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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This article compares properties of sterilization techniques and discusses some fundamentals of e-beam irradiation for Daikyo Crystal Zenith® cyclic olefin polymer syringes and cartridges.
This study evaluates the amount of moisture in vials with closures subjected to varying wash and sterilization/drying cycles.
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>