INSIGHTS ON CRITICAL ENVIRONMENTS
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![Lessons Learned From FDA 483s And Warning Letters – Strengthening GMP Cleanroom Compliance In Life Sciences]( "Lessons From FDA 483s And Warning Letters: Cleanroom Compliance")
Lessons From FDA 483s And Warning Letters: Cleanroom ComplianceLearn critical lessons from FDA 483 observations and Warning Letters to proactively address common GMP cleanroom compliance failures and build an inspection-ready facility.
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![RCMP-Gooseneck-Trailer-Exterior]( "A Comprehensive Solution For Critical Sample Analysis")
A Comprehensive Solution For Critical Sample AnalysisDiscover how Germfree Laboratories overcame challenges for the Royal Canadian Mounted Police by designing a mobile lab with advanced biocontainment and state-of-the-art communication systems.
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![GettyImages-1341291802 cleanroom]( "Normalized Data In Microbial Continuous Monitoring")
Normalized Data In Microbial Continuous MonitoringLearn 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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![Germfree Room Feature]( "Maintain Compounding Capacity: Discover The Benefits Of Mobile Compounding")
Maintain Compounding Capacity: Discover The Benefits Of Mobile CompoundingLearn more about a standard Mobile USP <797> / <800> compounding pharmacy and how they are the fastest way to ensure the delivery of life-saving medications to patients.
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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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Optimizing Cleaning And Disinfection As Part Of An Effective CCS6/6/2024
Watch to explore the relationship between a Contamination Control Strategy (CCS) and the development of a robust cleaning and disinfection program for cleanroom environments.
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Guide To PUPSIT And Annex 1 In Aseptic Processing12/5/2024
Pre-use, post-sterilization integrity testing (PUPSIT) ensures filters remain undamaged and effective during aseptic manufacturing. Discover how you can successfully perform PUPSIT with proven solutions.
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Quickly Set Up A Zone For Efficient Cleanroom Monitoring6/11/2024
Watch to see how easy it is to start collecting data according to your standard operating procedure with a portable particle counter.
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Constructing Capabilities: Holistic Infrastructure Development In Decentralized Manufacturing5/15/2024
In this panel discussion we review key considerations for decentralized cell therapy manufacturing, including the importance of designing identical and cloned processes.
CRITICAL ENVIRONMENT SOLUTIONS
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![GettyImages-2198092021-gear-futuristic-blue-highlight]( "Is Now The Time To Upgrade Your ÄKTAprocess™?")
Effectively managing maintenance for bioprocessing systems is challenging. Discover hardware that offers durability and proactive strategies that are essential to mitigate wear and optimize performance.
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![GettyImages-1370928101 regulatory compliance]( "Contamination Control Products For Annex 1 Compliant Facilities")
Explore the details of a contamination control strategy, tips for managing disinfectant residues, general guidelines for removing disinfectant residues, and a wide range of products for cleaning and disinfection.
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![bioGO Mobile cGMP]( "Mobile cGMP Biopharmaceutical Cleanroom Trailers: bioGo®")
Germfree’s bioGO® Mobile Cleanrooms are available in multiple configurations to meet a wide variety of cGMP product development, production, and training applications.
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As part of the standardised product range, Extract Technology’s Mobile Automated Glove Tester provides an effective means of a controlled automated pressure test of gauntlets and cuffed assemblies.
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![Let’s Get Checked – Mobile BSL-2+ Clinical Laboratory]( "Mobile BSL-2+ Clinical Laboratory Facility and Equipment from Germfree")
In the aftermath of the COVID-19 pandemic, clinical laboratories were faced with an urgent need to rapidly expand their testing capacity. Given the importance of disease surveillance in a public health crisis, Germfree's priority was to quickly create a series of rapidly deployable laboratory spaces that could be used for disease surveillance in emergencies, as temporary laboratory spaces, and as swing spaces.
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.
