INSIGHTS ON CRITICAL ENVIRONMENTS
-
From IND To NDA: The Role Of The Kilo Lab In A Seamless Scaleup
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.
-
Germfree's Comprehensive Suite Of Services
Learn about the maintenance strategy developed around the BSL-3 cGMP Modular Facility and how Germfree ensures the ongoing functionality and compliance of these groundbreaking facilities.
-
Biofluorescent Particle Counters Are Gaining Momentum
The 2025 BioPhorum report highlights challenges and trends in drug filling operations and how they are advancing towards biofluorescent particle counters. Discover an approach that aligns with industry needs.
-
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.
-
The Pain Of Change – Could Suppliers Be Part Of The Cure?10/15/2024
Change is a constant in the pharma industry, but it doesn't have to be painful. Discover how suppliers can help ease the burden of regulatory change management and streamline essential processes.
-
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.
-
Mobile Sterile Compounding Pharmacy USP 797/8006/19/2024
Learn how Germfree's 53-foot mobile cleanroom trailer ensured uninterrupted sterile drug compounding during a facility renovation.
-
Effective Environmental Monitoring And Control In Pharma Operations10/16/2025
A structured contamination control strategy uses the Plan, Do, Study, Act model, focusing on EMPQ, meticulous planning, trend analysis, and continuous improvement with CAPA and change control.
-
The Successful Implementation Of A New Aseptic Filling Line10/10/2024
Discover how a Quality by Design approach can streamline the development of new sterile product filling lines, featuring a real-life example illustrating its effectiveness.
CRITICAL ENVIRONMENT SOLUTIONS
-
Ensure efficient contamination control with Bioquell's innovative range of hydrogen peroxide vapor (HPV) bio-decontamination systems designed to meet the most stringent decontamination requirements.
-
Solujet cleaner is the detergent to consider for your next new pharmaceutical cleaning project. Unlike a leading CIP cleaner, Solujet has high wetting surfactants that enhance emulsifying, wetting, dispersing and rinsing. The surfactants allow faster, more efficient cleaning and easier rinsing.
-
Incorporating 45 years of particle counting experience, the Lasair® Pro Aerosol Particle Counter is designed with the latest technology to meet global requirements for data integrity.
-
Vertical or Horizontal Modules can be joined to form large zones of critical clean airflow within a larger cleanroom.
-
The AES litebeam is a patented and one-of-a-kind 4” [100mm] wide linear LED light which is fully flush and integrated into the 3” [75mm] AES marquee ceiling system, providing a fully flush surface on both surfaces of the ceiling. These lights have a lighting level dimmable controller, and provide greater flexibility when locating HEPA air filter diffusers in the cleanroom ceiling system.
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.
