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Safety and Regulatory Information
Quality Control/Good Laboratory Practices
Quality Control
The user should develop appropriate quality control procedures for the LC
Peltier Column Oven (and the entire LC system) to ensure suitability for its
intended use. These procedures typically consist of periodic performance
verifications and routine inspections and suitability tests.
Certificate of System Control
Each Series 200 Peltier Column Oven 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 (Certification No. FM 22179).
Instrument Performance Verification (IPV)
To maintain functional performance, PerkinElmer recommends a yearly
Instrument Performance Verification (IPV) of the Series 200 Peltier Column
Oven by a PerkinElmer Service Engineer to ensure its operation within
published specifications. These tests consist of measuring the most
important Peltier Column Oven characteristics, such as retention time
repeatability. Certification is available for regulatory compliance. Contact
your local Perkin-Elmer Sales and Service office.
Routine Inspection and Suitability Test
To ensure that the LC system is operating within established criteria (for
example, peak resolution, peak asymmetry, precision, retention time, column
plate count, pressure limits, signal/noise ratio, etc.), perform a system
suitability test (which closely resembles the intended assay) prior to running
a sample analysis with the Series 200 Peltier Column Oven in the LC system.
While the Universal Test Mix (UTM) P/N 0089-0893 can be used for a
system check, we recommend that you develop a separate system suitability
test and acceptance criteria for each of your assays.
Quality Control/Good Laboratory Practices
S-7
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