INSIGHTS ON CRITICAL ENVIRONMENTS

  • Considerations And Steps For Building A Contamination Control Strategy
    4/22/2021

    Past focus was placed on sampling methods for the measurement of potential contamination: particle counters, active air samplers, Petri dishes, and swabs for surface monitoring. This approach has been remodeled to prevent and control potential contamination from reaching the point of no return: the product. This paper outlines defining the CCS and designing the cleanroom that can achieve contamination control.

  • An Introduction To Particle Technology In Pharmaceutical Manufacturing
    1/14/2021

    A basic understanding of particles and particle counting to help improve your cleanliness levels. In this beginner's guide to particle technology, you will learn about the physical nature, origins and behavior of particles.

  • Building Modular Cleanrooms For Pharma At Warp Speed
    3/8/2021

    As the life sciences industry responds to the COVID-19 pandemic in record fashion, cleanroom technologies have proven vital to efforts to combat the COVID-19 pandemic.  In 2020, cleanroom provider AES Clean Technology introduced new offerings under their existing Faciliflex banner, delivering complete custom cleanrooms from scratch in as little as four months from concept initiation. 

  • Superior Biopharmaceutical Manufacturing Facilities Prioritize Cleaning & Disinfection During Design
    11/20/2020

    Thorough consideration of cleaning/disinfection during facility design eases maintenance across the facility lifecycle, optimizes workspace utility, and contributes to efficient facility operation.

  • Managing The Expectations Of Auditors For Microbial Data Collection
    5/4/2021

    Microbial environmental monitoring is a growing challenge for the pharmaceutical industry in an increasingly digitized industry, otherwise known as Industry 4.0. Manufacturers must be able to guarantee their blend of automated and operational processes are under statistical control while ensuring their data is secure and accurate. With the improvements made to other areas of production, there is a growing need for modern solutions to environmental monitoring and microbial data collection in critical areas.

CRITICAL ENVIRONMENT SOLUTIONS

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.