iia global
April 2014
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iia Newsletter

 

Dear Reader

 

Welcome to the Newsletter of the International Irradiation Association. For more information about the Association visit our website at iiaglobal.com 

We continue to evaluate ways to improve the form and content of the newsletter and are pleased to be able to report continuing growth in readership.

In this newsletter we report the addition of a new iia board member, the location and timing of the next IMRP conference, changes to the operational structure of the Association and much more.   
 
Readers are invited to send news and details of forthcoming events to the editor; Paul Wynne: 
IMRP - Puerto Rico 2016

  

Puerto Rico flag waving on the wind The next International Meeting on Radiation Processing (IMRP) will be held in Puerto Rico in late Spring 2016. STERIS Isomedix will be the Regional Sponsor for the event.

 

Puerto Rico was host to the inaugural IMRP meeting in 1976. It has a significant medical device and life science industry with many leading healthcare companies having a manufacturing presence on the island.

The rocky coast of Puerto Rico at El Morro  

 

IMRP 18 Puerto Rico will enable the irradiation industry to forge closer links with the healthcare and life science industry whilst continuing to represent all technologies and the diversity of existing and evolving applications.

IN THIS ISSUE
IMRP - Puerto Rico
iia - Board Appointment
Sterigenics to acquire Nordion
New iia Structure
Food Irradiation
Sterility Assurance
International Irradiation Forum
Other News
Key Diary Dates
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Joyce Hansen (J&J) joins the iia Board. 
  
Joyce Hansen joined Johnson & Johnson as Vice President of Sterility Assurance in 2012. She is responsible for providing strategic vision, leadership and governance for sterility assurance and lifecycle management for sterile products and is also responsible for the microbial control of non-sterile products across Johnson & Johnson.   

 

Joyce is a recognized industry leader in sterilization practices with over 35 years' experience in sterility assurance. She is experienced in the areas of radiation (gamma, electron beam and X-ray) and ethylene oxide sterilization

 

Joyce spent six years working for Baxter Healthcare Corporation as Vice President, Sterility Assurance and Sterilization Core Technical Competency Champion. She also held sterilization R&D and/or management positions at Sherwood Davis & Geck, Isomedix, and Becton Dickinson & Company.

 

Joyce is involved in a number of industry activities that are responsible for developing industry standards for sterility assurance. She previously served as Convenor of the ISO Working Group on Radiation Sterilization and as co-chair of the Association for the Advancement of Medical Instrumentation (AAMI) working groups to develop standards on Radiation Sterilization, SAL, and Microbiological Methods. 

Sterigenics enters definitive agreement to acquire Nordion. 

 

On 28 March 2014 Nordion announced that it had entered into a definitive agreement to be acquired by Sterigenics, a global leader in sterilization services and a portfolio company of GTRC LLC, a leading private equity firm based in Chicago, Illinois, USA.

 

The transaction will be implemented by way of a plan of arrangement under the Canada Business Corporations Act and is subject to court approval and approval of Nordion shareholders.

 

The transaction is also subject to certain closing conditions, including receipt of all regulatory approvals, such as under the competition/antitrust laws and the Investment Canada Act, and the coming into force of certain amendments to the Nordion and Theratronics Divestiture Authorisation Act.

 

Upon closure of this transaction Nordion will operate as a standalone company within Sterigenics and will continue to operate under the Nordion name.

 

All change - iia introduces a new structure
 

iia is changing. During the past 18 months the Association has made particularly good progress in expanding its membership base and improving its representation of all technologies and geographies. At the last IMRP meeting in Shanghai in late 2013 iia established four working groups - Technology, Food Irradiation, Healthcare, and Polymers.

 

The aim of the Association is to continue to expand and grow its membership base and to effectively represent the needs and interests of the irradiation community. A core aim of the Association is to promote the safe and beneficial use of radiation technology. In order to achieve this we will continue to Advocate on behalf of the industry and promote Education and Communication.

 

The Association continues to improve its web presence. In addition to the website iia has a growing presence on Linkedin and will be exploring ways to increase its social media presence over the coming months. 

 

The International Irradiation Association remains committed to providing a bridgehead between academia and commerce and between youth and experience. Our new structure aims to embrace these needs and aims
 so that we can better serve the need of the irradiation community.

 

 

The new structure is:

All of the above have Association wide responsibilities

As part of these changes John Woolston will be significantly reducing his commitment to the Association which will now be limited to supporting the Healthcare Working Group. The Association is very grateful to John for the support and guidance that he has provided since becoming involved with its activities six years ago.

Two new names appear above: 
  • Shamshad Ahmed has a doctorate in chemistry and is an IAEA recognised expert in the field of polymers and materials processing. Shamshad has authored and co-authored many papers. He lives in Pakistan.
  • Gustavo Varca has a PhD in Nuclear Technologies - Biomaterials and is an Associate Researcher in Sao Paulo, Brazil. He was a recipient of the iia Scientific Award at IRaP 2011 (Poland) and presented at IMRP 2013 Shanghai. He speaks English, Spanish and Portuguese. 

All members of the iia team provide services to the Association on a part time basis in the capacity of consultant. Time commitments range from several days per month to several days per week. If you have questions or ideas please feel free to contact a member of the iia team via the email link. 
Food Irradiation - a busy month.

  

The International Irradiation Association has reported a wide range of food related news items on its website during the past month. Why wait for the newsletter - for up-to-date news and information visit www.iiaglobal.com 
  • The American Spice Trade Association (ASTA) sent extensive comments to the Food and Drug Administration on 3 March 2014. This was in response to the draft risk profile on pathogens and filth in spices that was published in October 2013. The risk profile was initiated in response to food poisoning outbreaks caused by Salmonella contaminated spices. 
  •  Sterile Insect Technology (SIT) explained. The IAEA website includes an interesting podcast that explains Sterile Insect Technology -  IAEA Talk - Podcast.   
  • Irradiated fruit from Malaysia permitted into the USThe Federal Register dated 19 March 2014 announced that USDA-APHIS allowed the importation of fresh jackfruit, pineapple, and starfruit from Malaysia into the continental United States. As a condition of entry, all three commodities must be irradiated for insect pests, inspected, and imported in commercial consignments.  Click here  for more information. 
  • Food Standards Australia New Zealand (FSANZ) - Nutritional impact of phytosanitary irradiation of fruits and vegetables. FSANZ comments on the nutritional impact of phytosanitary irradiationĀ of fruits and vegetables on its website. Follow the link for further information.  - Steritech (iia member) highlights that the following fruits have already been approved by FSANZ: Tomatoes, Lychee, Rambutam, Custard Apple, Capsicum, Papaya, Bread Fruit, Persimmon, Mango, Longan, Carambola and Mongosteen. In addition to this list a number of fruits are set for future approval and some for assessment.
  • US - APHIS Importation of Mangoes from Jamacia into Continential United States. APHIS are proposing to amend the regulations concerning the importation of fruits and vegetables to allow the importation of fresh mangoes from Jamaica into the continental United States. For further details read the entry in the 

     
ISO, AAMI and PDA Sterility Updates.

 

 

ISO TC198 meeting in Sydney (Australia) -  The Sterility Assurance Task Group had its first face to face meeting in early April 2014. The meeting was well attended and the draft New Work Item Proposal was finalized for submission to the TC at the closing Plenary.  The scope is currently limited to strictly providing guidance on risk assessments for alternative SAL; this directly responds to the need for guidance to the note in EN556 Clause 4.1. 

 

AAMI WG90 meeting in Washington (USA) - The plan is for WG90 to move forward with the project to revise ST67, in this case including aseptic processing in the scope of the risk assessment for alternative SALs.  

 

Parentral Drug Association (PDA) Annual meeting in San Antonia - Possible opportunities to connect the Assurance of Sterility issue with the pharma world surfaced. Abbott Vascular's bioresorbable scaffold was presented by Byron Lambert as an example of the sterilization challenges of a sensitive combination product.  

 

Members can read full comments by visiting the iia website and accessing the recent news item.

 

International Irradiation Forum - are you connected? 
 

 

 

The creation of this "group" on Linked In represents another initiative by iia to facilitate debate and information exchange for members of the irradiation community. Discussions have been set to be private so that members can exchange views knowing that they are only visible to other members of the group. A pad lock should be visible which confirms the locked status of the group. If you are not yet a member of the International Irradiation Forum we invite members of the irradiation community to join us and to become part of the debate.

 

We will be asking seeking your input on the next IMRP shortly - if you want to express a view you will need to join our Forum so that you can comment.

Other News.

  • New Irradiation Facilities. 
    • In the UK Synergy Health plc have announced plans to build an additional new gamma irradiator at the facility in Bradford. The new plant with be a pallet irradiator.
    • In Malaysia Grand Tan Holdings loaded cobalt and commenced operations at their new gamma irradiation facility near Kuala Lumpur.
  • Texas A&M Eb and X-Ray Workshop.  
    • Anibal Abreu (LATU Uruguay) who participated in the workshop reports that it was attended by 16 attendees and 10 speakers from 10 countries. The workshop lasted from 31 March to 4 April and covered a large number of topics. Presentations were made by iia members: Dave Brown (Mevex), Larry Nichols/Kathleen O'Donnell-Cahill (NUTEK), Mike Pageau (GEX), David Staack/Victor Ugaz/Noah Cohen (Texas A&M), Rick Galloway (IBA) and John Williams (Baxter). 
  • Transport - Denial of Shipments. Paul Gray of GIPA recently attended meetings at the IAEA and provided members of GIPA and iia with an update on developments.
  • Baxter International.  Baxter International Inc  announces plans to create two separate independent global healthcare companies. One company will focus on developing and marketing innovative biopharmaceuticals and the other on life-saving medical products.  Both will be global leaders in their respective markets. Follow the link for more information.
  • Guidelines for the Development, Validation and Routine Control of Industrial Radiation Processes - now available as an e-learning training module  
  • Nordion and Adesto Technologies presented CBRAM data storage in late March. The product will enable medical devices with embedded electronics to be sterilised using gamma irradiation. For more information visit the iia website. 
  • Paul Mellor. Mike Pageau (Gex) has advised us of the passing of Paul Mellor who was a respected member of the irradiation community known for his professional integrity and warm personality. Paul was born in Cumbria, England and received his B.S. degree in Physics and Chemistry from the University of Newcastle-upon-Tyne, graduating with honors. Paul passed away on April 4th, 2014 at the young age of 57. He resided near Chicago, IL. Paul had worked previously for Reviss, Isomedix and most recently Best Medical. He will be sorely missed by his family and his many friends around the world. May he rest in peace.
Key Diary Dates 

  

 


MedTec Europe, Stuttgart, Germany. 3-5 June 2014.
 
MDM East, New York, USA 9-12 June 2014.

ASTM E61This Committee writes the Radiation Processing Standards, Jackson Hole, Wyoming, USA. 22-25 June 2014.
 
GEX Dosimetry Workshop, Denver, Colorado, USA 23-26 June 2014.

ASTM International Workshop on Dosimetry for Radiation Processing, Oxford, UK. 3-7 August 2014
 
The Science of Sterilisation Validation Seminar, Nelson Labs, Boston, USA, 19-21 August 2014. 
 
4th International Nuclear Chemistry Conference, Sao Paulo, Brazil, 14-19 September 2014.
 
Nutech 2014. Development and Application of Nuclear Technologies, Warsaw, Poland, 21-24 September 2014.
 
IRaP 2014. Jeju Island, Korea, 5-9 October 2014.

 

 

Contact Us

 

Editor: Paul Wynne

 

The iiA team consists of Paul Wynne - Director and General Manager, Yves Henon - Deputy General Manager, John Newcombe - Finance & Admin Manager, John Woolston - Deputy Chair Healthcare Working Group, Shamshad Ahmed - Deputy Chair Polymer Working Group, Gustavo Varca - Science, Social Media and Networking.

 

The iiA board: John Masefield (Executive Advisor Steris), Andrzej Chmielewski (Institute of Nuclear Technology), Kenneth Hsiao (Dasheng), Eamonn Hoxey (Johnson & Johnson), Byron Lambert (Abbot Vascular), Scott Mcintosh (Nordion), Dave Meyer (Sterigenics), Richard Steeves (Synergy).