INSIGHTS ON PHARMACEUTICAL INSPECTION
-
![Horizontal Optical Comparator]( "Inspecting On The Edge — Understanding Punch Tip Wear")
Inspecting On The Edge — Understanding Punch Tip WearWhy is a horizontal optical comparator highly recommended for tablet manufacturers as a measuring tool for punch tip inspection, and what strategies can be used to detect, reduce, and prevent tip wear?
-
![InQuest - problem video]( "What Is The Biggest Problem With Inspector Training And Qualification?")
What Is The Biggest Problem With Inspector Training And Qualification?Discover how a truly blind system eliminates bias from the human inspection process, improving data accuracy and validation of automated inspection systems.
-
![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-1690936576-inspection-in-factory]( "Physical Contamination Detection")
Physical Contamination DetectionLearn 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.
-
Advance Traditional CCIT With Dynamic Vacuum Decay5/22/2026
Dynamic vacuum decay advances traditional CCIT by improving leak detection. Learn how controlled, variable vacuum conditions deliver greater sensitivity and more reliable insight into package integrity.
-
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.
-
Autoinjector Testing: Addressing Sensitivity And Headspace Challenges1/30/2026
Micron‑level defects can jeopardize autoinjector sterility. Learn how vacuum decay offers a deterministic, repeatable way to verify container integrity and strengthen quality assurance.
-
Material Transfer Into A Cleanroom: How To Reduce Contamination Risk At Every Step4/20/2026
Evaluate packaging integrity and master wiping techniques to prevent cleanroom contamination. Focus on surface coverage and controlled transfer paths to ensure consistent product safety and quality.
-
Solving The Challenges Of Transdermal Patch Package Integrity1/5/2026
Ensuring transdermal patch packaging integrity is critical for safety and efficacy. See how advanced methods deliver precise, reliable leak detection, outperforming traditional approaches.
PHARMACEUTICAL INSPECTION SOLUTIONS
-
![GettyImages-1465073079-conveyor-belt-tablets-manufatcuring]( "Pharmaceutical Metal Detection Equipment")
Pharmaceutical Metal detectors identify small particles of stainless steel, ferrous, and non-ferrous metals that can enter the workflow from the manufacturing process, or raw materials.
-
![PTI owned image]( "Automated Deterministic Inspection Technologies For Complete QC Of Prefilled Syringes")
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.
-
![HDI 14]( "High Voltage Leak Detection for Blow Fill Seal (BFS) Vial Cards: HDI-14")
The HDI Pinhole Inspector from Nikka Densok offers 100% inspection for BFS vial card production.
-
![V35]( "Sophisticated 360° Inspection Of Round Containers")
V35- Advanced, automatic, high-throughput
Sophisticated 360° inspection of round containers. Get a complete picture of every package with six-camera configuration for maximum inspection.
Breakthrough Design
Unique six-camera configuration captures a 360° view of each product for 100% inspection of label design and packages up to 230 mm in diameter.
Automate Product Changeovers
Cameras adjust automatically to support a range of field-of-view-requirements on a variety of product sizes, enabling easier product changeovers.
High-Speed Configuration
Installs on new or existing production lines with speeds up to 1,000 ppm for minimal disruption to current processes.
-
![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.
