INSIGHTS ON CRITICAL ENVIRONMENTS

• Optimal Microbial Sampling Criteria

  Microbiological sampling ensures sterile conditions through surface, passive, and active air methods. The EU GMP Annex 1 emphasizes integrating these for comprehensive environmental monitoring.

• Activate Advanced Contamination Control Technology To Safeguard Your Cell Therapy

  The most common contamination risks in cell therapy manufacturing are open processes that leverage different products, inflexible instruments, labor intensive workflows, lack of in-line monitoring, and zero failure tolerance.

• Vaporized Hydrogen Peroxide (VHP) Resistance Testing

  Explore test results demonstrating the suitability of a robust microbial sampler for environments where frequent exposure to harsh cleaning and sterilization methods, like VHP in isolators, is routine.

• Inside Asymchem's Advanced R&D Capabilities In The UK

  Advanced experimentation, unified workflows, and continuous manufacturing are accelerating small‑molecule development, improving insight and creating more efficient paths from discovery to scale.

• Syntegon Virtual Pharma Expo May 2025: Aseptic Manufacturing And Packaging

  5/21/2025

  The 2022 EU GMP Annex 1 revision marks a pivotal shift in sterile manufacturing, emphasizing contamination control, advanced technologies, and global harmonization—driving industry-wide adaptation and regulatory interpretation challenges.

• From Open Cleanrooms To Closed Systems – What Is Driving The Change?

  3/14/2025

  Aseptic processing is evolving. Regulatory changes and technological advancements are driving a shift from open cleanrooms to closed systems for sterile drug manufacturing.

• Compressed Gas Contamination: Guidelines For Control In Aseptic Manufacturing

  10/18/2024

  Explore key guidelines for preserving the purity and quality of compressed gas, with an emphasis on contaminants, monitoring, and preventive maintenance practices.

• Effective Contamination Control

  6/16/2025

  Discover key strategies for contamination control in cleanrooms, as well as explore contaminant sources, behaviors, and best practices for cleaning and removal to ensure high standards of product and process quality.

• Inside The Cleanroom: Disinfectant Validation Demystified With Neil Simpson

  2/12/2026

  Ensure cleanroom compliance by aligning disinfectant validation with real-world application methods. Learn to justify your protocols and adapt to facility changes through expert technical insights.