Method of integrity testing of a single-use system
AssigneeHoffmann-La Roche Inc.
InventorsKaren Aechtler, Thomas Raetz, Gerald Zieres
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Abstract
Disclosed is a method of integrity testing of a single-use system for processing a fluidic material. In the inventive method, a single-use system for processing at least one fluidic material is provided. The single-use system has at least one plastic component. A test gas is applied to a lumen of the single-use system. The test gas has one or more of spectral absorption or spectral emission properties in the infrared spectral range distinguishable from ambient air. At least a part of the single-use system is monitored using an infrared camera. A method of processing a fluidic material by using a single-use system and a test system for integrity testing of a single-use system are also disclosed.
Claims26
A method of integrity testing of a single-use system for processing at least one fluidic material, the method comprising:
- i) providing at least one single-use system for processing at least one fluidic material, the single-use system having at least one plastic component;
- ii) connecting a lumen of the single-use system to a supply line, wherein the supply line is connected to a valve that is switchable between a test gas supply and a fluidic material supply;
- iii) switching the valve to apply only the test gas to the single-use system, wherein the test gas has one or more of spectral absorption or spectral emission properties in the infrared spectral range distinguishable from ambient air;
- iv) monitoring at least a part of the single-use system by using an infrared camera;
- v) confirming the integrity of the single-use system;
- and
- vi) automatically switching the valve to introduce only the at least one fluidic material through the supply line and into the single-use system.
A test system for integrity testing of at least one single-use system for processing at least one fluidic material, the single-use system having at least one plastic component, the test system comprising:
- a) at least one test gas supply configured for applying at least one test gas to at least one lumen of the single-use system, wherein the test gas has one or more of spectral absorption or spectral emission properties in the infrared spectral range being distinguishable from ambient air;
- b) at least one infrared camera for monitoring at least a part of the single-use system;
- and
- c) a supply line coupled to the single-use system comprising a valve configured to switch between the test gas supply and a fluidic material supply.
Dependencies are inferred from the claim text.