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Sterilization and Cleaning

All components of a container/delivery system undergo washing and sterilization—by either chemical (ethylene oxide), physical (hot-water, autoclave) or radiative (electron-beam, gamma) processes. These processes may have an effect on the physical/chemical properties of the system’s materials of construction, which in turn may affect system performance or interaction with drug product. This section presents papers on sterilization processes and resultant effects.

Understanding Gamma Sterilization. 
J. Martin.  BioPharm International, 25 (2) (February 1, 2012)

This article reviews the basic concepts of sterilization by gamma irradiation.

Link: http://www.biopharminternational.com/understanding-gamma-sterilization?id=&sk=&date=&&pageID=1

Guideline for Disinfection and Sterilization in Healthcare Facilities


This article by the Centers for Disease Control discusses the basics of different types of sterilization methods and their modes of action, in particular why high temperature steam is an effective method.

Link: https://www.cdc.gov/hicpac/Disinfection_Sterilization/13_0Sterilization.html

Steam Sterilization Principles.
M. Dion and W. Parker.  Pharmaceutical Engineering, 1-8 (November/December 2013)


This article discusses the basics of steam sterilization, including equipment and operation.

Link: https://www.ispe.gr.jp/ISPE/07_public/pdf/201504_en.pdf

Understanding Gamma Sterilization. 
J. Martin. BioPharm International, 25 (2) (2012)


This article discusses some of the basics of the gamma sterilization process.

Link: http://www.biopharminternational.com/understanding-gamma-sterilization?id=&sk=&date=&%0A%09%09%09&pageID=2

Sterilization by Gamma Irradiation
K. Aparecida da Silva Aquino


This paper discusses the fundamentals of sterilization by gamma radiation, in particular the chemistry and physics of how the the sterilization process occurs.

Link: http://www.intechopen.com/books/gamma-radiation/sterilization-by-gamma-irradiation

Sterilization Methods and Their Impact on Medical Devices Containing Electronics


This article briefly compares the different types of medical sterilization methods – steam, ethylene oxide, vaporized hydrogen peroxide, gamma irradiation and electron-beam - especially as they can affect devices that contain electronic components.

Link: https://www.maximintegrated.com/en/app-notes/index.mvp/id/5068

Overcoming Limitations of Vaporized Hydrogen Peroxide
J.P. Agalloco and J.E. Akers.  Pharmaceutical Technology, 37 (9) (September 2013)


Hydrogen peroxide, a very strong oxidant, is very effective at disinfection and sterilization.  This paper discusses the particulars and challenges of using hydrogen peroxide in vapor form.

Link: http://www.pharmtech.com/overcoming-limitations-vaporized-hydrogen-peroxide?pageID=1

Principles of Steam Steriliztion and Common Challenges
K. Ungar and A. Julian (Steris Life Sciences, Inc.)


This YOUTUBE.COM video is a webinar (ca. 40 minutes) that discusses the six key elements in a steam sterilization process:  time, temperature, steam contact, air removal, steam quality, and drying.