To understand the performance characteristics of liposomal systems, it is important to
understand the mechanisms of introducing drugs into liposomes. That process is achieved using …

A process is described for the in-place automated cleaning of manufacturing and hold tanks.
The process evaluations conducted during cycle development are described. A qualified …

A cycle was developed for an automated in-place steam sterilization process of a large
volume batch (LVB) sterile holding tank assembled with product and tank vent filters and …

An approach is described for the design and evaluation of a steam-in-place (SIP) process
for the in-line sterilization of cartridge filters with a receiving tank. The process and system …

A process is described for the steam in-place sterilization of a closed system sterile holding
tank assembled with product and vent filtration equipment. This process permits complete …

… Suggy Chrai, Robert Clayton, Lenny Mestrandrea, Ted Myers, Ray Raskin, Max Sokol
and Chuck Willis …

Filtration of test solutions through a 0.2 μm-rated pore size pleated membrane filter cartridge,
designed for operation in a tangential (crossflow) mode, shows that throughputs with such …

A vial washing process is described for preparing clean, endotoxin-free glass parenteral
containers. This process is for 10-100–cc vial sizes with a 20-mm neck finish processed on the …

The authors have, in this report, assembled information which others may find useful in
evaluating their filtration processes. We emphasize that there is no single “right way” to validate a …