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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.

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slide2

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

slide3

Dosimetry System Calibration

New batch of dosimeters

Calibrate

Analytical instruments

Dosimeters in a conditions similar to those in the actual production irradiator

Calibration verification should be performed periodically at the facility

Routine dosimeters

Measurement traceable to national standard

The level of measurement uncertainty at a specified confidence level should be known

slide4

Documented Procedure

  • Product handling before, during and after irradiation

Orientation of the product with diagrams

Documented procedure

Routine dosimetry

Required activities and functions for the irradiation of the products

slide5

Documentation for Dosimetry system

  • Dosimeter manufacturer

Dosimetry system selected

Type and batch number

Instruments used for analysis

  • Date

Dosimeter Calibration

Reference standard or transfer standard

Reference the calibration facility used

slide6

Documentation for Dosimetry performance

  • Temperature, Humidity. light

Effect of environmental conditions on dosimeter during irradiation and measurement

Dose rate

Energy spectrum

Uncertainty associated with the measurement

  • Reference the method used to convert dosimetry measurements to absorbed-dose values in water

Measurements

Measurement quality assurance plan used for the routine dosimetry

slide7

Records

  • Provide documentary evidence showing that the product received correct treatment

The main purpose of Records

Fulfill obligations to and requirements of the authorities

To settle disputes (if any)

slide8

Product Process record

Reception and inspection of product

  • Unique code identifying each product

Storage environment

Scheduling the irradiation

Record of

Loading the product onto the irradiator system

Unloading the irradiated product from the system

Inspection

checking of routine dosimetry, process parameters

Sign-off of any non-conformances

Approval for release and dispatch to the customer

slide9

Daily shift maintenance record

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

System

Condition

Record of

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

Shut down

details

Record shutdown details with time.

Record reason for shut down

Record action taken

slide10

Product log record

Product

Customer name,

Unique ID of the box,

Package number,

Carrier no. If any,

Details of

product

Required

dose

Cycle time

Conveyor speed

Record of

Package in

Date and time

Product

Processing

Package out

Date & time

Dosimeter

Dosimeter number

slide11

Irradiation Control record

Date

  • Time

Product type

Record of

Loading diagrams

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

slide12

Dosimetry record

Absorbed dose for each specific production runs

Calibration of dosimeters

Record of

Calibration of Dosimetry equipments

Maintenance of the dosimetry equipment

slide13

Facility record

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

Record of

Any special conditions of the facility that could affect the absorbed dose to the product

Name of the operator

slide14

Record for Review and Approval

Certificate for delivery of the dose to the product for each production run.

Record of

Names of authorized personnel who issued the certificate

Periodic audit of all documentation

slide15

Retention of Records at the facility

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

slide16

References

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”

slide17

Worked example

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?

  • Answer.
  • Minimum reading of the routine dosimeter
  • = Dose at the reference position X sterilization dose
  • Dose at the minimum position
  • = 30.5 x 25 kGy = 28.8 kGy
  • 26.5
  • Maximum reading of the routine dosimeter
          • = Dose at the reference position X sterilization dose
          • Dose at the maximum position
    • = 30.5 x 40 kGy = 33.0 kGy
    • 37.0
  • Therefore the minimum and maximum permissible reading of the routine dosimeter to register for the load to meet the specification are 28.8 kGy and 33 kGy respectively.
slide18

Worked example

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?

Answer.

Absorbed dose at the minimum dose position

= Sterilization dose X Routine dosimeter reading

Minimum routine permissible reading

= 25 x 31 kGy = 28.7 kGy

27

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

35

Therefore the minimum and maximum absorbed dose corresponds to the above routine dosimeter reading are 28.7 kGy and 35.4 kGy respectively.

slide19

Questions

?

  • Multiple Choice
  • 1. Penetration of electrons depends on:
    • A. Current of electron beam,
    • B. Electron energy,
    • C. Speed of conveyor.
  • 2. Radiation sterilization is performed according to:
    • A. ISO 11134,
    • B. ISO 11137,
    • C. ISO 11135.
  • 3. What does “dose mapping” mean?
    • A. Determination of minimum dose
    • B. Determination of maximum
    • C. Measurement of dose distribution
  • 4. Which dosimeter is used for monitoring of radiation processing of products?
    • A. Reference dosimeter
    • B. Routine dosimeter
    • C. Transfer standard dosimeters
  • 5. In radiation processing application, calorimeter is used as
    • A. Primary dosimeter
    • B. Transfer standard dosimeter
    • C. Routine dosimeter
  • 6. For absorbed dose measurements for radiation sterilization, dose is referred in
    • A. Water
    • B. Air
    • C. Graphite
slide20

Questions

?

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?

slide21

Questions

?

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?