SEVENTH INTERNATIONAL WORKSHOP ON DOSIMETRY FOR RADIATION PROCESSING

INTRODUCTION ASTM Subcommittee E10.01, Radiation Processing: Dosimetry and Applications, is proud to present the seventh edition of our International Workshop on Dosimetry for Radiation Processing. This event will be held June 24 th to 28 th, 2012, at the Sheraton San Diego Hotel & Marina in San Diego, California. ASTM Subcommittee E10.01 is proud to present the SEVENTH INTERNATIONAL WORKSHOP ON DOSIMETRY FOR RADIATION PROCESSING A unique opportunity for improving dosimetry knowledge through in-depth plenary sessions and comprehensive hands-on dosimetry exercises based on industry standards. June 24 th to 28 th, 2012 Sheraton San Diego Hotel & Marina San Diego, California Sponsors: This workshop is patterned after our previous six successful workshops. It includes lectures, practical hands-on exercises and follow-up roundtable discussions, with emphasis on the application of ASTM and joint ISO/ASTM standards. Attendance will be limited to the first 75 technical participants who register. The objective of this workshop is to enhance the knowledge and use of dosimetry through improved understanding of dosimetry principles, factors that influence dosimeter performance, dosimetry system calibration requirements, uncertainty in absorbed dose measurements, and application of dosimetry in process validation and process control. Active participation enhances participants understanding and application of ASTM and ISO/ASTM standards. This course provides essential information for all radiation processing applications, including the processing of medical products, foods, inks, packaging, polymers, and pharmaceuticals. This event will be valuable for anyone who uses dosimetry in radiation processing. This includes: OBJECTIVE WHO SHOULD ATTEND? Researchers Irradiator operators Medical products manufacturers Dosimeter suppliers Regulatory personnel Food processors Quality assurance personnel Auditors KEY WORKSHOP BENEFITS Gain a solid understanding of dosimetry principles, applications, and standards. Increase knowledge and understanding of ASTM and ISO/ASTM standards and their application to radiation processes. Benefit from the insights and experience of internationally recognized dosimetry experts. Hear regulatory agencies perspectives on standards and the radiation sterilization process. Build and strengthen contacts with developers, manufacturers, and users of current and new dosimetry systems. 1

WORKSHOP FORMAT This comprehensive standards-based program incorporates overview plenary sessions, extensive hands-on exercises and small roundtable follow up sessions. Attendees will choose a specialized hands-on program developed for either a photon-based (gamma or x-ray) or electron beam processing application. In plenary sessions, speakers address all participants and will outline the applicable standards that establish the foundation for the hands-on exercises that follow. For the hands-on exercises, attendees will be divided into smaller groups focusing on either a photon-based or electron beam process. Each hands-on group will be chaired by an experienced leader who will facilitate the group exercises. Following each hands-on exercise, a roundtable session will provide a forum that discusses the group exercises, encourages a free exchange of ideas, allows the opportunity for further clarification and maximizes participation from each attendee. Everyone is encouraged to bring specific problems or questions to the sessions with the expectation that they will be discussed and resolved by the end of the workshop. HANDS-ON DOSIMETRY Important aspects of dosimetry for gamma radiation, electron beam and X-ray processing will be covered through extensive hands-on activities. These sessions will include comprehensive data evaluation and calibration exercises. POSTER & DEMONSTRATION SESSION An informal poster session is also planned, with posters displayed for the duration of the workshop. Attendees interested in presenting their work should contact Pete Sidereas, peter.sidereas@steris.com for details. Titles and abstracts are due by March 2, 2012. Confirmation of approval of the poster abstract will be sent to the author by March 31, 2012. There also will be an equipment and technology demonstration session allowing attendees to meet "one-on-one" with developers, manufacturers, and users of current and new dosimetry systems. This session will focus on research activities and user/manufacturer interactions. SITE VISITS Several companies have offered to host participants during the Wednesday site visits. Participants will have the opportunity to travel to one of the following facilities: Beam-One, an electron beam irradiation service facility STERIS-Isomedix Services, a gamma irradiation service facility Sterigenics, a gamma irradiation service facility A minimum number of registrants will be required to permit all choices. Transportation will be provided. HOTEL ASTM has arranged special rates of $199.00 USD per night single and double occupancy at the Sheraton San Diego Hotel and Marina. This rate is valid for three days before and three days after the workshop. Participants are responsible for reserving and paying for their own hotel rooms. When making reservations please mention ASTM Workshop. COMPANIONS ACTIVITIES For workshop attendees who are traveling with a companion, we are happy to announce a dedicated Companion's Program. Companions' activities (fees to be determined) will include visits to local attractions, shopping, and a sightseeing trip. Companions are welcome to attend the Sunday evening social and Thursday evening banquet (both entail a nominal fee). TRANSPORTATION San Diego International Airport (SAN) is located 1 mile away from the hotel. The hotel offers a complimentary airport shuttle service that runs every 20 minutes from the San Diego International Airport between the hours of 4:45am and 12am. Outside of these hours guests may request a pickup by phoning the Hotel directly. REGISTRATION Space in the workshop is limited to 75 registrants. Register online as soon as possible to be eligible for the early registration rates listed below and to ensure space. Online registration opens approximately June 8, 2011 and closes when the 75 registrants cap is reached. The fees to attend the workshop are listed below. These fees include: registration, Sunday evening reception, four lunches, Thursday Banquet dinner, coffee breaks, site visits, and a 1-year membership to ASTM*. All participants are expected to stay for the full workshop. FEES (USD) Before April 1 to March 31 May 15 2012 2012 ASTM Member $920 $1220 Non-Member $995 $1295 To register, click the Register Now link at http://www.astm.org/e10work0612.htm *ASTM membership only applies to non-members and is included in the non-member price 2

SPONSORS In addition to the time and effort provided by the members of the organizing committee and other ASTM members, a number of corporations have agreed to provide funding for specific events or services. This support is greatly appreciated, since it assists in keeping the registration fees low. We will acknowledge these companies at the Workshop and in future correspondence. Contact Joe Koury (jkoury@astm.org) if your company is interested in becoming a sponsor. CANCELLATIONS A refund of the symposium fee will be honored only if requested at least 7 business days prior to the symposium. To cancel your registration and request a refund, please contact Hannah Sparks at hsparks@astm.org or 610-832- 9678. RECEPTION A reception will be held Sunday evening, June 24. For workshop registrants, the cost of the reception is included in the workshop fee. A nominal fee will be charged for companions who wish to attend. BANQUET DINNER A Banquet Dinner will be held Thursday, June 28. For workshop registrants, the cost of the banquet dinner is included in the workshop fee. A nominal fee will be charged for companions who wish to attend. QUESTIONS ABOUT REGISTRATION If you have questions concerning online registration, please contact Hannah Sparks at ASTM Symposia Operations at: Email hsparks@astm.org Telephone: +1 610 832-9677. CONTACTS Contact: Joe Koury ASTM International 100 Barr Harbor Drive West Conshohocken, PA, USA 19428 E-mail: jkoury@astm.org Remember to make your hotel reservations at Sheraton San Diego Hotel & Marina http://www.starwoodhotels.com/sheraton/property/overvie w/index.html?propertyid=127 Technical Contacts: Deepak Patil Steris-Isomedix Services E-mail: deepak_patil@steris.com John A. Williams Baxter Healthcare Corporation E-mail: john_a_williams@baxter.com Workshop Website and Online Registration Link: http://www.astm.org/e10work0612.htm 3

TECHNICAL SESSIONS The plenary sessions and the workshop group discussions will cover the following topics: I. Dosimetry Overview and Selection: This session will serve as an introduction to many of the topics covered in more detail in later sessions. Topics include definitions and concepts, dosimetry requirements, relationship of ASTM standards to other recognized standards, dosimetry system selection, introduction to calibration and measurement uncertainty. II. Influence Quantities: Many influence quantities can affect the performance of dosimeters and dosimetry systems used in radiation processing and must be considered during the performance characterization of the dosimeter and dosimetry system. Subcommittee E10.01 has produced a new standard to provide guidance to those performing studies to determine the effects of influence quantities. The topics include: Influence quantities to be considered Impact of influence quantities on routine processing dosimetry Design of experiments and its application in performance characterization Improvement of dosimetry results using acquired knowledge regarding the performance characteristics of the dosimetry system. III. Dosimetry System Calibration: This session will provide an overview of the objective and requirements of calibrating a routine dosimetry system. Details will be given for laboratory calibrations and in-plant calibrations. IV. Dose Mapping Gamma, X- Ray (Bremsstrahlung) and Electron: Radiation processing is usually associated with absorbed dose limits: a minimum to assure the desired effect (e.g., curing, and sterilization) and a maximum to avoid adverse effects (e.g., product degradation). Dose mapping is performed to determine the capability of the facility to process products within defined limits and to qualify individual products. Operational Qualification (OQ) and Performance Qualification (PQ) will be covered. V. Process Control: Accurate dosimetry is essential in process control to assure that the dose is delivered in an accurate, reliable and reproducible manner. Topics to be covered include: Process control methodology Impact of uncertainty and process variability on routine processing Calculation of process control limits 4 Investigation of dosimetry results that are outside of specified limits Special Topic: Regulatory Overview Speakers from regulatory agencies will present their agency s perspective on standards and the radiation sterilization process. Hands-On Sessions: The important aspects of dosimetry for gamma, electron beam, and x- ray processing discussed during the plenary sessions will be reinforced through a series of hands-on sessions. Attendees will choose from hands-on sessions that focus on either a photon source or electron source of radiation and will work in small groups to analyze data, make decisions about how to treat the data and prepare a rationalization documenting their decisions and treatment of the data. These hands-on sessions will allow participants to work through a series of specific examples related to: Calibration of dosimetry systems Dose mapping during Operational Qualification (OQ) Dose mapping during Performance Qualification (PQ) Process establishment and control Round Table Sessions: The roundtable provides a forum for group discussions following each hands-on session.

SEVENTH INTERNATIONAL WORKSHOP ON DOSIMETRY FOR RADIATION PROCESSING San Diego, CA, USA Jun-12 24-Jun-12 25-Jun-12 26-Jun-12 27-Jun-12 28-Jun-12 Sunday Monday (8:30-6:15) Tuesday (8:00-4:00) Wednesday (8 am- Thursday 7:30 BREAKFAST BREAKFAST BREAKFAST BREAKFAST 7:45 Continental Continental Continental Continental 8:00 8:15 8:30 WELC OM E A N D IN T R OD UC T ION RECAP RECAP RECAP 8:45 PLENARY I PLENARY III PLENARY IV PLENARY V 9:00 DOSIMETRY OVERVIEW DOSIMETRY SYSTEM DOSE MAPPING PROCESS 9:15 AND SELECTION CALIBRATION OQ & PQ CONTROL 9:30 9:45 BREAK (0.5 hrs) BREAK (0.5 hrs) BREAK (0.5 hrs) BREAK (0.5 hrs) 10:00 10:15 PLENARY II 10:30 INFLUENCE 10:45 QUANTITIES HANDS-ON SESSION I HANDS-ON SESSION II HANDS-ON 11:00 CALIBRATION DOSE MAPPING SESSION III 11:15 OQ PROCESS 11:30 LUNCH CONTROL 11:45 BOXED 12:00 12:15 LUNCH LUNCH LUNCH 12:30 (1.25 hrs) (1.25 hrs) (1.25 hrs) 12:45 Buffet Buffet Buffet 13:00 13:15 13:30 HANDS-ON SESSION I HANDS-ON SESSION II HANDS-ON 13:45 SITE VISITS CALIBRATION DOSE MAPPING SESSION III 14:00 Beam One - San Diego OQ/PQ PROCESS 14:15 Sterigenics - Corona CONTROL 14:30 Steris - Ontario 14:45 BREAK (0.5 hrs) BREAK (0.5 hrs) BREAK (0.5 hrs) 15:00 15:15 ROUND TABLE 15:30 HANDS-ON SESSION I HANDS-ON SESSION II PROCESS CONTROL 15:45 CONFERENCE CALIBRATION DOSE MAPPING WORKSHOP WRAP UP 16:00 REGISTRATION PQ AND Q&A 16:15 ROUND TABLE 16:30 CALIBRATION 16:45 REGULATORY OVERVIEW 17:00 Part 1: US FDA ROUND TABLE 17:15 WELCOME Part 2: DOSE MAPPING Free Time 17:30 RECEPTION Europe or ISO Auditor 17:45 REGULATORY Poster/Paper Sessions 18:00 Q&A and 18:15 1700-1900 Dosimetry Systems Demos 18:30 DOSIMETRY 18:45 SYSTEM 19:00 DEMONSTRATIONS 19:15 (2.5 hrs) 19:30 DINNER DINNER 19:45 (on own) (on own) DINNER 20:00 BANQUET 20:15 20:30 20:45 DINNER 21:00 (on own) 21:15 21:30 21:45 22:00 NOTE 1: Hands-on participants will be divided into groups according to their interest on the primary radiation source (photon versus electron beam). 5