PQ Check Standard, USP Count Reference Standard Surrogate

PQ Check Standard, USP Count Reference Standard Surrogate

• 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.
• Volume: 1000 mL
• 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 Conformance includes actual concentration testing data and mean size.