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Calibration Kit: Individual Calibration Kit Vial. Standards for particle sizes ≤ 25 µm
061F
Calibration Kit: Individual Calibration Kit Vial. Standards for particle sizes ≤ 25 µm
- Any of the vials included in Calibration Kit: PSS Accusizer™ LE400 Sensors-All Modes (MML 061B) may be purchased individually.
- MML recommends purchasing additional vials together with (MML 061B), costs to manufacture the spares is substantially lower at that time.
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- Designed specifically as a tri-modal PQ check standard for automated Light Obscuration particle counting systems being used for USP <789> ophthalmic product particulate testing applications.
- Volume: 250 mL
- HDPE Bottle w/PP Cap
- Standard material: NIST traceable size Polystyrene latex (PSL) spheres
- Nominal sizes and concentrations of standard particles:
- 10 µm PSL – 1,000 particles/mL
- 25 µm PSL – 500 particles/mL
- 50 µm PSL – 100 particles/mL
- Product batch will be ± 10% of the nominal concentration; individual standard bottles will be certified ± 15% of the mean concentration and particle sizes are certified ± 5% of the standard size (± uncertainty)
- The Certificate of Analysis includes actual concentration testing data and mean size
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- Particle size and count check standard with a known polydisperse concentration of polymer particles that closely resemble images of aggregated protein particles in biologics when analyzed using Flow Imaging instruments.
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- Designed specifically to mimic the USP Count Reference Standard (USP CRS) used during annual calibrations of Light Obscuration (LO) particle counters running USP <788> sub-visible particle count tests on parenteral preparations, this standard is used to verify the performance of an LO instrument performing this test.
- While it cannot be used in place of the USP CRS, this product should be used as a PQ Check in between annual calibrations to ensure the LO instrument is accurately counting particles in parenteral products. By running this standard weekly or bi-weekly, any out-of-specification (OOS) results can quickly be investigated and the instrument making the measurement can easily be ruled out (or confirmed) as the root cause of the OOS result.
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- Standard material: NIST traceable size Polystyrene latex (PSL) spheres.
- Nominal size and concentration of standard particles:
- 15 µm PSL – 3,750 particles/mL
- Product batch will be ± 10% of the nominal concentration; individual standard bottles will be certified ± 15% of the mean concentration and particle sizes are certified ± 5% of the standard size (± uncertainty)
- The Certificate of Analysis includes actual concentration testing data and mean size.