INSIGHTS ON QUALITY ASSURANCE

  • Materials Characterization In Pharma

    Materials science is now helping pharmaceutical companies to standardize and control areas such as drug form and manufacture to deliver new products more quickly and with greater quality.

  • Sterile Production Process Studies Using 100% Headspace Inspection Of Finished Product

    This app note describes the application of the PULSAR inspection platform to perform 100% headspace oxygen monitoring during the filling of oxygen-sensitive formulations, 100% container closure inspection of suspect batches, moisture inspection of freeze dried product, and automated media fill inspection.

  • CCI Testing And Revisions To EU Annex 1

    The new language in EU Annex 1 will likely have a significant impact on your CCI testing practices. In this webinar CCI testing strategies and the proposed revisions to EU Annex 1 are discussed.

  • Implementing FDA Guidance: CCI Testing In Lieu Of Sterility Testing

    This application note details FDA released guidance titled “Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products."

  • In-Process Monitoring Of Headspace Oxygen Levels In Parenteral Containers

    Using a high sensitivity detection technique known as Frequency Modulation Spectroscopy (FMS), LIGHTHOUSE rapid non-destructive headspace oxygen inspection can help streamline the monitoring of purge performance on the filling line. This paper demonstrates the correlation of the FMS rapid non-destructive technique for analyzing headspace oxygen levels with the most commonly used conventional destructive techniques for headspace oxygen inspection.

QUALITY ASSURANCE SOLUTIONS

  • Cleaning Validation Methods Alconox, Inc. has a range of 12 products, which vary from high emulsifying to low foaming and powder to liquid. Alconox aqueous cleaners are ideal for a variety of cleaning applications including ultrasonic, clean in place, machine, and parts washer.
  • Used Perkin Elmer Lambda 14 UV/VIS Spectrometer

    Used Perkin Elmer Lambda 14 UV/VIS Spectrometer, with controls on unit, 230 volts, serial# 50134.

  • Used Perkin Elmer Paragon 1000 PC FT-IR Spectrometer

    Used Perkin Elmer Paragon 1000 PC FT-IR Spectrometer, benchtop design, serial# 38716.

  • Endress+Hauser Service Portfolio

    Endress+Hauser is committed to your business, for improved plant performance.

  • Cleaning Validation (21 CFR Part 211.67) Alconox, Inc. can assist you in selecting an appropriate cleaner for cleaning pharmaceutical manufacturing equipment and utensils to prevent malfunctions or contamination that would alter the safety, identity, strength, quality or purity of the drug product beyond the official or other established requirements.