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Buffer Preparation

2013-11-03

Buffer solutions are required in many purification steps in the manufacturing process of biopharmaceutical ingredients, such as chromatography, ulrafiltration, dialysis and buffer preparation.
Filtration of buffers is critical to ensure the efficiency and final product quality. In order to extend the life time of chromatography columns and downstream ultrafiltration system, and to ensure endotoxin-free final products, it’s recommended to use sterilizing filters for buffers. Prefilters can extend the service life of final sterilizing filters.

Separation Goals

Prefiltration
Reduce particles and bioburden prior to sterilizing filtration
● Final filtration
Remove bacterial and particulate contaminants

Application Requirements
● There are usually sodium acetate, phosphates and sodium phosphates in buffers. It’ not recommended to use prefiltration in the case of buffers less than 1 M salts in it.
● If buffers are not made of reagent-grade materials or contain high concentration of salts, prefiltration is necessary. And high flow rates and consistent high throughputs can be accomplished by appropriate combination between prefilters and sterilizing filters.

Recommendation

Filtration Step

Recommendation

Prefiltration

PES pleated cartridge or capsule filter

LPGF

Final filtration

LPS

Sterile venting

LPTA

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