Drug manufacturers use filters widely in their manufacturing processes for bioburden
reduction and sterility assurance. In implementing a pharmaceutical filtration, it is essential …

Sterile filtration is one example of a process using a polymeric component for
whichextractables and leachables are a concern. Ideally sterile filtration removes …

This paper describes a comprehensive approach for the extractables analysis of filter
cartridges used in pharmaceutical production processes. For the extraction of the cartridges …

Biopharmaceutical companies are using disposable assemblies at a rapidly increasing rate.
Single-use technologies are becoming available for a range of applications and process …

Sterile filters are ubiquitous in biopharmaceutical manufacturing processes. Because such
filters are in direct contact with the process fluid, profiling of the extractables is of utmost …

Single-use systems for manufacturing biopharmaceuticals can include filter capsules,
connectors, tubing, and polymeric film biocontainers. In order to tackle the variety of …

This publication describes the development of an experimental set-up and testing protocol to
test the hypothesis that filters used for sterile filtration can act as scavengers of leachables …

Studies were conducted to characterize potential extractables from sterilizing grade filters.
The focus of this report is the 0.22 μm Durapore (hydrophilic modified PVDF) filter which is …

Users of single-use (SU) components need extractables data to demonstrate material safety
for regulatory bodies before incorporation in the biopharmaceutical process. In this context …

Many filters release particles and water-soluble materials when eluted with distilled water.
Some filters tend to shed a proportion of the filter matrix (media migration); membrane filters …