Pressure Decay Method
The Multi-Q Pressure Decay method is developed to detect leaks in vials, lyophilized vials, ampoules, bottles, and other containers containing toxic product, oil-based liquid, protein/glucose, lyo/powder, or other content not suitable for Vacuum Decay leak testing.
The Multi-Q pressure decay test is easy to perform. The sample is placed inside a chamber that is designed based on container type and size to create the required fit. The chamber is pressurised, stabilised and the change in pressure is monitored over time. Any change in pressure indicates air is leaking into the sample being tested, resulting in a fail.
Depending on container type and size, the method can give a pass/fail result as quickly as 10 seconds, as low as 5μm*. The non-destructive technique provides deterministic, reliable, and repeatable results in line with USP 1207 guidelines.
* Dependent on container type and content
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Features
- Non-destructive, deterministic, quantitative test method
- Utilises pressure decay to identify defects as low as 5µm (container and content dependent)
- Ideal for testing lyophilized vials, vials, ampoules, bottles and other containers containing toxic product, oil-based liquid, protein/glucose or lyo/powder
- Rapid test time as low as 10 seconds
- 21 CFR Part 11 compatible
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Technical Spec
Container Type
Vials, ampoules and bottlesContainer Content
Oil based liquid, toxic product, glucose/protein, lyo/powderMeasurement Range (dependent on container type and content)
As low as 5μmTest Cycle Time
Starting from 10 secondOperation
Custom tooling attachable to top of unit or via test portData Storage Capacity
UnlimitedASTM Standard Test Method
N/AUser HMI
10.1” PCAP TouchscreenConnectivity
Active Directory available (via .NET or LDAP), network printing, central network storage, MESConnect / OPC ConnectivityUtilities
Electrical 24V 5A; Air Supply: Min. 200L/ min at 0.6Mpa {ISO8573-1:2010 Class 2} or vacuum pumpFeatures
Flexible reporting available on request, 3 x USB, ethernet port, external calibrated leak portWarranty
Supplied with a 12-month warranty. (Service Level Agreements and/or extended warranties are available for additional support). -
Pressure Decay
How does pressure decay leak testing work?
To conduct a pressure decay test, the container is placed in a test chamber that is pressurised to a target level.
The chamber is then allowed to stabilize, and the decay or loss of pressure is measured over a set period of time. Any change in pressure indicates air is leaking into the container being tested, indicating the presence of a leak.
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