PTI insures the container closure integrity of pharmaceutical packaging formats that include parenteral products (vials, ampoules, syringes, autoinjectors) to blister packaging, induction sealed bottles and flexible packaging (pouches, sachets and suture packaging). The United States pharmacopeia released guidance in 2016 stating that deterministic methods are preferred over probabilistic test methods. Test methods offered by PTI are all deterministic and quantitative test methods that ensure the integrity of the supreme level. The PTI inspection systems for pharmaceutical packaging test methods are of the industry gold standard for sensitivity, reliability and performance. They are also non-destructive test methods that create zero waste.
The OptiPac One-Touch Tool-less system is designed for non-destructive blister package leak detection. Using principles similar to those applied in a vacuum based dye ingress test, the OptiPac applies controlled inputs and measured outputs without the hassle and reliability issues of the dye ingress method. OptiPac uses a volumetric imaging technology to measure the motion of a blister package under vacuum to detect leaks. The interface is practical and simple to setup with new blister package formats, requiring no tooling changeover or complex parameter adjustments experienced with other non-destructive blister package inspection systems.
The sample is placed on the testing area for vacuum-based measurement. After pressing the start button, vacuum is pulled to a defined vacuum. The blisters expand under vacuum, driving air out of the blister through any leaks present. If there is a leak in the blister, the air escapes into the chamber leaving a collapsed blister package. During the dynamic vacuum test sequence, a volumetric measurement reading is taken which determines which blister cavities are defective. A definitive pass/fail result is displayed as well as the quantitative measurement associated with each package test. Like other VeriPac systems, the OptiPac provides a definitive result based on accurate and measurable quantitative data, reliably detecting leaks down to 5 microns
The universal nature of the system comes from its ability to adapt from one package format to the next. The system captures the volumetric data from each cavity, adapting to different cavity shapes, sizes and arrangements of different blister pack formats. The intelligent measurement adaption allows for testing different package formats with absolutely no change-over, making it the most simple and universal blister package inspection system.
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Inspection Criteria
PTI insures the container closure integrity of pharmaceutical packaging formats that include parenteral products (vials, ampoules, syringes, autoinjectors) to blister packaging, induction sealed bottles and flexible packaging (pouches, sachets and suture packaging). The United States pharmacopeia released guidance in 2016 stating that deterministic methods are preferred over probabilistic test methods. Test methods offered by PTI are all deterministic and quantitative test methods that ensure the integrity of the supreme level. The PTI inspection systems for pharmaceutical packaging test methods are of the industry gold standard for sensitivity, reliability and performance. They are also non-destructive test methods that create zero waste.
- Leak detection and seal integrity testing of the entire package
- Test sensitivity down to 5 microns