INSIGHTS ON PHARMACEUTICAL INSPECTION
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Why A Dynamic, Digital Defect Library Is Now A Regulatory Expectation
Maintaining a dynamic, digital defect library is essential for modern sterile manufacturing. Learn how this approach helps ensure consistency in batch disposition and supports regulatory compliance.
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Small Bottle Side Grip Checkweigher
Ensure your small bottles are handled with stability and care on your production line while maintaining accuracy with a checkweigher that features a side-grip conveyor.
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Enhance Accuracy And Efficiency In Lightweight Applications
Streamline your operations within a single framework with advanced checkweighers that enhance industrial quality control with precise weight measurements and regulatory compliance.
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Visual Inspection Equipment To Deliver The Highest Product Integrity
Gain insight into an advanced inspection solution for pharmaceuticals that ensures drug integrity and reduces costs with flexible technologies, from lab development to high-volume production.
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A Comprehensive Guide To Sampling Protocols And Robust CCI Testing1/5/2026
Effective CCI testing hinges on strategic sampling and statistical rigor. Learn why 30 samples matter, how positive controls validate defect detection, and why risk assessment ensures long-term reliability.
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Microbial Ingress No Longer An Effective CCI Test Method1/5/2026
Microbial ingress testing is no longer a reliable measure of container closure integrity. Learn why its variability and limitations demand a shift to deterministic methods that deliver accurate results.
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5 Reasons To Invest In The Automatic Test System3/17/2026
Automated metal detector testing strengthens quality control. With faster checks and continuous system monitoring, operations gain higher accuracy, safer workflows, and better production efficiency.
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Lessons From FDA 483s And Warning Letters: Cleanroom Compliance12/8/2025
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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Advancing Drug Product Quality Through AVI And Future-Ready Infrastructure9/5/2025
Automated visual inspection (AVI) combines robotics, precision imaging, and sophisticated defect-recognition software to provide a scalable solution for expanding pipelines and rises in production volumes.
PHARMACEUTICAL INSPECTION SOLUTIONS
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Achieve ISO Class 5 containment for large-scale research equipment and robotics. These advanced enclosures ensure multi-level protection while maintaining rigorous aseptic standards.
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Our CVT inspection machine for syringes has been designed to process valuable drugs at an unparalleled speed, reaching up to 39,600 inspected units per hour. Thanks to its patented imaging technology, it provides reliable inspection results on difficult products such as foaming liquids, suspensions and viscous/gel-like products.
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The most current model, the Seal Integrity Monitoring System (SIMS) 1915+, is the ideal choice for your helium-based leak detection system. Compared to conventional vacuum bubble and dye penetration test methods, packages can be quantitatively tested using helium as the tracer gas that ensures higher levels of accuracy. Such an approach allows a comparison between multiple packaging materials and forms production line settings and stability storage conditions, supporting the entire lifecycle.
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The pharmaceutical industry continues to lead industries in terms of quality requirements and the value of data. The shift to more automated processes is less about the cost of human capital, but more about the pursuit of quality. The European Medicines Agency (EMA) updated Annex 1, driving for 100% inspection on fused containers and appropriate quality test measures for applications based on level of risk. The United States Pharmacopeia (USP) revamped Chapter 1207 on container closure integrity (CCI) to be prescriptive of deterministic technologies and encourages a deeper understanding of a container’s CCI requirements. The FDA continues to drive a ‘quality culture’ agenda versus a ‘compliance culture’, and the FDA has been explicitly targeting data integrity as a campaign for assuring quality. Every regulatory and guidance body is driving towards more reliable and accurate test methods.
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With the advent of more advanced drug development for a wide variety of injectable compounds and an increasing preference for self-administration, prefilled syringes are the largest parenteral package growth sector. In many ways, the prefilled syringe is more complex and intricate in comparison to a traditional vial, a sealed ampoule, or bottles with screw top closures. They have multiple sealing sites that require integrity, but there is also a functionality piece associated: the syringe plunger must be able to deliver a dose, and thus, is movable.