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Sterilisation of chromatography media within a chromatography column by means of gamma irradiation

IP.com Disclosure Number: IPCOM000244905D
Publication Date: 2016-Jan-28
Document File: 2 page(s) / 201K

Publishing Venue

The IP.com Prior Art Database

Abstract

This publication describes a method of irradiating a chromatography column using gamma radiation. In order to reduce the adverse impact of gamma irradiation on the chromatography gel or resin (capacity loss), the resin is irradiated in dry state when already filled inside the column. The method allows for a re‐swelling of the gel under sterile conditions when it is hydrated. Thereby, the subsequent column packing can be finalized under sterile factory conditions after gamma treatment but prior to shipping to the end customer. The customer will receive a sterile column enclosed with aseptic connectors and provided with certified performance.

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Sterilisation of chromatography media within a chromatography column by 

means of  gamma irradiation 

 

 

This publication describes a method of irradiating a chromatography column using gamma  radiation.  In order to reduce the adverse impact of gamma irradiation on the  chromatography gel or resin (capacity loss), the resin is  irradiated in dry state when already  filled inside the column. The method allows for a re‐swelling of the gel under sterile  conditions when it is hydrated. Thereby, the subsequent column packing can be finalized  under sterile factory conditions after gamma treatment but prior to shipping to the end  customer. The customer will receive a sterile column enclosed with aseptic connectors and  provided with certified performance. 

 

By experimentation the authors have found that gamma sterilization of dry chromatography  gels causes less damage than an irradiation of wet gels. In order to utilize this advantage, a  dry pack column packing method was  applied after the closed, dry gel containing, column  was irradiated. Sterile filtered fluids were used in the final production steps, in addition to a)  re‐swelling/packing, b) HETP testing and c) equilibration in storage solution.  

 

Depending on the end user needs,  multilayer packaging (d...