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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