INSIGHTS ON CRITICAL ENVIRONMENTS

CRITICAL ENVIRONMENT SOLUTIONS

  • Pharmaceutical companies, medical device manufacturers, biotech companies, healthcare facilities and other regulated organizations are subject to a variety of laws and regulations regarding the production, storage and testing of their products.

  • Some environments are specially controlled to minimize health and safety risks or for quality control. Testing and monitoring of these areas to ensure the health and safety of personnel and control product quality requires specialized equipment.

  • 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.

  • Achieve ISO Class 5 containment for large-scale research equipment and robotics. These advanced enclosures ensure multi-level protection while maintaining rigorous aseptic standards.

  • The AES Profile cleanroom system is another AES hallmark system, a 2” [50mm] thick modular wall system with a uPVC finish, with all seams cold welded together to create a monolithic finish. The reduced wall cross section with all flush finishes at doors and windows provides a superior performing 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.