INSIGHTS ON CRITICAL ENVIRONMENTS
-
6 Reasons To Use Biological Indicators During Your Sterilization Cycle
Understand the importance of biological indicators, and learn why they should be integral to any comprehensive sterilization program.
-
Contamination Control Strategies: Comparing Cleanrooms, RABS, Isolators
Sterile manufacturing relies on three main contamination control strategies (CCSs): cleanrooms, RABS, and isolators. Understand how each system compares in sterility assurance, startup cost, and operational flexibility.
-
Guide To PUPSIT And Annex 1 In Aseptic Processing
Pre-use, post-sterilization integrity testing (PUPSIT) ensures filters remain undamaged and effective during aseptic manufacturing. Discover how you can successfully perform PUPSIT with proven solutions.
-
Optimizing Cleanroom Cleaning And Disinfection To Meet Annex 1 Requirements
Explore Annex 1 updates on contamination control in pharmaceutical cleanrooms, emphasizing cleaning consistency, training, advanced tools, and technologies to achieve regulatory compliance.
-
Sustainability In Small Molecule API Manufacturing11/7/2025
Redesigning chemical processes with green chemistry principles can cut emissions, reduce waste, and improve efficiency. See how smarter synthesis and digital tools enable sustainable API manufacturing.
-
From Open Cleanrooms To Closed Systems – What Is Driving The Change?3/14/2025
Aseptic processing is evolving. Regulatory changes and technological advancements are driving a shift from open cleanrooms to closed systems for sterile drug manufacturing.
-
Nitrosamines - New Requirements To Evaluate Contamination Risks12/23/2024
Explore nitrosamine contamination, regulatory actions, and new evaluation requirements, featuring expert insights from Dr. Ulrich Reichert on prevention and risk assessment strategies.
-
Visually Clean And Beyond10/23/2024
Implement a robust cleaning and sanitization program to ensure the safety and quality of personal care and cosmetics products while complying with global regulations.
-
Applying Appropriate Limits In Cleanroom Monitoring6/18/2024
Explore ISO 14644-1:2015 and EU GMP Annex 1 in-depth, and learn about cleanroom classification, how to apply monitoring limits in cleanroom environments, and more.
CRITICAL ENVIRONMENT SOLUTIONS
-
Facility Monitoring System with industrial control systems assures data integrity, process automation, simplicity of use, and data integration.
-
Cost, clean-up and downtime are just a few things to consider when construction a cleanroom. Following is an overview of the advantages of modular project execution versus stick-built construction.
-
With AES pre-engineered modular construction, our clients are leveraging our clean construction techniques to ensure that the project site starts clean and stays clean throughout the construction of the facility.
-
Discover a maintenance service that keeps your instruments in top condition and is hassle-free, minimizes downtime, and enhances performance to ensure that your instruments deliver accurate data analysis.
-
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.
