INSIGHTS ON QUALITY CONTROL
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CDMO Audit Coverage: Key Focus Areas And Compliance Objectives
CDMO audits focus on compliance, quality, performance, and relationships to reduce risk, ensure clear documentation, and align customer expectations with CDMO capabilities.
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A Decision Focused Guide To Contamination Control From Design To Opening
Stop treating contamination control as a late-stage detail. Learn how making early, intentional design choices prevents startup delays and ensures your new cleanroom is ready for inspection.
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Lessons From FDA 483s And Warning Letters: Cleanroom Compliance
Learn 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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Understanding FDA Calibration Requirements And Best Practices For Reducing Risks
Become equipped with the tools and strategies needed to strengthen your calibration efforts and better position your organization for success in regulatory audits.
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Monitoring Microbial Contamination Of Mammalian Cell Cultures2/21/2025
Mammalian cells are widely used to produce complex processed molecules. Explore a system that effectively detects microbial contamination in mammalian cell cultures and utilizes a newly formulated lysis buffer.
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Multi-Lane Checkweigher Overview6/16/2026
Optimize high-speed lines with compact multi-lane checkweighing that monitors twelve channels on one screen, features detachable conveyors, and prevents product jams.
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Physical Contamination Detection3/23/2026
Learn how physical contaminants enter production lines and how detection systems like metal detection and X-ray inspection help prevent defects and recalls to strengthen quality control.
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The Scalability Of Depth Filters For CHO Cell Culture Clarification7/19/2024
Clarification using depth filtration is standard in monoclonal antibody (mAb) manufacturing. Here, we showcase the scalability of Stax™ mAx depth filters, demonstrating their effectiveness.
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Improved High-Speed Performance X-Ray6/16/2026
Maintain uncompromised inspection clarity at maximum operational speeds. Learn how a specialized sensor captures distortion-free imaging at 80 meters per minute.
QUALITY CONTROL SOLUTIONS
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Ensure aseptic integrity with zoned downflow technology. These customizable modules purge contaminants to maintain ISO Class 5 environments for critical filling and research processes.
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Protect your lab and ensure weighing accuracy with specialized containment enclosures. These units neutralize air turbulence and capture hazardous powders to maintain a safe, high-precision workspace.
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BioPass™ Pass Through: Seamless Transfers With Built-In Sterilization To Prevent Cross-Contamination
Streamline large equipment transfers with integrated bio-decontamination. This airtight system ensures a log 6 microbial reduction while maintaining strict ISO Class 5 cleanroom integrity.
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The Powder Rheology Accessory expands the DHR’s capabilities to powders, enabling the characterization of behaviors during storage, dispensing, processing, and end-use.
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Pyrogen detection is one of the mandatory release tests for sterile parenteral drugs testing in the course of pharmaceutical quality control. Test methods being used are the rabbit pyrogen test (RPT), the bacterial endotoxin test (or LAL test), and the monocyte activation test (MAT).