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ImageProVisionModel ipvAutoCount -Microscopic Particulate Matter Counter for Parenteral Drugs

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The ipvAutoCount, an enhanced version of the ipvPCount, is a specialized tool for determining the quantity of particulate matter in parenteral drugs. This system incorporates a trinocular microscope and a high-resolution camera, integrated with software compliant with 21 CFR Part 11. These features enable precise measurement and documentation crucial for pharmaceutical applications. The ipvAutoCount is particularly beneficial in the stages of new drug development and batch release, contributing to time and effort savings in these critical processes. The system is designed to facilitate FDA approval and ANDA filing, underscoring its importance in regulatory compliance. This software is both user-friendly and flexible, aiming to streamline workflows and improve efficiency for pharmaceutical professionals. By addressing common industry challenges, ipvAutoCount provides a robust solution for accurate particulate matter counting.
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The ipvAutoCount is an advanced version of the ipvPCount. It is used for calculating the amount of particulate matter in parenteral drugs. The set-up consists of a trinocular microscope along with a high-resolution camera integrated with 21 CFR Part 11 compliant software.

The pharmaceutical industry was facing these challenges:

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

The ipvAutoCount offers these solutions.

  • The microscopy technique is reliable & more accurate for particulate matter count
  • ipvAutoCount is 21CFR Part 11 Compliant solution.
  • One of the transparent methods for contamination study.
  • Auto focusing & auto image capturing is available with a high-end microscope
  • It is a microscopic solution for Injectable, Ophthalmic, MDI, Aerosol etc.
  • Filter paper analysis for small volume injection and large volume injection can be done.
  • Our system follows USP 788 for injectable and USP 789 for ophthalmic solutions.
  • Sample analysis of MDI (Meter Dose Inhaler) can be performed.