Protein Surrogate Standard (MML SVPS)
Protein Surrogate Standard (MML SVPS)
  1. Protein Surrogate Standard (MML SVPS)
  2. Protein Surrogate Standard (MML SVPS)

Protein Surrogate Standard (MML SVPS)

061P-0030 & 061P-0060

Protein Surrogate Standard (MML SVPS)

  • 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.
  • The Certificate of Analysis includes actual concentration testing data and mean size

 

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Volume

30 mL, 60 mL

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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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    Certified Clean LP Bottles

    Select options This product has multiple variants. The options may be chosen on the product page

    Certified 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.

     

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