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Supply of Sterile Buffer Filters

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The Challenge

A top 10 global pharmaceutical company with a European manufacturing site operating a continuous process line for the production of an enzyme for enzyme replacement had been let down by their existing buffer filter supplier who had failed to hold the required stock for them. 

The customer was very specific on delivery requirements, requesting pallet deliveries equivalent to two months' production and a single lot number per pallet of stock. 

The filters proposed for this application must also be compatible with the full range of buffers used in the customer's process.

Developing a Solution

Parker domnick hunter carried out some small-scale trial on buffer filtration applications and proposed PROPOR SG polyethersulphone sterilizing grade filter cartridges.

Our Technical Support Group (TSG) conducted filterability and compatiblity trials to confirm the filter's performance in the application as well as assisted in some integrity troubles shooting. 

The incumbent filter was a PVDF membrane filter so additional revalidation of of the PROPOR SG in the application was required because of the change in membrane material. 

The Results

Parker domnick hunter were able to offer the flexibility to accommodate the client's specific delivery requirements where the existing supplier could not.