INSIGHTS ON CRITICAL ENVIRONMENTS

  • Tips For Successfully Scaling Your cGMP Manufacturing

    What are the specific obstacles to expanding manufacturing capacity? Cell therapy industry leaders share what to look for in a solutions provider and recommendations for navigating your road ahead.

  • Leveraging Microbial Contamination Monitoring Data For Actionable Insights To Meet And Exceed The Auditor’s Expectations

    Modern pharmaceutical manufacturers are already generating and managing big data from environmental monitoring; the next step is to create actionable insights and ensure 21CFR11 compliance. This webinar discusses data collection, 21CFR11 data management and the generation of actionable insights.

  • Microbial Control And Monitoring In Aseptic Processing Cleanrooms

    Environmental Monitoring (EM), particularly in pharmaceutical manufacturing facilities where the risk of microbial contamination is controlled through aseptic processing, comprises both physical and microbiological test methods. This paper reviews how the data originating from these EM components provides critical information on how well a stable and suitable environment for the aseptic preparation of medicinal products is maintained.

  • The Evolution Of Pharmaceutical Modular Cleanroom Technologies And Project Execution

    AES Clean Technology is expediting the delivery of fully functioning cleanrooms. Modular technology allows for repeatable installations of proven systems. New facility projects are time consuming and have thousands of decision points. AES has simplified this process offering standardization. The three models AES offers have taken into consideration the trends seen with modern facilities offering built-in flexibility. AES is also capable of working collaboratively with clients to design–build high-quality customized cleanroom systems with guaranteed performance.

  • Viable Monitoring Solutions: Prepare Your Contamination Control Strategy (CCS) For EU GMP ANNEX 1
    10/31/2021

    The New Annex 1 has some critical changes that are important to understand and start applying. While the drafts cover many areas of environmental monitoring in-depth, this webinar by Particle Measuring Systems (PMS) experts focuses on the Viable/Microbial Air Monitoring aspects.

  • Litebeam LED Cleanroom Lighting
    12/10/2020

    In this video, learn aboutour state-of-the-art Litebeam™ LED cleanroom lighting system. This innovative cleanroom technology provides linear LED lighting designed for flush integration into our 3” thick (75 mm) cleanroom walkable ceiling system. Litebeam™ fixtures are installed as an integrated part of the ceiling system, eliminating cut openings for traditional fixture layouts while delivering a uniform light pattern throughout your modular cleanroom.

  • Transforming Your Biopharma Automation Capabilities
    6/24/2021

    Single-use technology equipped with a scalable distributed control system allows for collecting and sharing data while simultaneously creating a connected enterprise that grows with the pace of business.

  • Viable And Non-Viable Environmental Monitoring To Meet USP 797
    1/15/2021

    The USP 797 requires sterility of all Compounded Sterile Products (CSP). Environmental Monitoring is an essential component to prove that a cleanroom, or clean device, meets the defined ISO 14644-1 classifications. Learn more about what viable and nonviable monitoring involves.

  • Selecting The Most Suitable Particle Sample Point Locations In Your Cleanroom
    5/14/2021

    When considering where to place sample points for particle monitoring, whether it will be performed in a pharmaceutical cleanroom or clean device (RABS, isolator, etc.), the answer is not always straightforward. Here, we help to identify the considerations, establish the most suitable location for monitoring a process, and build a scientific rationale for that decision.

CRITICAL ENVIRONMENT SOLUTIONS

  • Learn what combinations are most effective when cleaning RNA contamination and important details regarding interfering residues.

  • The Hardwall IsoSphere™-ST is a positive pressure non-unidirectional airflow isolator or unidirectional CRABS for small, medium, and large volume sterility testing with vaporized hydrogen peroxide decontamination integration.

  • All NuAire FumeGard Fume Hood Cabinets are virtually metal free. Constructed from primarily stress relieved, fully seam-welded, and reinforced white polypropylene for demanding high corrosive applications. All fume hoods are independently test to Federal Stand

  • AES Omni integrates up to six gas supplies into the vertical posts of the AES modular cleanroom system.

  • Speed-to-market is the number one driver in the pharma/bio industry today ... the faster our clients can build facilities, the quicker they can get treatments into the hands of the patients who need them the most. The AES Fast Lane program is an accelerated Design, Manufacture, and Installation program that fast tracks your cleanroom facility project in seven months.

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.