INSIGHTS ON CRITICAL ENVIRONMENTS

CRITICAL ENVIRONMENT SOLUTIONS

  • In the spectrum of pharmaceutical manufacturing facilities, injectable product manufacturing facilities represent the most sophisticated and challenging to design, build, qualify and operate, particularly when products manufactured in these facilities are rendered sterile when complete, ready to inject directly into a human. For this reason, very careful consideration must be made when developing such a facility.

  • 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.

  • The cleanroom ceiling that started the walkable revolution, innovated and designed inhouse by AES engineers. The AES marquee system is AES’ hallmark system, a walkable monolithic ceiling system with an uPVC finish, with all seams cold welded together to create a monolithic finish. This system comes in either 2” [50mm] or 3” [75mm] thick, depending upon the application.

  • Presaturated cleaning wipes can offer many benefits over bottled solvents and dry wipes for cleanroom use. Contec’s presaturated wipes help reduce solvent use, increase convenience in hand wiping, reduce airborne VOCs, and increase process control and reliability.

  • Maintain compliance with modular monitoring systems. Integrate particle counters and microbial samplers into a secure data framework to ensure integrity and streamline your batch release process.

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