Biotek 405 LS, Operator'S Manual

Page: 168 / 240

148 | Chapter 5: Qualification
Qualification Overview
Instrument verification for the 405 LS involves three activities: qualification of
installation and setup, qualification of routine capability, and qualification of long-
term stability. These activities are called Installation Qualification
(IQ)
,
Operational Qualification
(OQ)
, and Performance Qualification
(PQ)
, respectively.
Review the
Qualification Schedule on the facing page
.
Verification testing includes:
l
The System Self Test verifies system components, such as the vacuum, manifold, and
carrier positioning.
Washer
l
Evacuation Efficiency: This test measures the residual volume per well after
aspiration. The lower the residuals per well, the better the evacuation efficiency of the
washer.
l
Dispense Precision: This test measures the variability of volumes dispensed from tube
to tube across the manifold.
l
Buffer Switching : This test measures the variability of volumes dispensed from tube to
tube across the manifold when using buffer switching.
l
Vacuum Filtration Evacuation Efficiency: When applicable, this test measures the
total residual volume of the plate after evacuation to verify it is performing to
specifications.
ll
Verify Sensor Test. Compares the ultrasonic level sensor's measurement precision
against a microplate absorbance reader's determination to ensure accurate, repeatable
volume-level detection.
Washer Qualification Tests
:
l
Dispense Precision (96) on page 157
l
Dispense Precision Test (192) on page 161
l
Evacuation Efficiency Test (96) on page 158
l
Evacuation Efficiency Test (192) on page 162
l
Buffer Switching Dispense Test on page 160
l
Vacuum Filtration Evacuation Efficiency Test on page 165
405™ Microplate Washer LS