Buffers are used throughout the production of pharmaceuticals and buffer filtration is essential in protecting downstream chromatography and ultrafiltration equipment, controlling bioburden throughout the process and maintaining an endotoxin-free final product.
Growing pressure to decrease production time and increase throughput means the optimization of buffer filtration stages has never been more important.
PES membrane is recognized as having exceptional flux rates compared to alternative membranes such as PVDF, as well as being more chemical-resistant.
Parker domnick hunter supplies a choice of PES-based filters – the PROPOR range - for bioburden reduction or assurance of sterility, which can be used for a wide range of buffers, including difficult to filter buffers such as 6M urea.
The PROPOR range of filters provide a more efficient, cost-effective system.
Benefits of the PROPOR range
- Using a filter from the PROPOR range speeds up filtration time by up to 40%, meaning more batches can be processed per day, relieving the bottleneck that often occurs in the buffer preparation area.
- The range can provide a smaller system size, reducing the cost per batch.
- The PROPOR range has been shown to outperform its competitors in filtering a wide range of common buffers, including those which are more difficult to filter, such as 6M urea.
Standard sterilizing grade filtration
- PROPOR SG single layer 0.2 micron filters are configured for maximum flow rates and assured sterility
- For standard buffers requiring sterility such as those used as fermenter additions or in final product formulations, PROPOR SG offers reduced batch processing time.
Bioburden reduction filtration
- PROPOR BR 0.2 micron filters deliver bioburden reductions of >log5 and incorporate an integral depth prefilter layer to extend filter life under high precipitate loading.
- PROPOR BR filters are ideal for buffers used in applications that only require bioburden reduction such as chromatography and diafiltration.
Sterilization of difficult to filter buffers
- PROPOR HC dual layer 0.2 micron filters maximize throughput to ensure sterility of more difficult to filter buffers
- The highly asymmetric PES prefilter layer provides up to 10 times improvement in capacity compared to single layer membrane filters.
Reducing filtration system size
Tests have been completed on competing sterilizing-grade PES membrane products using a standard range of buffers. Results show that significant benefits can be achieved using the PROPOR range.
Buffers chosen for test were:
- 1M hydrochloric acid (pH=1)
- 1M sodium hydroxide (pH=13)
- 50mM tris-buffered saline (pH=8)
- 10mM phosphate-buffered saline (pH=7)
- 50mM phosphate-citrate buffer (pH=5)
- 0.1M acetic acid
- 10% ethanol
- 6M Urea
This post was contributed by Andrew Kelly, Filtration Product Manager (Life Sciences), Parker domnick hunter Process Filtration, UK.
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