Irradiator Technology HRTD · 2012. 12. 5. · Self-Shielded Irradiators ¾ANSI definition of a...

Irradiator Technology HRTDHuman ResourcesTraining & Development

Self-ShieldedIrradiator

Safety

July 2011- Slide 1 of 55Irradiator Technology Course (H-315)

Safety Inspections& Licensing

Self-Shielded Irradiators

ANSI definition of a Category I irradiator

Irradiator in which sealed sources are


completely contained in a dry container constructed of solid materials, the sealed sources are shielded at all times, and human access to the sealed sources and the volumes undergoing irradiation is not physically possible in its designed configuration.


Are


Inherently Safe


• May Contain Thousands of Curies

• Designed to Be Placed in Unshielded R


Rooms

• Very Low Doses to Authorized Users

Examples of Self-Shielded Irradiators


Gammacell 40Exactor

Gammacell 1000IBL-437C

Examples of Self-Shielded Irradiators


J. L. Shepherd Mark IGammacell 220

Examples of Irradiators (Calibrators)


J. L. Shepherd 89-400 FEMA CDV-794

Example of a Movable Source Irradiator

• Sources are mounted on shielded operating rods

• Sources moved up from the “shielded” to the “irradiate” position


• Door is interlocked to prevent opening when source is in sample chamber

• Bypassing or failure of interlock can result in high radiation levels

J. L. Shepherd Mark I

Example of Self-Shielded Irradiator With Fixed (Non-Movable) Sources

• Sources are fixed and housed within the radiation shield.

• The shield contains a rotor that is operated by an electric drive.


The sample chamber is contained within the rotor and has an electric turntable. During operation, the rotor turns 180 degrees and the sample chamber is exposed to radiation. Best Theratronics Ltd.Gammacell 1000

Uses

• Irradiate Blood Products In Order To Prevent Graft-Versus-Host Disease (GVHD) in Immune Compromised Patients– Donor (Graft) T-cells may perceive the

R i i t (H t) f i d tt k


Recipient (Host) as foreign and attack • Irradiate Small Animals (e.g., for stem cell

research)• Irradiate Biological Samples• Sterilize insects


• Typically located at– Blood Banks– Hospitals

U i iti


– Universities– Research Labs

Self-Shielded Irradiator Safety Inspections

• Generally, straight forward and uneventful• Typically located Indoors at a medical facility or

research lab• Majority of licensee’s program is within one room


• Not a lot of complicated procedures or regulations

• Emergency response actions are common sense (i.e., leave area and control access)

• Can typically be completed within several hours

Self-Shielded Irradiator Safety Inspections

• NRC Inspection Procedure – 87122, “Irradiator Programs”

• Determine if licensed activities are being conducted in a manner that will protect the health


and safety of workers and the general public• Determine if licensed activities are being

conducted in accordance with regulatory requirements

Inspection Preparations

• Review Docket File– Incidents, Follow-up Items, Inspection and

Enforcement History, and Violations for Closeout

• Review SSDR


– Maximum Source Activity– Maximum External Dose Rates– Details of Device Operation

• Review NMED Events• Be aware that J. L. Shepherd Mark I and 81-22

irradiators are subject to enhanced monitoring requirements

Inspection Focus Areas

• 1) Security & control of licensed materials• 2) Shielding• 3) Comprehensive safety measures• 4) Radiation dosimetry program


4) Radiation dosimetry program• 5) Radiation instrumentation and surveys• 6) Radiation safety training and practices• 7) Management oversight

Gather Information on Scope of Program

• Type of Irradiator(s)?• Irradiators IAW material authorizations in the

license?• No. of curies (or Bequerels;o)


• Irradiator Uses IAW Material License?• Frequency of use?• RSO is the same as the license? • Number of Authorized Users?

Location of Use, Comprehensive Safety Measures, & General Access Controls*

• Location(s) of use IAW license?• Licensee evaluated floor loading?• Sources are adequately protected from fire,

hazardous chemicals, industrial hazards, the


elements• Licensee limits unescorted access* to only

authorized and trained personnel?– Physical barriers and key control?– Trained Personnel?

* Specific access controls are evaluated in detail during an IC inspection

Shielding

• Perform independent radiation surveys to evaluate adequacy of shielding– Irradiator dose rates IAW SSDR?– Irradiator room dose rates?


– Areas adjacent to irradiator?

Personnel Monitoring

• Licensee issues NVLAP Dosimetry to AUs• A review of dosimetry results shows that radiation

exposures are ALARA• OR


• Licensee maintains a prospective evaluation that demonstrates that unmonitored individuals are not likely to receive, in one year, a radiation dose in excess of 10% of the allowable limits in 10 CFR 20

• The licensee’s prospective evaluation is reasonable

Personnel Monitoring and Public Dose

• Licensee has properly investigated any unusual dosimetry results?

• Licensee advises workers who are required to be monitored, and whose exposure exceeds 100

f th i di ti ?


mrem, of their radiation exposures?• Members of the public will not exceed 1 mSv (100

mrem) in one year, AND dose in an unrestricted area does not exceed 2 mrem in any one hour?

• Licensee should maintain documentation demonstrating compliance with the public dose limit?

Radiation Monitoring Instrumentation

• Licensee possesses or has access to properly calibrated radiation survey instruments

• Due to self-shielding design features, it is not required for a licensee to possess a survey i t t H th d t


instrument. However, they may need one to – Verify source integrity– Verify occupational dose w/I regulatory limits– Verify public dose w/I regulatory limits

• It is a good practice to possess a survey meter and use an area radiation monitor

J. L. Shepherd Mark I or 81-22 Irradiators

• An interlock failed on a J. L. Shepherd Mark I irradiator that allowed the shielded door to be opened when the sources were positioned in the sample


were positioned in the sample chamber

• This could subject the user to substantial radiation dose

J. L. Shepherd Mark I or 81-22 Irradiators

• NRC Issued an Order to Amend All J. L. Shepherd Mark I or Model 81-22 licensees to add additional monitoring requirements


Additional Monitoring Requirements for J. L. Shepherd Mark I or 81-22 Irradiators

• Irradiator cannot be used unless licensee provides a calibrated and operable radiation survey meter OR a room monitor

• Requires operator to visually verify that the source position is in safe condition before opening door


• Each room monitor (if used)– Operable at all times when irradiator is in use– Activates visual and audible alarms when radiation

levels exceed 2 mR/h– Properly located to detect radiation escaping from door– Visible to AU when next to the irradiator

Additional Monitoring Requirements for J. L. Shepherd Mark I or 81-22 Irradiators

• If a room monitor is not installed, a survey meter shall be used to– Check radiation level at door when door is closed– Check door for increase in radiation level when


door is opened• Operator shall position body to minimize dose• If abnormal radiation or malfunction occurs,

immediately notify regulatory authority• Do not attempt or authorize repair unless authorized

by license

Training

• Authorized users have been adequately trained in and are knowledgeable:– Device operation– Use of radiation survey meters


– Techniques to limit their exposure– Operating and emergency procedures– Access control procedures, and– Their responsibility to control access to the

device.

Radiological Postings

• Licensee uses appropriate radiological postings to alert personnel to the presence of radioactive material

• NOTE: For security purposes, to minimize unwarranted attention, the licensee may elect to remove Caution posting from outer door and move it to inside the


irradiator room• 10 CFR 20.1903 Posting Exemption – room or area is not

required to be posted with a Caution sign due to the presence of a sealed source, provided radiation is

Leak Tests & Inventory

• Sealed sources are leak tested are performed as prescribed by license condition.– 6 months when in use– 10 years when in storage


• Licensee conducts a physical inventory as prescribed by license condition– Typically, six-month frequency– Record: Manufacturer’s name, model no.,

radionuclide, quantity, and date of inventory

Irradiator Maintenance, Repair, or Alteration

• Determine if licensee has performed non-routine maintenance, and if so, verify that licensee is authorized to perform non-routine maintenance

• Licensee must have specific authorization to repair, remove, replace or alter:


p , , p– Electrical or mechanical systems that control

shielding or source movement– Shielding or sealed sources– Safety interlocks, or– Anything that affects the safe operation of the

irradiator

Irradiator Maintenance, Repair, or Alteration

• If the licensee’s authorization is limited to the performance of routine maintenance, verify that the licensee follows the manufacturer’s procedures for routine:

Cl i d l b i ti


– Cleaning and lubrication,– Mechanical or electrical maintenance, or– Other non-safety critical repairs

Operating and Emergency Procedures

• Include an analysis of each type of material to be irradiated to determine compatibility with the irradiator design, and any special safety proceduresI l d i t ti f d ti


• Include instructions for use and routine maintenance, according to manufacturer’s instructions

• Include instructions for maintaining security• Include steps to maintain ALARA• Include instructions for maintaining

accountability


• Include steps to control access to a malfunctioning or damaged irradiator

• Include steps to take and whom to contact when an irradiator is damaged or malfunctions


• Include specific operating procedures for irradiators with movable sources

• Are maintained current and provided to all users • Posted in irradiator room, or instructions for

access to the procedures

Emergency Procedures

• Common Sense & Include the following:– Leave irradiator room to reduce exposure– Control access– Contact individual responsible for program


p p gand to initiate emergency response

– Telephone numbers for Responsible Individual, Manufacturer, Security, Fire Department, Police, NRC or State Regulator

• Survey outside room to determine if further restrictions are required


• Licensees can change their operating and emergency procedures only if:– The changes are reviewed and approved and

documented by licensee management


– Affected staff are trained in the procedures before implementation

– Changes are consistent with license conditions and commitments in license application, and

– The changes do not degrade safety

Management Oversight

• Licensee performs annual review of radiation protection program content and implementation

• Licensee has procedures for reporting defects• RSO is knowledgeable and ensures activities are


conducted IAW approved procedures and regulations

• RSO has sufficient authority, organizational freedom, time, resources, and management prerogative to identify radiation safety problems; initiate, recommend, or provide C/A; stop unsafe operations; and verify implementation of C/A

Self-Shielded Irradiator Shipment


Loading into Cask Ready To Ship

Examples of Self-Shielded Irradiator NMED Events: 2000 - 2011

• Elevated extremity exposure (27.8 rem) received due to source transfer rod becoming disengaged during source reload of a J.L. Shepherd 81 series irradiator.

• Leaking sealed source capsule (contaminated weld leached over time)• Source rack on a J.L. Shepherd 81-16A irradiator failed to retract due to reduced

air pressure in the operating piston due to water in compressor supply line.• Eldorodo irradi. shutter mechanism failed to close due to a faulty solenoid valve.


• 3 examples of door to J.L. Shepherd Model 68A Mark I failed to open due to a mechanical failure

• Sources in a J.L. Shepherd Mark I irradiator stuck in up position during testing due to a timer failure

• Multiple examples of badges with elevated readings that were determined to be dose to the badge only.

• Shepherd Mark I door and source interlock failures• Type B shipping container that did not meet the required Certificate of Compliance

Self-Shielded Irradiator Licensing


Good NewsLicensing is Not Difficult

• Follow Guidance in

NUREG 1556 V l 5


• NUREG 1556, Vol. 5

• As always, the application is easier to review if the licensee uses the checklist

Ensure Licensee

• Provides Device and Source Make & Model Nos.• Specifies Device with an Approved SSDR• Includes a Total Possession Limit IAW SSDR


Financial Assurance


• Typically, self-shielded Irradiator Licensees do not need Financial Assurance

Training Requirement is Easy to Meet


Training Requirement is Easy To Meet


Irradiator Training


Facility & Equipment

• Use Standard Boiler Plate Response• “We will ensure that where each self-shielded

irradiator is located corresponds to the – Conditions of Use (In SSDR)


Limitations and Other Conditions of Use From SSDR


Licensee to Ensure

• The floor beneath the Self-Shielded Irradiator is adequate to support the weight

• Each area where a Self-Shielded Irradiator is located is equipped with an automatically

t d fi d t ti d t l t


operated fire detection and control system (sprinkler, chemical, or gas)

• OR• The location of the area or other controls ensure

low level radiation risk attributed to fires.

Standard License Condition Required for Shepherd Mark I or 81-22 Irradiators

• Irradiator cannot be used unless licensee provides a calibrated and operable radiation survey meter or room monitor

• Requires operator to visually verify that the source position is in safe condition before opening door


• Each room monitor (if used)– Operable at all times when irradiator is in use– Activate visual and audible alarms when radiation levels

exceed 2 mR/h– Properly located to detect radiation escaping from door– Visible to AU when next to the irradiator

Standard License Condition Required for Shepherd Mark I or 81-22 Irradiators

• If a room monitor is not installed, a survey meter shall be used to– Check radiation level at door when door is closed– Check door for increase in radiation level when door is

opened


p• Operator shall position body to minimize dose• If abnormal radiation or malfunction occurs, immediately

notify regulatory authority• Do not attempt or authorize repair unless authorized by

license


• Include an analysis of each type of material to be irradiated to determine compatibility with the irradiator design, and any special safety proceduresI l d i t ti f d ti


• Include instructions for use and routine maintenance, according to manufacturer’s instructions

• Include instructions for maintaining security• Include steps to maintain ALARA• Include instructions for maintaining

accountability


• Include steps to control access to a malfunctioning or damaged irradiator

• Include steps to take and whom to contact when an irradiator is damaged or malfunctions


• Include specific operating procedures for irradiators with movable sources

• Are maintained current and provided to all users • Posted in irradiator room, or instructions for

access to the procedures

Emergency Procedures

• Common Sense & Include the following:– Leave irradiator room to reduce exposure– Control access– Contact individual responsible for program


p p gand to initiate emergency response

– Telephone numbers for Responsible Individual, Manufacturer, Security, Fire Department, Police, NRC or State Regulator

• Survey outside room to determine if further restrictions are required


• Licensees can change their operating and emergency procedures only if:– The changes are reviewed and approved and

documented by licensee management


– Affected staff are trained in the procedures before implementation

– Changes are consistent with license conditions and commitments in license application, and

– The changes do not degrade safety

Routine Maintenance and Lubrication

• Licensee should provide standard response:

• We will implement and maintain procedures for routine maintenance of our self-shielded


irradiators according to each manufacturer’s written recommendations.

• Note: Routine Maintenance Does Not Include Any Activities that Involves the Source, Source Drive Mechanism, or removing shielding or source and any other activity in which personnel could receive high doses

Non-Routine Maintenance

• Most Licensee’s Rely on the Manufacturer

• Licensee should provide a response such as


• We will have the self-shielded irradiator manufacturer or other person authorized by NRC or an Agreement State perform non-routine Maintenance.

Standard Responses For

• Instruments• Inventory• Dosimetry• Public Dose


• Leak Tests• Minimization of Contamination, and Waste

Management

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