Equipment Cleaning

Authored by: Destin A. LeBlanc

Encyclopedia of Pharmaceutical Science and Technology

Print publication date:  July  2013
Online publication date:  July  2013

Print ISBN: 9781841848198
eBook ISBN: 9781351124874
Adobe ISBN:

10.1081/E-EPT4-v2-46

 Download Chapter

 

Abstract

Cleaning of process equipment has been part of the good manufacturing practices (GMPs) for pharmaceutical manufacturing for many years (1,2). This has included recommendations for written procedures, cleaning logs, and appropriate design of equipment to facilitate cleaning. Good cleaning practices are necessary to ensure the safety and efficacy of the manufactured drugs and drug products. Possible consequences of inadequate cleaning include crosscontamination (the presence of one drug active in another drug product at an unacceptable level), the presence of foreign material (e.g., a cleaning agent, solvent, degradation product, or excipient from another drug product), the presence of microbial contamination (numbers and/or species of microbes), or the presence of endotoxins (particularly in parenteral products). The presence of such residues in a drug product may pose safety problems depending on the level of the residue. Such residues may also affect the efficacy of a drug product; effects could include modifying the bioavailability of the active, the dissolution time of tablets, or the stability of the finished drug. Needless to say, failing to follow GMPs relating to cleaning processes, even though there is no demonstrated or observable effect on safety or quality, also renders the product “adulterated” and subject to regulatory action.

 Cite
Search for more...
Back to top

Use of cookies on this website

We are using cookies to provide statistics that help us give you the best experience of our site. You can find out more in our Privacy Policy. By continuing to use the site you are agreeing to our use of cookies.