Biosepra Inc.

Hans Peter Lettner

Alois A Jungbauer

A method for sterilizing liquid chromatography resins that are highly resistant to oxidation by strongly oxidizing agents and a sterilization solution for use therein. In a preferred embodiment, the invention comprises contacting an oxidant-resistant chromatographic resin with an aqueous solution of peracetic acid and up to 40% ethanol. In particular, where the solution is to be used to sterilize a positively charged ion-exchange resin, the solution preferably additionally includes an acetate buffer of a sufficient ionic strength to prevent adsorption of the peracetic acid ions on the resin.

Method for sterilizing liquid chromatography resins highly resistant to

A liquid chromatography column well-suited for in situ sterilization effected by washing with a sterilization solution. In a preferred embodiment, the column comprises a liquid chromatography tube packed with a liquid chromatography resin. A piston assembly is mounted within the liquid chromatography tube towards the upper end thereof, the piston assembly including an upper portion and a lower portion, the lower portion being shaped to include a fluid distribution channel and a downwardly-extending collar, the downwardly-extending collar including an annular slot and defining an orifice in fluid communication with the fluid distribution channel. The column further includes a distributor for distributing fluid conducted through the fluid distribution channel over the entirety of the orifice, the distributor being positioned over the liquid chromatography resin and a corrugated expanding ring for mounting the distributor within the orifice, the corrugated expanding ring being mounted in the annular slot and serving to support the distributor. Preferably, the distributor is a metal plate, either in the form of a multilayer sintered metal filter, a perforated plate with a hole diameter less than the lower grain diameter of the resin particles, or a woven and/or sintered stainless steel monolayer welded onto a metal ring.

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Vienna, Austria

Hans Peter Lettner