Abstract

Cleanroom Cleanliness

Author(s): Mulder Kyle

Issue: Jan/Feb 2021 - Volume 25, Number 1

Page(s): 6-12

Download in electronic PDF format for $75
  • Cleanroom Cleanliness Page 1
  • Cleanroom Cleanliness Page 2
  • Cleanroom Cleanliness Page 3
  • Cleanroom Cleanliness Page 4
  • Cleanroom Cleanliness Page 5
  • Cleanroom Cleanliness Page 6
  • Cleanroom Cleanliness Page 7

Abstract

Over the last century, the concept and use of the cleanroom have continually evolved to provide an increasingly restricted environment with a low burden of contaminants (especially those that are airborne). Although no cleanroom in active use can be kept sterile, the particulate burden circulated via airflow and deposited on surfaces in such areas must be reduced to levels considered acceptable, especially when sterile compounding is performed. In this article on cleanroom cleanliness, pivotal events in cleanroom development are briefly reviewed, contamination control in the sterile-compounding environment is discussed, factors that affect levels of contamination in cleanroom suites are examined, and suggestions for contamination prevention are presented.

Related Keywords

  • Kyle Mulder, NSF, CETA SCF, NEBB CPT CP
  • cleanroom
  • contamination control
  • particulate burden
  • airflow patterns
  • sterile compounding
  • aseptic preparations
  • airborne contaminants
  • work surface contamination
  • high-efficiency particulate air filtration
  • HEPA filters
  • United States Pharmacopeia Chapter <797>
  • USP
  • personnel training
  • air cleanliness
  • air quality
  • air changes per hour
  • air-exhaust vents
  • cleanroom surfaces
  • equipment

Printer-Friendly Version

Related Articles from IJPC

Issue/Page
View/Buy		 Title/Author
(Click for Abstract / Details / Purchase)
Jan/Feb 2021
Pg. 6-12
Cleanroom Cleanliness
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
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
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
Jan/Feb 2023
Pg. 39-46
Sterile Basics: How to Know if Your Cleanroom Can Consistently Operate Within a State of Control
Author(s): Summers Amy, Stephens Pat
Jan/Feb 2020
Pg. 7-12
Primary Engineering Controls in Pharmaceutical Compounding, Part 2: Biosafety Cabinets
Author(s): Mulder Kyle
Sep/Oct 2018
Pg. 369-384
Certification of Powder-containment Hoods for Nonsterile Compounding
Author(s): Mulder Kyle, Dozzi Raphael
Sep/Oct 2022
Pg. 411-418
Sterile Basics of Compounding: Contamination Control Strategies, Part 1
Author(s): Summers Amy
Jul/Aug 2021
Pg. 276-281
Expecting the Expected: Planning Considerations for Cleanroom Construction
Author(s): Roberts Patricia A, Kroon Laura
May/Jun 2015
Pg. 232-238
Basics of Sterile Compounding: Contamination Control
Author(s): Akers Michael J
May/Jun 2022
Pg. 219-228
Sterile Basics of Compounding: Particulates in Parenteral Preparations: Sources, Minimization, and Detection
Author(s): Allen Loyd V Jr
Jul/Aug 2015
Pg. 268-278
Safer Sterile Compounding: Choosing and Using Disinfectants for the Cleanroom
Author(s): Kastango Eric S, Douglass Kate, Patel Kedar, Givehchi Babak, Brister Paul, Postlewaite Jay, Taraban Laura
Mar/Apr 2023
Pg. 114-121
Advanced Compounding; How to Investigate Microbiological Excursions at a Sterile Compounding Facility
Author(s): Summers Amy
Sep/Oct 2018
Pg. 387-398
Compounding Enclosures: Ensuring Safety During the Preparation of Sterile and Nonsterile Formulations
Author(s): Ashe Krystina, Baskett Dustin
Jan/Feb 2015
Pg. 49-56
Basics of Sterile Compounding: Aseptic Processing
Author(s): Akers Michael J
Jan/Feb 2022
Pg. 72-79
Evaluation of Closed-system Transfer Devices in Reducing Potential Risk for Surface Contamination Following Simulated Hazardous-drug Preparation and Compounding (Reprint)
Author(s): Soefje Scott, Rickabaugh Keith, Rajkumar Rahul, Wall Kathryn P
Sep/Oct 2017
Pg. 395-404
Basics of Sterile Compounding: Particulate Matter
Author(s): Akers Michael J
May/Jun 2009
Pg. 234-238
Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 13: Environmental Quality and Control
Author(s): Allen Loyd V Jr, Okeke Claudia C
Nov/Dec 2014
Pg. 446-454
Depyrogenation Options for the Compounding Cleanroom
Author(s): Weller Tom, Bell Jeff, Dullinger Roger, Allen Vern, Anthenat Bruce