Packaging Q&A
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Can you supply copies of Medical Packaging and Labelling Standards?No. These documents are subject to copyright and originals must be purchased. The Medical Device Directives and list of applicable standards are available on the Internet at http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/medical-devices/.
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I am new to medical device packaging. Why do so many products have porous windows in their packaging even though they are not gas-sterilised?Products that might be exposed to low atmospheric pressure, such as the pressure that occurs when an unpressurised aircraft makes an emergency ascent or when a product travels up a high mountain, must have a means of equalising interior and exterior pressure if the seals are not to be stressed. Peel seals may fail when the packaged air expands in a nonporous package.
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Rolande Hall is a Fellow of the Irish Institute of Packaging. Hall has more than 40 years of experience in packaging, gained in a variety of technical positions at both packaging manufacturers and packagers. Hall’s packaging career began when he joined John Waddington of Leeds. Hall’s area of expertise is medical device packaging and labelling. Several of his papers have been published in MDT magazine (now EMDT). He served on CEN technical committees CEN/TC 225 and CEN TC 357, contributed a chapter to the Medical Devices Manual and currently offers his services as a Medical Packaging Consultant, trading as Medical Pack Solutions, based in Ireland. He is a member of the Editorial Advisory Board of EMDT and ASTM Committee D10 on Packaging. With more than 30 years of experience in medical device packaging, Hall has helped companies in Europe, Israel and Australia resolve their packaging and labelling issues.