INSIGHTS ON CRITICAL ENVIRONMENTS
-
Sustainable Solutions For Medical Devices
Explore how medical device companies aim to balance patient safety with environmental stability by offering bio-based UHMWPE, which reduces carbon footprints by up to 70%.
-
A Risk-Based Decision Framework For Selecting Aseptic Barrier Technologies
EU GMP Annex 1 requires a risk-based approach to selecting Isolators or RABS. This framework evaluates human intervention and decontamination to ensure robust sterility assurance.
-
Sustainability, Corporate Social Responsibility In Capital Equipment Purchasing And Asset Management
Learn how pharmaceutical companies can reduce waste, cut emissions, and improve financial performance by prioritizing equipment reuse and optimizing asset management.
-
Sustainability By Design In API Manufacturing
Explore the urgent need for sustainability in small molecule API manufacturing, as well as reveal regulatory drivers, green chemistry innovations, and practical strategies to reduce emissions.
-
Maintain Control Of Pharmaceutical Water Systems4/10/2026
Early TOC excursions often reveal hidden risks in water systems. Capturing samples at the moment of deviation helps teams confirm root causes faster, reduce uncertainty, and maintain control.
-
Cleanroom Conceptual Design Paradigm: Converting Spaces For GMP Operations9/26/2024
Gain insights into the nuances of cleanroom conceptual design for GMP operations and learn how an integrated approach can ensure regulatory compliance, functionality, and environmental performance.
-
Why Is 50% The Limit For Particle Counting Efficiency Sizing Thresholds In Cleanrooms?6/18/2024
Particle counting efficiency is vital, especially when using optical particle counters. Learn why 50% is the limit for counting efficiency sizing thresholds in optical particle counters.
-
Rethinking Sustainability In Bioprocessing5/22/2025
Discover how sustainability is transforming bioprocessing through innovative single-use technologies that help reduce environmental impact and support responsible, forward-thinking biomanufacturing.
-
Be Smart: Flexible Production With Module Type Package (MTP)4/29/2026
Modular production is moving from vision to practice. Learn how the Module Type Package enables flexible manufacturing while unlocking valuable process data based on real implementation experience.
CRITICAL ENVIRONMENT SOLUTIONS
-
Unused IMA Life Nitrogen Dioxide sterilizer, model NO2 Sterilizer 3.5, 316L stainless steel product contact surfaces, with (5) 916mm wide x 916mm deep usable shelves, 270mm shelf spacing, NO2 sterilant storage and dosing system, set up for SIP, Siemens controls with SIMATIC S7-1500 Siemens PLC controller, stoppering with 5 hp hydraulic power pack, (2) Edwards GXS160SF dry vacuum pumps, scrubber system with 5.5 kw blower, 200 cf vapor cooler, buffer tank, chamber certified by Amherst Stainless Fab, rated 7 psi and full vacuum at +200/-76 f, serial# 1535, national board# 1320, IMA Life serial# EFC001, project# SA35-00148, built 2019 and Unused new on shipping skids and crated.
-
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.
-
The cleanroom ceiling that started the walkable revolution, innovated and designed inhouse by AES engineers. The AES marquee system is AES’ hallmark system, a walkable monolithic ceiling system with an uPVC finish, with all seams cold welded together to create a monolithic finish. This system comes in either 2” [50mm] or 3” [75mm] thick, depending upon the application.
-
Apex® Biological Indicator (BI) products are designed specifically to meet the unique needs of the pharmaceutical, food, and medical device industries utilizing vaporized hydrogen peroxide (VH2O2) decontamination.
-
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.
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.
