Cardinal Health 414, LLC - Amendment Request for License ... · Cardinal Health 414, LLC Quality & Regulatory 7000 Cardinal Place Dublin, OH 43017 tel 61 4.757.4120 fax 614.652.4598

~ alHealth

April 24, 2020

Radioactive Materials Licensing U.S. NRG Region Ill 2443 Warrenville Road , Suite 210 Lisle, IL 60532

Cardinal Health 414, LLC Quality & Regulatory 7000 Cardinal Place Dublin, OH 43017 tel 61 4.757.4120 fax 614.652.4598

www.cardinalhealth .com

RE: Amendment Request for Radioactive Material License Number 34-32840-01 , Card inal Health PET Manufacturing Services, East Lansing , Ml.

Licensing:

Cardinal Health 414, LLC (PET Manufacturing Services, hereafter Cardinal Health) requests an amendment for the above referenced license to add Courtney Mautz, Jacob Chybowski and Misael Vega as cyclotron operators/ authorized users (AU). Training documents are attached.

In addition , please remove the following AU : Hoppe Achuonjei , Matthew Anderson , Michael Gannon Connolly-Ng , John Taylor Vernon and Brandon Xiong.

If you have any questions regarding this request, please contact me at 614 .757.9586.

Sincerely,

Glenn Sullivan Corporate Radiation Safety Officer Director, Health Physics Nuclear & Precision Health Solutions

Encl: AU Training Documents

cc: Colten Conrad , MRSO, Loe. 5860 Rob Symons, Loe. 5860 License File 5860 (3)

RECEIVED APR 2 9 2020

~ ·

CardinalHealth

PET Manufacturing Services Training Authorization

May 11, 2012

Cardinal Heallll Nudeat PMrma~y Servloe~ QUNi\y & RegulatolY 7000 Ca(dll\81 PlftC$ Dubllo, OH ~3017 (81 614.767,&000 rax 614.662.~ ~Q&

www.ca1dlnal.com

I have reviewed the education and training documents listed below and they meet the training requirements outlined in the PET Manufacturing Services Radiation Safety Manuat Section 9.

PET Trace Cyclotron Training (30-60-90 Day Training Documentatl~m)

Basic Radioisotope Handling Techniques Worksheet

Didactic Training Certificate .

Therefore, I authorlze Misael A Vega to act as an AU/Cyclotron operator on any PE.T Manufacturing License that grants selfwapproval for Authorized Users/Cyclotron Operators. A copy of 1hls approval letter must be kept on file at all locations where the above named Individual has worked for 5 years after the last date of employment.

~ - - --- -Director, Health Physics Nuclear Pharmacy Sewloes

•

Cardinal Health Manufacturing Training summary

Mleael A Vega has wmp!eted the fol!owlng Cardln1;1I Health Manufacturing training al the Tampa, FL cyclotron site on 10/07/2011. This training was pert'ormed on a GE P~Trace cyclotron by .in authorized user and cyclotron operator who received manufacturer

or equivalent training on the OE PETrace cyclotron,

PE'1' Trace Cyclotron Training 1. Haalth, General and Radiation Safety 2. Cyclotron Theory and Physics 3. Controls and Displays 4. Operating lnetrucllons 6. Preventive Maintenance 6. Cyclotron sonwaro 7. cyclotron Shielding 8. Cyclotron Pot:umentatlon

FDG Chemtcal synuiesle 1. Chamlcal Syntheses Theory 2. Materials Praparallon 3. Chernlcal Preparation 4. Coincidence synthesis Sox Preparallon 5. Coincidence Synthesis Box Operation 6. Handling UP lo 3 Ci of FOG 7, GMP Practices 8. Production Abnormalities

Quallly Control . 1. R11dlonuclldlc ldentlflcallon: Half-life test

100 hours

60 hours

2. Pll Testing 3. Chemlcal Purlly of Fludeoxyglucose F-1 B Injections: Gas Chromotography 4. Radlochemical Identity and Purity ofFludeoxyglucose F·10 ln]ec\ion: Radio-TLC 5. Chemical Purity of Fludeoxyglucose F-18 lnJection: l<ryptot1X TLC 6. Bacterial Endotoxin Testing: LAL 7. Membrane FIiler integrity Test 8. Radlonucldic Purity of Fludeoxyglucose F-18 lnjecllon: MGA Analyals 9. Sterilltyiesllng 80 hours

Radiation Testing and Equlpmcmt 1. Radiation Safe!yTreinlng for Individuals Worl<lng In or Frequenting Restricted.Areas 2. Portabla survey Meters and Wipe Tests 3. Tronsport and Receipt of Radioactive Materials 4. Dose Calibrator and Furna Hood

Component Materials Managamunl 1, Receiving 2. Tr"acklng 3. Ba!c.h Record OosnpHance 4. Record Retention 6. Inventory

2ll hours

15 hours

TOTAL:

Certlflcatton of Review of Training

I certify !hat I have rovlewcd the training and experience documenlntlon of the above named lndlllldual and have detormlned that the individual ha~ saUsfaclt>tlly completed tho training and experitir\ce requlrernenla set forth lo (he PET Manufacturing Services

Radiation SafetyT,alnlng Manual.

Willie Reglts, Ph O. Dlrootor, Health Physics

· Quality and Regulatory

RADIOISOTOPE HANDLING EXPERIENCE

Name: Misael Vega Date 1/02/2020

Document the actual use/handltng of radioactive material under the supervision of an Authorized User.

ISOTOPE MAXIMUM USE EXPERIENCE WHERE ACTIVITY See key Actual clock hours EXPERIENCE HANDLED below: (Include date range GAINED

1,2,3,4,6 6 7 of experienc~)

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/ :/' Key for "Use": the number, or numbers, entered 1,1nder "Use" should correspond to the handllng experience for each Isotope.

1, Ordering, shipping, receiving radioactive materials and performing related radiation surveys

2. Calibrating, using and performing checks for proper operation of dose calibrators, scinlllla!lon detectors, survey meters, and, if appropriate, Instruments used to measure alpha· or beta.emltling radlonuclldes

3. Calculating, assaying and safely prP.parlhg dosages for patients or human research subjects

4. Using appropriate Internal controls to avoid mlstakes In the labeling and/or administration of by product or accelerator material

5. Using procedures to prevent or minimize contamination and usJng proper decontamination procedwes

6. Learntng emergency procedures to handle and oon!ain spilled materials safely, Jncfudlhg related decontamination procedures, surveys, and wipe tests

7. Production of radioactive materials via bombardment In a nuclear reaction.

I i

I i l

I I I I

r ' t

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name: Misael Vega

BREAKDOWN OF COURSE CONTENT IN CLOCK HOURS-Total Radiation Raaiation Ma1h Radiation Racf!Opharmaceutical

Location of Training Date(s) of Course Title Clock Physics& Protection Pertaining Biology Chemistry Accordance Hours of instrumentation to Radio-

Course ac6vity

CARDINAL HEALTH CARDINAL HEAL 11-i 10/03/11 NUCLEAR PHARMACIST

DUBLIN.OH Thru /AUTHORIZED USER 11/14/11 EDUCATION PROGRAM

200 85 58 25 32 0

"Note:. Show a breakdown of hours by institution, dmes. and subjects. TOTAL.HOURS 200 85 58 25 32 0 Ust each hour only once (i.e., undedhe most appli~le subject category}

Signature: ~~ Date: 11/14/11 Coiporate Radcation Safety Officer

- •=.,.,.,, .. , .... ., ,_,,..,,.,...,..._,~,h-.,,_,._~-• .. •,.y~,,~ .. ,r._ .,, .. . ~,~,,,..-, • -

O!rdinal Health PET Manufacturing Services

Dida·ctrc Training Summary Cyclotron Appfications Training

?artiopants Name: M"lSl!el Vega

Location ofTraming Date{s)of Training

Fort l.auderrlale, FL Site ll/2/2015 .:. ssoi ll/4/2f116

NQte: Show a breakdown. of hours by

institution, dates and subjects. List eac::h hour only once (i.e., under the most applicable category.

Jnstructor Comments.

Course Title Total

dock Hours of ·course

Cardinal Health

Cyclotron 24

Operator Applications

Course

Total Hours 24

CONFJDENTIAl .For Internal Use Only

Instructor's Name: 8ob Chicoine Manager, PET Engineering

t~~~~s~~~ffe~.r;:t®~N~~.e-~~ifi* lntrodu!::tlon Startup Op.eration Shutdown Maintenance (Subsystem & {Che&and {Monitoring & {PrO<luctron (Operator Level,

Beam/Radiation Start ControC Termination &. Loss of Power Hazards} Sequence Error Investigation) Restoration

1-W~lcome l. Site 1.. Master Sys 1. Error Log· 1. Target leaks 2. Objectives Chec!cs 2. S"ign In 2. Diagnostics 2- Frit ctianges s. f:listorv :i. HV:A.C 3. Start Up 3. rnvestlgations 3. LTF 4.Theory ·3. Exhaust 4- $elecr/R!l 4. Troublesl'locting 4. Helium Cooling 5. Stibsystems 4.Cooling s. Irradiation 5. Safety 5. ·seam Loss 6. Making Seam Water ·6. Monitoring 6. Shutdown 6. Power Loss 7. Hazards :!i. Vacuum 7 . Seivicesystem 7. End of day Maint 7. Extractloo Sys

6. Vault/ 8.. SysMaint &. Rao. Area Work 8. ·Tanl<Tour Shield .9. Interlocl<s 9. Evaluation

10_ -Target Fun ct

8 1 3 4 g

Miseal was: eager to learn and provided input during the class. He :fourid the infomiation useful <ind informative and rlisplayed a . true respect forthe Cvdotron. the theory of operation and the uniqueness of our industry, He is eager·t'O share his newfound knowledge with his group and .looks forward to having his team attend future classes.

Course Exam Score: 100°.Ai

\\x\~ n},d-1~1~ --- ·,·· ·-·· .............. -Instructor Signature/Date: -- -, .. . ··---... ,., .. __ ,, ,,___ ___ ···----- - ··-····· ..... -···· ·-·. -··--· .. ...... , __ ,, ___ ·--·-·- _ .. ___ - ·- _...., ,... ... -... ·--·-··--... ----;-"'"-J-~""\ ~$l'X~"-·---··

•••"~~,,,,~" "" " 'Y>. = . • ...... ,~" -" " ""''" < •

~ al Health


April 25, 2020

Cardinal Health 414, LLC Quality & Regulatory 7000 Cardinal Place Dublin, OH 43017 tel 614.757.5000 fax 614 .652.4598

www.cardinalhealth.com

I have reviewed the education and training documents listed below and they meet the training requirements outlined in the PET Manufacturing Services Radiation Safety Manual , Section 9.

PETtrace Cyclotron Training (30-60-90 Day Training Documentation)


Didactic Training Certificate

Therefore, I authorize Courtney Mautz to act as a PET Technician AU/Cyclotron operator on any PET Manufacturing License that grants self-approval for Authorized Users/Cyclotron Operators. A copy of this approval letter must be kept on file at all locations where the above named individual has worked for 5 years after the last date of employment.


Cardinal Health Manufacturing Training Summary

Courtney Mautz has completed the following Cardinal Health Manufacturing training at the East Lansing , Michigan cyclotron site on April 14, 2020. This training was performed on a GE PETtrace_cyclotron by an authorized user and cyclotron operator who received manufacturer or equivalent training on the GE PETtrace_cyclotron.

PET Trace Cyclotron Training 1. Health, General and Radiation Safety 2. Cyclotron Theory and Physics 3. Controls and Displays 4. Operating Instructions 5. Preventive Maintenance 6. Cyclotron Software 7. Cyclotron Shielding 8. Cyclotron Documentation

100 hours FDG Chemical Synthesis

1. Chemical Syntheses Theory 2. Materials Preparation 3. Chemical Preparation 4. Coincidence Synthesis Box Preparation 5. Coincidence Synthesis Box Operation 6. Handling up to 3 Ci of FOG 7. GMP Practices 8. Production Abnormalities

60 hours Quality Control

1. Radionuclidic Identification : Half-life test 2. Ph Testing 3. Chemical Purity of Fludeoxyglucose F-18 Injections: Gas Chromatography 4. Radiochemical Identity and Purity of Fludeoxyglucose F-18 Injection: Radio-TLC 5. Chemical Purity of Fludeoxyglucose F-18 Injection: Kryptofix TLC 6. Bacterial Endotoxin Testing 7. Membrane Filter Integrity Test 8. Radionucidic Purity of Fludeoxyglucose F-18 injection 9. Sterility Testing

80 hours Radiation Testing and Equipment

1. Rad iation Safety Training for Individuals Working in or Frequenting Restricted Areas 2. Portable Survey Meters and Wipe Tests 3. Transport and Receipt of Radioactive Materials 4. Dose Calibrator and Fume Hood

25 hours Component Materials Management

1. Receiving 2. Tracking 3. Batch Record Compliance 4. Record Retention 5. Inventory

15 hours

TOTAL: 280 hours

Certification of Review of Training

I certify that I have reviewed the train ing and experience documentation of the above named individual and have determined that the individual has satisfactorily completed the training and experience requirements set forth in the PET Manufacturing Servi ces Radiation Safety Training Manual.


4/25/2020 Date


Name: C,ol)(>'t(\~ {Y\oo+-z.. Date IL.\ A~ 7...0

Document the actual use/handling of radioactive material under the supervision of an Authorized User.


1,2,3,4,5,6,7 of experience)

?.©~ ,.1, tt, 5, \oi""I 1..nc'°'~ L~'b P\~\',c.Brncn

0 -l5t~~C\ - 14~to O('\ '$8(.0 ~' tc..

10C;, \, 2. , 4, ~.~., 3:lOw'S LA 'o F\ W\\ c.a."t\ CY\

o,~€ffl, --11.JI\Vt:w OC"\ SS(Qo .;.~

Key for "Use": the number, or numbers, entered under "Use" should correspond to the handling experience for each isotope.

1. Ordering, shipping, receiving radioactive materials and performing related radiation surveys

2. Calibrating, using and performing checks for proper operation of dose calibrators, scintillation detectors, survey meters, and, if appropriate, instruments used to measure alpha- or beta-emitting radionuclides

3. Calculating, assaying and safely preparing dosages for patients or human research subjects

4. Using appropriate internal controls to avoid mistakes in the labeling and/or administration of by product or accelerator material

5. Using procedures to prevent or minimize contamination and using proper decontamination procedures

6. Learning emergency procedures to handle and contain spilled materials safely, including related decontamination procedures, surveys, and wipe tests

7. Production of radioactive materials via bombardment in a nuclear reaction .


Name: Courtney Mautz

BREAKDOWN OF COURSE CONTENT IN CLOCK HOURS* Total Radiation Radiation Math Radiation Rad iopharmaceutical

Location ofTraining Date(s) of Course Title Clock Physics & Protection Pertaining Biology Chemistry Accordance Hours of Instrumentation to Radio-

Course activity

CARDINAL HEAL TH CARDINAL HEAL TH 1/6/2020- AUTHORIZED USER

DUBLIN, OH 2/17/2020 EDUCATION PROGRAM

200 85 58 25 32 0

*Note: Show a breakdown of hours by institution, dates, and subjects. TOTAL HOURS 200 85 58 25 32 0 List each hour only once (i.e., under the most applicable subject category)

Signature: e!:f~CL<._ Date: 2/21/2020 Glenn Sullivan, Corporate Radiation Safety Officer

~ al Health


April 25, 2020

Cardinal Health 414, LLC Quality & Regulatory 7000 Cardinal Place Dublin, OH 43017 tel 61 4.757.5000 fax 614.652.4598

www.cardinalhealth.com

I have reviewed the education and training documents listed below and they meet the train ing requirements outlined in the PET Manufacturing Services Radiation Safety Manual, Section 9.

PETtrace Cyclotron Training (30-60-90 Day Training Documentation)


Didactic Training Certificate

Therefore, I authorize Jacob Chybowski to act as a PET Technician AU/Cyclotron operator on any PET Manufacturing License that grants self-approval for Authorized Users/Cyclotron Operators. A copy of this approval letter must be kept on file at all locations where the above named individual has worked for 5 years after the last date of employment.


Cardinal Health Manufacturing Training Summary

Jacob Chybowski has completed the following Card inal Health Manufacturing training at the East Lansing, Michigan cyclotron site on Apri l 1 O, 2020 . This training was performed on a GE PETtrace_cyclotron by an authorized user and cyclotron operator who received manufacturer or equivalent training on the GE PETtrace_cyclotron .

PET Trace Cyclotron Training 1. Health, General and Radiation Safety 2. Cyclotron Theory and Physics 3. Controls and Displays 4. Operating Instructions 5. Preventive Maintenance 6. Cyclotron Software 7. Cyclotron Shielding 8. Cyclotron Documentation

100 hours FDG Chemical Synthesis

1. Chemical Syntheses Theory 2. Materials Preparation 3. Chemical Preparation 4. Coincidence Synthesis Box Preparation 5. Coincidence Synthesis Box Operation 6. Handling up to 3 Ci of FOG 7. GMP Practices 8. Production Abnormalities

60 hours Quality Control

1. Radionuclidic Identification : Half-life test 2. Ph Testing 3. Chemical Purity of Fludeoxyglucose F-18 Injections: Gas Chromatography 4. Radiochemical Identity and Purity of Fludeoxyglucose F-18 Injection: Radio-TLC 5. Chemical Purity of Fludeoxyglucose F-18 Injection: Kryptofix TLC 6. Bacterial Endotoxin Testing 7. Membrane Filter Integrity Test 8. Radionucidic Purity of Fludeoxyglucose F-18 injection 9. Sterility Testing

80 hours Radiation Testing and Equipment

1. Radiation Safety Training for Individuals Working in or Frequenting Restricted Areas 2. Portable Survey Meters and Wipe Tests 3. Transport and Receipt of Radioactive Materials 4. Dose Calibrator and Fume Hood

25 hours Component Materials Management

1. Receiving 2. Tracking 3. Batch Record Compliance 4. Record Retention 5. Inventory

15 hours

TOTAL: 280 hours

Certification of Review of Training

I certify that I have reviewed the training and experience documentation of the above named individual and have determined that the individual has satisfactorily completed the training and experience requirements set forth in the PET Manufacturing Servi ces Radiation Safety Training Manual.


4/25/2020 Date


Name: )~cob C kfow s.k', Date IOAP~'2..0

Document the actual use/handling of radioactive material under the supervision of an Authorized User.


1,2,3,4,5,6,7 of experience) (o.,Jiflo.1/fJ!li f t8 l~Cv 1,1. , «;1,"e;.),,1 t, bOQ ~hrs Eo.t.f 1.&t1&t~

N13 12,.,..Cv ,, 1.. I "i, ~, G: , 1 le'. Se.p !Ci! ~ IOA~ . MI D-S °' P£ 'f reJ, .

'

• ·111 . r.:~, .-·--·" - t .... )l,

•,10-,T. l' 111"'1 i"I: '\.~ ..• - -

Key for "Use": the number, or numbers, entered under "Use" should correspond to the handling experience for each isotope.

1. Ordering, shipping, receiving radioactive materials and performing related radiation surveys

2. Calibrating, using and performing checks for proper operation of dose calibrators. scintillation detectors, survey meters, and, if appropriate, instruments used to measure alpha- or beta-emitting radionuclides

3. Calculating, assaying and safely preparing dosages for patients or human research subjects

4. Using appropriate internal controls to avoid mistakes in the labeling and/or administration of by product or accelerator material

5. Using procedures to prevent or minimize contamination and using proper decontamination procedures

6. Learning emergency procedures to handle and contain spilled materials safely, including related decontamination procedures, surveys, and wipe tests

7. Production of radioactive materials via bombardment in a nuclear reaction.


Name: Jacob Chybowski

BREAKDOWN OF COURSE CONTENT IN CLOCK HOURS* Total Radiation Radiation Math Radiation Radiophamiaceutical

Location of Training Date(s) of Course Title Clock Physics & Protection Pertaining Biology Chemistry Accordance Hours of Instrumentation to Radio-

Course activity

CARDINAL HEAL TH CARDINAL HEAL TH 1/6/2020- AUTHORIZED USER

DUBLIN, OH 2/17/2020 EDUCATION PROGRAM

200 85 58 25 32 0

*Note: Show a breakdown of hours by institution, dates, and subjects. TOTAL HOURS 200 85 58 25 32 0 List each hour only once (i.e. , under the most applicable subject category)

Signature: e!:/L/~ Date: 2/21/2020 Glenn Sullivan, Corporate Radiation Safety Officer

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