INSIGHTS ON QUALITY CONTROL
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Software Simplifies 21 CFR Part 11 and Annex 11 Compliance
21 CFR Part 11 and Annex 11 regulate electronic records and signatures in biomanufacturing, ensuring data integrity, security, and compliance while enabling efficient processes and regulatory alignment.
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Optimizing Contamination Control: Strategy Planning And Execution
In a highly regulated environment, maintaining facility compliance is paramount. See how a robust contamination control strategy ensures compliance, product quality, and operational efficiency.
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Engineering Controls For Sterile Compounding — USP Requirements And Equipment Selection
Aligning compounding operations with USP <797> and <800> requires an integrated control strategy. Discover key criteria for cleanroom equipment selection.
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Designing An Environmental Monitoring Solution For GMP Applications
Implement robust contamination control strategies that align with current regulatory requirements. Optimize your environmental monitoring framework through precise design and data-driven analysis.
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Sterilization Of APIs – The Alternative: Sterile Filtration Following Aseptic Processing5/21/2026
When terminal sterilization isn't an option for heat- or radiation-sensitive APIs, sterile filtration with aseptic processing protects quality. Get the technical framework.
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QC In The Whole Genome Sequencing Library Preparation Workflow3/19/2026
Take a look at how electrophoresis systems differ in sizing accuracy and why those distinctions matter for assessing high‑molecular‑weight DNA and protecting QC checkpoints across sequencing workflows.
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Pharmaceutical Product Solutions6/16/2026
Discover how advanced inspection technologies, precise checkweighing, and data-driven automation secure pharmaceutical lines, protect product integrity, and ensure strict regulatory compliance.
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Ensuring Consistent Quality In Pharmaceutical Water For Injection (WFI) Systems Application Note3/6/2026
Maintaining high-quality water for injection is essential for pharmaceutical safety. Discover how strategic design, proactive maintenance, and risk-based monitoring ensure reliable results.
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Ensuring Consistent Quality In Pharmaceutical Water For Injection (WFI) Systems Presentation3/5/2026
Maintaining high-purity water is vital for pharmaceutical production. Explore key strategies for system design, risk mitigation, and rigorous process control to ensure consistent regulatory compliance.
QUALITY CONTROL SOLUTIONS
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Protect your clean suites with active material airlocks. These systems utilize vertical laminar airflow to flush contaminants, ensuring seamless, compliant transfers between cleanliness zones.
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The United States Pharmacopeia USP 1207 guidance has been revised, encouraging the preference to deterministic, quantitative, and reliable non-destructive technologies to comply with quality standards.
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Bioburden testing and microbial limit testing are quality control tests for determining the total number of viable microorganisms of pharmaceutical and medical products. Thanks to its many cleverly designed features, the Milliflex Oasis® is a particularly productive and reliable membrane filtration method for performing bioburden testing in accordance with USP, EP, and JP recommendations, ensuring that patients can call upon microbially safe products.
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The Milliflex® Rapid System 2.0 brings together membrane filtration and ATP bioluminescence to detect, image and quantify microcolonies of bacteria, molds and yeasts up to 4 times faster than compendial bioburden or sterility testing methods.
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Sterility testing is a requirement to confirm that pharmaceutical products purporting to be sterile do not contain viable microorganisms before being released and administered to patients. So, it is vital that the method used for testing medical devices, pharmaceutical products, formulations, tissue materials, and other products is both reliable and accurate.