Biotek BioStack 4 Operator's Manual page 92

70 | Chapter 5: Qualification
Overview
Qualification of the BioStack involves two activities:
Qualification of installation and setup (IQ)
l
Qualification of routine capability (OQ)
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Qualification tasks and tests for the BioStack include installing the BioStack with the
interfacing instrument, and running these tests:
The
System Test
l
input and output stack lifters, carrier, gripper, and wrist.
The
Checksum Test
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interfacing instrument against internal checksum values to ensure that no
corruption has occurred.
The
Instrument Alignment Utility
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interfacing instrument's carrier or supply station (Precision/XS).
The
Verify Test
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aligned with the interfacing instrument's carrier or supply station.
The
Scanner Test
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An instrument qualification package (PN 7310530) for the BioStack is available
n
for purchase. The package contains detailed procedures for performing
Installation/Operational Qualification (IQ/OQ) and Preventive Maintenance
(PM), and extensive checklists and logbooks for recording data and results.
Contact BioTek for more information.
Recommended Qualification Schedule
TASKS/TESTS
Set Up the BioStack:
— Unpack/Inspect the BioStack
— Check required and optional components
— Review safety information
— Select an appropriate location
BioStack™ Microplate Stacker
verifies the BioStack's system components, such as the
verifies the basecode software of the BioStack or
aligns the BioStack's gripper with the
confirms whether the BioStack's gripper has been properly
confirms installation of the optional barcode scanner.
IQ OQ
Initially Every 3
months
P
P
P
P