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Tablets and capsules, the backbone of oral medication, are commonly encapsulated in blister packs. These packs, crafted from thermoformed plastic and sealed with aluminum foil or film, offer a trifecta of advantages: protection, tamper evidence, and convenience. Shielding pharmaceuticals from physical damage, moisture, and light, blister packs ensure dosing accuracy and provide tamper evidence, instilling confidence in consumers. Furthermore, their user-friendly design facilitates easy dispensing and portability of individual doses.

Package integrity testing emerges as a critical component in pharmaceutical quality control. Compromised packaging poses multifaceted risks, including product loss, contamination, and degradation. Leaking or damaged packages can lead to economic setbacks for manufacturers and jeopardize consumer safety. Exposure to external elements such as moisture, light, or oxygen can degrade the quality of medication, compromising its therapeutic efficacy.

OptiPac Technology: Pioneering Non-Destructive Integrity Testing

The OptiPac Leak Detection System is a non-destructive container closure integrity testing method specifically designed for blister packs. Employing One-Touch Technology, OptiPac ensures a swift test cycle without the need for changeovers or sample preparation. This innovative technology enables rapid detection of sub-5-micron defects, contingent on blister cavity volume. Unlike the vacuum-based blue dye test, OptiPac applies controlled inputs and measured outputs, eliminating the complications and reliability issues associated with dye ingress methods.

Technology Overview

OptiPac employs volumetric imaging technology under vacuum, coupled with topographic imaging, to identify the presence and location of leaks. The testing process involves placing the sample on the testing area, initiating a vacuum-based measurement upon pressing the start button. As the blisters expand under vacuum, air is drawn out through any leaks present. In the case of a leak, the air escapes into the chamber, causing a collapsed blister cavity. The dynamic vacuum test sequence captures volumetric images and measurement readings, pinpointing defective blister cavities. The system delivers a clear pass/fail result, along with quantitative measurements for each package test. OptiPac systems by PTI yield definitive results based on accurate and measurable quantitative data, reliably detecting leaks down to 5 microns. The interface is user-friendly, requiring no intricate parameter adjustments for new blister packaging formats, setting it apart from other non-destructive blister package inspection systems.

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

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

Blister packs also known as press through packs are common packaging formats for 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 consumers. Blister packages are commonly used by drug manufacturers 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 amount of environmental contaminants that can enter a package depends on leak size, with blister packages, even minute leaks can become troublesome. Therefore, ensuring blister package integrity is extremely crucial.

Earlier traditional destructive methods such as the dye ingress method was used to test blister packages. But these methods were subjective, probabilistic and lacked accuracy in test results. This encouraged manufacturers to use non-destructive Container Closure Integrity test (CCIT) methods that were accurate and produced quantitative results with measurable result data.

PTI’s VeriPac Universal Blister Verification (UBV) system is a reliable and hassle-free technique to ensure blister package leak detection. These are deterministic non-destructive solutions specifically designed for multi-cavity blister packs. PTI’s VeriPac UBV utilizes volumetric imaging under vacuum to identify the presence and location of leaks.

Under this method, sample packages are placed inside the test chamber. After pressing the start button, vacuum is pulled to a pre-determined level. If any leaks are present, the packages expand under vacuum, and air escapes into the chamber causing blister packages to collapse. Volumetric measurement readings are taken during the vacuum test, that analyzes which blister cavities are defective. It is a rapid test that allows operators to get quantitative measurements associated with each package test in addition to definitive pass or fail results.

The UBV technology offers leak detection down to 10 microns with minimal test time, averaging 10-30 seconds depending on blister cavity volume. Test system requires no tooling changeover or other complex adjustments with simple interface for testing various blister package formats. This technology is specifically useful for tiny blister cavities which are quite difficult to detect using standard vacuum systems due to its low headspace.

Benefits of VeriPac UBV technology:

• Non-destructive package inspection system
• Accurate and reliable results
• Definite pass/fail result based on quantitative test data
• Accommodates multiple blister packaging formats with no tooling changeover
• Eliminates destructive, subjective testing methods
• Effective in detecting even minute leaks