INSIGHTS ON CRITICAL ENVIRONMENTS
-
Nitrosamines - New Requirements To Evaluate Contamination Risks
Explore nitrosamine contamination, regulatory actions, and new evaluation requirements, featuring expert insights from Dr. Ulrich Reichert on prevention and risk assessment strategies.
-
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.
-
Inside The Cleanroom: Disinfectant Validation Demystified With Neil Simpson
Ensure cleanroom compliance by aligning disinfectant validation with real-world application methods. Learn to justify your protocols and adapt to facility changes through expert technical insights.
-
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.
-
Use Of Conductivity As A Tool For On-Site Residue Management3/7/2025
Residues from cleaning and disinfection are under increased scrutiny in cleanrooms. A new method using conductivity measurements offers a more accurate and objective way to quantify these residues.
-
The Advantages Of Creating A Workflow When Monitoring A Cleanroom6/11/2024
Discover a portable particle counter that enables you to create a scheduled workflow and ensure you never miss a sample during cleanroom monitoring or sample the wrong area.
-
Implementing Rapid Microbial Identification In Biotherapy Manufacutring5/27/2025
Learn about rapid microbial identification strategies that enhance environmental monitoring and compliance with regulatory requirements for your manufacturing processes.
-
10 Practical Tips For GMP Cleanroom Contamination Monitoring2/13/2026
A robust cleanroom monitoring program is your best defense against contamination. Align your strategy with Annex 1 to detect risks early, protect your product, and ensure patient safety.
-
Bacteria To Consider For The Growth Promotion Test: Should Anaerobic Cultures Be Included?2/20/2025
The Growth Promotion Test (GPT) evaluates whether the culture media is suitable for use in environmental monitoring sampling. Explore recommendations to follow to ensure a successful GPT.
CRITICAL ENVIRONMENT SOLUTIONS
-
Glatt GPCG 60/30/18" Fluid Bed Dryer Granulator System with Allen Bradley PanelView 1200 Color Touch Screen Controller, Air Handler, (Qty 2) Granulation Bowls, (1ea} Wurster and Product Bowl. and System Power Distribution Control Panel. SN# 5912.
-
Bio-decontaminate equipment, small areas, and large rooms too with Ecolab’s Bioquell L-4. This versatile, multi-purpose bio-decontamination system is easy to set up and operate.
-
BioTrak Real-Time Viable Particle Counter offers best-in-class features and versatility in the exciting new field of real time airborne viable particle detection.
-
AES Clean Technology offers a variety of specialty cleanroom doors for use throughout your cleanroom facility. Sliding doors are available as manual or automatic. Single or bi-parting sliding doors are offered as FRP, fiberglass or stainless steel, with a variety of hardware and door frame options in sizes up to 8' x 8' for manual doors and 10' x 10' for powered doors.
-
Microbial impactors for continuous viable monitoring, minimize false positives, and are Annex 1 compliant.
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.
