AMY K. DOANE, ROBIN I. LIVINGSTON
CordenPharma Colorado
2075 55th Street, Boulder, Colorado  80301, USA

Abstract

CordenPharma’s Colorado API manufacturing facility has a long history of successfully implementing innovative solutions to ensure containment of Highly Potent Active Pharmaceutical Ingredients (HPAPI), designed to protect workers from the unique hazards presented by potent compound handling. While the success of CordenPharma’s programs requires effective Engineering Controls, the critical aspect to a robust containment program is the strength of the softer elements, including a Containment Culture, Process Development, Occupational Health Pre-Planning, and an ongoing Containment Execution Cycle. Without these supporting elements, even state-of-the-art containment equipment will not consistently and reliably contain HPAPI.

INTRODUCTION

CordenPharma’s manufacturing facility in Boulder, Colorado is an Active Pharmaceutical Ingredient (API) contra ... ...