MARVIN JOHN FABER*, GIUSEPPE GALATI, JEFFREY STEPHEN DINYER
*Corresponding Author
Patheon, 2100 Syntex Court, Mississauga, L5N 7K9, ON Canada

Abstract

Manufacturing highly potent pharmaceutical products can be challenging and must be done in a contained manner in order to ensure the protection of employees handling these materials. An example of a control banding method for pharmaceuticals that is used to categorize employee hazard is presented. A summary of the key components of an effective potent compound containment strategy is also discussed. This strategy is based on a “containment at the source” philosophy with engineering controls being the primary method of control. Also of consideration are secondary control methods (e.g. air flow, administrative control, work practices, etc.) and Personal Protection Equipment needs.

WHAT IS A HIGHLY POTENT COMPOUND?

To date, there is not a universally accepted or regulatory-defined position as to what exactly is a highly potent compound. However, the pharmaceutical industry generally suggests that a potent compound may include an active pharmaceutical ingredient (API) with a therapeutic dose ≤10 mg; with an Occupational Exposure Limit (OEL) ≤10 μg/m³ as an eight-hour time-weighted average (8-hr TWA); with carcinogenicity, mutagenicity, teratogenicity, or reproductive toxicant potential at low doses; or, by default, a novel compound with unknown potency/toxicity (1).

CONTROL BANDING AND OELS
With these general guides in place, one can begin to differentiate between low potent and high potent compounds. It is recommended to have a specific OEL value for every API. For details regarding the calculation of an OEL, the reader is referred to previous publications (2-7). In the absence of a specific OEL value, it is still possible to group an API into a low potent or high potent category using a categorization banding system. In essence, control bands are estimates of where a qualified toxic ...