Activities of radioisotope unit of application division of TAEK-ÇNAEM

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ACTIVITIES OF

RADIOISOTOPE UNIT OF

APPLICATION DIVISION OF

TAEK-CNAEM

HÜLYA YILDIZ,Coordinator of Radioisotope Unit HÜLYA YILDIZ,Coordinator of Radioisotope Unit C

Cekmece Nuclear Research and Training Centre, ekmece Nuclear Research and Training Centre, Yarimburgaz Mah. Nukleer Arastirma Yolu, 34303, Yarimburgaz Mah. Nukleer Arastirma Yolu, 34303,

Istanbul, TURKEY Istanbul, TURKEY

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RADIOISOTOPE UNIT

Radioisotope applications are mainly for

peaceful

uses

of

atomic

energy.

peaceful

uses

of

atomic

energy.

Radioactive isotopes are being widely used

in nuclear medicine, industry, agriculture,

veterinary and research. Nuclear medicine

applications of isotopes are being used for

more than 40 years in the diagnosis and

therapy

with

developed

therapy

with

developed

radiopharmaceuticals.

(3)

Radiopharmaceutical is consist of a

bioactive component which locates in the

desired organ and radionuclide which labels

to this bioactive component. It is desired that

a diagnostic radionuclide should give

minimum dose and has high photon

efficiency.

(4)

For this reason using radioisotopes

emitting highly ionizing alpha and beta

radiation are not suitable On the other

hand these alpha and beta radiation which

localizes in a limited region are used for

therapeutic purposes due to their

damaging property for the cells. Nuclear

medicine institutes in Turkey have shown

considerable progress

. .

(5)

The contemporary techniques applied in

developed countries are being traced and

are applied in a short time in Turkey. The

most

important

application

of

most

important

application

of

radioisotopes in industry is using them for

radiographical

purposes,

i.e.

radiographical

purposes,

i.e.

nondestructive testing of materials. Mostly

used ( about 90 %) radioisotope in

radiography is Ir-192.

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HISTORY OF RADIOISOTOPE

UNIT

 19621962 The establishment of isotope The establishment of isotope

production unit in chemistry group in production unit in chemistry group in

CNAEM Reactor building. CNAEM Reactor building.

 19631963 The first production of radioisotope The first production of radioisotope

(Na-24) (Na-24)

 19641964 The production of Tc-99m and colloidal The production of Tc-99m and colloidal

Au-198 in the prefabric building near Au-198 in the prefabric building near

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 19701970 The establishmentThe establishment of Radioisotope of Radioisotope

Production Department and moving in Production Department and moving in

this new building. this new building.

 19711971 Production of Na-24, K-42, Br-82, P-32, Production of Na-24, K-42, Br-82, P-32,

Tc-99m, colloidal Au-198, etc.Tc-99m, colloidal Au-198, etc.

 1982 1982 Changing the name of Radioisotope Changing the name of Radioisotope

Production Department as Radioisotope Production Department as Radioisotope

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

1983

Production of high specific activity

radioisotopes.



1985

The establishment of

Radiopharmaceutical Department.



1990

Production of MDP kit.



1992

Production of I-131

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 19941994 Combining of Radioisotope and Combining of Radioisotope and

Radiopharmaceutical Departments as Radiopharmaceutical Departments as

Radioisotope and Radiopharmaceutical Radioisotope and Radiopharmaceutical

Department. Department.

 19951995 Production of Mo-99/Tc-99m generator. Production of Mo-99/Tc-99m generator.  20022002 Establishment of Central Radiopharmacy Establishment of Central Radiopharmacy

Laboratory ( MRL).Laboratory ( MRL).

 20062006 With the new organization putting the With the new organization putting the

Radioisotope and Radiopharmaceutical Radioisotope and Radiopharmaceutical

Department under the Application Division as Department under the Application Division as

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ACTIVITIES OF RADIOISOTOPE UNIT

 Production of MDP(bone), DTPA( kidney) and

PYP(hearth, bone) which are labelled with Tc-99m. These are used in nuclear medicine

centres for diagnosis of various illnesses.

 Production of Mo-99/ Tc-99m generator as

sterile and apyrogen form by using fission produced Mo-99.

 Dispensing of I-131 and Tl-201 imported from

abroad as bulk amount and high activity as patient doses.

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 Making the radionuclidic, radiochemical, Making the radionuclidic, radiochemical,

chemical and biological quality controls of

radiopharmaceuticals and kits produced in radiopharmaceuticals and kits produced in Turkey or imported from abroad.

Turkey or imported from abroad.

 Changing of low activity radiography sources Changing of low activity radiography sources

such as Ir-192 and Se-75 with high activity

sources in the special hot cells.sources in the special hot cells.

 Development of new and important radioisotope Development of new and important radioisotope

generators and radiopharmaceuticals used

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 Preparation of Licence Application File for the Preparation of Licence Application File for the

Ministry of Health for the production of new Ministry of Health for the production of new

pharmaceuticals. pharmaceuticals.

 Preparation and keeping of documents of the Preparation and keeping of documents of the

produced kits for Tc-99m generators.

 Supporting of M.Sc. and Ph.D studies by Supporting of M.Sc. and Ph.D studies by

cooperating with various universities.

 Giving “Basic Radiopharmacy ” course twice a Giving “Basic Radiopharmacy ” course twice a

year to the radiopharmaceutical technicians

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PRODUCTION AND QUALITY CONTROL

LABORATORIES OF RADIOISOTOPE UNIT



Cold Kit Production Laboratory:

In this laboratory established in 1990 cold

_{In this laboratory established in 1990 cold}

kits which could be labelled with Tc-99m

such MDP,DTPA and PYP are being

produced as sterile and apyrogen form .

This laboratory has been constructed as

B-class ,air change ( 30/cycles/hour) and

compatible with GMP and GLP.

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Working under LAF _{Lyophilization}

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• Mo-99/Tc-99m Generator Production

_{Mo-99/Tc-99m Generator Production}

Laboratory:

In this laboratory established in 1995, Tc-99m generator In this laboratory established in 1995, Tc-99m generator

are produced in special hot cells as sterile and apyrogen,

form. This laboratory has been constructed as C-class air

change ( 20 cycles /hour) and compatible with GMP and

GLP. Generator production was performed between 1997

and 2001 by cooperating with a private company for

every week. According to the cooperation the private

company was importing fission produced Mo-99 from

abroad and buying the finished generator from TAEK

and distributing them to the nuclear medicine institutes

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Radiochemical Quality

Control Laboratory _{Chemical Quality} Control Laboratory

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• I-131 and Tl-201 Radiopharmaceuticals I-131 and Tl-201 Radiopharmaceuticals Production Laboratory :

Production Laboratory :

This laboratory was established in 2006 as

C-class ,air change anda are compatible

with GMP and GLP.

These hot cells were bought through IAEA

TC Project and capable of dispensing high

activity I-131 and Tl-201.

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•

Laboratory for Handling of Radiography Sources:Laboratory for Handling of Radiography Sources:

In this laboratory low activity Ir-192 and

Se-75 radiography sources coming from

companies are changed with high activity

ones.These special hot cells have been

constructed

by

Radioisotope

Unit

constructed

by

Radioisotope

Unit

personnel and CNAEM Technical Support

group.

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Special Hot Cells for Changing

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DPT PROJECT OF

RADIOISOTOPE UNIT

Most of the activities of Radioisotope Unit

have been supported by national State

Planning Organisation (DPT).

In 2008 in the Unit;



DPT Nuclear Science Research and

Development - Radiopharmaceutical

Development

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IAEA –TC PROJECTS OF

RADIOISOTOPE UNIT

 IAEA TCIAEA TC “ “Radiopharmaceutical Production”Radiopharmaceutical Production”

(TUR/2/009) ,1987 -1994

 IAEA TC “Establishment of a National IAEA TC “Establishment of a National

Radioisotope and Radiopharmaceutical Quality

Control Laboratory” (TUR/2/014) , 2003 -2005Control Laboratory” (TUR/2/014) , 2003 -2005

 IAEA TC “Strengthening of Radioisotope IAEA TC “Strengthening of Radioisotope

Production Facility at Cekmece Nuclear

Research Center ” (TUR/2/015) , 2005 -2008Research Center ” (TUR/2/015) , 2005 -2008

 IAEA TC “Quality Control of Advanced IAEA TC “Quality Control of Advanced

Radiopharmaceuticals”

(TUR2007001),2009-2011

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PROJECT SUPPORT CONTRACT

OF RADIOISOTOPE UNIT

“

Tumor Scintigraphy with Peptides

Labelled with Ga-68”

Participants :

Authority :

TAEK-ANKARA

Contractor:

_Contractor:

Associated

_Associated

Prof.Dr. N.Ozlem KUCUK

Ankara University Medical Faculty Nuclear

_{Ankara University Medical Faculty Nuclear}

Medicine Department-ANKARA

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Instrument for Peptite Labelling with Ga-68 Having Prepurification System

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BASIC RADIOPHARMACY

COURSE

The content of the course given to the _{The content of the course given to the}

radiopharmaceutical technicians and

radiopharmacists twice a year is given below:

 Basic nuclear physics. Basic nuclear physics.

 Radioactivity measurement and calibration of Radioactivity measurement and calibration of

instruments.

 Production and quality control of Production and quality control of

radiopharmaceuticals

 Labelling of cold kits with Tc-99m radioisotope Labelling of cold kits with Tc-99m radioisotope

and their quality control.

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RESULT

Radioisotope unit has the necessary knowledge _{Radioisotope unit has the necessary knowledge}

for the production and quality control of cold kits

and radiopharmaceuticals and training of

personnel. The cold kits and

radiopharmaceuticals being produced in the unit

are contributing to the Turkish economy. In

addition to these the enhanced importance of

nondestructive testing has highly increased the

transfer of radiography sources for the

projectors.

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If the Central Radiopharmacy Laboratory could _{If the Central Radiopharmacy Laboratory could}

be a national quality control reference

laboratory, quality controls of the cold kits and

radiopharmaceuticals produced in Turkey or

imported from abroad will be performed in this

laboratory. So the nuclear medicine centres

would have used the radiopharmaceuticals

having quality control. Until now with the

support of IAEA and TAEK projects, the new

developments in the world were traced and

applied in our laboratories.