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November 2022: Panel issues open letter to European Medicines Agency to revise EU GMP Annex 12 - Use of ionising radiation in the manufacturer of medicinal products.
The Annex must be updated to align with current international standards and guidance on radiation sterilization including the adoption of X-ray technology. The Irradiation Panel volunteers to lead updating Annex 12. The Panel requests your support in advocating this update. Open letter can be downloaded below:
April 2022: Panel meets on-line and appoints new officers and endorses plan for the future
The working groups met on April 5 and this day saw the long-established Dosimtery Working Group renamed to the Irradiation Working Group and the leadership of the group handed on from Peter Sharpe (NPL) to Florent Kuntz (Aerial). At our Annual General Meeting on April 6 we also welcomed back returning member Ionisos to the Panel. The membership endorsed the new Road Map for the Panel future introduced by the Chair Adam Whaites (Cytiva) which incorporates a name change to 'The Irradiation Panel' reflecting the increased use of X-ray for sterilisation. The meeting also saw the appointment of Claire Frogley (Steris/Harwell Dosimeters) as Deputy Chair and Jeremy Brison (IBA) as Secretary, the previous appointees having served out their terms.
November 2021: Panel meets on-line and welcomes 3 new members
On November 2/3 we welcomed new members Corning, Cytive and TRAD. The Microbiology Working Group launched its Sterilisation Dose Audit failure 'Focus Group' and hosted a presentation on rapid micro methods. The Dosimetry Working Group finalised a comprehensive guide on dose mapping, to be published shortly. In the main Panel the new Chair, Adam Whaites, presented the results of a recent membership survey and outlined a 'Road Map' to increase the Panel's relevance and impact. There were also presentations on the activities of and collaboration with iia and SfSAP, and on parametric release and the Monte Carlo code RayXpert.
April 2021: Panel AGM sees appointment of new Panel Chair
The Annual General Meeting of the Panel was held on-line on 14 April and attended by 40 members. Adam Whaites of Cytiva was appointed the new Panel chair and April Ambridge of Scapa Healthcare as Treasurer. The meeting also welcomed Micronclean as new industrial member and Kees Fremery as an individual member. Presentations were made on sterility standards activity, updates from both iia and SfSAP, and recent joining members from S+N and ITHPP gave introductory presentations on their respective companies. Well attended Working Group meetings were also held on 12/13 April.
November 2020: Panel publishes new guidance document
The Microbiology Working Group has now published a guide on Risk Assessment following Sterilisation Dose Audit failure, in acordance with ISO11137-2 section 10.4. It is available to all to download from the Guides area of the website.
November 2020: Panel meetings online!
Both the Microbiology and Dosimetry Working Groups met on November 3, followed by the full Panel meeting on Zoom on November 4. The minutes to all meetings will be circulated and uploaded to the Documents area shortly. The full Panel meeting welcomed two new members to the Panel: Sartorius and MVS Limited. If you are interested in joining please get in contact!
April 2020: Panel welcomes 3 more members
The Panel is pleased to confirm the involvement of 3 further corporate/industrial members. These are Framatome, ITHPP Alcen and Smith+Nephew.
April 2020: Panel publishes article on X-ray Sterilization in Medical Device and Diagnostics Industry
The Panel has prepared an article published today in the online industry journal Medical Devices and Diagnostics Industry on it's recently published guidance on adoption of X-ray sterilization technology. The article also highlights other Panel guidance recently issued on aspects of ISO standards for microbiological methods and sterilization of health care products. The article is availalbe here: https://www.mddionline.com/adopting-x-ray-sterilization-medical-devices
November 2019: Panel Meeting at Novotel, Birmingham Airport, UK. The Panel Working Groups and main Panel met on 5/6 November. The Working Groups on Microbiology and Dosimetry/X-ray were particularly well attended with 50% more attendees than the April meetings. New guidance documents on sterility and sterilisation have been completed and will be issued shortly. The Panel also welcomed new individual members from our third continent, Africa. These are Stanley Acquah of the RTC in Accra, Ghana and Mohammed Mouhib of the INRA irradiation facility in Tangier, Morocco.
April 2019: Panel announces results of survey on X-ray technology. The Panel AGM saw the release of the results of a survey of 13 relevant Panel organisations regarding the need and focus for the new X-ray Working Group. Results are available in the documents area of the website
April 2019: Panel Annual General Meeting at Bushy house, National Physical Laboratory, Teddington, London. Well attended Working Group meetings on Microbiology and Dosimetry preceeded the AGM which saw the re-appointment of Mario Bernkopf as Chair and John Woolston as Treasurer. The meeting also welcomed Nelson Labs as a new Panel member.
November 2018: Two guidance documents added to Panel Publications
The Dosimetry Working Group have produced two guidance documents which have now been added to the Panel publications available here. They are an updated version of the Panel's guide on the use of Statistical Process Control in radiation sterlisation, reflecting terminology changes in ISO 11137 and a detailed comparison of the 2017 and 2006 versions of ISO 11137 Part 3 which provides guidance on dosimetric aspects of radiation sterilisation.
November 2018: Panel Meeting on 7 November at Novotel, Brussels Airport. The meeting was preceeded on 6 November for the very first time by meetings of all three of the Panel's Working Groups, Dosimetry, Microbiology and X-ray. All the meetings were well attended and the main Panel welcomed 6 new members, including four Organisations (Etigam, Gammatom, Institute of Isotopes and Scapa Healthcare) as well as two Individual members. Presentations were also provided by IBA, Etigam and Institute of Isotopes.
September 2018: Panel Dosimetry Training Course
The latest in our 'hands-on' training courses in dosimetry for radiation processing was held 4-6 September 2018 hosted by Aerial CRT in Strasbourg. The course received very positive results in participant feedback and the Panel looks forward to offering such training again in the future.
March 2018: Panel Annual General Meeting at Bushy House, National Physical Laboratory, Teddington, London. The AGM was preceeded by meetings of both the Microbiology and Dosimetry Working Groups. The AGM meeting witnessed the arrival of four new organisations to the Panel, Abbott, Iotron, MEVEX and MSB, as well as Martin Comben as an individual member. The meeting also saw the appointment of Josef Mittenfdorfer as Deputy Chair and Martin Comben as Secretary. Presentations from the AGM are available in the Documents area of the website.
October 2017: Panel provides feedback to EU on Legal Frameword for Food Irradiation
The Panel has responded to a consultation request for feedback on the current legal framework for food irradiation within the European Union. The feedback submitted is available for download here
September 2017: Panel organises Dose Mapping Workshop to be held 17 October
The next Panel meeting is on Wednesday 18 October at the Birmingham Airport Novotel, preceded by the Dosimetry Working Group meeting on Tuesday 17 October. The morning session of the Dosimetry WG will be a workshop on Dose Mapping, starting at 10am, with presentations on gamma, e-beam and X-ray, together with regulatory issues and requirements. If your organisation is a Panel member and you would like to attend please contact Peter Sharpe (firstname.lastname@example.org) for more details.
March 2017: Panel AGM welcomes 4 new members and a new chairman.....
At a well attended Panel AGM on March 15 we welcomed 4 new members (IBA Industrial, JSC Isotope, Nordion/REVIS and Wright Medical). The meeting also witnessed the transition in chairman from John Harries of Steris AST to Mario Bernkopf of BBF steriXpert. John Woolston also superseded Adam Whaites as Panel treasurer. Many thanks to our hosts NPL who provided the sunny meeting venue at Bushy House, Teddington to the west of London as seen in the photograph above.
October 2016: Panel meeting in Birmingham
The Panel meeting on Wednesday October 12 was well attended and included informative presentations by the International Irradiation Association (iia) and Comet ebeam. The next meeting is scheduled for March 2017 at NPL.
August 2016: iia and the Panel meet
The Panel and the International Irradiation Associate (iia) recently met to discuss areas of potential cooperation under the Affiliate Agreement signed in January this year. It is recognised that while both organisations work to promote best practice in radiation processing they wish to remain independent and have different areas of strength. The Panel has productive Working Groups, a strong role in developing, reforming and implementing standards and holds regular member meetings. The iia has international reach, effective communication with the irradiation industries and has forged relationships with multiple regulatory, regional and industry specific organisations. It has been agreed that the iia will assist the Panel with promotion of its activities to the wider irradiation community including publication of the output from Panel Working Groups on the iia website. A representative of the iia will attend future Panel meetings to provide an update on current iia activities and to be available to discuss and learn more of relevant industry issues. There is also a desire from both sides to develop joint activities and to arrange joint meetings to address wider industry issues where working together can maximise impact.
June 2016: Aerial and IBA announce new irradiation development centre - electron beam and X-ray
Official press release on 13 June regarding a cooperation between Aerial and IBA to build a unique radiation centre for the development, test and training cente for irradiation processes using 10MeV electron beam and 5/7MeV X-ray based on IBA Rhodotron technology. The Centre will be known as FEERIX. Full Press Release is available here: IBA Press Release
May 2016: Successful Panel training course in radiation dosimetry (24-26 May, Strasbourg)
Aerial hosted a training course in Practical Dosimetry for Radiation Processing organised by the Panel and delivered by Panel members from Riso, NPL and Aerial. Participant Katja Follner of Beta Gamma Service commented 'I learned about the types of dosimeters and systems in use and how they are calibrated. There were also sessions on process definition, validation and control which relate to the standard ISO 11137. The training involved hands-on practical sessions as well as theory. I particularly enjoyed the practical session on calibration and the stimulating exchange with other participants. I would recommend this course to anyone who needs to learn more about dosimetry in radiation processing'.
March 2016: Panel AGM held at NPL, Teddington, UK
The Panel on Gamma and Electron Irradiation held its Annual General Meeting on 16 March 2016 at Bushy House, National Physical Laboratory, Teddington UK. It was attended by a good cross-section of the membership and was preceeded by a meeting of the Dosimetry Working Group the previous day.