Package Sterilization White Papers, Case Studies, & Application Notes

1. Converting Large Ethylene Oxide Contract Sterilizer Chambers To Small In-House Chambers 7/28/2017

   This paper addresses cycle development/validation considerations when converting from EO sterilization at a contract sterilizer in a large chamber that holds one or more pallets of final pack product, to sterilization in-house, in a smaller chamber with less than one pallet in capacity in primary packaging.

2. Why Production Forecast Affects Sterilization Method 9/15/2016

   To choose a sterilization method, device manufacturers typically look at what materials the device is made of and which sterilization method the design can withstand. This paper discusses the effect that a production forecast has on both up-front and long-term costs of EO sterilization and Gamma sterilization.

3. Sterilization Of 3D Printed Medical Devices 7/21/2015

   Fused Deposition Modeling™ (FDM® ) can be used to produce an array of medical devices; however, for such devices to be practical, they must be manufactured using sterilizable materials. By David Espalin, Francisco Medina, Mireya Perez, and Ryan Wicker, The University of Texas at El Paso; and Terry Hoppe and Rob Winker, Stratasys

4. Sterilization Methods And Their Impact On Medical Devices Containing Electronics 7/10/2015

   Although there is considerable literature about sterilization methods and equipment, there is very little written about the impact of sterilization on electronics. This article compares popular sterilization methods and discusses their suitability for objects containing electronics.

5. Designing Successful Cleaning and Sterilization Studies for Reprocessed Devices 4/27/2015

   This white paper from WuXi AppTec describes a list of expert tips to consider when designing validation testing programs in order to successfully demonstrate the efficacy of procedures being used. Some tips include reviewing/updating reprocessing instructions, using the “most challenging conditions,” and including replicates in your studies.

6. Effects Of Sterilization Methods On Key Properties Of Specialty Optical Fibers Used In Medical Devices 8/13/2013

   Optical fibers with different types of polymer coatings were exposed to three sterilization conditions: multiple autoclaving, treatment with ethylene oxide and treatment with gamma rays. Effects of different sterilization techniques on key optical and mechanical properties of the fibers are reported. The primary attention is given to behavior of the coatings in harsh sterilization environments. The following four coating/buffer types were investigated: (i) dual acrylate, (ii) polyimide, (iii) silicone/PEEK and (iv) fluoroacrylate hard cladding/ETFE.

7. The Benefits Of Package Integrity Testing

   In a world full of hungry microorganisms, it is critical that medical devices, designed to heal, do not inadvertently do the opposite by infecting the patient. To prevent infection, a device’s packaging or “sterile barrier system” must maintain sterility over the product’s entire shelf-life. By Ed Emerson