INSIGHTS ON CRITICAL ENVIRONMENTS

CRITICAL ENVIRONMENT SOLUTIONS

  • Your next cleanroom is more akin to a piece of equipment than a room. Operational efficiencies, compliant flow of materials and personnel, and lifecycle considerations should dictate the selection of your cleanroom partner. AES designers have been engineering functional cleanroom facilities for over three decades, guaranteeing the performance of each and every facility. Our in-house designers work as a team with our cleanroom construction personnel to engineer a cost-effective project while maximizing performance, value, and constructability. The greatest value is realized when AES is integrated into the design team at the start of the project. Early project integration with the AES experts helps the infrastructure team decide what support and cleanroom solutions the clean space requires. Early participation by AES saves design costs, expedites schedule, and eliminates a duplication of services.

  • Take a closer look at combining aseptic processing and HPAPI containment through modular design, integrated decontamination, automated leak and glove testing, and flexible automation.

  • Per Center for Disease Control (CDC) guidelines for cleaning and disinfecting viruses and other pathogens, any form of disinfection necessarily follows cleaning. The process of cleaning will remove any residues that might shield any virus or pathogen from the disinfection step that comes next. Disinfection, following thorough cleaning and rinsing, can be done with bleach solutions, 70% alcohol solutions, or other products with EPA-approved emerging viral pathogens claims. As outlined by CDC, bleach solutions should reside on surface for at least one minute and can be made as follows:

    • 5 tablespoons (1/3rd cup) bleach per gallon of water, or
    • 4 teaspoons bleach per quart of water

    An excellent cleaning and wiping solution can be made with 0.5% (0.75- 1.5 oz/gal or 5 mL/L) Alconox® Powdered Precision Cleaner or Liquinox® Critical Cleaning Liquid Detergent, depending on preference for powder or liquid concentrate, respectively. Following which, per the CDC guidelines, wipe with the above bleach solution or other disinfectant solution. Allow wiped-down surfaces to sit for several minutes before rinsing to complete the disinfection.

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

  • 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.

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.