INSIGHTS ON QUALITY ASSURANCE
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![Cleanroom GettyImages-184293451]( "ISO/DTR 14644 -21 Cleanrooms And Associated Controlled Environments")
ISO/DTR 14644 -21 Cleanrooms And Associated Controlled EnvironmentsHere, we review the Technical Report outlining how particle counters are used to classify and monitor cleanroom performance, ensuring it meets required standards under normal operating conditions.
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![450_300-screenshot_2025_08_11_113144]( "Reducing Risk, Decreasing Timelines, And Optimizing Outcomes")
Reducing Risk, Decreasing Timelines, And Optimizing OutcomesExplore the challenges of cell line development (CLD) in biologics commercialization and discover how integrated solutions can streamline your strategy, reduce risks, and optimize outcomes.
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![GettyImages-1441662840-lab-team-communication-collaboration]( "Design Testing Strategies To Develop A Drug-Device Combination Product")
Design Testing Strategies To Develop A Drug-Device Combination ProductLeveraging the expertise and experience of a trusted partner can reduce risk and accelerate the time to market for drug-device combination products by creating an optimal Validation Master Plan.
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![GettyImages-2163506576-computer-ai-compliance-regulatory]( "Ensuring AI Compliance In Life Sciences: 5 Critical Requirements")
Ensuring AI Compliance In Life Sciences: 5 Critical RequirementsLife sciences manufacturers face growing pressure to adopt AI while staying compliant. Discover five key areas to evaluate AI tools and how to simplify adoption with regulatory assurance.
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How Robotic Isolator Technology Aligns To Annex 1 Principles4/28/2025
Robotic gloveless isolators provide exceptional automation to eliminate human intervention and reduce contamination risk. Discover how they ensure compliance with the EU Annex 1 guideline to enhance sterility, precision, and monitoring.
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Understanding ISO/TR 14644-21 Airborne Particle Sampling Techniques2/26/2025
Industry expert Mark Hallworth guides viewers through the latest ISO document (ISO 14644), exploring the reasons behind the decisions made by the team during its development.
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Best Practices In Commissioning And Qualification7/5/2024
An integrated approach to C&Q ensures coordination and synchronization between commissioning and qualification activities, enhancing both regulatory compliance and product safety.
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EU GMP Annex 11: Compliance Strategy And Digital Solutions11/18/2025
Explore how EU GMP Annex 11 revisions could reshape global pharmaceutical compliance, as well as strategies for navigating implementation challenges and building future-ready validation programs.
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The Next Leap In Pharma Manufacturing8/8/2025
Explore how Industry 4.0 integration transforms pharma manufacturing through connected systems, data-driven insights, and predictive, compliant operations.
QUALITY ASSURANCE SOLUTIONS
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![ÄKTA oligosynt™ oligonucleotide synthesizer]( "Meet The Latest Member Of The Oligo Synthesis Family")
Discover a system with a flexible synthesis scale, intuitive software, and robust process control that is ideal for labs moving from research to production.
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![Software Validation GettyImages-1357020474]( "Reduce The Burden Of Software Validation Testing")
Are you bogged down by the endless protocols and documentation CSV requires? Do you feel overwhelmed by exhaustive testing but unsure of how to implement CSA?
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The FMS-Water Activity Analyzer is a non-destructive gas analyzer for making water activity measurements of solid dosage drug product samples.
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![GettyImages-1849575910-scientist-laboratory-lab-coat-inspection]( "Expert Support For Container Closure Integrity")
Accelerate compliance with CCI methods that deliver reproducible results, ultra-sensitive leak detection, and global regulatory alignment to ensure product integrity while reducing risk and delays.
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![image1]( "Cleaning Validation (21 CFR Part 211.67)")
Alconox, Inc. can assist you in selecting an appropriate cleaner for cleaning pharmaceutical manufacturing equipment and utensils to prevent malfunctions or contamination that would alter the safety, identity, strength, quality or purity of the drug product beyond the official or other established requirements.
