Volumetric Imaging

The OptiPac inspection system for multi-cavity blister packaging offers a tool-less changeover mechanism, allowing easy switching between different blister package formats.

Blister package manufacturing involves using materials like plastic or foil to create cavities that protect tablets or capsules, ensuring the product’s shelf-life by acting as a barrier against environmental contaminants. One common test used for assessing package integrity is the dye ingress test, where the package is visually inspected for blue dye penetration after being subjected to a vacuum cycle while submerged in dye. Despite its apparent simplicity, this method can be affected by various conditions, leading to unreliable results and reduced effectiveness in assuring product quality.

PTI ensures the container closure integrity of various pharmaceutical packaging formats, including parenteral products (vials, ampoules, syringes, autoinjectors), blister packaging, induction-sealed bottles, and flexible packaging (pouches, sachets, and suture packaging). In 2016, the United States Pharmacopeia emphasized the preference for deterministic methods over probabilistic test methods. PTI offers deterministic and quantitative test methods, ensuring the highest level of package integrity. Their inspection systems for pharmaceutical packaging are known as the industry’s gold standard, delivering exceptional sensitivity, reliability, and performance. Moreover, these methods are non-destructive, contributing to zero waste.

The OptiPac One-Touch Tool-less system is specifically designed for non-destructive blister package leak detection. Similar to vacuum-based dye ingress tests, it applies controlled inputs and measured outputs without the complications and reliability issues associated with dye ingress methods. The system utilizes volumetric imaging technology to measure the motion of a blister package under vacuum, effectively detecting leaks. It offers a user-friendly interface for easy setup with new blister package formats, requiring no tooling changeover or complex parameter adjustments found in other non-destructive blister package inspection systems.

During the dynamic vacuum test sequence, the blister sample is placed on the testing area, and vacuum is pulled to a defined level. The blisters expand under vacuum, driving air out of the blister through any leaks present. Leaking blisters collapse, and a volumetric measurement reading is taken to determine defective blister cavities. The system provides a definitive pass/fail result, along with quantitative measurements for each package test. The OptiPac reliably detects leaks down to 5 microns, ensuring highly sensitive and accurate inspection.

What sets this system apart is its universal adaptability from one package format to another. It captures volumetric data from each cavity, allowing testing of different package formats with no changeover required. This adaptability makes it the simplest and most versatile blister package inspection system available.