INSIGHTS ON PHARMACEUTICAL INSPECTION
-
A Comprehensive Guide To Sampling Protocols And Robust CCI Testing
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.
-
Effective Strategies To Minimize Product Loss During Fill Finish
Every drop of high-value biologic lost in fill finish is money left on the table. Learn practical strategies to protect your yield.
-
EU And PIC/S Annex 1: CCS Shortfalls After 2 Years Of Implementation
Explore how to elevate Contamination Control Strategies from static documents to inspection-ready, lifecycle tools, as well as practical approaches to Annex 1 compliance and risk-based CCS development.
-
Microbial Ingress No Longer An Effective CCI Test Method
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.
-
Multi‑Sample Testing With Precise Failure Detection For Throughput12/29/2025
Test multiple samples at once with a multi‑sample testing platform that ensures accurate detection for low headspace formats and integrates into automated lines for high-volume efficiency.
-
Start Packaging Development Early5/12/2026
To avoid costly delays later in the product lifecycle, it is essential to plan for key variables early and select container closure systems with confidence from the outset.
-
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.
-
Visual Inspection Equipment To Deliver The Highest Product Integrity4/1/2025
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.
-
USP Draft Chapters On CCS: What You Need To Know5/12/2026
Learn why it's important to stay aligned with evolving Annex 1 expectations to support sterility assurance, regulatory compliance, and patient safety across sterile drug manufacturing operations.
PHARMACEUTICAL INSPECTION SOLUTIONS
-
Until now, inspecting vials and syringes has required two separate machines. Discover a high-quality inspection solution for small batches of syringes and vials on a single machine.
-
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.
-
As the governing regulatory document of the European Medicines Agency (EMA), EU GMP Annex 1 discusses a full host of concepts related to manufacture of sterile medicinal products. In contrast to guidance documents issued by the FDA, EU GMP Annex 1 is interpreted as law, requiring strict adherence to the regulatory expectations contained, numerous of which allude to container closure integrity testing. In fact, current proposed and ongoing revisions increase the expectations of scrutiny on package integrity.
-
Versatile, Reliable Inspection.
Next generation industrial metal detector delivers high sensitivity with ease of use to deliver affordable quality control. Suitable for dry or wet product inspection. -
The Thermo Scientific Quickfit metal detector conveyors are a high quality material handling solution for the APEX metal detector family.