Serving approximately 3,000 customers across 12 facilities in the United States, Mexio, Asia and Europe, Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. With an array of over 900 laboratory tests and the expertise of Regulatory Compliance Associates, the company supports its customers from initial product development and sterilization validation, through regulatory approval and ongoing product testing for sterility, safety and quality assurance.

In this conversation, Christine Walton, Senior Scientist, Nelson Labs, dives into the proposed regulatory chapters USP <1119> and <1119.1>, discussing their purpose, scope, limitations, potential impact and more.

Contract Pharma: What are the new proposed regulatory chapters USP <1119> and <1119.1>, and what impact will they have on bioburden testing and biopharmaceutical manufacturing?

Christine Walton: Before we look at the specifics of these new chapters it may be helpful to review the history that led to these chapters’ creation. The new general chapters in…