News : Healthcare

6June2008

San Diego Drug-Device Workshop Reflections

Reflections on the recent iiA Workshop on Radiation Sterilization of Advanced Drug-Device Combination Products John Masefield and Ruth Brinston, Medical Device Technology, Vol. 18 no. 2 March-April 2007 .pdf copy On December 6, 2006 pharmaceutical, biotech, medical device manufacturers and radiation processing experts came together in La Jolla, San Diego California at a Workshop sponsored […]

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6June2008

San Diego Drug-Device Workshop Reflections

Reflections on the recent iiA Workshop on Radiation Sterilization of Advanced Drug-Device Combination Products John Masefield and Ruth Brinston, Medical Device Technology, Vol. 18 no. 2 March-April 2007 .pdf copy On December 6, 2006 pharmaceutical, biotech, medical device manufacturers and radiation processing experts came together in La Jolla, San Diego California at a Workshop sponsored […]

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6June2008

Washington Drug-Device Workshop Presentations

21 -22 June 2007 | A total of 65 people attended this 1 1/2 day workshop. Click here for a copy of the circular. Below are various presentations that speakers have agreed to share with us. Also attached is a copy of the survey results of the attendees. Radiation Sterilization Drug-Device Healthcare Products Presentations: Scientific […]

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6June2008

Developments in Radiation Sterilization MDT 2008

R. Brinston, Manager, iiA, Ottawa, Canada, A. Miller Radiation Research Department, Riso National Laboratory, Roskilde, Denmark and C. Deeley, International Marketing Manager, REVISS Services (UK) Ltd, Chesham, United Kingdom and deputy-chair IMRP 2008 Program Committee This article outlines some of the most significant recent developments in radiation sterilisation and initiatives currently underway.  Click here for […]

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6June2008

SAL Survey Results

10 June 2008 | The iiA sponsored a survey on Sterility Assurance Levels (SALs) because the Healthcare industry is increasingly developing more complex, radiation-sensitive healthcare products, such as advanced combination drug-device products. AAMI ST 67 “Sterilization of health care products – Requirements for products labeled “STERILE” is currently being re-balloted, and it is timely to […]

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28March2007

Why the Changes and Additions to ISO 11137

Readers of iiA eNewsletter will be aware of the publication in 2006 of the two normative ‘radiation’ standards, (EN) ISO 11137-1 Requirements for development, validation and routine control of a sterilization process for medical devices and (EN) ISO 11137-2 Establishing the sterilization dose; these, with time, will replace the original standards, EN 552:1994 and ISO […]

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22February2007

The Position of EN ISO 11137-2 in Europe

Following the joint CEN and ISO revision of EN 552:1994 and ISO 11137:1995 (with ISO lead) and the requisite CEN and ISO approvals of the resulting documents, ISO published the first edition of ISO 11137-2, Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose on 15 April 2006. As is […]

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22February2007

AdvaMed Statement to National Academy of Sciences

AdvaMed, the world’s largest association representing manufacturers of medical devices, diagnostics and information systems submitted their statement on January 29, 2007 to the USA National Academy of Sciences’ (NAS), Nuclear and Radiation Studies Board re: Radiation Source Use and Replacement. This nine-page Advamed report clearly outlines the importance and very serious consequences regarding the potential […]

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1June2006

A New Concept in Aseptic Filling: Closed-vial Technology

Pharmaceutical Technology Europe in the January 2006 issue published this interesting article by Benoit Verjans, Jacques Thilly and Christian Vandecasserie. Integral to this “new concept” is using irradiation to sterilize the closed plastic vial prior to filling. In the filling process, a needle penetrates the closed vial through the stopper, injects the liquid into the […]

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5January2005

AAMI Meeting Highlights

2005 June 27 to 30th Lisa Foster, Sterigenics reports on the AAMI Sterilization meeting in Washington, USA. As expected the meetings were brief. Highlights: * Craig Herring, Ethicon EndoSurgery is leading a task group on to develop a TIR which expands VDmax 25 kGy to other sterilization doses with the goal to issue a draft […]

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