INSIGHTS ON CRITICAL ENVIRONMENTS
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Global Regulatory Harmonization: Comparisons In Aseptic Barrier Systems
Compare global aseptic standards from the FDA, EMA, PIC/S, and WHO. Gain insights into how advanced barrier systems harmonize international requirements to ensure sterile product integrity and safety.
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Selecting A Platform Filter For High Concentration mAbs
Read more about how Fujifilm Diosynth Biotechnologies evaluated a prime filter with challenging simulant solutions and how the experimental data confirmed superior performance, which demonstrated twice the throughput.
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Inside Asymchem's Technology-Led Expansion Of Oligonucleotide Capabilities
Advances in synthesis, enzymatic ligation, and purification are reshaping oligonucleotide manufacturing, improving scalability, sustainability, and complexity from research to production.
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Inside The Cleanroom: Disinfectant Validation Demystified With Neil Simpson
Ensure cleanroom compliance by aligning disinfectant validation with real-world application methods. Learn to justify your protocols and adapt to facility changes through expert technical insights.
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10 Practical Tips For GMP Cleanroom Contamination Monitoring2/13/2026
A robust cleanroom monitoring program is your best defense against contamination. Align your strategy with Annex 1 to detect risks early, protect your product, and ensure patient safety.
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Environmental Monitoring In Advanced Therapeutic Medicinal Products Facilities3/5/2026
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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A Compact, Mobile Sterile Tube Welder5/11/2026
Streamline fluid handling connections while improving flexibility across lab and process environments with a compact, mobile sterile tube welding solution that supports multiple tube sizes.
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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.
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Minimizing Cleanroom Contamination Risks In Drug Manufacturing7/2/2024
Considering ergonomics is crucial for optimizing cleaning efficiency and minimizing contamination risks. Explore key ergonomic considerations in cleanroom cleaning, best practices, and more.
CRITICAL ENVIRONMENT SOLUTIONS
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Safeguard your cleanroom environment with secure material transfer solutions. Interlocking pass boxes prevent cross-contamination and maintain critical sterility during item transit.
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Biofluorescent Particle Counters (BFPC), like the TSI BioTrak® Real-Time Viable Particle Counter, are an alternative microbiological method that serves as the solution for Annex 1 compliance and Pharma 4.0 implementation.
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Discover the nanoparticle engineering, formulation and GMP manufacturing services that can drive forward your market success and unlock the power of “small."
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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.
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Contec’s autoclavable Compact Bucket System is an all-in-one solution to make cleaning and disinfecting easier and more efficient. The cart is designed for use with Contec's VertiKlean® MAX™, VertiKlean® MAX™ Sealed Edge, EasyCurve™ and QuickTask™ Mopping Systems.
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.
