Are you still using traditional leak detection methods to ensure your packaging stays dry? It’s time to throw out the old methods with the blue dye bath water and look toward the future of testing packaging for leaks with non-destructive leak testing. Read on to learn more.
What Is Non-Destructive Leak Testing?
Non-destructive leak testing (NDT) is used to ensure that pharmaceutical packaging is free of leaks that could cause product damage, decrease shelf life, or lower product effectiveness.
To meet good manufacturing practice (GMP) requirements, all pharmaceutical, food and beverage, and medical device packaging requires leak detection. However, traditional testing methods, such as Blue Dye testing, increase costs and product waste. Modern packaging companies are turning to non-destructive leak testing methods to save time and money, reduce waste, and improve testing processes to achieve more reliable, repeatable results.
Explaining How Leaks Impact Pharmaceuticals
If your packaging has leaks, you increase the chances of your product becoming contaminated due to oxygen or moisture exposure from the outside environment, degrading its quality and effectiveness and decreasing its shelf life significantly.
Different Types of Non-Destructive Leak Testing Methods
Non-destructive leak testing (NDT) methods allow you to test your packaging for leaks without destroying test samples.
Some drug manufacturers test packaging for leaks and sub-par seal standards using destructive methods that include placing the packaging in water or blue dye baths. Then, they wait and observe if liquid makes its way into the packaging. If the packaging passes, it’s still required to be destroyed since it was used in a test, making this traditional way of leak testing expensive and time-consuming. Using an NDT method allows the examined packaging to survive the test unharmed, saving you money and resources. Different types of NDT methods are:
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. The vacuum decay leak test can be used to test a wide range of packaging types for leaks, such as:
- Rigid, non-porous containers
- Plastic, screw-capped bottles containing solids
- Flexible, non-porous sachets and pouches
- Glass or plastic vials containing liquids
- Glass or plastic ampoules containing liquids
- Glass, pre-filled syringes containing liquids or solids
Pressure Decay Leak Test
Pressure decay is a non-destructive leak testing 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 NDT method. Pressure decay testing is currently referenced in the revised USP 1207 guidance as one of the recommended deterministic test methods preferred over other testing methods, such as the blue dye or bubble test. The revised chapter applies to vials, ampoules, syringes, and bags.
Vacuum Deflection Leak Test
The vacuum deflection leak test is an NDT method that tests for blister pack leaks on packaging with multiple cavities or pockets. Its 3D scanning technology provides sensitive results as low as 5 microns, depending on the pack type and material used. This method is commonly used to check for leaks during packaging production and for stability trials to ensure that faulty packs aren’t included in the study.
Force Decay Leak Test
Force decay is a non-destructive leak testing method that identifies leaks or weak seals in non-porous, sealed packaging. Force decay is an ideal NDT method for pouches, sachets, bags, and stick packs to ensure the integrity of flexible packaging containing solid or dry products.
Leak Testing Equipment for Blister Packs
Traditional leak detection methods are destructive, costly, and time consuming—improving leak detection processes for your blister packaging is as easy as purchasing a high-quality, modern leak testing equipment for blister packs that supports NDT methods:
The Sepha VisionScan 3D
The Sepha VisionScan 3D uses the ASTM F3169-16 standard vacuum deflection non-destructive leak testing method to test the integrity of blister packs with multiple cavities or pockets. Using a 3D volumetric scanner, the VisionScan 3D measures the deflection of blister pack surfaces in response to a vacuum, providing sensitive results to detect leaks as small as 5 microns.
Seal Integrity Testing Equipment for Other Packaging Types
Seal integrity testing equipment is crucial to confirm that bottles and other packaging types are equipped with the right seal strength and integrity to make sure your packaging is leak-free and your product inside stays safe and effective. Weak or partial seals can occur during the final sealing stage, so it’s important to invest in a machine that uses a non-destructive leak testing method to minimize recalls and reduce costs.
The Sepha BottleScan
The Sepha BottleScan is a bottle leak testing machine that uses a multi-bottle leak tester for induction-sealed pharmaceutical bottles containing dry products. By offering impressive capabilities like testing up to four bottles per cycle in 30 to 90 seconds and detecting leaks down to 15 microns, the BottleScan is an ideal solution for production lines with multiple products—but that’s not all. It can also store up to 30,000 recipes, is GMP certified, and can be part of a system that’s 21 CFR Part 11 compliant.
The Sepha PakScan
Using force decay NDT technology, the Sepha PakScan is a seal integrity testing machine that tests the strength and integrity of seals in pouches, sachets, bags, and stick packs containing dry powder or medical devices. The PakScan can test four large sachets simultaneously and is equipped with an intuitive software that offers a clear result for each separate package in the batch.
Providing You With High-Quality, Non-Destructive Leak Testing Equipment
Ascend Packaging Systems partners with Sepha Ltd. to provide you with high-quality, non-destructive leak testing equipment that supports NDT methods for pharmaceutical packages. No matter how unique your packaging demands are, Ascend has the leak detection solutions you need to ensure packaging integrity and product quality. Contact us today to learn more about our leak testing equipment.
