Quality Control/Good Laboratory Practices - PerkinElmer 200 UV/VIS Series User Manual

Safety and Regulatory Information Safety and Regulatory Information

Quality Control/Good Laboratory Practices

Quality Control
The user should develop appropriate quality control procedures for the Series 200 UV/VIS
Detector to ensure suitability for its intended use. These procedures typically consist of peri-
odic performance verifications and routine inspections and suitability tests.
Certificate of System Control
Each Series 200 UV/VIS Detector is carefully built and tested in a controlled system in
accordance with the requirements specified in its applicable PerkinElmer Final Assembly
and Test Specification.
Each instrument is certified to meet its functional and performance specification upon
release to shipment. The integrity of this quality system is routinely audited and is certified
by the British Standards Institution as meeting all requirements of ISO 9001:1987.
Instrument Performance Verification (IPV)
To maintain functional performance, PerkinElmer recommends a yearly Instrument Perfor-
mance Verification (IPV) of the Series 200 UV/VIS Detector and its other system compo-
nents by a PerkinElmer Service Engineer to ensure its operation within published
specifications. These tests consist of measuring the most important UV/VIS characteristics
such as noise drift and wavelength accuracy. Certification is available for regulatory compli-
ance. Contact your local PerkinElmer Sales and Service office.
Routine Inspection and Suitability Test
Prior to any sample analysis, a system suitability test, which closely resembles the intended
assay, should be performed to ensure that the LC system is operating within established cri-
teria (e.g., peak resolution, peak asymmetry, precision, retention time, column plate count,
pressure limits, signal/noise ratio, etc.)
While the Universal Test Mix (UTM) P/N 0089-0893 can be used for a system check, we rec-
ommend that you develop a separate system suitability test and acceptance criteria for each
of your assays.
Hazardous Chemicals
Before using mobile phase solvents, you should be thoroughly familiar with all hazards and
safe handling practices. Observe the manufacturer's recommendations for use, storage and
disposal. These recommendations are normally provided in the material safety data sheets
(MSDS) supplied with the solvents.
S - 13