Bot Detector
IJPC Seal
Download FREE Sample Issue or Article
LEARN MORE
Subscribe Today
A subscription to IJPC includes a print copy delivered by postal mail and on-line access to electronic PDF copies of your subscribed issues.

Cleanroom Cleanliness

Author(s):  Mulder Kyle

Issue:  Jan/Feb 2021 - Volume 25, Number 1
View All Articles in Issue

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




Download in electronic PDF format for $45

Related Articles from IJPC
Title (Click for Abstract / Details) Author Issue Page View/Buy
Cleanroom Cleanliness Mulder Kyle Jan/Feb 2021 6-12 Buy
Primary Engineering Controls in Pharmaceutical Compounding, Part 1: Unidirectional-airflow Workstations, Compounding Aseptic Isolators, and Compounding Aseptic Containment Isolators Mulder Kyle Nov/Dec 2019 447-452 Buy
Certification of Powder-containment Hoods for Nonsterile Compounding Mulder Kyle, Dozzi Raphael Sep/Oct 2018 369-384 Buy
Contamination Control in Compounding Areas Mulder Kyle, Gonzales Ben A Jul/Aug 2019 271-278 Buy
Quality Control: Testing for "Micromonsters": Viable Air and Surface Sampling in Aseptic Compounding Mulder Kyle May/Jun 2021 211-216 Buy
Primary Engineering Controls in Pharmaceutical Compounding, Part 2: Biosafety Cabinets Mulder Kyle Jan/Feb 2020 7-12 Buy
Compounding Enclosures: Ensuring Safety During the Preparation of Sterile and Nonsterile Formulations Ashe Krystina, Baskett Dustin Sep/Oct 2018 387-398 Buy
Basics of Sterile Compounding: Particulate Matter Akers Michael J Sep/Oct 2017 395-404 Buy
Sterile Filtration Akers Michael J Sep/Oct 2015 393-401 Buy
Trace Level Analysis of Airborne Hormone Particulates Trimble John O, Hampton Shanna May/Jun 2018 257-263 Buy