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Primary Engineering Controls in Pharmaceutical Compounding, Part 1: Unidirectional-airflow Workstations, Compounding Aseptic Isolators, and Compounding Aseptic Containment Isolators

Author(s):  Mulder Kyle

Issue:  Nov/Dec 2019 - Volume 23, Number 6
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Abstract:  In pharmaceutical compounding, the term “primary engineering control” usually refers to a device used to reduce the number of airborne particles and microorganisms in the compounding suite by channeling filtered unidirectional high-efficiency particulate air into areas that must be as contaminant free as possible. In this article, which is the first in a 2-part series, several types of primary engineering controls (unidirectional-airflow workstations, compounding aseptic isolators, compounding aseptic containment isolators) used to achieve that goal are discussed, as is laminar airflow in those units and the use of casters and hydraulic lifts. In part 2, several classes of biosafety cabinets used for that purpose in compounding are examined.

Related Keywords: Kyle Mulder, NSF, CETA, RCP-SCF, NEBB CPT CP, primary engineering control, airborne contaminants, personnel protection, unidirectional high-efficiency particulate air, unidirectional-airflow workstations, compounding aseptic isolators, compounding aseptic containment isolators, HEPA-filtered air, laminar airflow, Institute of Environmental Sciences and Technology, IEST, International Standards Organization, ISO 14644-1 Class 5, restricted-access barrier systems, recommended practice standards, aseptic compounding environment, cleanroom

Related Categories: ENVIRONMENTAL , PARENTERALS, STERILE PREPARATIONS, TECHNOLOGY, QUALITY CONTROL

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