INSIGHTS ON QUALITY CONTROL
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![Large-System-2016_Combo3]( "Pharma Custom Isolator For Sterile Lab Process")
Pharma Custom Isolator For Sterile Lab ProcessThis project showcases Germfree’s capacity to provide cutting-edge, bespoke solutions in pharmaceutical manufacturing, underpinning their dedication to innovation, safety, and quality.
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![Clinical Collaboration GettyImages-1288871608]( "Key Pillar Of A Successful CDMO: Exceptional Regulatory Compliance")
Key Pillar Of A Successful CDMO: Exceptional Regulatory ComplianceEnsuring regulatory compliance is paramount for a CDMO to meet manufacturing standards, warrant patient safety, and maintain its reputation.
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![GettyImages-1465073112-tablet-pill-OSD]( "A Closer Look At Multi-Lane Checkweighing In Pharma")
A Closer Look At Multi-Lane Checkweighing In PharmaLearn how multi-lane checkweighing boosts operational efficiency, ensures accurate dosing, and simplifies changeovers, making it ideal for applications like dual-chamber sachets and nutraceutical products.
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![Field Service Automation]( "EMPQ And Validation Support Services")
EMPQ And Validation Support ServicesA growing pharmaceutical/biotech company hired a global consulting firm for a project that required EMPQ services for qualification activities on a newly completed aseptic processing suite.
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Essential Insights Into Pharmaceutical Product Release: Part 21/13/2025
Optimizing pharmaceutical product release requires effective planning, specification development, electronic systems, and collaboration with CMOs, ensuring compliance, efficiency, and quality in the drug manufacturing process.
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Leachables Method Development, Validation And Relevant ICH References5/16/2025
It is crucial to develop and validate analytical methods capable of detecting a wide range of potential organic and inorganic leachables specific to the drug and its packaging.
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The Seamless Path To Market: End-To-End CDMOs As Your Strategic Ally Douglas CDMO5/14/2025
Partner with an experienced end-to-end CDMO to streamline development, reduce risk, and accelerate your drug’s path to market in today’s complex and competitive pharmaceutical landscape.
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Essential Insights Into Pharmaceutical Product Release, Part 1 Of 212/27/2024
Pharma product release ensures drug quality, safety, and regulatory compliance by evaluating manufacturing and quality processes. It’s a critical, comprehensive process essential for FDA approval and patient safety.
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ICH Q9 Revision 1: Enhancing Quality Risk Management8/12/2024
ICH Q9 Revision 1 advances the framework of Quality Risk Management (QRM) in the pharmaceutical industry, by addressing technological advancements and evolving regulatory expectations.
QUALITY CONTROL SOLUTIONS
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![Milliflex Oasis Filtration System for Bioburden Testing]( "Membrane Filtration Method For Productive And Reliable Bioburden Testing")
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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![GettyImages-1096502334-lab-microscope-research]( "R&D And Analytical Services")
Our team of analytical experts provides experience, efficiency, and technical proficiency in the development/validation of analytical methodology and GMP testing support for your project.
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![Milliflex Quantum Rapid Detection System]( "Rapid Bioburden Testing System To Detect Microbial Contamination Earlier")
Traditional bioburden testing (or microbial limit testing) takes several days to grow visible colonies of microorganisms, so identifying these and initiating corrective action takes longer. The Milliflex® Quantum system quantitatively detects microbial contamination in filterable samples in as little as a third of the time it takes with traditional plate-based monitoring methods. The Milliflex® Quantum system is based on fluorescent staining of all viable microorganisms, making emerging microcolonies visible to the system when they’re still too small to be seen with the naked eye. After rapid detection, the colonies can be reincubated to grow into visible colonies and be identified by any method—an approach that cleverly combines rapid and compendial bioburden testing.
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![Alliance iS HPLC System]( "Intuitively Simple HPLC System")
This intuitive and reliable HPLC system supports First Time Quality (FTQ) by reducing the risk of common errors and improving the accuracy of analytical measurements.
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![Lighthouse]( "Container Closure Integrity Testing Using Gas Ingress")
The CCI Test Vessel provides a simple means of preparing samples for container closure integrity testing (CCIT) using the highly-sensitive and non-destructive laser-based headspace analysis technology. When combined with a LIGHTHOUSE FMS Headspace Gas Analyzer, the CCI Test Vessel offers a robust solution for container integrity tests on a wide range of container types and packaging conditions.
