INSIGHTS ON CRITICAL ENVIRONMENTS

  • USP Draft Chapters On CCS: What You Need To Know
    5/12/2026

    Learn why it's important to stay aligned with evolving Annex 1 expectations to support sterility assurance, regulatory compliance, and patient safety across sterile drug manufacturing operations.

  • 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.

  • Faster Support To Minimize Downtime
    4/7/2025

    See how real-time visual guidance, call recording, and multi-user collaboration help resolve issues quickly while reducing downtime and minimizing the environmental impact of traditional models.

  • Selecting A Platform Filter For High Concentration mAbs
    4/9/2025

    Read more about how Fujifilm Diosynth Biotechnologies evaluated a prime filter with challenging simulant solutions and how the experimental data confirmed superior performance, which demonstrated twice the throughput.

  • 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.

CRITICAL ENVIRONMENT SOLUTIONS

  • Lightly used Bausch Advanced Technologies isolated filling and closing machine, type 515, currently set up for 5mL BD Luer Syringes and Luer Caps, speeds up to 30/minute. Capable of handling 1mL to 30mL syringes with change parts at additional cost, 3 phase, 208 volt, 60 hertz, 14 kw, serial# 515031, built 2021.

  • Protect your controlled environment by neutralizing particulate threats at the entry point. High-velocity filtration ensures stringent air quality standards remain consistent and validated.

  • Ensure aseptic integrity with zoned downflow technology. These customizable modules purge contaminants to maintain ISO Class 5 environments for critical filling and research processes.

  • Explore the benefits of a biofluorescent particle counter that provides real-time viable and total particle monitoring of critical environments, including the aseptic core, without the need for operator intervention.

  • Modernize oligonucleotide manufacturing with robust filtration systems built for hazardous environments. Enhance purity and speed across every batch to ensure reliable and scalable production.

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.