INSIGHTS ON CRITICAL ENVIRONMENTS
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Normalized Data In Microbial Continuous Monitoring
Learn how EU GMP Annex 1 (2022) redefines cleanroom air monitoring standards and emphasizes continuous viable sampling in Grade A and B environments to ensure aseptic integrity and compliance.
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The Crucial Role Of Cleaning In Effective VPHP Decontamination For Isolators
Effective isolator cleaning is crucial for vapor phase hydrogen peroxide (VPHP) decontamination. Proper tools, techniques, and training ensure sterility, and regulatory compliance.
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At-A-Glance Monitoring: Inside The TSI FMS Web Client Dashboard
Understand your environment quickly with real-time, customizable data and interactive controls, whether you manage a single site or multiple locations.
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Sustainable Manufacturing Through Efficient BioProduction Unit Operations
Delve into the critical environmental and economic aspects of bioprocessing. Explore the urgent need to manage the industry’s growing plastic waste issue and a three-pronged approach to address this challenge.
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Is Sustainability The Key To Agile Biopharma Manufacturing?3/18/2025
In biologics manufacturing, change is constant. Discover how new innovations and a focus on sustainability have gotten 62% of executives to prioritize eco-friendly practices, which reflects a commitment to long-term viability.
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Why Compounding Pharma Manufacturers Should Evaluate BFS Systems12/5/2024
Discover how BFS technology offers compounding pharmacies and 503B facilities enhanced sterility, reduced errors, cost savings, and superior product integrity for aseptic pharmaceutical manufacturing.
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Airflow Visualization Studies: The Impact Of Annex 1 On Sterility Assurance12/18/2024
Airflow visualization techniques like Smoke Studies and CFD analyses are crucial for contamination control, aiding cleanroom qualification, environmental monitoring, and optimizing contamination control strategies under Annex 1.
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Monitor Cleanrooms Anytime, Anywhere8/4/2025
Remotely monitor cleanroom environments with secure, real-time data access from any device, anywhere, helping to streamline operations and ensure compliance.
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A Data-Driven Approach to Cleaning Validation10/21/2024
Discover how Ongoing Process Verification, guided by PAT and digital integration, ensures consistent cleaning efficacy, reduces risks, and optimizes production efficiency in the pharmaceutical industry.
CRITICAL ENVIRONMENT SOLUTIONS
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A widely used method to inactivate bio-contamination on surfaces in GMP controlled areas is sporicidal gassing using vaporized hydrogen peroxide (VHP). This decontamination process uses a free radical reaction to kill microorganisms on surfaces.
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The newly redesigned equipment includes Laminar Flow Hoods, Biological Safety Cabinets, and Cleanroom Pass-Through Boxes. These new products build on Germfree's 60 years of aseptic PEC expertise in both the hospital compounding and pharmaceutical industries. The equipment has been designed to meet and exceed the strict cGMP and USP <797>/<800> regulatory requirements found in these industries.
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Natoli Scientific’s preclinical stability studies represent a critical facet of our pharmaceutical testing services, providing essential data on the shelf life and storage conditions of drug candidates. These studies are expertly designed to evaluate physical, chemical, and microbiological stability, ensuring that formulations retain their safety, efficacy, and quality over time. Our state-of-the-art facilities simulate various environmental conditions to scrutinize the integrity of products under stress-testing scenarios. The results gleaned from our stability studies guide the development of robust drug formulations and packaging, aid in regulatory submissions, and lay the groundwork for successful commercialization.
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Solujet cleaner is the detergent to consider for your next new pharmaceutical cleaning project. Unlike a leading CIP cleaner, Solujet has high wetting surfactants that enhance emulsifying, wetting, dispersing and rinsing. The surfactants allow faster, more efficient cleaning and easier rinsing.
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Ensure GMP compliance for your bioproduction systems by investing in an extended warranty for optimal performance, high product quality, and effective cost management throughout your system's life cycle.
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.
