INSIGHTS ON QUALITY CONTROL

QUALITY CONTROL SOLUTIONS

  • The United States Pharmacopeia USP 1207 guidance has been revised, encouraging the preference to deterministic, quantitative, and reliable non-destructive technologies to comply with quality standards.

  • The Palltronic Flowstar V integrity test instrument ensures accurate filter integrity testing with a further reduction in test time, full compliance with 21 CFR Part 11, advanced automation capabilities, and simplified network integration saving the user time while improving process efficiency.

  • Airborne ultrasound is a referenced technology in the new USP <1207> Chapter Guidance as a deterministic test method for seal quality testing, is an ASTM Test Method F3004 and FDA Recognized Standard for seal quality integrity testing.

  • This intuitive and reliable HPLC system supports First Time Quality (FTQ) by reducing the risk of common errors and improving the accuracy of analytical measurements.

  • An integrated development and manufacturing approach that cuts handoffs, manages risk, and accelerates timelines by uniting formulation, analytics, production, and packaging.