Abstract

Considerations for Choosing a Primary Engineering Control for Compounding Sterile Products

Author(s): Wagner James T

Issue: Jul/Aug 2005 - Human Hormone Replacement Therapy

Page(s): 284-290

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Abstract

The introduction of United States Pharmacopeia (USP) Chapter <797> and the National Institute for Occupational Safety and Health (NIOSH) alert for preventing occupational exposure to hazardous drugs have renewed interest in engineering controls used for compounding sterile drugs. Engineering controls are engineered equipment or machinery that eliminate or reduce the potential exposure of a preparation or personnel to contamination or a hazard. Primary engineering controls are employed directly at the point of use. Examples of primary engineering controls used in aseptic compounding are laminar airflow workstations, biological safety cabinets, and barrier isolators. The design and construction of a facility contributes to protection of both the preparation and personnel, and thus is considered a secondary engineering control. Other secondary engineering controls include cleanrooms and negative-pressure containment rooms. This article reviews primary engineering controls along with a rationale for choosing one

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