GRIFOLS DG Spin - 8 Operation Qualification (OQ); 8.1 Required Materials for OQ

DG Spin Procedure for Qualification of the Operation (OQ)
8-1
8 OPERATION QUALIFICATION PROCEDURE (OQ)
The DG Spin centrifuge has two non-adjustable independent time basis controlled
by the centrifuges program itself. Given that the speed has been calibrated by the
manufacturer, if no function alarm is activated (see sections 12.1 and 12.2), it is
warranted that
DG Spin centrifuge will correctly work for all its useful life, without
any additional calibration.
However, the procedure described below aims to provide a method for those
laboratories which, under a quality management system, should periodically verify
that the
DG Spin centrifuge works under specifications.
The Operation Qualification Procedure (OQ)
of the DG Spin centrifuge consists
of verifying the correct function of the following parameters:
- Centrifugation speed
- Balance control system
8.1 Required materials
To qualify operation of the DG Spin centrifuge the following materials are
required:
- Calibrated optical tachometer
- 24
DG Gel cards
To warranty the veracity of measurements, these materials should be calibrated
using instruments controlled regularly with traceable materials at primary or
secondary reference standards.
NOTE:
The use of any tachometer is possible as long
as it complies with the following specifications:
Tachometer
: Optical
Scale division (rpm)
: ≤1 rpm
Range (rpm)
: 1.00 - 99,999 rpm
Maximum uncertainty permitted:
± 3 rpm
Detection distance
: < 35 cm with visible red
light