INSIGHTS ON PHARMACEUTICAL INSPECTION
-
![Lessons Learned From FDA 483s And Warning Letters – Strengthening GMP Cleanroom Compliance In Life Sciences]( "Lessons From FDA 483s And Warning Letters: Cleanroom Compliance")
Lessons From FDA 483s And Warning Letters: Cleanroom ComplianceLearn critical lessons from FDA 483 observations and Warning Letters to proactively address common GMP cleanroom compliance failures and build an inspection-ready facility.
-
![GettyImages-1356054921-glass-vials-pharmaceutical]( "Helium Leak Detection On Glass Cartridge Containers")
Helium Leak Detection On Glass Cartridge ContainersHelium leak detection offers unmatched sensitivity for verifying glass cartridge seal integrity. Learn how this advanced method outperforms traditional tests and provides confidence in packaging.
-
![GettyImages-1166528597-scientist-lab-equipment-tubing]( "Automated PUPSIT For Drug Product Applications")
Automated PUPSIT For Drug Product ApplicationsAutomated filtration systems streamline PUPSIT, leak testing, and integrity checks to ensure sterile drug product processing. Learn how these methods improve contamination control and compliance.
-
![GettyImages-1622777883-water-for-injection-ampule-glass-wfi-ampules]( "Ensuring Consistent Quality In Pharmaceutical Water For Injection (WFI) Systems Presentation")
Ensuring Consistent Quality In Pharmaceutical Water For Injection (WFI) Systems PresentationMaintaining 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.
-
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.
-
EU And PIC/S Annex 1: CCS Shortfalls After 2 Years Of Implementation4/16/2026
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.
-
Part II: Defining The Dye Ingress Operating Window2/12/2026
Learn about the viscosity-driven limits of dye ingress testing, translating qualitative constraints into a quantitative feasibility boundary shaped by defect size, pressure behavior, and plunger mechanics.
-
Nebulizers: Package Integrity Testing Challenges And Solutions1/5/2026
Maintaining sterile packaging for nebulizer drugs is vital to prevent contamination. Learn how regulatory standards and advanced leak detection methods address integrity challenges in high-risk formats.
-
Why Is It Important To Have Properly Trained Visual Inspectors?8/4/2025
Properly trained visual inspectors are crucial for identifying defects in parenteral drugs, safeguarding patient safety and product quality.
PHARMACEUTICAL INSPECTION SOLUTIONS
-
![Vials GettyImages-483051555]( "Deterministic Micro Leak Testing System For Parenteral Products")
The VeriPac 465 performs leak detection based on the basic principles of physics and does not require the use of trace gasses or sample preparation to perform the test. The VeriPac 465 core technology is based on the ASTM vacuum decay leak test method (F2338) recognized by the FDA as a consensus standard for package integrity testing. This test method was developed using VeriPac leak test instruments.
-
![Anritsu - XR75]( "Pharmaceutical X-Ray Inspection System for Blister Packaging: XR75")
The XR75 Pharma X-ray is optimized for the quality control of pharmaceutical, nutraceutical, and cosmetic products in thin opaque packaging materials that cannot be inspected manually or with visual systems.
-
![Seal Integrity Monitoring system]( "Seal Integrity Monitoring System (SIMS) 1915+ (Helium Leak Detection)")
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.
-
![GettyImages-GettyImages-1438426028-meat-label-steakmeat-label-steak]( "Advanced System For Bottom Inspection")
Efficient, customizable, intuitive use
Advanced bottom inspection of a variety of packages. The system supports customized lighting and can be extended with top cameras for further applications such as seal contamination inspection.
Effective Bottom Inspection
Supporting up to 400 ppm, capture the nuances associated with various product shapes or sizes where a larger field of view is required.
Application Based Design
Cameras and advanced lighting options help overcome challenging applications where wet, reflective, or uneven surfaces interfere with imaging.
Intuitive Software
Powerful CIVCore software offers a range of inspection options for easy setup and configuration.
-
![Compliance-virtual-diagram-GettyImages-1370928101]( "Annex 1 Pharmaceutical Container Closure Integrity Testing Requirements")
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.
