Maintaining Process Effectiveness. Regular Testing and Calibration. Process equipments. Analytical equipments. Regularly test and calibrate. Dosimetry systems. Characterizing the magnitude, distribution, and reproducibility of the dose absorbed in a material of homogeneous density.
Regularly test and calibrate
Characterizing the magnitude, distribution, and reproducibility of the dose absorbed in a material of homogeneous density
New batch of dosimeters
Dosimeters in a conditions similar to those in the actual production irradiator
Calibration verification should be performed periodically at the facility
Measurement traceable to national standard
The level of measurement uncertainty at a specified confidence level should be known
Orientation of the product with diagrams
Required activities and functions for the irradiation of the products
Dosimetry system selected
Type and batch number
Instruments used for analysis
Reference standard or transfer standard
Reference the calibration facility used
Effect of environmental conditions on dosimeter during irradiation and measurement
Uncertainty associated with the measurement
Measurement quality assurance plan used for the routine dosimetry
The main purpose of Records
Fulfill obligations to and requirements of the authorities
To settle disputes (if any)
Reception and inspection of product
Scheduling the irradiation
Loading the product onto the irradiator system
Unloading the irradiated product from the system
checking of routine dosimetry, process parameters
Sign-off of any non-conformances
Approval for release and dispatch to the customer
Date & shift
Personnel on duty - time in &out with signature
Record various operational parameters such as Conveyor speed, cycle time, running time of the irradiator, total number of packages transferred
Technical details of each equipments employed for operation (exhaust fan, hydraulic motor, recirculation pump, etc) and values of other monitoring instruments such as survey meters, contamination monitors, conductivity, hydraulic pressure recirculation water temperature, pH, etc
Record shutdown details with time.
Record reason for shut down
Record action taken
Unique ID of the box,
Carrier no. If any,
Date and time
Date & time
Absorbed doses for products processed
Process parameters of specific production runs
Reference the calibration of processing equipment
Reference the calibration of dosimetry systems and other analytical instruments
Absorbed dose for each specific production runs
Calibration of dosimeters
Calibration of Dosimetry equipments
Maintenance of the dosimetry equipment
Each lot of product that is processed with unique identification number
Date the product is processed and the starting and the ending times of the irradiation
Any special conditions of the facility that could affect the absorbed dose to the product
Name of the operator
Certificate for delivery of the dose to the product for each production run.
Names of authorized personnel who issued the certificate
Periodic audit of all documentation
Copies of receiving documents.
Copies of shipping documents
For each production run, retain record at the facility for inspection
Dose calibration documents
Irradiation control records
Routine Dosimetry data
Certificate of irradiation
Retain the records for a period
Time specified by relevant authorities
Guidelines for the Development, Validation and Routine Control of Industrial Radiation Process.
IAEA Radiation Technology Series No.4 (2013)
ISO 11137:2006 “Sterilization of Healthcare Products – Radiation”
Part 1: Requirements for development, validation and routine control of a sterilization process
for medical devices
Part 3: Guidance on dosimetric aspects
Trends in radiation Sterilization of Health Care Products. IAEA, STI/PUB/1313 (2008)
ISO/ASTM 51649 “Standard Practice for Dosimetry in an Electron BeamFacility for Radiation Processing at Energies Between 300 keV and 25MeV”
ISO/ASTM 51702 “Standard Practice for Dosimetry in Gamma Irradiation Facilities for Radiation Processing”
ISO/ASTM 51261 “Standard Guide for Selection and Calibration of Dosimetry Systems for Radiation Processing”
Example. 1: The sterilization dose specified for a product is 25 kGy and maximum dose is specified as 40 kGy. Data from a dose mapping exercise at the irradiation facility for the product shows dose at
Reference position - 30.5 kGy
minimum position - 26.5 kGy
maximum position - 37.0 kGy
Find out the minimum and maximum reading that is permissible for the routine dosimeter during routine processing of the product at the facility?
Example. 2: The sterilization dose specified for a product is 25 kGy and maximum dose is specified as 40 kGy. If the routine permissible range is from 27 kGy to 35 kGy, find out the absorbed dose at minimum and maximum dose position in the product if the routine dosimeter registers a reading of 31 kGy?
Absorbed dose at the minimum dose position
= Sterilization dose X Routine dosimeter reading
Minimum routine permissible reading
= 25 x 31 kGy = 28.7 kGy
Absorbed dose at the maximum dose position
= Maximum specified dose X Routine dosimeter reading
maximum routine permissible reading
= 25 x 31 kGy = 35.4 kGy
Therefore the minimum and maximum absorbed dose corresponds to the above routine dosimeter reading are 28.7 kGy and 35.4 kGy respectively.
Which standard do you follow for the sterilization of health care products?
Which standard do you follow for the selection of dosimetry systems?
Which standard do you follow for the calibration of dosimetry systems?
Which standard do you follow for estimating uncertainty in your dosimetry systems?
Name few reference standard dosimeters for calibration gamma irradiation facilities
What are the differences between reference standard and routine dosimeters?
What are the required procedures to validate the radiation processing of products?
How do you achieve measurement traceability for your dosimetry systems?
What are the roles of dosimetry in the validation of radiation processing?
How do you ensure quality assurance during routine production of radiation processed product?
Name few routine dosimeters used in the range of 400 Gy to 1 kGy dose range for food irradiation facilities.
How do you calibrate 10 MeV electron beams?
Name few routine dosimeters used in electron beam irradiators.
What are important differences between the dosimetry of electron beam facility and gamma irradiation facility?
What are the main aims of carrying out dose mapping in IQ, OQ and PQ?
Why do you require different dosimeters during different stages of validation process?
What are the important environmental conditions that affect the performance of the dosimeters during its applications?
How do you ensure accuracy of measurement?
How do you correct systematic error in your dosimetric measurement?
What are operational and performance qualifications?
How is dose mapping in operational qualification is different from performance qualification?
Which standard do you follow for dose mapping during validation?
Which standard do you follow for the validation of radiation processing gamma irradiator?
What standard do you follow for the validation of electron beam irradiator?