INSIGHTS ON CRITICAL ENVIRONMENTS
-
Clarification & Prefiltration In Biopharm Formulation And Filling
Improve biopharma workflows with clarification and prefiltration that cut particulates and bioburden, protect downstream steps, and maintain protein product integrity.
-
Faster, Smarter Quality Decisions: Powered By TSI FMS Web Client Charts
Quickly visualize and access manufacturing data over time with customizable graphs. Prioritize critical information for faster, smarter quality decisions.
-
Beyond Breakdowns: Building A Culture Of Proactive Maintenance
Reactive maintenance can drive costly downtime, deviations, and reliability challenges. Learn how proactive maintenance strategies help improve equipment uptime and strengthen compliance.
-
OptiRun Connect: Faster Support To Minimize Downtime
Real-time monitoring and rapid support help detect issues early and keep critical equipment performing reliably. See how proactive alerts enable faster resolution and more efficient operations.
-
Sterile Filter Membrane Selection For Cell Culture Media Filtration8/24/2026
Membrane design and filtration capacity affect pressure, throughput, and scale-up. See how comparative testing reveals opportunities to reduce required filtration area, capsule use, and changeouts.
-
Protecting Product Integrity Through Cold Chain2/5/2026
Reliable temperature‑controlled storage, monitoring, and safeguards keep sensitive materials stable from fill to patient, protecting quality, preventing degradation, and ensuring safety.
-
Why You Need Spare Parts On Hand For Pharma And Lab Equipment8/19/2026
Advanced spare parts planning can reduce downtime. Learn why precise component specifications matter and how seemingly identical parts can differ significantly in quality, performance, and failure risk.
-
Bacteria To Consider For The Growth Promotion Test: Should Anaerobic Cultures Be Included?2/20/2025
The Growth Promotion Test (GPT) evaluates whether the culture media is suitable for use in environmental monitoring sampling. Explore recommendations to follow to ensure a successful GPT.
-
Advancing Clean Manufacturing Through Contamination Control That Never Compromises11/12/2025
Hear how real-time contamination monitoring helps life sciences teams protect yield and ensure sterility. Discover smarter ways to defend product integrity and respond confidently to contamination risks.
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.
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.
