Manufacturing Sterile Parenteral Pharmaceuticals: How To Protect Oxygen Sensitive Formulations

By Derek Duncan

How well do you protect your oxygen sensitive formulations during filling? Many biopharmaceutical drug formulations have some degree of oxygen sensitivity. Monitoring the headspace gas composition of oxygen-sensitive product during filling serves as an in-process control of the nitrogen purging and can help ensure that the product being produced will retain stability and efficacy. This E-Book describes how to protect oxygen sensitive formulations, covering methods for in-process monitoring of oxygen, nitrogen purge optimization and validation, including nitrogen purge qualification and process development data of a manufacturing filling line.