Control Banding in the Pharmaceutical Industry

The pharmaceutical industry embraced the concept of control banding many years ago. Control banding is a process of assigning a compound to a hazard category that corresponds to a range of airborne concentrations – and the engineering controls, administrative controls, and personal protective equipment – needed to ensure safe handling. While the terminology used was different, the high potency of some pharmaceutical compounds required the use of alternatives to setting numerical occupational exposure limits (OELs), e.g., performance-based exposure control limits (PB-ECLs) or occupational exposure bands (OEBs), especially for early development compounds with limited information. The long experience in setting OELs for active pharmaceutical ingredients, and the myriad of engineering solutions required to achieve these internal exposure standards, paved the way for a more performance-based approach. Enrolment criteria were developed that were more descriptive than the prescriptive risk phrases used in the UK’s COSHH Essentials. The latter do not adequately address the types of effects potentially produced by pharmaceuticals, especially highly potent compounds. Internal experts are available in pharmaceutical companies to interpret the preclinical and clinical data for new drug products, including those with novel therapeutic mechanisms, against technical enrolment criteria that require more professional judgment.