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US 7,732,216 B2Granted
System and method for testing chromatography media and devices
AssigneePall Corporation
InventorsSamuel Nochumson, Peter Levison
Life of this patent
Estimating the term…
Abstract
Methods for testing the chromatography type and/or the integrity of a chromatography membrane or monolith, preferably, for testing the chromatography type and integrity of a chromatography device comprising a chromatography membrane or chromatography monolith while the membrane or monolith is sealed in a housing, are disclosed.
Claims18
A method for testing the integrity of a chromatography membrane sealed in a housing comprising:
- obtaining a chromatography device comprising a housing and having one or more chromatography membranes to be tested sealed in the housing;
- obtaining a selected analyte that will bind to the membrane(s) under standard binding conditions;
- placing the analyte in contact with the membrane(s) under standard binding conditions;
- eluting the analyte from the membrane(s) with an elution fluid to form an eluate containing the eluted analyte, the eluted analyte having a measurable concentration in the eluate;
- measuring a change in the concentration of the eluted analyte in the eluate over a period of time to provide an elution pattern for the tested membrane(s);
- comparing the elution pattern for the tested membrane(s) to a reference elution pattern for a membrane of known integrity;
- and
- determining the integrity of the tested membrane(s).
5 more elements
A method for testing the integrity of a chromatography monolith sealed in a housing comprising:
- obtaining a chromatography device comprising a housing and one or more chromatography monoliths to be tested sealed in the housing;
- obtaining a selected analyte that will bind to the monolith(s) under standard binding conditions;
- placing the analyte in contact with the monolith(s) under standard binding conditions;
- eluting the analyte from the monolith(s) with an elution fluid to form an eluate containing the eluted analyte, the eluted analyte having a measurable concentration in the eluate;
- measuring a change in the concentration of the eluted analyte in the eluate over a period of time to provide an elution pattern for the tested monolith(s);
- comparing the elution pattern for the tested monolith(s) to a reference elution pattern for a monolith of known integrity;
- and
- determining the integrity of the tested monolith(s).
5 more elements
A method for testing the type and integrity of a chromatography membrane sealed in a housing comprising:
- obtaining a selected analyte, the analyte being capable of binding, under standard binding conditions, to a chromatography membrane having a specified chromatography type;
- obtaining a chromatography device comprising a housing and one or more chromatography membranes to be tested sealed in the housing, the one or more chromatography membrane(s) having a chromatography type to be tested to determine whether the membrane(s) has/have the specified chromatography type;
- placing the analyte in contact with the membrane(s) under standard binding conditions wherein the analyte binds to the membrane(s) if the membrane(s) has/have the specified chromatography type;
- contacting the membrane(s) with an elution fluid to form an eluate, wherein the eluate contains the eluted analyte if the membrane(s) to be tested has/have the specified chromatography type, the eluted analyte having a measurable concentration in the eluate;
- measuring a change in the concentration of the eluted analyte in the eluate over a period of time to provide an elution pattern for the tested membrane(s);
- comparing the elution pattern for the tested membrane(s) to a reference elution pattern for a membrane of known integrity;
- and
- determining the integrity of the membrane(s) and whether the membrane(s) has/have the specified chromatography type.
5 more elements
A method for testing the type and integrity of a chromatography monolith sealed in a housing comprising:
- obtaining a selected analyte, the analyte being capable of binding, under standard binding conditions, to a monolith having a specified chromatography type;
- obtaining a chromatography device comprising a housing and one or more chromatography monoliths to be tested sealed in the housing, the one or more chromatography monolith(s) having a chromatography type to be tested to determine whether the monolith(s) has/have the specified chromatography type;
- placing the analyte in contact with the monolith(s) under standard binding conditions wherein the analyte binds to the monolith(s) if the monolith(s) has/have the specified chromatography type;
- contacting the monolith(s) with an elution fluid to form an eluate, wherein the eluate contains the eluted analyte if the monolith(s) to be tested has/have the specified chromatography type, the eluted analyte having a measurable concentration in the eluate;
- measuring a change in the concentration of the eluted analyte in the eluate over a period of time to provide an elution pattern for the tested monolith(s);
- comparing the elution pattern for the tested monolith(s) to a reference elution pattern for a monolith of known integrity;
- and
- determining the integrity of the monolith(s) and whether the monolith(s) has/have the specified chromatography type.
5 more elements
Dependencies are inferred from the claim text.