Development and Validation of an Integrity Test Method for a Sterile Connection Device ( WEBDVTEST )
Single-use systems are known to offer a variety of advantages to users within biopharmaceutical manufacturing. The adoption of single-use systems requires suppliers to provide the industry with adequate single-use alternatives of existing and non single-use technologies. Sartorius Stedim Biotech developed a new connector for sterile fluid transfer that has been qualified applying the most stringent and innovative test regimes. This presentation will focus on the development and validation of an integrity test method for the Opta® SFT sterile connector.
Participants will have a better understanding on how to use the sterile connector by receiving an extensive walk-through of the product and learning its applications. Participants will also receive a overview on validation with a focus on the air flow test, the bacterial challenge test and the connection between the two.
At the conclusion of this session, participants will be able to: