6.
Operational Radiation Protection
6.1 General
Operational radiation protection involves radiological surveillance during routine operations,
maintenance and off-normal situations. Management and surveillance of radioactive waste is
also an important component to ensure radiation safety.
This section deals with
i) Radiological surveillance
ii) Radioactive waste management which includes management of solid, liquid and
gaseous radioactive waste generated during operation, maintenance and off-normal
situations of MCF.
iii) Record keeping
6.2 Radiological Surveillance:
Radiological surveillance essentially includes area monitoring, personnel monitoring and
contamination monitoring.
6.2.1 Area Monitoring:
The objective of area monitoring is achieved through use of installed gamma and
neutron monitors as well as hand held survey meters.
a. Installed gamma and neutron radiation area monitoring devices with audio-
visual alarm should be provided in all areas that can have continuous
occupancy and where radiation levels are likely to rise above the permissible
levels.
b. The output of all the fixed radiation monitors should be easily legible and
measurement data from all locations should be displayed at a centralized
control center in the facility preferably control room for the cyclotron.
c. The area monitors should have appropriate preset alarm conditions depending
on the location of installation of the same.
d. Low and high range gamma radiation survey instruments, neutron survey
meters should be available for measurement of ambient radiation fields.
e. The radiation monitoring and measuring instruments should undergo periodic
calibration and performance checks.
f. A portable air sampler may also be made available at the facility to collect and
measure air samples.
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6.2.2 Personnel Monitoring
a. All radiation workers and trainees entering the controlled areas should be
covered by personal monitoring services.
b. In addition the facility should also have sufficient numbers of Direct Reading
Dosimeters (DRDs)/ Digital Pocket Dosimeters with alarm setting for
instantaneous recording of personnel exposure.
c. Maintenance personnel should be issued with DRDs
whenever they enter radiation areas.
d. In addition, wherever appropriate, extremity dose measurement using badges
should also be undertaken.
6.2.3 Contamination Monitoring
a. Hand and Foot monitors at appropriate location interfacing the R & R room to
other areas of the MCF should be provided to detect the presence of any
radioactivity contamination on the skin, body, personnel protective clothing,
personal clothing and foot wear etc.
b. In case of spillage of any radioactive material, the presence of
loose/transferrable contamination on any work surface should be evaluated
either by direct survey or taking a smear/swipe sample for counting.
c. Periodic surveillance for possible contamination from activation products either
in the cyclotron vault or radiochemistry laboratory or QC labs should be
ensured.
d. Provision of instruments and de-contamination facilities both for equipment
and personnel should be made.
e. Contamination, should be promptly addressed through proper decontamination
procedures.
6.3 Radioactive Waste Management
The radioactive waste management policies and procedures at the medical cyclotron
facility should be as per the relevant Rules.
The licensee should put in place an appropriate procedures to ensure safe collection,
segregation, storage, transfer/disposal of the radioactive waste generated during
routine operations, maintenance and off-normal situations.
6.3.1 Solid Waste
a. Generation of solid waste:
Solid radioactive waste is generated during cyclotron maintenance and
following production of radiopharmaceuticals. The common solid wastes
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generated during cyclotron maintenance are cyclotron targets, foils,
components etc; which have induced radioactivity. Other solid radioactive
waste that is generated is from components in the cyclotron tank that break
during the wear and tear of normal use.
Solid radioactive waste are also generated during the cleaning of targets.
In routine radiochemistry operations, the solid wastes like cassettes, separation
and purification cartridges, tubings, reagent vials, syringes, membrane filters,
etc. are generated during radiopharmaceutical synthesis and dispensing
operations
The radioactive waste generated during Quality Control procedures are paper
chromatography strips, pipette tips, syringes, needles, tissue papers, rubber
bungs, aluminum caps etc;
b. Management of solid waste:
i. All radiation safety precautions should be undertaken during handling,
removal, collection, transfer and storage of generated radioactive
waste. The contents inside the pit should be safely stored, adequately
labeled with ‘restricted access’ to authorized personnel in order to
prevent inadvertent handling by other staff.
ii. The entire procedure of radioactive waste handling, storage, removal
and disposal should be carried out under the guidance and supervision
of facility’s RSO..
iii. Solid wastes generated during preventive maintenance should be
collected and transferred to the dedicated lead lined storage pit inside
the cyclotron vault in an impermeable polythene bag.
iv. Solid radioactive waste generated during the wear and tear of normal
use and radioactive Havar Foils, should be stored in a customized lead
pot inside the lead lined pit since these require long term storage.
v. The solid radioactive waste generated during the target cleaning
process should be monitored and stored in the lead pit.
vi. Waste related to cyclotron components having induced radioactivity,
may be characterized using a Multi-Channel Analyzer Gamma Ray
Spectrometry System to identify and understand the typical profile of
the induced radionuclides per µAh operation of the Medical Cyclotron.
This will be beneficial in management of waste generated in
subsequent operations.
vii. The waste generated during radiopharmaceutical synthesis and
dispensing operations should be handled next day, collected and stored
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for decay in a lead lined storage bin and stored inside the
radiochemistry laboratory.
viii. The generated waste prior to its disposal should be monitored for the
presence of any detectable radioactivity.
ix. The radioactive waste generated during Quality Control procedures
should be stored in a lead lined foot operated waste bin inside the QC
laboratory.
x. Short-lived 18F, 11C, and 13N radioactive waste should be stored for
decay to acceptable levels and discarded as non-radioactive waste.
However, provision for interim storage of longer-lived radionuclides
like Cu-64 and I-124, if produced should be made in addition to the
short-lived radionuclides.
6.3.2 Liquid Waste
a. Generation of liquid waste:
The liquid radioactive wastes are generated during target maintenance and
during synthesis of radiopharmaceuticals.
b. Management of liquid waste:
i. Liquid waste generated during target maintenance should be contained
in leak proof containers and stored in lead storage pit till decay to
acceptable limits.
ii. Liquid waste collected during synthesis should be stored for interim
period for decay, monitored and disposed off in laboratory sinks.
iii. Disposal of liquid waste should be such that the activity and
concentration is well within the limits prescribed by regulatory body
for disposal through sanitary sewerage.
6.3.3 Gaseous Waste
a. Generation of gaseous waste:
Gaseous radioactivity can be generated during cyclotron operation by
activation of air in the cyclotron vault and chronic release of radioactivity
particularly F-18 during synthesis operations in the radio-chemistry hot-cell.
b. Management of gaseous waste:
i. Radioactive gases generated during radiochemistry synthesis
operations should be through a Waste Gas Compressor System, which
will compress and store the radioactive waste air in leak proof
cylinders for an appropriate period for radioactive decay. The
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mechanism of operation of the waste gas air compressor system should
be such that it permits release of contents only when the radioactivity
levels are below the set threshold values, and released through the
stack.
ii. Air-changes provided by design in the cyclotron vault should be such
that there is a proper venting of gaseous radioactive waste through
stack. The stack should be provided with a calibrated stack monitor to
quantify the activity released through the stack and a record of such
releases to be maintained and reported.
iii. The facility should have provisions to promptly detect any releases of
air-borne radioactive contamination during radioisotope production and
radiopharmaceutical synthesis procedures. For this continuous on-line
monitoring systems should be provided in the stack/chimneys at the
vault exhaust.
6.3.4 Disused, Spent Sources and long-lived radioactive waste
Sealed spent or disused calibration sources, if available, should be collected, stored
and subsequently disposed off by taking necessary permissions from the regulatory
body.
6.4 Record Keeping
RSO of the Medical Cyclotron should maintain a log of the following data;
a. Radiological Survey Data
b. Personnel Dose Records including DRDs
c. Unusual Incidents and Occurrences Record
d. Radioactive Waste Storage and Disposal Record
e. Preventive Maintenance Procedures
f. Logbook for Operation of Cyclotron
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