DAVID E. KAELIN Sr.
Chilworth Technology, Inc., 113 Campus Drive, Princeton, NJ 08540, USA

Abstract

This article reviews those aspects of Oral Solid Dosage, OSD operations where a dust deflagration hazard may exist and suggests an approach to the management of the risk based on a Basis of Safety. The Basis of Safety for the management of dust deflagration hazards is based on the fire triangle and the control of fuel, oxidant and/or ignition sources. Specific discussion is included on several common OSD unit operations including: powder charging, fluid bed drying, dust collection and dust collectors, powder milling and tableting.

Many of the solid ingredients (powders) used in the creation of Pharmaceutical oral solid dosage (OSD) formulations have been shown to be combustible. Such materials can form flammable atmospheres when suspended in the air. In addition, many of the unit operations typically required in pharmaceutical facilities can create flammable atmospheres. The deflagration hazards associated with powdered combustible materials will influence process equipment specifications, the design of HVAC systems, need and specification of electrical area classification, and room construction techniques. It is therefore necessary for OSD manufacturers to clearly understand the deflagration hazards presented by the powdered materials utilized in their processes, and be able to assess the level of deflagration risk that their operations may present. It is the expectation of the Occupational Safety and Health Administration, OSHA, that employers maintain a workplace free of hazards that are likely to cause injury or death to employees including combustible dust deflagration hazards. In addition, OSHA expects employers to assess dust explosion hazards and apply appropriate safeguards in keeping with curren ...