INSIGHTS ON CRITICAL ENVIRONMENTS

CRITICAL ENVIRONMENT SOLUTIONS

  • In addition to our manufacturing capabilities, which meet the needs of multiple cleanliness and validation options, Thermo Fisher Scientific offers specialty service capabilities for delivering the appropriate level of cleanliness for your process.

  • 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.

  • A streamlined transfer approach brings monitoring plates into controlled areas without decontamination delays. With plates kept organized and accessible, teams can maintain productivity.

  • Environmental monitoring ensures cleanroom certification, microbial control, utility testing, digital data management, and rapid remediation to maintain cGMP compliance and safeguard product integrity.

  • Used Kiefel Technologies Bag Making Machine, Model KIF 52, Serial #416-030, for forming, filling, and sealing medical-grade bags and IV bags.

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.