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Blister packaging is a popular form of packaging used in the pharmaceutical, medical device, and consumer goods industries. It consists of a cavity or pocket made from a formable web of plastic or aluminum, which securely holds the product (such as tablets, capsules, or small devices) and is sealed with a lidding material.

Ensuring the integrity of blister packages is of utmost importance, especially for products that are sensitive to moisture, air, or contaminants. A leak in the blister package can compromise the quality, efficacy, and shelf life of the enclosed product, leading to potential safety risks for consumers and financial losses for manufacturers.

Leak testing is a critical quality control process that assesses the seal integrity of blister packages to identify potential leaks or weak seals. By performing leak testing, manufacturers can identify defective packages and take corrective action before products reach the market.

OptiPac Technology for Blister Package Leak Detection

The OptiPac One-Touch Tool-less system is designed for non-destructive Container Closure Integrity Testing (CCIT) of blister packages. It is a deterministic technique that utilizes volumetric imaging in vacuum together with topographic imaging to identify leaks and where they are located. The OptiPac employs controlled inputs and measured outputs using concepts similar to those used in a vacuum-based dye ingress test, but without the inconvenience and reliability difficulties of the dye ingress approach. By utilizing One-Touch Technology, OptiPac provides a quick test cycle without the need for complicated parameter modifications or changeovers, as seen with other non-destructive blister package inspection systems.

OptiPac Blister Package Inspection System which makes use of volumetric imaging technology provides high levels of sensitivity and reliability. The volumetric imaging method uses many imaging techniques with a complex deep algorithm. The test operator selects a recipe for the blister package using the HMI touch screen, then arranges it in any direction on the test plate. Vacuum is drawn to a predetermined vacuum as soon as he presses the start button. Under vacuum, the blisters enlarge, and any air leaks cause the air to be forced out of the blister. If the blister has a leak, air enters the chamber and collapses the blister cavity. To identify which blister cavities are defective, volumetric images and measurements can be acquired during the test technique. Additionally, the system shows the quantitative measurement for each product tested along with a clear pass/fail result.

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.
• No changeover to test different blister formats.
• Pre-loaded recipe library with easy recipe setup and validation of new blister formats.
• Completely tool-less.
• Identifies defective cavity.

Proper leak testing can improve production efficiency and reduce waste by identifying and resolving issues in the packaging process promptly. It enhances overall product quality and increases consumer confidence, which are essential factors for maintaining a competitive edge in the market.

As technology advances, we can expect further developments in leak testing methods, leading to even more accurate, efficient, and cost-effective solutions. Manufacturers should stay updated on these advancements and continuously improve their testing procedures to stay at the forefront of quality assurance.

Container Closure Integrity (CCI) refers to whether a container keeps the sterile barrier intact. Environmental pollutants can quickly turn a life-saving therapy into a microbial soup if there is a leak or breach of the sterile barrier. The CCIT of blister packages is a critical process in ensuring the quality and safety of pharmaceutical products. Blister packages are commonly used to package solid-dose medications such as tablet and capsules.

The CCI testing of blister packages is performed to ensure that the package is properly sealed and that there are no leaks or defects that could compromise the quality of the medication inside. This testing is important because if the package is not properly sealed, moisture and oxygen can enter, potentially degrading the medication and reducing its effectiveness.

Overview of OptiPac Technology

OptiPac One-Touch Tool-less Leak Detection Technology is a non-destructive method for testing the integrity of blister packaging that is designed to detect any leaks or defects in the package's seal. OptiPac uses volumetric imaging technology to measure the blister cavities under vacuum and identify leaks. The OptiPac applies controlled inputs and measurable outputs without the inconvenience and reliability concerns of the dye ingress approach. It is designed with One-Touch Technology to accomplish a quick test cycle needing no changeover or tools for various blister formats. Unlike other non-destructive blister package inspection systems that demand complicated parameter modifications, OptiPac requires no tooling replacement with new blister package forms.

The test begins by placing the sample on the testing area for vacuum-based measurement. Vacuum is pulled to a definite vacuum after pushing the start button. Under vacuum, blisters expand and push air out of the blister through any leaks that may be present. If there is a leak in the blister, air leaks into the chamber and collapses the blister package. The defective blister cavities are identified using a volumetric measurement reading during the dynamic vacuum test cycle. Along with the quantitative measurement related to each package test, a clear pass/fail result is displayed.

Functions Offered by OptiPac's Insightful Technology

• 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.

In addition to selecting the appropriate method for leak testing, other factors to consider when performing blister package leak testing include the type of material used for the package, the seal strength of the package, the packaging process, and the potential for environmental factors to affect the package's integrity. By carefully considering these factors and implementing an effective leak testing (pharmaceutical package testing) process, pharmaceutical companies can ensure that their products are of the highest quality and meet regulatory requirements.