IMRP Pre-Conference Day – The Fundamentals of Radiation Processing

The Pre-Conference Day is designed as an interactive educational session to improve participants understanding of radiation processing fundamentals and to help enhance the IMRP experience for new and seasoned attendees alike.

The Pre-Conference Day will feature a common introductory session followed by a choice between two streams into either Healthcare or Advanced Applications, depending on the interest of the participant. Lecturers for the sessions will be industry and academic experts with extensive technical knowledge and expertise.

Separate registration fees apply for the Pre-conference Day (Monday, November 7).

The Fundamentals of Radiation Processing – Part 1

Chair: Mohamad Al-Sheikhly

8:30am Introduction Mohamad Al-Sheikhly

The speaker will present an overview of the pre-conference program, the purpose of the training and how it ties into the objectives of IMRP.

8:45am Radiation interaction with matter Mohamad Al-Sheikhly

This section will cover some of the fundamentals of what happens when materials are exposed to ionizing radiation, what are the intended consequences and what are the unintended consequences, and include the following:

  1. Physics of Radiation
    The interaction of photons and electrons with matter, the photoelectric effect, Compton scattering, pair production, mass attenuation coefficients, the columbic interactions of electrons with various matters, dose depth plots, LET effects, etc.
  2. Radiation effects on common materials (Jim Wishart)
    Fundamentals of radiation-induced scission and crosslinking of polymers and their applications in advanced synthesis and manufacturing, basic principles of the radiation-chemical yields (G-values) in gases, liquids, and solids, formation and decay of the radiolytically produced transient species such cations, anions, and free radicals.

9:15am Radiation interaction with biological organisms Mohamad Al-Sheikhly

General mechanisms of the radiation effects on DNA, RNA, and protein, explanation the definition of Bioburden, destruction of pathogenic microorganisms for the purpose of sterilization, extension of shelf life, disinfection, sprout inhibition, and insects.

9:30am Radiation measurements Arne Miller

This section will provide an introduction to dosimetry used in radiation processing, how dosimeters work and units of measurement, including the following topics:

  1. Dosimetry system selection
    Introduction to some common dosimetry systems, their applications and limitations
  2. Influence Quantities
    Influence quantities are external influences that can affect the performance of a dosimetry system, this section will look at identifying influences and characterizing the performance of a dosimetry system.
  3. Calibration and Uncertainties
    Basics of how dosimetry systems are calibrated for use in routine production, including in-plant and laboratory calibrations. Determination of components of uncertainty and their implication in calibration and use.

10:15am Break
10:30am Irradiator design Mark Smith (or EC)

Design of Co-60 gamma, electron beam, and x-ray facilities for radiation processing including the following:

  1. Shielding and Safety
    Design of radiation protection systems, referencing international standards.
  2. Gamma Systems
    Design of gamma systems, overlapping product vs overlapping source and considerations for different products.
  3. Electron beam and X-ray systems
    Components of Electron beam accelerators systems and how they work, x-ray targets and Bremsstrahlung.

11:00am Radiation Process Validation Betty Howard

Understanding the validation of a radiation process, using ISO 11137-1 as a guideline, and including the following:

  1. Installation and Operational Qualification
    General requirements for dose mapping studies required to demonstrate that an irradiator is installed and operates as expected. Guidance on when Operational Qualification needs to be repeated.
  2. Product Qualification
    How do you introduce a new product to an irradiator, design of dose mapping studies based on OQ and product characteristics, placement of routine monitoring dosimeters and how this may be different for different irradiation systems.
  3. Process Control
    Considerations in setting process target values. Leveraging IQ, OQ and PQ to ensure that your process delivers the required dose specifications.

11:45am Conclusions Mohamad Al-Sheikhly

The conclusions should focus on tying in the different topics discussed in the morning to relevant sessions and/or posters that the attendees can see during the main conference.

The Fundamentals of Radiation Processing – Part 2

1:00pm-5:00pm

The afternoon sessions dig in to the question of why we irradiate. Attendees will select between one of two concurrent streams.

Stream 2A – Introduction to Advanced Applications

Chair: Mohamad Al-Sheikhly

1:00pm Introduction Mohamad Al-Sheikhly

The speaker will present an overview of the afternoon objectives and set the stage for the panel discussion at the end of the session.

1:15pm Radiation-synthesis of advanced materials Piotr Ulanski

The lecture will discuss the fundamentals of the ionizing radiation synthesis of nano materials, nano composites, and grafting for various applications.

1:45pm Radiation effects on polymers Fraser J Buchanan

The lecture will explain the fundamentals of radiation-induced sessions and crosslinking of polymers and their applications in advanced synthesis and manufacturing.

2:15pm Food irradiation and food packaging materials Kim M. Morehouse

The lecture will concentrate on the following basic principles:

  1. General consideration: Destruction of pathogenic microorganisms, extension of shelf life, disinfection, sprout inhibition
  2. Radiation-induced chemical changes food components
  3. Food packaging materials

2:45pm Break
3:00pm Waste management Andrzej Chmielewski

The lecture will address the use ionizing radiation in the remediation of toxic materials. The lecture will include:

  1. Radiation treatment of flue gasses
  2. Sewage and sludge
  3. Wastewater and disinfection of liquid animal wastes

3:30pm Panel Discussion – Spur Innovation in Radiation Processing

Panelists: Mohamad Al-Sheikhly, Arne Miller, Piotr Ulanski, Olgun Guven, Kim M. Morehouse and Andrzej Chmielewski

Pending charge statement for the panel which will include the following concepts:

The panel will identify and prioritize measurement, standards and technology needs currently creating barriers to innovation in radiation processing in an effort to impede full realization of the societal and economic benefits of new discoveries in the field.

The panel will focus on:

  • Health Care – improving health through radiation technology for sterilization for medical device manufacturers, the pharmaceutical industry and other product and tissue applications
  • Agriculture – increasing yield, quality and safety in the world’s food supply;
  • Environment – understanding waste applications and future needs
  • Manufacturing – obtaining higher quality products through better technology developments
  • Interpreting ASTM and ISO standards
Education and outreach: It will also include discussions on how to educate the public on the importance and safety of the radiation processing.

The panel will target yielding a high level “road map” list of measurement, standards and technology needs that will inform and guide the radiation processing industry, government, and academia.

Stream 2B – Challenges in Radiation Sterilization

Chair: Martell Winters

1:00pm Introduction Martell Winters

The speaker will present an overview of the afternoon objectives. This session will be presented in a workshop style; including input and discussion from the participants to drive most of the content.

1:15pm Case Study #1 – Gamma irradiator Operational Qualification (OQ) investigation Deepak Patil, Kevin O’Hara

The speaker will present information and lead a discussion on a dosimetry investigation into operational qualification (OQ).

2:00pm Break
2:15pm Case Study #2 – Gamma irradiator Performance Qualification (PQ) investigation Deepak Patil, Kevin O’Hara

The speaker will present information and lead a discussion on product dose mapping.

3:00pm Case Study #3 – Reviewing a Validation/Dose Audit Failure Martell Winters

The speaker will provide information from a failed VDmax validation or dose audit and lead a discussion on items that should be investigated in order to obtain passing results. The discussion will include aspects such as the importance of Population C and specific items which should be addressed in the investigation.

3:45pm Case Study #4 – Bioburden Data Evaluation Martell Winters

The speaker will provide different sets of bioburden data and lead a discussion of interpretation of the data including whether the data should be used as is, or if investigation is necessary. The discussion will include aspects such as less-than values (e.g. <4), use of statistics with bioburden data, the meaning of spore and anaerobe testing and recovery efficiency results.