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