INSIGHTS ON CRITICAL ENVIRONMENTS

  • The Open Standard For Plug-And-Produce

    Take a look at how standardized, modular production simplifies line integration, reduces engineering effort, and enables faster changeovers. Ideal for teams seeking flexible manufacturing models.

  • Minimizing Particulate Risk

    While visible particles often draw immediate attention, visual inspection alone is insufficient, as subvisible particulate matter can pose equally significant risks to patient safety.

  • Risked-based Cleaning Validation Process Checklist

    Is your cleaning validation process truly aligned with current regulatory expectations? This checklist helps you implement a risk-based approach, focusing resources to effectively mitigate your highest-risk areas.

  • Isokinetic Sampling In Unidirectional Flow

    Accurate cleanroom particle monitoring requires precise isokinetic sampling. Understand how to maintain sampling accuracy and meet regulatory airflow requirements for your facility.

CRITICAL ENVIRONMENT SOLUTIONS

  • Unused Groninger Aseptic Vial Filling Line, speeds up to 150 vials/minute. Line is designed to CE-norms. Set up for 3 mL, 5 mL with 13mm neck size, 10R, 10Ml, with 20mm neck size, speeds up to 150 vials/minute, 20H, with 20mm neck size, speeds up to 60 vials/minute, and 30mL with 20mm neck size range, speeds up to 50 vials/minute.

  • The CC-IS is a Cell Culture Isolator cGMP Class A/ISO 5 system specifically designed to provide the users with a cell culture environment which is safer than environments on traditional biosafety cabinets, clean booths or standard cleanrooms, by eliminating any risk from human contamination of cell cultures.

  • Since 2000, the AES team has been working with companies in their development of autologous and allogeneic cell and tumor processing technologies. As this market segment has evolved (and continues to evolve), AES has continued to work with clients to develop modular cleanroom technology that drives efficient, safe, and compliant process operations.

  • Esco Pharma's Downflow Booth Generation 3 (DFBG3) is a new generation of Esco powder containment booth which provides simplicity with assured quality.

  • Facility Monitoring System with industrial control systems assures data integrity, process automation, simplicity of use, and data integration.

FREE CLEANING VALIDATION E-BOOK

Learn how to employ science-, risk-, and statistics-based approaches to cleaning and cleaning validation at your facility with this free, 100-page e-book, written by a global team of cleaning validation experts, pharmaceutical toxicologists, statisticians, and Six Sigma professionals.