Regulatory

  1. Faciliflex Cleanroom Module For Therapeutic Drug Manufacturing 1/4/2021

    The Faciliflex Module is a transformational new concept in designing cleanrooms for the production of lifesaving therapeutics.

  2. How RTU Solutions Can Meet GMP Annex 1 Requirements 5/14/2025

    EU GMP Annex 1 urges better contamination control. RTU containers help pharma firms reduce risks, cut costs, and streamline aseptic manufacturing with simplified, compliant solutions.

  3. Establishing A Container Closure System 5/13/2026

    As a trusted partner to both established and emerging drug developers, we support the safe, effective containment and delivery of life-saving and life-enhancing medicines.

  4. How Crucial Is Culture Media Selection In Environmental Monitoring? 6/20/2023

    Explore culture media regulatory requirements, the impact of manufacturing guidelines and media features and specifications on environmental monitoring, and the importance of media supplier selection.

  5. The Sensitivity Trap: Building Confidence In CCIT Performance 3/2/2026

    Effective CCIT goes beyond micron claims, focusing instead on repeatability, confidence, and real‑world relevance. Learn how to define a defensible LOD and understand what auditors truly prioritize.

  6. Annex 1 FAQs: How Are We Responding To Foster Trust With Customers? 5/11/2026

    When regulations evolve, your suppliers’ ability to adapt shapes your ability to deliver. Learn how stronger manufacturing, quality, and personnel standards combined with radical transparency make compliance an advantage.

  7. The Pathway To Operational Readiness 6/24/2025

    Ready to ensure your facilities, systems, and teams are prepared for success from Day One? Discover a proven framework to accelerate operational readiness, mitigate risks, and achieve sustainable results.

  8. VeriPac 465 Micro Leak Test System For Parenteral Products And Rigid Containers 11/16/2021

    The VeriPac 465 is a deterministic micro leak test system for container closure integrity testing combines technological innovation and practical adjustments to patented dual vacuum transducer technology, PERMA-VAC, to make it the most sensitive and versatile vacuum-based leak detection technology to date.

  9. How To Evaluate The Integrity Of Intravenous (IV) Bags 7/7/2023

    Testing IV bags in compliance with Annex 1 guidelines requires a robust technology strategy to ensure product quality and patient safety. Learn how to deploy and validate technologies for IV bag CCI.

  10. Bioburden And EU GMP Annex 1: Risk Assessment, Reduction, And Testing

    Experts on regulation, filtration, sampling, and quality control discuss risk assessment and filtration-based strategies to reduce bioburden.