Traditional leak detection methods are destructive and costly, but improving leak detection processes and techniques for your packaging needs is as easy as purchasing a high-quality, modern machine that supports a non-destructive testing (NDT) method.
Explaining Leak Testing for Packaging
To meet good manufacturing practice (GMP) requirements, pharmaceutical packaging like blister packs, pouches and sachets, and rigid and flexible containers, must pass a leak test. If packaging fails the test, your product becomes exposed to oxygen or moisture, decreasing its quality and shelf life.
Destructive vs Non-Destructive Testing
Drug manufacturers test packaging for leaks in traditional facilities by placing them in water or blue dye baths. Then, testing professionals wait and observe if liquid makes its way into the packaging. If the packaging passes, it still has to be destroyed because it was used in a test, making this traditional way of leak testing destructive and expensive.
Using an NDT method allows the examined packaging to survive the test unharmed, saving you money and resources.
Choosing an NDT Method
There are five different types of NDT methods used to detect packaging leaks:
Vacuum Decay Leak Test
The vacuum decay leak test is used to ensure container closure integrity (CCI). The vacuum decay method identifies gross defects and micron leaks in packaging made for the pharmaceutical, medical device, and food packaging industries.
Pressure Decay Leak Test
The pressure decay leak test is an NDT method used to identify leaks and micron holes in plastic or glass containers filled with liquid or powder. Pressure decay testing is commonly used to test vials and ampoules that contain toxic products, oil-based liquid or lyo powder, glucose protein, or other products that can’t be tested using the vacuum decay method.
Force Decay Leak Test
The force decay leak test identifies leaks or weak seals in non-porous, sealed packaging. An ideal NDT 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.
Vacuum Deflection Leak Test
Used to test the integrity of pharmaceutical blister packs and packaging with multiple cavities or pockets, the vacuum deflection leak test is an NDT method that uses a 3D volumetric scanner to measure the deflection of blister pack surfaces in response to an applied vacuum. Its 3D scanning technology provides sensitive results as low as 5 microns, depending on the pack type and material used.
All NDT methods and techniques provide you with repeatable, accurate, and reliable results. However, successful leak detection is dependent on a highly trained, certified technician with experience performing the test. The technician should be certified in your preferred NDT method and also understand how to operate the equipment used to gather data.
Benefits of NDT Methods
Switching to NDT methods has a variety of benefits:
- Cost Savings: With NDT, your packaging survives the testing process unharmed, allowing your product to make it to market while saving you money and resources.
- Efficiency: With NDT, you can evaluate your assets thoroughly and quickly, a crucial factor for ensuring continued safety and performance at your facility.
- Accuracy: NDT is proven to be more accurate, predictable, and reliable than destructive testing methods.
Modern NDT Methods Matched With High-Quality Equipment
Ascend Packaging Systems partners with Sepha Ltd. to provide you with high-quality, non-destructive leak testing equipment that supports modern NDT methods for pharmaceutical packages.
The Sepha Multi-Q
The Sepha Multi-Q is a non-destructive, deterministic, and multi-functional CCI testing system designed to detect leaks in non-porous, rigid, or flexible packaging. This modern NDT machine is compatible with a variety of testing methods, including vacuum decay (ASTM F 2338-09) and pressure decay (ASTM E290-13).
Sepha’s lab-scale Multi-Q system is designed with a small footprint and offers the flexibility to switch between testing methods, depending on product and specified test requirements. Its CCI testing methods are easily changed, and relevant recipes for selected attachments are available. The Multi-Q’s non-destructive and deterministic test methods provide quick, reliable, and repeatable results, improving leak detection accuracy and reducing costs.
Other features of the Sepha Multi-Q include:
- Quick test time and recipe-driven
- Fast, tool-less changeover
- Batch data stored or printed
- Built for cGMP environments
- Grade 304 stainless steel body
The Sepha VisionScan 3D
The Sepha VisionScan 3D is a blister leak test solution that takes NDT methods to the next level. This next-generation machine is built around a new, patented 3D scanning technology that uses vacuum deflection to test the integrity of pharmaceutical blister packs.
With the latest technology, the VisionScan 3D provides a clear pass or fail result for each blister package, down to the exact cavity where leaks exist. The tested pack is unharmed, allowing your quality tablets to be put back on the production line. This simple but vital, non-destructive element saves you money and time and provides you with a more modern, reliable leak detection process.
Other features of the Sepha VisionScan 3D include:
- Flexible, mobile tabletop device
- Tool-less that are ideal for production lines running multiple products
- Can test multiple packs per cycle
- Simple operator use via a touch screen interface
- Patented, 3D volumetric scanner combined with differential vacuum and pressure
- Rapid test time down to 60 seconds for micron holes and 30 seconds for gross holes
- Capable of storing and exporting data for audit and quality control purposes
To learn more about Sepha’s leak detection equipment, reach out to Thomas today.
