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ImageProVisionModel ipvPCount -Microscopic Particulate Matter Counter for Parenteral Drugs

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The ipvPCount is designed to accurately calculate the quantity of particulate matter present in parenteral drugs. This comprehensive solution includes a high-resolution camera and dedicated software that complies with 21 CFR Part 11 regulations. The system integrates seamlessly with any microscope, making it a versatile tool for pharmaceutical applications. The ipvPCount addresses critical industry challenges such as aiding in the new drug development process, facilitating FDA approvals, and assisting in Abbreviated New Drug Applications (ANDA) filings. It features user-friendly, flexible, and interactive software, making it accessible for varied technical skill levels. The software's ability to simplify and enhance particulate counting ensures accuracy and compliance with regulatory standards, thus supporting overall drug safety and efficacy.
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ipvPCount is a one-stop solution for calculating the amount of particulate matter in parenteral drugs. The set-up consists of a high-resolution camera and dedicated 21 CFR Part 11-compliant software which can be integrated with any microscope.

The pharmaceutical industry was facing these challenges:

  • Which technique to use for particulate matter count?
  • Do you have a particle counter?
  • How to identify foreign particles in injectable & ophthalmic solutions?
  • A 21CFR Part 11 Compliant Solution
  • Does your system follow USP 788 & USP 789?
  • How to do filter paper analysis?
  • How to perform a particulate matter test for a viscous solution?
  • How to do a contamination study?
  • What about the accuracy of the result?

The ipvPCount offers a wide variety of solutions.

  • The microscopy technique in ipvPCount is reliable & more accurate for particulate matter count
  • The ipvPCount is a 21CFR Part 11 Compliant solution.
  • It offers a microscopic solution for injectables, ophthalmic, MDI, and aerosol.
  • Filter paper analysis for small volume injection and large volume injection can be performed.
  • Our system follows USP 788 for injectable and USP 789 for ophthalmic solutions
  • Sample analysis of MDI (Meter Dose Inhaler) can be performed.