56...
  • Page 4 Suitability Reports, 49 Viewing and Printing Reports, 49 Maintenance, 49 APPENDIX A: Specifications, 51 PA 800 System, 51 Computer Requirements, 52 Detector, 52 Detector, 53 PA 800 Plus Pharmaceutical Analysis System System Overview Guide 4 / 56 RUO-IDV-05-5521-A | A51963AE...
  • Page 5 Contents Detector, 53 Sample Cooling, 54 Revision History, 55 System Overview Guide PA 800 Plus Pharmaceutical Analysis System RUO-IDV-05-5521-A | A51963AE 5 / 56...
  • Page 6 Contents PA 800 Plus Pharmaceutical Analysis System System Overview Guide 6 / 56 RUO-IDV-05-5521-A | A51963AE...

  • Page 7: Safety, Notices And Labels

    Safety, Notices and Labels Overview A description of the symbols and labels that are used on the SCIEX PA 800 Plus Pharmaceutical Analysis System, or that are shown in this guide, can be found in this section. Do not attempt to perform any procedure before carefully reading all instructions. If in doubt as to how to proceed in any situation, contact your SCIEX Representative.

  • Page 8: Alerts For Warning, Caution, Important, And

    To avoid injury due to moving parts, observe the following: • Keep loose clothing and hair away from the plate area. • Never attempt to physically restrict movement of the plate assembly. PA 800 Plus Pharmaceutical Analysis System System Overview Guide 8 / 56...

  • Page 9: Chemical Precautions

    Safety, Notices and Labels Chemical Precautions • A description of the symbols and labels that are used on the SCIEX PA 800 Plus Pharmaceutical Analysis, or that are shown in this guide, can be found in this section. • Work in a well-ventilated area.

  • Page 10: General Biohazard Symbol

    Environmentally Friendly Use Period (EFUP) date, and indicates the number of calendar years the product can be in operation. Upon the expiration of the EFUP, the product must be immediately PA 800 Plus Pharmaceutical Analysis System System Overview Guide...

  • Page 11: China Rohs Environmental

    The date code on the label or product indicates the date of manufacture. Other Instrument Labels This section provides information for some labels and symbols appearing on the PA 800 Plus housing. These labels and symbols may be associated with user-serviceable procedures. Individual hazards associated with a specific procedure in this guide may use these labels and symbols, and are included in Warnings or Cautions within the procedures for that task.

  • Page 12: Disposal Of Devices Containing Mercury

    Safety, Notices and Labels For products under the requirement of WEEE directive, please contact your dealer or local SCIEX office for the proper decontamination information and details on the take back program that facilitates proper collection, treatment, recovery, recycling, and safe disposal of this device.

  • Page 13: System Overview

    System Overview Instrument The main components of the PA 800 Plus Pharmaceutical Analysis System include trays that hold vials of sample, buffer, and other solutions, an interface block, a high-voltage power supply and electrodes, a source optics module and detector, temperature control hardware, and a sample injection mechanism.
  • Page 14 System Overview Figure 2.2 PA 800 Plus System Side View 1. Outer Door or Sample Cover (open) 5. Sample Trays 2. Inner Door or Cartridge Cover (open) 6. Buffer Trays 3. Indicators 7. Fluid Bubble Indicator 4. Fluid Fill Port 8.

  • Page 15: Sample Handling System

    Refer to Figure 2.3. Figure 2.3 PA 800 Plus Trays 1. Inlet Sample Tray (48) or 96-Well Plate 3. Outlet Sample Tray (48) or 96-Well Plate 2.
  • Page 16 The universal vials are pressurized during rinse and separation-with-pressure events. To reduce the risk of breakage and expelled particles, use only SCIEX vials (PN A62251), and inspect every vial for damage before use. Do not use any vial that appears cracked or damaged in any way.

  • Page 17: Capillary Cartridge

    LIF detectors. The procedures to install a capillary in a cartridge are included in the Maintenance section of this guide. System Overview Guide PA 800 Plus Pharmaceutical Analysis System RUO-IDV-05-5521-A | A51963AE 17 / 56...

  • Page 18: Fluid Delivery, Power Supply, And Syringe Pump

    Cartridge and Sample Cover Interlocks The hinged doors of the PA 800 Plus system have interlock sensors that prevent unsafe access to the inside of the instrument. The first door is called the outer door or sample cover; the second is called the inner door or cartridge cover.

  • Page 19: Uv Detector Optics

    8 must be left open (no filter). The filter wheel will accommodate ½ inch (12.7 mm) diameter filters with wavelengths from 190 nm to 600 nm. System Overview Guide PA 800 Plus Pharmaceutical Analysis System RUO-IDV-05-5521-A | A51963AE 19 / 56...

  • Page 20: The Photodiode Array (Pda) Detector

    32 Karat workstation for processing by the software. The PDA detector always uses filter wheel position #8. When the PDA is in use, it is essential that no filter is in position #8. PA 800 Plus Pharmaceutical Analysis System System Overview Guide 20 / 56...

  • Page 21: The Laser Induced Fluorescence (Lif) Detector

    10. Fiber Optic Connector The Laser Induced Fluorescence (LIF) Detector The LIF Detector consists of the LIF Detector Module and a Laser Module. A PA 800 Plus capillary cartridge with an LIF Detector plug installed is required for use with this system.

  • Page 22: Laser Module

    System Overview as a peak on the electropherogram. For more information on the LIF system, refer to the PA 800 Plus Pharmaceutical Analysis System Maintenance Guide. The initial installation of the LIF Detector is performed by a SCIEX Field Service Engineer (FSE). The PA 800 Plus system can easily be changed between LIF and UV/PDA modes because the detector components are modular.

  • Page 23: Supported Applications

    (pI 4-10) screening and pI identification of proteins and peptides. Carbohydrate Analysis The Carbohydrate Labeling and Analysis assay separates and quantifies oligosaccharides released from glycoproteins. System Overview Guide PA 800 Plus Pharmaceutical Analysis System RUO-IDV-05-5521-A | A51963AE 23 / 56...
  • Page 24 This assay also provides a glucose size marker for relative size determination and a maltose standard for quantitation and mobility characterization of the released oligosaccharides. PA 800 Plus Pharmaceutical Analysis System System Overview Guide 24 / 56 RUO-IDV-05-5521-A | A51963AE...

  • Page 25: Chapter 3: System Procedures And Training Guide

    Controller and Instrument Start Up Controller/Network Logon The PA 800 Plus software, which includes The 32 Karat software, runs on a Windows 7 controller. If the instrument is installed on a network, the user name and password will be supplied by the network administrator.

  • Page 26: Pa 800 Plus Software

    System Procedures and Training Guide PA 800 Plus Software Launch the PA 800 Plus software by double-clicking the PA 800 Plus icon on the Windows desktop. The PA 800 Plus window displays. The upper right buttons activate the major functions. Hover the mouse over the buttons to obtain a balloon tip on its function.

  • Page 27: Instrument Start Up

    PA 800 Plus software. System Administration System administration is a feature used to control access to the software. PA 800 Plus and 32 Karat software access can be restricted by user, instrument, or project. At installation, system administration is enabled.
  • Page 28 Wizard Tools A project is a set of folders for file types commonly used in the 32 Karat and PA 800 Plus software. For example, if you are doing carbohydrate analysis with LIF detection and protein analysis with diode array detection, it would be convenient to store your method and report files in folders with the appropriate names.

  • Page 29: Configuration

    This is convenient when multiple users run different applications on the same system. System administration enables a much greater degree of security on your system. Configuration All of the instrument configurations required to run the supported PA 800 Plus applications are pre- defined. System Overview Guide...

  • Page 30: Online Versus Offline

    In the previous section, the user opened the Performance instrument online. The current project should be Performance. If the instrument is PA 800 Plus Pharmaceutical Analysis System System Overview Guide 30 / 56...
  • Page 31 Performance Tests project from the File menu on the instrument window. Refer to Figure 3.7. Figure 3.7 File Menu Select Project Select . Refer to Figure 3.8. Direct Control System Overview Guide PA 800 Plus Pharmaceutical Analysis System RUO-IDV-05-5521-A | A51963AE 31 / 56...
  • Page 32 Inspect the interface block Load by using an angled mirror and penlight. Clean the interface block as required using the procedure in the PA 800 Plus System Maintenance Guide. PA 800 Plus Pharmaceutical Analysis System System Overview Guide...

  • Page 33: How To Run A Method

    • Install the correct vials and trays as described in the application guide. Once these steps are completed, a method can be run. To Start a Method Select Single Run Figure 3.10 Single Run Icon System Overview Guide PA 800 Plus Pharmaceutical Analysis System RUO-IDV-05-5521-A | A51963AE 33 / 56...
  • Page 34 Method data file field. The data file path will default to the data folder in the currently selected project. Optionally, add additional information for sample description. PA 800 Plus Pharmaceutical Analysis System System Overview Guide 34 / 56 RUO-IDV-05-5521-A | A51963AE...
  • Page 35 Refer to Figure 3.13. Notice the button instead Submit Start Figure 3.13 Single Run Acquisition - Running a Method System Overview Guide PA 800 Plus Pharmaceutical Analysis System RUO-IDV-05-5521-A | A51963AE 35 / 56...

  • Page 36: Analysis

    At the bottom of the menu, the available data channel views display. Select the Window PDA - view. An electropherogram with two main peaks displays. 214nm PA 800 Plus Pharmaceutical Analysis System System Overview Guide 36 / 56 RUO-IDV-05-5521-A | A51963AE...
  • Page 37 Integration is used to automate this process. Select the icon to display the Integration Events table. Refer to Figure 3.16 Integration Events Figure 3.17. System Overview Guide PA 800 Plus Pharmaceutical Analysis System RUO-IDV-05-5521-A | A51963AE 37 / 56...
  • Page 38 Step 4. By arranging the Integration Events and 214nm window, users can observe how changes to the Integration Events table affect how peaks are detected in the electropherogram. Refer to Figure 3.18. PA 800 Plus Pharmaceutical Analysis System System Overview Guide 38 / 56 RUO-IDV-05-5521-A | A51963AE...
  • Page 39 • Minimum Cluster Distance software identifies the group of cluster points as a peak. Optimization of the integration parameters is described in the PA 800 Plus Pharmaceutical Analysis System Methods Development Guide. System Overview Guide PA 800 Plus Pharmaceutical Analysis System...

  • Page 40: Area Calculation

    Figure 3.19 Injection Volume vs. Migration Time and Peak Area 901499L.AI PA 800 Plus Pharmaceutical Analysis System System Overview Guide 40 / 56 RUO-IDV-05-5521-A | A51963AE...

  • Page 41: Annotations

    . The Trace Annotations Properties dialog will display. At the bottom of the Trace Annotations Annotations Properties dialog there are options for general graph properties. System Overview Guide PA 800 Plus Pharmaceutical Analysis System RUO-IDV-05-5521-A | A51963AE 41 / 56...

  • Page 42: Peak Identity

    Peak table. For details on adding peaks to the peak ID table, refer to the PA 800 Plus Methods Development Guide. Run Multiple Methods with a Sequence Once the method and analysis are optimized, the method can be run repeatedly on different samples or multiple times on a single sample to calculate the performance.
  • Page 43 Wizard. The Sequence Wizard runs the same method the specified number of times. There are many additional selections for run customization using the Sequence Wizard. For details on using the Sequence Wizard, refer to the PA 800 Plus Methods Development Guide. Process the Sequence...
  • Page 44 3.23. Select the text next to the check box. In the right side of the window a report template can be specified. Select a report template file and select PA 800 Plus Pharmaceutical Analysis System System Overview Guide 44 / 56...
  • Page 45 To prevent over-writing data, the file can be appended with one or more fields. The available fields are shown by selecting the arrow to the right of the filename field. Refer Figure 3.25. Select Next System Overview Guide PA 800 Plus Pharmaceutical Analysis System RUO-IDV-05-5521-A | A51963AE 45 / 56...
  • Page 46 In the Vials window, the positions of the sample vials are specified. Vials can be incremented by row or by column. Refer to Figure 3.26. Select Next Figure 3.26 Sequence Wizard - Vials PA 800 Plus Pharmaceutical Analysis System System Overview Guide 46 / 56 RUO-IDV-05-5521-A | A51963AE...

  • Page 47: Viewing Reports

    Advanced Reports Detailed information on advanced reports available from the PA 800 Data System Help that is delivered with the PA 800 Plus system. How To Write an Advanced Report Select File >...
  • Page 48 Save the report as a template using the file name This file is a report shell that is ready to summarize and report a sequence when it is run. PA 800 Plus Pharmaceutical Analysis System System Overview Guide 48 / 56...

  • Page 49: Suitability Reports

    Run window, method or sequence reports are automatically printed. Maintenance Refer to the PA 800 Plus System Maintenance Guide for the following procedures. Start with the type of detector to be installed, then proceed to the remaining items.
  • Page 50 System Procedures and Training Guide PA 800 Plus Pharmaceutical Analysis System System Overview Guide 50 / 56 RUO-IDV-05-5521-A | A51963AE...

  • Page 51: Appendix A: Specifications

    SCIEX certified controller Installation Category Category II Pollution Degree Sound Pressure Level Maximum sound pressure: 70 dB Maximum sound pressure at 1 meter away: 66 dB System Overview Guide PA 800 Plus Pharmaceutical Analysis System RUO-IDV-05-5521-A | A51963AE 51 / 56...

  • Page 52: Computer Requirements

    Specifications Computer Requirements These are the specifications that must be met if the customer is providing the Personal Computer. SCIEX provided computers will meet or exceed these specifications. Table A.2 System Specifications for Owner-Provided Personal Computer Specification Type Description IBM M51 Computer with 3.2 GHz processor...

  • Page 53: Pda Detector

    Depth: 7.0 inch (17.7 cm) Weight: 5 lbs (2.3 kg) Wavelength Ranges (for Excitation: 300 nm to 700 nm optics) Emission: 350 nm to 750 nm System Overview Guide PA 800 Plus Pharmaceutical Analysis System RUO-IDV-05-5521-A | A51963AE 53 / 56...
  • Page 54 ±1 °C Accuracy Temperature of environment: ±2 °C within the range of ±15 °C from ambient; ±3 °C outside the range of ±15 °C for ambient. PA 800 Plus Pharmaceutical Analysis System System Overview Guide 54 / 56 RUO-IDV-05-5521-A | A51963AE...

  • Page 55: Revision

    This guide applies to the latest software and firmware listed above, and any higher subsequent versions. When a subsequent software or firmware version affects the information in this guide, a www.sciex.com new issue will be released to the SCIEX website. For updates, go to and download the latest version of the guide.
  • Page 56 Revision History PA 800 Plus Pharmaceutical Analysis System System Overview Guide 56 / 56 RUO-IDV-05-5521-A | A51963AE...

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