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.
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West employs very often electron-beam (e-beam) irradiation to sterilize syringes and cartridges comprising Daikyo Crystal Zenith® cyclic olefin polymer (henceforth called COP). It is gentle, effective, and convenient – product can be sterilized in its final package and shipped to a customer in a ready-to-use state. Energy transferred by the e-beam during irradiation breaks the chains of DNA in living organisms (such as bacteria), resulting in their death and rendering the space irradiated as sterile. E-beam irradiation is common in the sterilization of medical products, as well as aseptic food packaging, and disinfestation of unprocessed bulk crops. Moreover, it can be operated continuously. This article discusses some fundamentals of e-beam sterilization.
This study evaluates the amount of moisture in vials with closures subjected to varying wash and sterilization/drying cycles.
Various needle shields/tip caps were exposed to ozone for different times and varying sterilization processes to determine any effects on the elastomers.
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.
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. <p><em>J.P. Agalloco and J.E. Akers. Pharmaceutical Technology, 37 (9) (September 2013)</em></p>
<p>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.</p> <p><em>K. Ungar and A. Julian (Steris Life Sciences, Inc.)</em></p>
This article discusses the basics of steam sterilization, including equipment and operation. <p><em>M. Dion and W. Parker. Pharmaceutical Engineering, 1-8 (November/December 2013)</em></p>
<p>This paper discusses the fundamentals of sterilization by gamma radiation, in particular the chemistry and physics of how the sterilization process occurs.</p> <p><em>K. Aparecida da Silva Aquino</em></p> <p> </p>
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.
This article reviews the basic concepts of sterilization by gamma irradiation. <p><em>J. Martin. BioPharm International, 25 (2) (February 1, 2012)</em></p> <p> </p>