INSIGHTS ON CRITICAL ENVIRONMENTS
-
Key Factors For Optimized Microbial Air Sampling
Learn about active air sampling and the characteristics of various microbiological sampling methods that are designed to optimize collection efficiency.
-
Your Environmental Monitoring Can't Be Your Only Line Of Defense
Environmental monitoring (EM) is essential, but it’s only part of the picture. Discover why a proactive contamination control strategy is key to keeping your cleanroom truly audit-ready.
-
Airflow Visualization Studies: The Impact Of Annex 1 On Sterility Assurance
Airflow visualization techniques like Smoke Studies and CFD analyses are crucial for contamination control, aiding cleanroom qualification, environmental monitoring, and optimizing contamination control strategies under Annex 1.
-
Syntegon Virtual Pharma Expo May 2025: Aseptic Manufacturing And Packaging
The 2022 EU GMP Annex 1 revision marks a pivotal shift in sterile manufacturing, emphasizing contamination control, advanced technologies, and global harmonization—driving industry-wide adaptation and regulatory interpretation challenges.
-
5 Key Principles Of Cleanroom Particle Counting6/24/2025
Discover the five essential principles of cleanroom particle counting and how they ensure compliance, prevent contamination, and protect product quality in highly regulated manufacturing environments.
-
How Robotic Isolator Technology Aligns To Annex 1 Principles4/28/2025
Robotic gloveless isolators provide exceptional automation to eliminate human intervention and reduce contamination risk. Discover how they ensure compliance with the EU Annex 1 guideline to enhance sterility, precision, and monitoring.
-
Project Management Process During A Mobile cGMP Compliant Facility Build4/12/2024
Delve into what it took to drive a recent Mobile cGMP Facility from concept to completion.
-
Automated Bioburden Testing Solution11/7/2025
Automation is transforming microbial quality control labs, boosting productivity, minimizing errors, and ensuring data integrity. Discover how digitalization is driving Pharma 4.0 and reshaping lab workflows.
-
From IND To NDA: The Role Of The Kilo Lab In A Seamless Scaleup7/29/2025
To derisk your manufacturing, work with an outsourcing partner that prioritizes the kilo lab as a space to develop a proven, robust, and reliable workflow from clinical to commercial scale.
CRITICAL ENVIRONMENT SOLUTIONS
-
A widely used method to inactivate bio-contamination on surfaces in GMP controlled areas is sporicidal gassing using vaporized hydrogen peroxide (VHP). This decontamination process uses a free radical reaction to kill microorganisms on surfaces.
-
AES Omni integrates up to six gas supplies into the vertical posts of the AES modular cleanroom system.
-
Many Contec wipes and mops were developed through customer requests. Explore our wipes and mops along with how we minimize the risk of endotoxin contamination of a pharmaceutical product.
-
GFRMC panels are primarily used in the production of 40-foot mobile labs and mini labs. Due to their weight and the efficacy of the Dry Build installation process, GFRMC panels are also used to construct cleanrooms in challenging or remote locations.
-
When transparency is paramount, the AES infinity system provides the viewer with a close-up and very clear viewing experience, enabling interested personnel to see the process without entering the cleanroom environment. The AES infinity glass wall system is easily integrated with other wall systems.
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.
