Do you rely on your expertise to guarantee that your blister packaging is leak-free? At Ascend Packaging Systems, we recommend having background knowledge on preventing blister pack leaks, but we also believe it’s crucial to perform blister pack testing using non-destructive testing (NDT) equipment that meets test method standards to ensure your product remains safe and effective in the package.
NDT equipment performs blister pack testing for leaks using a wide range of industry-standard methods based on packaging materials, products, systems, and services. At Ascend, we offer a variety of leak testing machinery for blister packs that meets the following regulations and standards:
21 CFR Part 11 is a set of regulations administered by the FDA pertaining to electronic records and digital signatures. To meet 21 CFR Part 11 compliance, many of our systems have:
ASTM F3169-16 is the industry-standard test method for leak detection in blister packaging using the vacuum deflection method by laser measurement. This international standard was developed by ASTM International, formerly the American Society for Testing and Materials. Our NDT equipment that uses the ASTM F3169-16 vacuum deflection method is an ideal solution for testing blister pack leaks in non-porous blister packs sealed with flexible lidding material.
ASTM F2338-09 is the standard test method administered by the FDA for non-destructive leak detection in blister packs using the vacuum decay method. The vacuum decay leak testing technique is ideal for non-porous flexible packages, rigid and semi-rigid packaging, and rigid, non-porous containers. Ascend offers multi-functional non-destructive leak testing equipment with different test methods, including the vacuum decay method outlined in the ASTM F2338-09 standard.
Traditional leak detection methods are destructive and costly—improving leak detection processes for your packaging needs is as easy as purchasing a high-quality, modern machine from us that supports NDT methods.
The Sepha VisionScan 3D uses the ASTM F3169-16 standard vacuum deflection leak test method to test the integrity of blister packs with multiple cavities or pockets. Using a 3D volumetric scanner, the vacuum deflection technique measures the deflection of blister pack surfaces in response to an applied vacuum, providing sensitive results to detect leaks as small as 5 microns.
Various industries depend on our leak detection equipment to test blister packaging integrity. Discover the industries we serve today.
Container closure integrity testing (CCIT) is crucial for testing pre-filled syringes and vials for leaks. CCIT can be a challenging process, but with Ascend’s NDT methods, you can rest assured your products are safe and effective in their packaging.
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 5 microns in vials, ampoules, bottles, pre-filled syringes, and blow fill seal strips.
Cutting Edge
Non-destructive, deterministic quantitative test method
Accuracy
Utilizes vacuum decay to identify leaks and micron holes as low as 5µm (container and content dependent)
Objective
Ideal for testing vials, ampoules, bottles, pre-filled syringes, blow fill seal strips, and other containers containing water-based liquid.
Speed
Rapid test time as low as 10 seconds
Validatable
Utilizes the ASTM F2338-09 standard test method to perform the leak test
Compliance
21 CFR Part 11 compliant
Container Type
Vials, ampoules, bottles, pre-filled syringes, BFS strips
Container Content
Water based liquid
Measurement Range (dependent on container type and content)
Down to 5μm
Test Cycle Time
Starting from 10 second
Operation
Custom tooling attachable to top of unit or via test port
Data Storage Capacity
Unlimited
ASTM Standard Test Method
ASTM F2338-09
User HMI
10.1” PCAP touchscreen
Connectivity
Active directory, network printing, central network storage, custom MES/OPC data connectors available. 3x USB, ethernet port, external calibrated leak port
Utilities
Electrical 24V 5A; Air Supply: Min. 200L/ min at 0.6Mpa {ISO8573-1:2010 Class 2} or vacuum pump
Features
Flexible reports
The Sepha Multi-Q HD is also an NDT machine that aligns with the FDA-approved ASTM F2338-09 standard test method, as well as the 21 CFR Part 11 compliance standard. This reliable machine also uses the vacuum decay method to detect leaks as low as 1 micron in pharmaceutical containers.
As an industry leader in packaging solutions, Ascend offers a wide range of packaging equipment and solutions for a variety of industries, including blister packaging machines and leak detection equipment to ensure your finished product is safe and leak-free. With Ascend and our manufacturing partners, you get reliable leak detection equipment that meets regulatory and industry standards. To learn more about Ascend and leak detection for blister packages, contact us today.
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