8
OsmoTECH XT Single-Sample Micro-Osmometer User Guide
Quality control
1
United States Pharmacopeia (USP) Standard 785 Osmolality and Osmolarity (2009). United States Pharmacopeia.
2
European Pharmacopeia (EP) Standard 7.3, Section 2.2.35 Osmolality (2012). European Pharmacopeia.
3
Japanese Pharmacopeia (JP) Standard XVI, Section 2.47 Osmolarity Determination, Japanese Pharmacopeia
This page describes quality control materials recommended by Advanced Instruments for use with the OsmoTECH XT.
Advanced Instruments recommends that you incorporate these materials into your quality control management system.
Regulatory Guidance
•
United States Pharmacopeia (USP) Standard 785:
Confirm the instrument calibration with a solution such
that the osmolality of the
Standard Solution
lies within
50 mOsm/kg of the expected value of the
Test
Solution
or the center of the expected range of
osmolality of the
Test Solution
.
1
•
European Pharmacopeia (EP) and Japanese
Pharmacopeia (JP) may also be referenced.
2,3
Calibration standards, reference solutions, and controls
Advanced Instruments calibration standards, reference
solutions, and controls consist of stable sodium chloride
solutions of known freezing points which bracket those
of the expected unknowns. These standards are
traceable to the National Institute of Standards and
Technology (formerly the National Bureau of Standards).
If you use your osmometer to test biological solutions,
you should also test the osmometer using actual
biological solutions or controls formulated to simulate
biological solutions. Contact your Advanced Instruments
representative to obtain Protinol Protein-Based Serum
Controls.
In addition, Advanced Instruments recommends that you
check with your professional associations and regulatory
bodies for their guidelines, rules, and regulations.
Verifying calibration daily
Verify the accuracy of the OsmoTECH XT daily using
Advanced Instruments reference solutions and controls.
Compare the test results produced by the instrument to
expected values. Recalibrate the instrument if the test
results are outside of the expected ranges. After
recalibrating, re-run the reference solutions and controls
to verify that you obtain the expected results.
We recommend using Clinitrol 290 Reference Solution
and an osmolality control closer to your expected
osmolality range. Use these reference solutions and
controls:
•
Daily, prior to testing samples, to verify instrument
operation and confirm calibration
•
After performing a recalibration
Verifying linearity
Verify the linearity of the OsmoTECH XT using the
Osmolality Linearity Set. Use the linearity set:
•
To verify the linearity and reportable range of the
instrument
•
After performing a recalibration
Strengthen your laboratory’s Quality Control program
by using products made specifically for your
osmometer. Use Advanced Instruments reference
solutions and controls to evaluate the performance
and precision of your osmometer:
•
Clinitrol™ 290 Reference Solution
: Clinitrol is a true
reference designed specifically for osmometers. It
provides results that approximate the osmolality of
normal serum.
•
Protinol™ Protein-Based Osmolality Controls
Protinol
Controls are formulated to mimic serum at 240, 280,
and 320 mOsm/kg H
2
O.
•
Osmolality Linearity Set
: Helps laboratories easily
monitor osmometer performance specifications.
