UV Validator. Temperature Probe Accessory IQ/OQ Plan

Transcription

1 UV Validator Temperature Probe Accessory 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...4 TP1 Unit installation...4 Local Control...4 TP2 Accessory recognition...4 TP3 Temperature measurement...4 VISION...5 TP4 Accessory recognition...5 TP5 Temperature measurement...5 TP6 Correct location of probe...6 Appendix A: Test Result Sheet...7

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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. Temperature Probe 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 Sheets 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 on 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 Temperature Probe 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 guides. Smart Rotary 7-Cell Changer. 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 VISIONlite. 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. Temperature Probe IQ/OQ Plan 3

8 Test Procedures TP1 Unit installation Install the unit following the sequence of instructions detailed in the user s guide supplied with the accessory. If a second probe is to be installed, install this also. Correct location and connection of the probe(s) in the instrument completes this test and constitutes a pass. Local Control Access the system as described in the Local Control section of the accessory user s guide. TP2 Accessory recognition Power up the instrument. Initialization of the accessories will take place automatically. If the accessory has been hot-plugged (i.e., installed while the instrument is powered up), initialize it as follows: 1. From the Main Menu press the Utilities function key. 2. Choose Initialize all Accessories and press Enter. Correct appearance of a live temperature reading (or two live readings if temperature probes have been installed in both the sample and reference position) in the top status bar completes this test constitutes a pass. TP3 Temperature measurement Insert each temperature probe into a standard 1cm pathlength stoppered cell placed in the applicable cell holder. Set up a Fixed Method using the default parameters and press Run. When the measurement is completed, the sample temperature (and reference temperature if a reference temperature probe has been installed) should be displayed on the Fixed Results page, and the recorded value(s) should be in agreement with the live status. 4 Temperature Probe IQ/OQ Plan

9 Successful completion of this test and display of temperature as described and without error constitutes a pass to this test. Note VISION If performing these tests using Local Control, proceed to TP6, Correct location of probe. Accesses the system as described in the accessory user s guide and the on-line Help within the VISION software. TP4 Accessory recognition Power up the instrument. Initialization of accessory will take place automatically. If the accessory has been hot-plugged (i.e., installed while the instrument is powered up), initialize it by selecting Command > Initialize > Accessories. Successful completion of this test and display of temperature as described and without error constitutes a pass to this test. TP5 Temperature measurement Insert each temperature probe into a standard 1cm stoppered cell placed in the applicable cell holder. Set up a Fixed Method using the default parameters and press Run. Correct initialization of the temperature probe is indicated by the appearance of the temperature probe icon with live temperature reading in the status bar. Ensure that both All Samples in Batch and All Cycles in Sampler are checked in the dialog when adding the Result Details to the report. The recorded value(s) should be in agreement with the live status. Successful completion of this test and display of temperature as described and without error constitutes a pass to this test. Temperature Probe IQ/OQ Plan 5

10 TP6 Correct location of probe Fill a 1cm pathlength stoppered cell with appropriate laboratory grade purified water. The volume used should be sufficient to ensure that the tip of the probe will be immersed in the sample but no so great as to cause an overflow when the probe is inserted. Place the cell in the sample beam. Using the default Fixed Method, measure the absorbance of the cell and contents with the normal cell stopper in place. Remove the cell stopper, fit the temperature probe and remeasure the absorbance. Repeat the test with the second probe if applicable. Agreement between the measured absorbance values (indicating that the probe does not obstruct the beam) and successful immersion of the probe tip in the sample, for both probes when applicable constitutes a pass to this test. Note Agreement means that the measured values should fall within the range consistent with the published instrument performance specifications. It does not mean that the measured absorbance values should necessarily be identical. 6 Temperature Probe IQ/OQ Plan

11 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 TP1 Date: Date: Date: TP2 Date: Date: Date: TP3 Date: Date: Date: TP4a Date: Date: Date: TP5b Date: Date: Date: Temperature Probe IQ/OQ Plan 7

12 Page_2 of 2_ TP6 Date: Date: Date: Tester signature: Print name: Witness signature*: Tester initials: Date: Date: Print name: *Sign only if page(s) is/are completed. 8 Temperature Probe IQ/OQ Plan