Bi-Mix: 10 µm & 25 µm
600-BA
Bi-Mix: 10 µm & 25 µm
- Volume: 500 mL
- Standard material: NIST traceable size Polystyrene latex (PSL) spheres
- Nominal sizes and concentrations of standard particles:
- 10 µm PSL – 1,500 particles/mL
- 25 µm PSL – 150 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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Calibration Kit for SPOS Instrument in CMP Application
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PQ Check Standard, USP Count Reference Standard Surrogate
Select options This product has multiple variants. The options may be chosen on the product pagePQ Check Standard, USP Count Reference Standard Surrogate
061UI-125 & 061UI-250 & 061UI-500 &061UI-1000
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.
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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.
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PQ Check Standard, Tri-Mix for PSS Accusizer™ Autodiluter / APS Configuration
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Certified Clean LP Bottles
Select options This product has multiple variants. The options may be chosen on the product pageCertified Clean LP Bottles
021A-125 & 021A-250 & 021A-500 & 021A-1000 & 021B-125 & 021B-250 & 021B-500 & 021B-1000
Batch Certified Clean LP Bottles
Designed as a clean sample bottle for most particulate testing applications, this container is suitable for most sample fluids. Before filing, please consult material compatibility charts for HDPE and PP for your specific material.
Using an appropriate sampling plan, a sample set of bottles from each batch is filled with particle-free water and tested. The entire batch of bottles is certified clean if the mean particle count ≥ 0.7 µm in that sample set is not more than 10 particles/mL.
Individually Certified Clean LP Bottles
Designed as a clean sample bottle for most particulate testing applications, these HDPE containers with PP caps are suitable for most sample fluids. Before filing, please consult material compatibility charts for HDPE and PP for your specific material.
By ordering this option, each bottle is filled with particle-free water and tested individually. The bottle is certified clean if the mean particle count ≥ 0.7 µm is not more than 10 particles/mL.
Includes individual C of A for each bottle along with particle test report.