INSIGHTS ON QUALITY CONTROL

• Contamination Control Of Particulate And Shuttle Blow-Fill-Seal Compliance

  Does shuttle blow-fill-seal truly meet Annex 1’s stricter contamination standards? New particle burden data challenges industry assumptions and reveals what manufacturers need to know.

• Pharmaceutical X-Ray Counts Capsules & Pills

  Learn how advanced X-ray inspection ensures exact pill counts in multi-supplement pouches, automatically identifying missing components and generating time-stamped visual data logs.

• Scaling Down For Success: Optimizing Single-Use Virus Filtration For Small-Scale Bioprocessing

  Automation can bring greater consistency, product recovery, data capture, and operational efficiency to small-scale viral filtration once processes are sufficiently defined, helping gene therapy developers transition beyond highly manual workflows.

• Material Transfer Into A Cleanroom: How To Reduce Contamination Risk At Every Step

  Evaluate packaging integrity and master wiping techniques to prevent cleanroom contamination. Focus on surface coverage and controlled transfer paths to ensure consistent product safety and quality.

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

  9/1/2026

  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.

• Software Simplifies 21 CFR Part 11 and Annex 11 Compliance

  12/9/2024

  21 CFR Part 11 and Annex 11 regulate electronic records and signatures in biomanufacturing, ensuring data integrity, security, and compliance while enabling efficient processes and regulatory alignment.

• Compliance To Confidence: Annex 1 For Small-Batch, High-Value Production

  10/3/2025

  Get strategies for meeting the updated GMP Annex 1 in small-batch aseptic filling. Learn about contamination control, quality management, and equipment design for high-value liquid and powder products.

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

  5/21/2026

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

• 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.