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John Merritt to address the "Implications of Changes in Regulations for Porous Packaging and Ethylene Glycol Residuals" at MEDTEC China 2010
Grand Rapids, Michigan, USA...John Merritt, Oliver-Tolas' International Managing Director, will address the 2010 Medical Device Innovation & Technology Forum in Shanghai, China on Wednesday, August 25.
Pending changes in regulation, not yet compulsory, will dictate the use of porous packaging for Ethylene Oxide sterilized packages and also limits the maximum level of ethylene glycol residuals in sterile devices. These regulations have a profound impact on the packaging of medical devices, with significant implications to the selection of material and machinery and a significant impact on sterilization utilization as well as manufacturing work flow. This presentation will provide a brief overview of these regulations and highlights considerations in each of the following areas.
Material Selection
A survey of common systems applicable under these regulations; their relative disadvantages and advantages
Machinery selection
Machinery selection will be dictated to a large degree by material selection and depending on machinery selected could have a profound affect on work flow.
Implications to Sterilization Utilization
The above change and the limitations set by regulations will have an impact on sterilizer utilization. While the limits on ethylene glycol residual will have a negative impact on the venting and degassing stages of sterilization, the conversion to more porous materials will have a positive impact on the front end of the sterilization cycle as well as offset some of the disadvantages of a longer venting and degassing required to minimize ethylene glycol residuals.
Oliver-Tolas Healthcare Packaging, a Mason Wells company, is a leading supplier of innovative die-cut lid, roll stock, and pouch products to the medical device and pharmaceutical markets. Manufacturing operations are located in Grand Rapids, MI; Feasterville, PA; Hamilton, OH and Venray, the Netherlands. Sales offices are located throughout the United States, Europe and Suzhou, China.
For more information, contact:
John Merritt
International Managing Director
86.512.6917.1258
jmerritt@oliver-tolas.com
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