Do you rely on your expertise alone to guarantee that your blister packaging is leak-free? While it’s recommended to have background knowledge on preventing blister pack leaks, it’s crucial to perform pack integrity testing to ensure your product remains safe and effective in the package.
Explaining the Effects of Micro Leaks and Pinholes on Blister Packaging
The truth is, there is always a tiny leak in all types of packaging. The factor that determines if a leak affects the product inside is the hole size. It’s typically up to the company’s quality control department to determine what size micro leak or pinhole would cause defects.
If micro leaks and pinholes are large enough, they can lead to unsterile products, and even a tiny defect allows microorganisms into the packaging, reducing the product’s shelf life significantly. When developing your packaging design, consider the smallest hole size allowed to keep your product safe and functional.
The Importance of Pharmaceutical Package Integrity Testing for Blister Pack Leaks
Pharmaceutical package integrity testing is crucial to ensure the packaging protects its contents from damage by maintaining sterility. An adequate sterile package prevents ingress of air and keeps the product safe and effective. Ingress of air through blister pack leaks, like micro leaks and pinholes, can negatively impact pharmaceuticals significantly, so you must be 100% confident in your pharmaceutical packaging integrity, ensuring it passes the proper integrity test.
Non-Destructive Leak Test Procedures for Pharmaceuticals
The best way to ensure your pharmaceutical packaging has no significant blister pack leaks is with a non-destructive testing (NDT) method. Using NDT methods allows the examined packaging to survive the integrity test unharmed, saving you money and resources.
Non-Destructive Blister Pack Leak Test Types
Several blister pack leak tests are considered NDT methods:
Vacuum Decay Leak Test
Used to confirm container closure integrity (CCI), the vacuum decay leak test locates pinholes and micro leaks in non-porous, rigid, and flexible packages. This NDT method provides several benefits. It:
- Reports pressure or flow loss
- Tests in pressure or vacuum environments
- Identifies leak rate based on pressure or vacuum
- Detects micro leaks and pinholes due to increased sensitivity
Pressure Decay Leak Test
A common test used for vials and ampoules that contain toxic products, the pressure decay leak test is an NDT method used to identify micro leaks in plastic or glass containers filled with liquid or powder. Pressure decay testing is often used on products that can’t be tested using the vacuum decay method.
Force Decay Leak Test
A perfect method for pouches, sachets, bags, and stick packs, the force decay leak test ensures the integrity of flexible packaging that contains solid or dry products. It’s an ideal NDT method to identify blister pack leaks or weak seals in non-porous, sealed packaging.
Vacuum Deflection Leak Test
The vacuum deflection leak test is a leak test procedure for pharmaceutical packaging with multiple cavities or pockets. It uses a 3D volumetric scanner to measure blister pack surface deflection by responding to an applied vacuum. Its 3D scanning technology provides sensitive results as low as five micron leaks, depending on the pack type and material used.
Micro Leak and Pinhole Detection for Blister Packaging
At Ascend Packaging Systems, we offer innovative blister pack leak testing machinery that ensures your packaging meets good manufacturing practice (GMP) requirements and passes integrity testing.
The Sepha VisionScan 3D
A perfect machine for micro leak and pinhole detection for blister packaging, the Sepha VisionScan 3D is a tool-less, non-destructive leak and pinhole detection device designed specifically for pharmaceutical blister packs with all foil types. An excellent alternative to destructive tests, like blue dye baths and other destructive options, the VisionScan 3D provides a precise pass or fail result for each blister package, detecting even the tiniest leaks down to the exact cavity where it exists. With the VisionScan 3D, your blister packs are unharmed, saving you time and money while taking the hassle out of your leak detection process.
VisionScan 3D features include:
- Simple operator use via a touch screen interface
- Uses a Vacuum Deflection Test Method according to ASTM standard F3169-16
- Cutting-edge, tool-less components for production lines running multiple products
- Rapid test time down to 60 seconds for micron holes and 30 seconds for gross holes
- Patented 3D measurement technology combined with differential vacuum and pressure
Preventing Blister Pack Leaks With High-Quality Machinery and Support
At Ascend, we help our customers prevent blister pack leaks that negatively impact product integrity and shelf life with our high-quality machinery and superior support. With more than 50 years of experience in the pharmaceutical packaging industry, we always keep an eye on the future, focusing on new solutions that improve blister pack leak detection. Our knowledge allows us to provide you with the best leak test procedure for pharmaceuticals available today. Contact us today to learn more about our blister pack leak detection solutions.
