INSIGHTS ON CRITICAL ENVIRONMENTS

CRITICAL ENVIRONMENT SOLUTIONS

  • Don't let the traditional cleanroom design build process delay getting therapies into the hands of those who need it most. When deadlines matter AES has the knowledge and technology to rapidly execute your cleanroom project. AES has built more cell & gene therapy cleanrooms than anyone else in the world. Why have cell & gene therapy clients selected AES? Because we understand and will meet the critical nature of your deadlines. Our system provides the speed, flexibility, and risk reduction to ensure that your facility is built on time and on budget.

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

  • 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.

  • Whether your Cytiva instrument is brand new or well-seasoned you’ll have trained help at the ready. Explore the services we provide for each stage of your equipment’s life.

  • Build practical confidence in chromatography system care and troubleshooting. Learn how to prevent downtime, resolve common issues independently, and maintain reliable performance.

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.