New Methods Can Ease Validation by Maximizing Consistency of Results Viral filtration operations are evaluated and validated using scaled-down models of production processes. In a scaled-down study, a ...

It is a complicated and lengthy process to bring a product to market, even more so when producing a sterile product, for example, ophthalmic preparations, injections, dialysis solutions, irrigation ...

Membrane filters play a critical role in providing sterile air and gases in pharmaceutical, biotechnology and containment applications. The filters must be proficient in removing airborne viruses ...

It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the ...

Pre-use integrity testing of sterilizing-grade filters eliminates the potential adverse effects of filter loading on the integrity-test results, allowing unambiguous correlation with the ...

Model organisms are useful when validating sterile filtration, but successful retention of the model organism does not always guarantee that effluent is sterile. The authors explore the various ...