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Blister packs are pre-formed packaging that are commonly used for tablets, capsules and certain consumer goods. They are made up of two primary components - a cavity made from a form of plastic or aluminum and a covering made from aluminum, paper or a lamination of soft foil. The cavity holds the product while the covering seals the product in the package.

While filling tablets into blister packs, the product is first fed into the desired cavities followed by sealing the cavity covering. Manufacturers of sterile pharmaceuticals highly depend on package integrity testing to verify product quality and safety.

Package Inspection Techniques

1. OptiPac Leak Detection System

OptiPac Leak Detection System is a non-destructive container closure integrity testing method developed specifically for multi-cavity blister packs. This leak detection method uses One-Touch Technology to achieve a rapid test cycle without requiring any changeover or sample preparation. Practical operation, sensitivity and reliability are the key features that make OptiPac technology ideal for blister package inspection.

To conduct the test, the operator places the blister pack on the test plate and presses the start button. The next step involves pulling vacuum to the desired vacuum level. The blisters expand under vacuum, driving air out of the blister through any leaks present. If the pack is defective, the air escapes into the chamber leaving a collapsed blister cavity. Depending on the blister cavity, OptiPac technology provides rapid detection of upto sub-5-micron defects. Additionaally, the technology displays a definitive pass/fail result along with quantitative measurement for each package tested.

2. VeriPac 410 Series

The VeriPac 410 inspection system utilizes a combination of Vacuum Decay technology and differential force measurement for container closure integrity test (CCIT) and leak detection of blister packs, sachets, and pouches with low headspace, such as transdermal patch packaging and suture packs. This technology can be used to test multiple packages in a single test cycle based on the package specifications. Additionally, it can also precisely identify which package or blister cavity is defective. VeriPac 410 inspection systems are proven to provide quantitative test results with a definitive pass/fail result. Being a non-destructive technique, VeriPac 410 allows tested products to be returned to the production line. This eliminates the cost and waste associated with destructive leak test methods. The ROI for the VeriPac 410 makes this a powerful solution for the pharmaceutical industry.

Benefits of VeriPac 410 Series

• Non-destructive, non-invasive, no sample preparation
• Non-subjective, accurate and repeatable results
• Capability to test multiple packages in a single test cycle
• Identifies which package is defective
• Simplifies the inspection and validation process
• Supports sustainable packaging initiatives
• ASTM test method and FDA standard
• Cost effective with rapid return on investment
• Scalable to automated inline testing.

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