INSIGHTS ON CRITICAL ENVIRONMENTS
-
Adapting To Evolving Needs: How Modular Cleanrooms Enhance Safety In Pharmaceutical Manufacturing
High-potency therapies demand stringent containment and worker safety. Discover how scalable, modular infrastructure simplifies compliance and protects product integrity in regulated facilities.
-
How To Inspect Used Stainless Steel Tanks And Reactors To Avoid Risk
Used stainless steel tanks can cut costs and lead times, but only with a thorough evaluation. Verify specifications, inspect welds and surfaces, and confirm dimensions to ensure reliable performance.
-
Mastering Material Transfer: Keeping Contamination Out Of Your Cleanroom
Master the nuances of material transfer through expert-led training. Learn to assess packaging integrity, ensure complete disinfection coverage, and manage time-sensitive items with precision.
-
Strategic Monitoring: Leveraging TSI FMS Web Client Floor Plan Mapping
Discover how you can visualize your cleanroom or factory, place sample points, and see live data in a dynamic, interactive floor plan.
-
Identifying Worst-Case Locations Assessing Homogeneity Using BIs And EIs7/27/2026
Combine quantitative enzyme indicators, computational fluid dynamics, and traditional biological indicators to improve VPHP isolator validation and process confidence.
-
Enhancing Automated Environmental Monitoring In Gloveless Isolators1/7/2026
Explore how automation and robotic-friendly solutions are transforming fill-and-finish operations and gain insights into gloveless processes, EM testing challenges, and collaborative innovations.
-
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.
-
Inside The Cleanroom: Building A Culture Of Clean Beyond The CCS Blueprint2/12/2026
Achieving sterile excellence requires more than just rigid protocols. Learn how to foster a proactive mindset across your entire organization to ensure long-term facility integrity.
-
Sterilizing Filtration During Small Molecule Drug Formulation And Filling6/22/2026
Sterile drug production relies on both prevention and remediation of contamination. A multi-stage filtration strategy reduces microbial load, protects critical filters from fouling, and ensures consistent product quality, process efficiency, and patient safety.
CRITICAL ENVIRONMENT SOLUTIONS
-
Achieve commercial-scale inhalation blister manufacturing with outputs up to 2,400 cavities per minute, flexible powder dosing, and integrated containment options.
-
Explore a broad range of ready-to-use culture media designed to detect a wide range of microorganisms and meet the highest requirements of microbial monitoring in sterile production environments.
-
Providing a suitable cGMP environment for operators to perform either sampling or dispensing task in a safe and comfortable atmosphere, Extract Technology facilities are high class state of art pieces of equipment. Complete with material and personnel airlocks and a downflow booth, the facility operates with a positive pressure to aid in achieving a clean cGMP environment.
-
Restricted Access Barriers (RABs) were developed to enhance pharmaceutical aseptic processes carried out in conventional clean rooms. Extract Technology customer RABs are designed to fully comply with our customers’ requirements for aseptic pharmaceutical processing.
-
Monitor your viable and non-viable particles according to the most recent regulatory requirements. Count, report, document and manage your pharmaceutical environmental monitoring data meeting 21 CFR Part 11 data integrity requirements.
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.
