ELx808™

Absorbance Microplate Reader, All Models

Qualification & Maintenance Procedures

June 2011 Model:

© 2011 Serial Number:
Part Number 7341026
Installation Date:
Revision E
BioTek® Instruments, Inc. Location:
ii | Preface

Notices
BioTek® Instruments, Inc.
Highland Park, P.O. Box 998
Winooski, Vermont 05404-0998 USA

All Rights Reserved

© 2011, BioTek® Instruments, Incorporated. No part of this publication may be

reproduced, transmitted, transcribed, stored in a retrieval system, or translated into
any language without the written permission of BioTek Instruments, Incorporated
with the following exceptions: The original purchaser of this publication is authorized
to print copies of the procedures, checklists, and logbooks for use with any number of
instruments at a single facility. They may also extract sections for use in their
procedures at the same facility.

Trademarks

BioTek® is a registered trademark, and ELx808™ and Gen5™ are trademarks of BioTek
Instruments, Inc.
Microsoft®, Windows®, and Excel® are either registered trademarks or trademarks of
Microsoft Corporation in the United States and/or other countries.
Adobe® Acrobat® is either a registered trademark or trademark of Adobe Systems,
Incorporated in the United States and/or other countries.
All other trademarks are the property of their respective holders.

Restrictions and Liabilities

Information in this document is subject to change and does not represent a

commitment by BioTek Instruments, Inc. Changes made to the information in this
document will be incorporated in new editions of the publication. No responsibility is
assumed by BioTek for the use or reliability of software or equipment that is not
supplied by BioTek or its affiliated dealers.

BioTek Instruments, Inc.

 Contents | iii

Contents

Preface................................................................................................ ii
Notices..............................................................................................2
Contacting BioTek...............................................................................6
Document Revision History..................................................................6i

Section 1: Introduction.......................................................................1
Overview...........................................................................................2
Recommended Qualification Schedule....................................................4
Recommended Maintenance Schedule...................................................5
Design Qualification (DQ)....................................................................6

Section 2: Installation Qualification....................................................7

IQ-1: Unpack and Inspect the Reader....................................................8
IQ-2: Check Required Components.......................................................9
IQ-3: Check Optional Components........................................................9
IQ-4: Select an Appropriate Location.....................................................9
IQ-5: Install the Filter Wheel..............................................................10
IQ-6: Check/Adjust Power Input Voltage Setting...................................11
IQ-7: Connect Power.........................................................................11
IQ-8: (Optional) Connect Printer.........................................................12
IQ-9: Turn on Reader and Run System Test.........................................12
IQ-10: Record Reader Software Information.........................................13
IQ-11: Configure Reader Settings.......................................................13
IQ-12: Connect Host Computer...........................................................14
IQ-13: Install Gen5 Software..............................................................15
IQ-14: Establish Communication.........................................................15
IQ-15: Run Final System Test.............................................................16
IQ-16: Review Safety Information.......................................................17
IQ-17: Register with BioTek...............................................................17
IQ-18: Investigate and Document Test Failures....................................17
IQ-19: Sign and Date the IQ Checklist.................................................18

Section 3: Operational Qualification..................................................19

OQ Procedure...................................................................................20
OQ-1: Verify/Record Software Information...........................................21
OQ-2: Verify the Filter Table...............................................................21
OQ-3: System Test...........................................................................22
OQ-4: Empty Carrier Test..................................................................23
OQ-5: Shake Test.............................................................................23

ELx808 Qualification and Maintenance Procedures

iv | Preface

OQ-6: Barcode Scanner Test..............................................................24

OQ-7: Absorbance Plate Test..............................................................25
OQ-8: Absorbance Liquid Test 1..........................................................26
OQ-9: Absorbance Liquid Test 3..........................................................26
OQ-10: Run Final System Test............................................................26
OQ-11: Investigate and Document Test Failures...................................27
OQ-12: Sign and Date the Checklist....................................................27

Section 4: Performance Qualification................................................29

PQ Procedure...................................................................................30
PQ-1: Verify/Record Software Information...........................................31
PQ-2: System Test............................................................................31
PQ-3: Absorbance Plate Test..............................................................32
PQ-4: Absorbance Liquid Test 1..........................................................33
PQ-5: Absorbance Liquid Test 3..........................................................33
PQ-6: Perform ‘Run Assay’ Test..........................................................34
PQ-7: Investigate and Document Test Failures......................................34
PQ-8: Sign and Date the Logbook.......................................................34

Section 5: Preventive Maintenance....................................................35

Recommended Maintenance Schedule..................................................36
Warnings & Precautions.....................................................................37
PM-1: Clean Exposed Surfaces............................................................38
PM-2: Inspect/Clean Wavelength Filters...............................................38
PM-3: (Optional) Lubricate Components...............................................39
PM-4: Run System Test.....................................................................39

Section 6: System Description...........................................................41

Theory of Operation..........................................................................42
System Test.....................................................................................42
Filter Gain Test..............................................................................43
Air-Dark Read Test.........................................................................44
Noise Test.....................................................................................44
Incubator System Test and Alternate Test.........................................44
Checksum Test.................................................................................46
Empty Carrier Test............................................................................47
Plate Shaker Test..............................................................................47
Barcode Scanner Test........................................................................47
Absorbance Plate Test.......................................................................48
Mechanical Alignment.....................................................................49
Accuracy and Linearity....................................................................49
Repeatability Test..........................................................................49
Channel-to-Channel Variation Test...................................................50

BioTek Instruments, Inc.

 Contents | v

Absorbance Liquid Test 1...................................................................53

Repeatability.................................................................................53
Alignment and Channel-to-Channel Variability...................................53
Absorbance Liquid Test 3...................................................................54
Assay Review...................................................................................54

Section 7: Specifications...................................................................55
Technical Specifications.....................................................................56
All Models.....................................................................................56
Standard Model.............................................................................57
Ultraviolet (“UV”)/Incubator Model...................................................58
(Optional) Internal Barcode Reader..................................................58
(Optional) Robot Interface...............................................................58

Section 8: Liquid Tests......................................................................59

Overview.........................................................................................60
Absorbance Liquid Test 1...................................................................61
Required Materials.........................................................................61
Procedure.....................................................................................62
Calculations...................................................................................63
Absorbance Liquid Test 3...................................................................64
Required Materials.........................................................................64
Procedure.....................................................................................65
Calculations...................................................................................66

Checklists/Logbooks
IQ Checklist
OQ Checklists
PQ Logbook
PM Logbook
Traceability Logbook

ELx808 Qualification and Maintenance Procedures

vi | Preface

Contacting BioTek
BioTek Instruments, Inc.
Highland Park, P.O. Box 998
Winooski, Vermont 05404-0998 USA

Customer Service and Sales

Internet: www.biotek.com
Phone: 888-451-5171 (toll free in the U.S.)
802-655-4740 (outside the U.S.)
Fax: 802-655-7941
E-Mail: customercare@biotek.com

Service/Technical Assistance Center (TAC)

Phone: 800-242-4685 (toll free in the U.S.)

802-655-4740 (outside the U.S.)
Fax: 802-654-0638
E-Mail: tac@biotek.com

European Coordination Center/

Authorized European Representative

BioTek Instruments GmbH

Kocherwaldstrasse 34
D-74177 Bad Friedrichshall
Germany

Internet: www.biotek.de
Phone: +49 (0) 7136 9680
Fax: +49 (0) 7136 968 111
E-Mail: info@biotek.de

BioTek Instruments, Inc.

 Contents | vii

Document Revision History

For BioTek part number 7341026:

ELx808 Qualification and Maintenance Procedures

viii | Preface

Rev Date Changes

A 07/2002 First issue
B 02/2004 Replaced most references to the ELx808 Operator’s Manual with actual
instructions. Rearranged step order in IQ to better reflect installation
process. Added step to IQ to review safety information in the Operator’s
Manual. Moved plate shaker and bar code scanner tests from IQ to OQ.
Combined System Test and Incubator Test into one step in OQ. Added
‘Run Assay’ test in OQ. Removed Operator’s Manual excerpt ‘Performance
Verification’ and incorporated appropriate instructions throughout.
Updated IQ checklist and OQ/PQ, Traceability, and Maintenance logbooks.
Republished entire document using new styles and format.
C 09/2006 General: Changed “ELx808 Automated” Microplate Reader to “ELx808™
Absorbance Microplate Reader,” “Bio-Tek” to “BioTek,” and “Universal Test
Plate” to “Absorbance Test Plate.” Added Gen5™ instructions wherever
KCjunior™ and KC4™ instructions were included in the manual.
Cover and title page: Updated the cover with a current photo of the
instrument. On cover and title page, clarified that this manual covers “All
Models” of the ELx808™ and updated BioTek logo to new graphic.
Introduction: Removed “The ELx808 Operator’s Manual in Adobe PDF file
format” from the CD contents; added “A README document in Adobe PDF
file format” to the CD contents. In the Recommended Maintenance
Schedule, removed “Clean Lamp Contact” and added “Clean Exposed
Surfaces,” “Run System Test,” “Replace Lamp/Clean Lamp Contacts,” and
“Decontaminate the Reader.”
Installation Qualification: Removed instructions in IQ-8, Check/Adjust the
Line Input Voltage Range; added reference to Appendix F in the ELx808
Operator’s Manual, for instructions. Added installation instructions for the
external power supply in IQ-9. Added Gen5 instructions to IQ-15, IQ-16,
and IQ-17. Updated the existing IQ Checklist accordingly.
Operational Qualification: Added Gen5 instructions to OQ-2, OQ-3, and
OQ-7.
Performance Qualification: Added Gen5 instructions to PQ-2 and PQ-3.
Preventive Maintenance (formerly Periodic Maintenance): In the
Recommended Maintenance Schedule, removed “Clean Lamp Contact” and
added “Clean Exposed Surfaces,” “Run System Test,” “Replace
Lamp/Clean Lamp Contacts,” and “Decontaminate the Reader.” Added
Gen5 instructions to PM-4. Updated the existing PM Logbook accordingly.
Specifications: Added reading speeds and external power supply.
Liquid Tests: Liquid Tests 1 and 3, added recommendation to shake the
plate for four minutes (or wait for 20 minutes) after pipetting the diluted
test solution, before reading the plate. Added PBS tablets to list of
materials for Liquid Test 3.
D 03/2010 Introduction: Clarified the contents of the Product Qualification CD.
Removed redundant Required Materials list.
Installation Qualification: In ‘IQ-3 Check Required Components,’ removed
non-critical documents from the list. Added ‘IQ-17 Register with BioTek’.
Rearranged order of steps to better represent actual practice.
Operational Qualification: Changed references to the ‘OQ/PQ Logbook’ to

BioTek Instruments, Inc.

 Contents | ix

Rev Date Changes

‘OQ Checklist.’
Performance Qualification: Changed references to the ‘OQ/PQ Logbook’ to
‘PQ Logbook.’
Preventive Maintenance: Removed unnecessary comprehensive Required
Materials list. To the recommendation that filters be cleaned every three
months, added ‘less frequently if air quality is good.’
System Description: Clarified the “Incubator Self Test” portion of the
System Test Report. Updated the sample System Test and Absorbance
Plate Test reports.
Liquid Testing: Added instructions for using the supplied Gen5 software
protocols to assist with the test procedures. For Liquid Test 3 removed
infrequently-used instructions for creating the former Solution A: 10x
concentrate PBS.
Replaced the former OQ/PQ Logbook with OQ Checklists and PQ Logbook.
E 6/2011 General: Removed references to KC4 and KCjunior software.
Preface: Updated Trademark section.
Operational Qualification: Removed “Perform ‘Run Assay’ Test”. Added
OQ-10, Run Final System Test. Updated the OQ Checklist accordingly.
Performance Qualification: Updated “Perform ‘Run Assay’ Test” to reflect
the fact that it is no longer required initially.
IQ and OQ Checklists: Added a comment box for each N/A checkbox.
Added data entry fields for Gen5 2.x version information. Added “N/A”
checkbox for the Reviewed/Approved By signature boxes. In the OQ
Checklist, added a field to record the Absorbance Test Plate serial number.

ELx808 Qualification and Maintenance Procedures