Figure 1: Sartopore® Platinum TwinPleat () Sterile filtration using 0.2-µm rated filters is a critical step in upstream and downstream biomanufacturing alike. Typical applications comprise sterile media addition into the bioreactors, cell harvest clarification post-depth filter, chromatography column protection, and final sterile filtration of purified bulk drug substance. Total throughput, flow rate, unspecific adsorption, and wettability of sterile filters can have direct impact on total cost of ownership. There have been innovative application-specific approaches in sterile filtration…
Author Archives: Mandar Dixit
Sartopore® 2 XLM
Filters rated at 0.1 µm have been increasingly used for cell culture media filtration due to concerns about mycoplasma contamination of cell cultures. Sartorius Stedim Biotech has recently launched a new 0.1-µm, mycoplasma-retentive, sterilizing grade filter: Sartopore® 2 XLM. it is a heterogeneous, double-layer PES membrane filter with a highly asymmetric 0.2-µm prefilter layer in-built with the same 0.1 µm mycoplasma-retentive final membrane as its predecessor, Sartopore® 2 0.2/0.1. Sartopore® 2 0.1-µm. 10″ cartridges have been validated as mycoplasma-retentive by…
Optimum Prefilter Selection and Filter Train Sizing for Media Filtration
The use of 0.1-µm rated sterilizing grade filters has been increasing in cell culture media filtration due to mycoplasma contamination concerns. Currently, no standards exist for conducting mycoplasma retention testing on these 0.1-µm labeled filters. A task force has been established at PDA to publish a technical report to standardize testing. Until such guidelines are published, conducting side-by-side tests under identical conditions is the only fair way to compare different 0.1-µm rated filters. Sartorius Stedim…
High-Performance Sterile Filtration
Figure 1: Dead-end filters using microporous membranes of synthetic polymers such as PES, polyamide, cellulose acetate, and PVDF are extensively used for microbial control in a wide range of biopharmaceutical liquid filtration applications. Typical applications include sterile media addition into bioreactors, cell harvest clarification, chromatography column protection, and final sterile filtration of purified bulk drug substances. Downstream processing in the biopharmaceutical industry requires multiple bioburden reduction steps that commonly use 0.2-µm sterilizing grade filters. There are innovative application-specific approaches in…