Overview This Qualification & Maintenance package contains BioTek Instruments’ recommended Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Preventive Maintenance (PM) procedures for the ELx808 Absorbance Microplate Reader. The CD contains: a manual in Adobe Acrobat PDF format; the Microsoft® Word source files used to generate the manual; Microsoft® Excel spreadsheets for analyzing and recording liquid test results; and, for Gen5 software users, protocols for performing the liquid tests and analyzing/recording the results. The manual contains: Recommended Qualification and Maintenance Schedules Step-by-step instructions and required materials lists for performing the qualification and maintenance procedures IQ Checklist, OQ Checklists, and PQ Logbook for recording that the installation, operational, and performance qualification tasks were performed Preventive Maintenance Logbook for recording that the preventive maintenance tasks were performed Traceability Logbook for recording information on equipment calibration, test solutions, reagents, etc.
The contents of the Qualification & Maintenance package may be
printed or modified as needed by the original purchaser. All files are subject to the copyright restrictions outlined on page ii.
The original package was fully validated in accordance with BioTek
Instruments’ Product Validation policies and procedures. It is the customer’s responsibility to validate any modifications to the original package.
BioTek Instruments, Inc.
Design Qualification (DQ) | 3
BioTek Instruments, Inc. conducts extensive testing on every new or serviced ELx808 to ensure that it meets BioTek’s published specifications before leaving the factory. Many of the factory tests have been documented in this manual for you to perform to confirm that your reader continues to meet the published specifications. “Published specifications” refers to the specifications that are guaranteed by BioTek. BioTek recommends using the published specifications for your qualification procedures. It is possible, however, that your intended use of the ELx808 may require less stringent specifications. As a result, you may decide to customize the specifications for your tests.
It is important that you choose specifications that are adequate
for all uses of the instrument, but never any that exceed the published specifications. BioTek cannot guarantee that specifications more stringent than those we publish can be met.
BioTek does not warranty repair or other service for
the inability of the instrument to meet customer- derived specifications.
Document any limited qualification performed in the
appropriate checklist or logbook.
When performing the qualification and maintenance procedures, please consider the following: Proof that the qualification was performed should be kept for Good Laboratory Practice (GLP) purposes. Checklists, logbooks, and spreadsheets should be signed/initialed and dated by the person performing the qualification and (if required) by the person reviewing or approving the qualification. Any printouts generated during qualification should be signed and dated by the person performing the qualification, and kept with the appropriate checklist, logbook, or spreadsheet. All test failures must be corrected or sufficiently explained prior to using the instrument for actual analysis.
Significant out-of-tolerance conditions found during periodic
qualification testing require that the data generated between test cycles be analyzed for potential problems.
ELx808 Qualification and Maintenance Procedures
4 | Section 1: Introduction
Recommended Qualification Schedule
The schedule below defines the factory-recommended intervals for qualifying an ELx808 used two to five days a week. The actual frequency, however, may be adjusted depending on your usage of the instrument. This schedule assumes the reader is properly maintained as outlined in Section 5, Preventive Maintenance.
IQ OQ PQ Tasks/Tests Initially & Every Every Initially Annually Month 3 Months
Installation, Setup, & Configuration
Basecode and Assay
Software Verification
System Test Software Filter Table Verification
Empty Carrier Test
Plate Shaker Test
(Optional) Barcode Scanner Test
Absorbance Plate Test
Absorbance Liquid Test 1
Absorbance Liquid Test 3 (optional, for 340 nm testing on UV model)
Run Assay Test
(if required)
BioTek Instruments, Inc.
Design Qualification (DQ) | 5
Design Qualification (DQ)
Your facility may have conducted a Design Qualification (DQ) prior to purchasing the instrument on which you will be conducting the qualification procedures. During that process, the functional and operational specifications for the instrument were most likely considered. The device requirements should have been selected based on the intended use and location of the instrument. If the device will be used for only a few types of assays, you may not require its full functional capabilities and therefore you may be able to reduce the range of your Operational Qualification testing. If the device is intended for a wide range of uses, the entire set of Operational Qualification tests should be conducted. The instrument should be located in an environment that meets the published specifications listed in Section 7, Specifications. You should compare the DQ device requirements to the published specifications. Document your comparison, note any differences, and explain why they are not critical to your intended use. Attach or reference the location of the DQ and the comparison below.
Was a Design Qualification conducted? Yes Not Applicable
If Yes, documentation is attached , or is located at: _______________________________________________________________________
If a Design Qualification was conducted, a comparison of the DQ device requirements to
the instrument pecifications was performed and documentation is attached , or is located at: ________________________________________________________________________
