Blogs

Blister packs are common packaging formats for solid dose drugs in the form of tablets and capsules. Such packages not only preserve the quality of the drug, but also ensure ease of use to the consumer. Blister packages are commonly used by drug manufactures to ensure protection of the product from oxidation, moisture or other atmospheric pollutants which may lead to product degradation.

However, in recent years, the industry has seen a tremendous increase in the number of high-risk medicines, which are more sensitive to environmental condition than other tablets or capsules. This has further increased blister package integrity challenges. Although the number of environmental contaminants that can enter a package depends on leak size, with blister package, even minute leaks can become troublesome. Therefore, Container closure Integrity Testing (CCIT) of blister packs is extremely crucial.

OptiPac inspection system for non-destructive blister package testing

The OptiPac Leak Detection System is a deterministic non-destructive package integrity testing method created specifically for blister packs. Designed and engineered with One-Touch Technology, OptiPac achieves a rapid test cycle without requiring any changeover or sample preparation. This unique technology can provide rapid detection of sub-5-micron defects depending on blister cavity volume. Although OptiPac system uses similar principles applied in a vacuum-based blue dye test, it applies controlled inputs and measured outputs without the hassle and reliability issues of the dye ingress method. OptiPac uses 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 complex parameter adjustments experienced with other non-destructive blister package inspection systems.

Technology overview

OptiPac utilizes volumetric imaging under vacuum with topographic imaging to detect the presence and location of leaks. The test begins by placing the sample 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, and air is drawn out of the blister through any leaks present. In the presence of a leak, the air escapes into the chamber causing a collapsed blister cavity. A volumetric image and measurement reading is taken during the dynamic vacuum test sequence, that determines which blister cavities are defective. A definitive pass/fail result as well as the quantitative measurement associated with each package test is also displayed. PTI's OptiPac systems provide a definitive result based on accurate and measurable quantitative data, reliably detecting leaks down to 5 microns.

OptiPac’s insightful technology offers a suite of advanced functions:

• Auto configuration for easy recipe setup and validation of new blister formats
• Auto orientation of blister packs (test blister packs in any position –no specific orientation)
• Auto calibration is an integrated one-touch function
• Advanced batch reporting with audit trail including image of blister pack and defect results

OptiPac Benefits

• Non-destructive technology - Pass/Fail results backed by quantitative test data
• Completely tool-less
• No changeover to test different blister formats
• Identifies defective cavity
• Pre-loaded recipe library with easy recipe setup and validation of new blister formats