INSIGHTS ON CRITICAL ENVIRONMENTS

CRITICAL ENVIRONMENT SOLUTIONS

  • Viable, Non Viable and Environmental Monitoring Software.

  • Your future cleanroom is the most crucial asset within the entire manufacturing environment. It surrounds critical manufacturing processes where your pharma or biotech company makes its life-changing products. The investment you make in the cleanroom facility should reduce your manufacturing risk and guarantee your performance. AES is the cleanroom expert because it's the only thing we do. Singular focus in providing the most flexible cleanroom technology solutions for over 35 years.

  • Since 2000, the AES team has been working with companies in their development of autologous and allogeneic cell and tumor processing technologies. As this market segment has evolved (and continues to evolve), AES has continued to work with clients to develop modular cleanroom technology that drives efficient, safe, and compliant process operations.

  • 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.

  • In such a highly regulated environment, change is not undertaken lightly. As a result, a lack of internal resources can often obstruct the implementation of change.

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.