Product Sterility

START 5 Product Sterility

1. Turnaround time: 4 weeks

USP <71>

Sterility studies may be carried out via membrane filtration method (liquid products and extracts from solid products) or via direct transfer method (solid products). Using the direct transfer method, products are aseptically transferred directly into the appropriate media. Using the membrane filtration method, products are agitated, the extract fluid filtered through a filter membrane, and then the membrane is transferred onto the appropriate media. The media used are TSB and FTM per USP guidance.