UV Validator. Smart Linear Cell Changer IQ/OQ Plan

Transcription

1 UV Validator Smart Linear Cell Changer IQ/OQ Plan

2 The information in this publication is provided for reference only. All information contained in this publication is believed to be correct and complete. Thermo Fisher Scientific shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing, performance or use of this material. All product specifications, as well as the information contained in this publication, are subject to change without notice. This publication may contain or reference information and products protected by copyrights or patents and does not convey any license under our patent rights, nor the rights of others. We do not assume any liability arising out of any infringements of patents or other rights of third parties. We make no warranty of any kind with regard to this material, including but not limited to the implied warranties of merchantability and fitness for a particular purpose. Customers are ultimately responsible for validation of their systems Thermo Fisher Scientific Inc. All rights reserved. No part of this publication may be stored in a retrieval system, transmitted, or reproduced in any way, including but not limited to photocopy, photograph, magnetic or other record, without our prior written permission. For Technical Support, please contact: Thermo Fisher Scientific 5225 Verona Road Madison, WI U.S.A. Telephone: us.techsupport.analyze@thermofisher.com World Wide Web: For International Support, please contact: Thermo Fisher Scientific Telephone: support.madison@thermofisher.com World Wide Web: All trademarks are the property of Thermo Fisher Scientific Inc. and its subsidiaries , Rev A

3 Contents Introduction...1 Test Plan Overview...2 Testing Requirements...3 Test Procedures...5 LCC1 Unit installation...5 LCC2 Local Control...5 LCC3 VISION...5 LCC4 Operational performance test (8-cell)...5 LCC5 Operational performance test (16-cell)...6 LCC6 Variation check...7 Appendix A: Test Result Sheet...9

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5 Introduction The processes detailed below form an essential part of any System Validation. These documents and structure are based on the requirements of the UK Pharmaceutical Industry Computer Systems Validation Forum (PICSVF). These guidelines were published in their document "Pharmaceutical Industry Supplier Guidance - Validation of Automated Systems in Pharmaceutical Manufacture", and have now been formally adopted as the GAMP Guidelines. This document describes the tests required for the specific Installation Qualification (IQ) and Operational Qualification (OQ) of the accessory. Smart Linear Cell Changer IQ/OQ Plan 1

6 Test Plan Overview Each procedure should be performed and the accompanying sheet(s) (see Appendix) must be completed and inserted into the UV Validator log book replacing any previous unused versions. The sheet(s) include spaces for signatures of the tester and a witness, where appropriate, for regulatory compliance. When you have completed and signed the sheet(s), you will have a complete record of your testing activity. Completion of these sheets requires the following: 1. Results must be recorded on the Test Result Sheet supplied with this plan. If the result is information (e.g., computer Domain name), then enter the information in the space provided. If the result of the test is a pass, the should be circled. If the result is a failure, the should be circled. If a test is software-specific, and is not present, the should be circled ( meaning Not Applicable). 2. In the event of a test failure and corrective action taken, this should be reported on a copy of the Test Incident Sheet. A master of the Test Incident Sheet is supplied in the Template Masters section of the UV Validator CD. Once the corrective action has been taken, restart the test using the next Run column on the sheet. Any blocks not filled in (uncompleted run or 2 nd run not required) should be crossed out. Note A warning message stating that a method is not compatible with the spectrophotometer may occur when default or demonstration files are loaded. This is spectrophotometer dependent and should be cleared by pressing OK, and does NOT constitute a fail for the test. 2 Smart Linear Cell Changer IQ/OQ Plan

7 Testing Requirements Testing will require the presence of two persons: one to perform the test, the other to act as a witness. To perform this System Acceptance Test, the following must be available (dependent on the system supplied): Appropriate user s guides. Performance Verification and Best Practices for Performance Qualification. If system is to be operated using VISION: Completed and qualified installation of the software if the accessory is to be used with VISIONpro or VISIONlife. Completed installation of security administration for VISIONsecurity software, which requires three user accounts (profiles), one with Network Administrator rights with the ability to use all functions of the software, if required. Alignment tool (supplied with the UV Validator) (for 8-cell only). A low absorbance sample ( A) and a high absorbance sample (1-2 A). To ensure that only the cell changer is affecting the reading precision, we suggest that traceable neutral density filters (0.0 to 0.1 A and 1-2 A) be used for initial testing. If a neutral density filter is not available, use an empty macro cell or one filled with distilled water as the low absorbance, and a macro cell with a material that has a broad absorbance band (such as green food dye or potassium dichromate) for the high absorbance sample. This will ensure that the only parameter tested is the cell changer positioning. Smart Linear Cell Changer IQ/OQ Plan 3

8 When doing performance qualification testing, repeat this test using the types of cells (e.g., macro, semi-micro, micro, sub-micro, etc.) that will normally be used for sample testing. Notice Use either cells or glass filters to perform this test. DO NOT use screen filters. 4 Smart Linear Cell Changer IQ/OQ Plan

9 Test Procedures LCC1 Unit installation Install the unit following the sequence of instructions detailed in the accessory user s guide. Correct location of the accessory in the instrument, followed by the recognition of its presence by the operating software, constitutes a pass to this test. LCC2 Local Control Unit operation with Local Control software. 1. From the Main Menu, press the Accessories function key. 2. Choose Cell Changer and press Enter. 3. Ensure the cell changer is set to On and select Initialize. Appearance of the status box on the top right-hand side of the screen constitutes a pass to this test. LCC3 VISION Unit operation with VISION software. Select Initialize > Accessories from the command drop-down menu. Appearance of the accessory icon in the status bar constitutes a pass to this test. LCC4 Operational performance test (8-cell) 1. Start the Fixed application of the control software and set the Integration Time to 5 s. The remaining method parameters may be left at their default values, but check that Wavelength = nm and Bandwidth = 2.0nm. 2. Ensure that both the Sample and Reference beam cell holders are empty. 3. Press Zero (Local Control) or click on the Zero icon (VISION). Smart Linear Cell Changer IQ/OQ Plan 5

10 4. Insert the alignment tool into the cell changer. The alignment tool has two apertures. Ensure that it is inserted so that the 8.5mm beam height aperture is used. If in doubt, use the White Light setting (see below) to check that the aperture is in the beam. 5. Press Run (Local Control) or click on the Run icon (VISION). Problem free operation of this function constitutes a pass to this test. Note If the White Light facility is required, set the instrument to White Light as follows: Local Control -- From the Main Menu, press the Utilities function key and then press the White Light function key. VISION -- Choose Command > White Light. LCC5 Operational performance test (16-cell) 1. Start the Fixed application of the control software and set the Integration Time to 5 s. The remaining method parameters may be left at their default values, but check that Wavelength = nm and Bandwidth = 2.0nm. 2. Ensure that both the Sample and Reference beam cell holders are empty. 3. Press Zero (Local Control) or click on the Zero icon (VISION). 4. Insert flowcells in positions Press Run (Local Control) or click on the Run icon (VISION). A light beam centered on the clear portion of the cell in each cell position, constitutes a pass to this test. Note If the White Light facility is required, set the instrument to White Light as follows: 6 Smart Linear Cell Changer IQ/OQ Plan

11 Local Control -- From the Main Menu, press the Utilities function key and then press the White Light function key. VISION -- Choose Command > White Light. LCC6 Variation check 1. Place the low absorbance (0 to 0.1A) sample in the cell changer position Measure the absorbance of the sample using a Fixed measurement with a 1 s integration and at 546nm. 3. Repeat this process with positions 2 to 8 (or 16 where applicable). 4. Place the high absorbance sample in cell changer position Measure the absorbance of the sample using a Fixed measurement with a 1 s integration and at 546nm. 6. Repeat the high absorbance sample measurement with positions 2 to 8 (or 16 where applicable). If the low absorbance sample measurements have a maximum difference between their absorbance values of A, and the high absorbance measurements have a maximum difference between their results of A, then this test is passed. Smart Linear Cell Changer IQ/OQ Plan 7

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13 Appendix A: Test Result Sheet Page_1 of _2 System (Customer generated number for the complete system): Test reference Run #1 Tester initials Run #2 Tester initials Run #3 Tester initials Accessory position Sample Reference Sample Reference Sample Reference LCC1 Date: Date: Date: LCC2 Date: Date: Date: LCC3 Date: Date: Date: LCC4 Date: Date: Date: LCC5 Date: Date: Date: Smart Linear Cell Changer IQ/OQ Plan 9

14 Page_2 of _2 LCC6 Date: Date: Date: Tester signature: Print name: Witness signature*: Tester initials: Date: Date: Print name: *Sign only if page(s) is/are completed. 10 Smart Linear Cell Changer IQ/OQ Plan