INSIGHTS ON CRITICAL ENVIRONMENTS
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Sustainable Solutions For Medical Devices
Explore how medical device companies aim to balance patient safety with environmental stability by offering bio-based UHMWPE, which reduces carbon footprints by up to 70%.
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Can Your Cleaning And Monitoring Withstand Regulatory Scrutiny?
Explore facility cleaning, monitoring, and disinfection strategies to meet regulatory standards, emphasizing planning, stakeholder involvement, testing, documentation, and improvement.
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Environmental Monitoring In Advanced Therapeutic Medicinal Products Facilities
Discover how to adapt your environmental monitoring framework to meet the distinct risk-management and regulatory needs of ATMP facility production.
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Sourcing Pharmaceutical And Industrial Equipment In Auctions
More and more industrial gear is hitting the auction block. Unlock significant savings by understanding the nuances of pharmaceutical and industrial equipment auctions.
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How A Rigorous Approach Delivers Unparalleled Results6/12/2025
In critical environments where mistakes have serious consequences, a disciplined, methodical approach isn't just a preference—it's the only path to success and long-term operational excellence.
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Beyond Flexibility: The Strategic Value Of Single-Use In Virus Filtration7/24/2026
Single-use virus filtration offers key strategic benefits beyond operational convenience, enabling faster time to market, scalable manufacturing, and flexible supply chains for biopharma production.
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Sterilizing Filtration During Small Molecule Drug Formulation And Filling6/22/2026
Sterile drug production relies on both prevention and remediation of contamination. A multi-stage filtration strategy reduces microbial load, protects critical filters from fouling, and ensures consistent product quality, process efficiency, and patient safety.
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The Impact Of Annex 1 (2022) On Sterility Assurance4/24/2025
Airflow visualization studies, crucial for GMP compliance, validate unidirectional airflow effectiveness in contamination control. Discover their enhanced role in quality by design and revised Annex 1 guidelines.
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Glove Integrity Testing: Changes In EU GMP Annex 16/25/2026
EU GMP Annex 1 now defines clear expectations for glove integrity testing. Examine how reliability, efficiency, and equipment usability are becoming essential factors for maintaining compliance.
CRITICAL ENVIRONMENT SOLUTIONS
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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.
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Take a closer look at combining aseptic processing and HPAPI containment through modular design, integrated decontamination, automated leak and glove testing, and flexible automation.
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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.
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Environmental monitoring ensures cleanroom certification, microbial control, utility testing, digital data management, and rapid remediation to maintain cGMP compliance and safeguard product integrity.
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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.
