INSIGHTS ON CRITICAL ENVIRONMENTS

CRITICAL ENVIRONMENT SOLUTIONS

  • Accelerate your biomanufacturing capacity with purpose-built modules

    KUBio™ box modular bioprocessing environments are designed to help biopharmaceutical manufacturers bring high-quality biopharmaceuticals to market more quickly. By reducing typical design and construction times and streamlining process execution, they support future expansion and replication needs. Available KUBio™ box modular environments for biosafety levels 1 and 2 (BSL-1 and BSL-2) can be delivered in 10 to 15 months for implementation inside existing infrastructure. The result? Reduced project risk, accelerated delivery of next-gen therapies, and greater flexibility at different production scales and product technologies.

  • An optimized and effective Contamination Control Strategy (CCS) helps you organization spend less time cleaning and more time manufacturing. Ecolab Life Sciences experts are dedicated to helping you drive the best possible strategy to meet and exceed the GMO Annex 1 CCS requirements.

  • Extract Technology integrated the necessary viable and non-viable particle monitoring within the machine along with the use of a 21CFRPart 11 validated paperless (touch screen) chart recorder to enable the customer to review each stage of the cycle in full detail.

  • 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.

  • Real-time environmental monitoring can streamline QC workflows. Learn how continuous particle detection and advanced microbial sampling support proactive contamination control and data-driven oversight.

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.