Explaining Leak Tests for Vials
Leak tests for vials detect the presence of a leak in the container or package used to store and transport a product, but what are the different types of leak tests?
What Is Leak Testing for Vials?
Vial leak tests involve putting a pressure difference between the outside and inside of the container, then looking for a pressure drop over time or any other changes in the pressure that could indicate a leak. The pressure difference is usually generated by vacuum, compressed gas, or other methods.
When conducting a leak test for vials, there are several factors that must be taken into account, such as the type of material used to make the vial, its size, and the pressure used. It’s also important to consider the environment in which the test will be conducted, such as temperature and humidity levels and leak testing equipment.
Leak Testing for Vials: Destructive vs. Non-Destructive
Traditional leak detection testing involves drug manufacturers placing packaging in a water or blue dye bath to test for any leaks. If a leak is detected, the packaging is destroyed, and the entire process starts over again. Traditional leak testing techniques are not only destructive and expensive, but they also take up valuable time and resources.
How Non-Destructive Leak Detection Works
Non-destructive leak detection uses non-invasive methods to detect package leaks. NDT can be performed by applying pressure to the package, drawing a vacuum on the package and measuring for changes in pressure or flow, or using helium mass spectrometry to measure for gas escaping from the package. By using NDTmethods, you can identify any flaws in pharmaceutical packaging that could lead to harmful leaks quickly and accurately.
NDT is important for several reasons. It not only helps to prevent product waste, but it also eliminates the risk of exposure to oxygen and moisture from the outside environment that could potentially degrade your product. With non-destructive leak detection, you can make sure that your packaging isn’t compromised and that your product’s shelf life remains intact.
Different Methods of Leak Tests for Vials
Vacuum Decay
The vacuum decay leak test is an accurate, reliable, and efficient method for identifying gross defects and micron leaks in packaging used for medical devices and pharmaceuticals. The vacuum decay method works by exposing the sealed packaging to a vacuum. First, the package is placed in a vacuum chamber and the pressure is reduced until the package is subjected to a predetermined level. Then, the pressure inside the chamber is monitored over time to see if it rises back to its original level. Rising pressure indicates that the packaging has a leak.
Force Decay
Using a force decay leak test is simple and effective. The force decay method uses a device known as a gas-tight seal tester to apply a vacuum to the package to measure pressure changes. If the packaging is airtight, the vacuum remains unchanged. If the package contains a leak, the vacuum will slowly decrease, indicating a failed seal. The accuracy and reliability of the force decay leak test make it an ideal choice for quality assurance professionals in the food and beverage industry. It’s fast and easy to set up and requires minimal maintenance.
Pressure Decay
The pressure decay leak test is often used to detect leaks and micron holes in plastic or glass vials that contain a variety of products, such as toxic liquids, oil-based liquids, powders, and glucose proteins. This NDT method works by placing the container in the machine’s pressurized test chamber. To detect a leak or micron hole, the pressure is reduced and monitored for any drop in pressure. If the pressure drops, there’s a leak or micron hole in the container.
Vacuum Deflection
The integrity of pharmaceutical blister packs and multiple cavity packaging is essential for the safe delivery of medications and medical devices. That’s why the vacuum deflection leak test is a critical NDT method. This test uses a 3D volumetric scanner to measure the deflection of blister pack surfaces when exposed to an applied vacuum. By using the vacuum deflection method, you can even detect leaks as low as five microns, depending on the type of pack and material used.
Whether you run a small pharmacy or a large company, a deblistering machine can provide the efficiency you need.
A Vial Leak Testing Machine
The Sepha Multi-Q is an NDT machine that aligns with the FDA-approved ASTM F2338-09 standard test method and the 21 CFR Part 11 regulations. Using the vacuum decay method, the Multi-Q detects leaks as small as five microns in vials, ampoules, bottles, pre-filled syringes, and blow fill seal strips.
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
Providing You With Superior Leak Testing Equipment
At Ascend Packaging Systems, we understand the importance of using NDT methods to save you time, money, and resources. We make it a priority to provide you with superior leak testing equipment that uses a wide range of methods to ensure your packaging is leak-free, keeping your product safe and effective until it reaches the end user. We have over 50 years of experience in the pharmaceutical packaging industry, so you can trust that our leak testing solutions will help you maintain the quality of your products. Contact us today to learn more.
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Ascend Packaging Systems LLC is focused on bottle filling and blister packaging for the pharmaceutical industry. With our mix of self-manufactured and distributed products, we can support our customers with all their packaging equipment needs.
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Ascend Packaging Systems LLC.
3885 Industrial Avenue
Rolling Meadows, IL 60008
