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.