INSIGHTS ON QUALITY CONTROL

• Sterilization Of APIs – The Alternative: Sterile Filtration Following Aseptic Processing

  When terminal sterilization isn't an option for heat- or radiation-sensitive APIs, sterile filtration with aseptic processing protects quality. Get the technical framework.

• Characterizing The Physical Properties Of Spray Dried Powders

  Ensure the success of your spray-dried powder formulations by thoroughly assessing their physical properties early in the development process to optimize handling, stability, and performance in final dosage forms.

• Delivering Value Across Sites With Unified Quality Operations

  Standardizing quality processes across 14 sites has enabled faster lead times. Discover how a unified platform reduces complexity, improves compliance, and delivers greater value for customers.

• How Can A Stage-Based Program To Determine HME Applicability Benefit Your API?

  Poorly soluble APIs can be converted into amorphous solid dispersions to improve bioavailability. A stage-gated approach reduces risk, optimizes polymer selection, and speeds manufacturing.

• A System For Annex 1 Data, Reporting, And Interpretation Requirements

  5/13/2026

  Watch this tech expo video to discover how multi-dimensional sensor placement and integrated data dashboards optimize cleanroom environmental monitoring for Annex 1 compliance.

• Contamination Control Strategy: Compressed Gas Monitoring Of Microbes

  3/3/2026

  Microbial survival during gas decompression is a proven risk. Learn why point-of-use monitoring is essential for Annex 1 compliance and how to ensure process gas purity in sterile environments.

• FDA's Risk-Based Inspection Shift: What It Actually Rewards

  7/20/2026

  FDA’s revised pre-approval inspection program prioritizes risk-based determinations over routine site visits. Review risk assessment factors and transition toward continuous audit readiness.

• How To Achieve Stable, High-Output Stickpack Production

  9/9/2026

  Explore practical ways to improve stickpack production through accurate dosing, reliable sealing, automated quality control, and efficient material handling while reducing complexity.

• Engineering Controls For Sterile Compounding — USP Requirements And Equipment Selection

  7/24/2026

  Aligning compounding operations with USP <797> and <800> requires an integrated control strategy. Discover key criteria for cleanroom equipment selection.