Abstract

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

Page(s): 447-452

Download in electronic PDF format for $75
  • Primary Engineering Controls in Pharmaceutical Compounding, Part 1: Unidirectional-airflow Workstations, Compounding Aseptic Isolators, and Compounding Aseptic Containment Isolators Page 1
  • Primary Engineering Controls in Pharmaceutical Compounding, Part 1: Unidirectional-airflow Workstations, Compounding Aseptic Isolators, and Compounding Aseptic Containment Isolators Page 2
  • Primary Engineering Controls in Pharmaceutical Compounding, Part 1: Unidirectional-airflow Workstations, Compounding Aseptic Isolators, and Compounding Aseptic Containment Isolators Page 3
  • Primary Engineering Controls in Pharmaceutical Compounding, Part 1: Unidirectional-airflow Workstations, Compounding Aseptic Isolators, and Compounding Aseptic Containment Isolators Page 4
  • Primary Engineering Controls in Pharmaceutical Compounding, Part 1: Unidirectional-airflow Workstations, Compounding Aseptic Isolators, and Compounding Aseptic Containment Isolators Page 5
  • Primary Engineering Controls in Pharmaceutical Compounding, Part 1: Unidirectional-airflow Workstations, Compounding Aseptic Isolators, and Compounding Aseptic Containment Isolators Page 6

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
  • HAZARDOUS DRUGS

Printer-Friendly Version

Related Articles from IJPC

Issue/Page
View/Buy		 Title/Author
(Click for Abstract / Details / Purchase)
Nov/Dec 2019
Pg. 447-452
Primary Engineering Controls in Pharmaceutical Compounding, Part 1: Unidirectional-airflow Workstations, Compounding Aseptic Isolators, and Compounding Aseptic Containment Isolators
Author(s): Mulder Kyle
Jan/Feb 2020
Pg. 7-12
Primary Engineering Controls in Pharmaceutical Compounding, Part 2: Biosafety Cabinets
Author(s): Mulder Kyle
May/Jun 2021
Pg. 211-216
Quality Control: Testing for "Micromonsters": Viable Air and Surface Sampling in Aseptic Compounding
Author(s): Mulder Kyle
Jul/Aug 2005
Pg. 284-290
Considerations for Choosing a Primary Engineering Control for Compounding Sterile Products
Author(s): Wagner James T
Nov/Dec 2019
Pg. 511-518
Evaluation of Containment Ventilated Enclosure Performance in Absence of Negative Pressure Containment Secondary Engineering Control
Author(s): Hutson Chad, Day A J
May/Jun 2004
Pg. 181-185
Compounding in the Pharmacy Curriculum: Beyond the Basics
Author(s): Hinkle Amanda R, Newton Gail D
Sep/Oct 2018
Pg. 369-384
Certification of Powder-containment Hoods for Nonsterile Compounding
Author(s): Mulder Kyle, Dozzi Raphael
Mar/Apr 2006
Pg. 128-133
Controlled Environment Testing Association Applications Guide for the Use of Barrier Isolators in Compounding Sterile Preparations in Healthcare Facilities, Part 1
Author(s): Wagner James T
May/Jun 2006
Pg. 208-211
Controlled Environment Testing Association Applications Guide for the Use of Barrier Isolators in Compounding Sterile Preparations in Healthcare Facilities, Part 2
Author(s): Wagner James T
Jan/Feb 2003
Pg. 42-43
Technology Spotlight: Barrier Isolators
Author(s): Moussa Magdy, Rahe Hank, Lo Katharine
Jul/Aug 2004
Pg. 269-274
Current Topical Treatments in Wound Healing - Part 1
Author(s): Helmke Christopher D
Jul/Aug 2015
Pg. 315-320
Basics of Sterile Compounding: Barrier Isolator Technologist in Aseptic Processing
Author(s): Akers Michael J
Jul/Aug 2021
Pg. 276-281
Expecting the Expected: Planning Considerations for Cleanroom Construction
Author(s): Roberts Patricia A, Kroon Laura
Jul/Aug 2019
Pg. 271-278
Contamination Control in Compounding Areas
Author(s): Mulder Kyle, Gonzales Ben A
Nov/Dec 2022
Pg. 497-504
Sterile Basics of Compounding: Contamination Control Strategies, Part 2
Author(s): Summers Amy
Nov/Dec 2007
Pg. 492-499
Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 4: Considerations in Selection and Use of Disinfectants and Antiseptics
Author(s): Allen Loyd V Jr, Okeke Claudia C
Sep/Oct 2022
Pg. 411-418
Sterile Basics of Compounding: Contamination Control Strategies, Part 1
Author(s): Summers Amy
Mar/Apr 2007
Pg. 149-151
Basics of Compounding for Hazardous Drugs, Part 4: Developing the Hazardous Drugs List and Containment Workstations
Author(s): Allen Loyd V Jr
Sep/Oct 2016
Pg. 367-374
Pharmaceutical Compounding: The Oldest, Most Symbolic, and Still Vital Part of Pharmacy
Author(s): Kochanowska-Karamyan Anna J
Jan/Feb 2014
Pg. 6-12
The Role of Compounding in Closing Therapeutic Gaps--Abstracts from FIP 2013
Author(s): Lutz Eugene, Pauletti Giovanni, Carvalho Maria, Davidson Gigi, Ashworth Lisa, Subramaniam Vaiyapuri, Llambí Francesc