 Rolande Hall Medical Pack Solutions Packaging Consultant Visit Website |
Rolande Hall is a Fellow of the 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.
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Packaging Q&A
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How often do we need to revalidate our packaging equipment?Answered February 28th, 2012 by Expert:The answer is dependent upon many factors. The most important is that no change that might negatively impact the package performance should happen without validation review. Examples of such changes are introduction of a new component manufacturer, change of polymer, introduction of a new thermoforming machine, overhaul of a packaging machine, relocation of a packaging line or a change of pack size. Care must be taken so that small, apparently insignificant changes do not accumulate and lead to unvalidated use.
Validation review may lead to full or partial revalidation and should take place regularly at intervals determined by knowledge of the process and usage of the equipment. Likely validation review intervals are in the order of two to five years.
More specific guidance would need a full knowledge of the packaging process, equipment used and the environment in which it is used.