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RADIOCHEMISTRY TECHNOLOGY

RADIOCHEMISTRY TECHNOLOGY. 511 keV radiation  4.1 mm HVL (Pb) HVL = Halving layer 74 GBq (2 Ci)  *A/d 2 = 188*74 ≈ 14 mSv = gamma specific constant (µSv m 2 GBq -1 h -1 ) A = activity (GBq) D = distance from source Max body exposure (per year, professional worker) = 50 mSv.

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RADIOCHEMISTRY TECHNOLOGY

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  1. RADIOCHEMISTRY TECHNOLOGY

  2. 511 keV radiation  4.1 mm HVL (Pb) HVL = Halving layer 74 GBq (2 Ci)  *A/d2 = 188*74 ≈ 14 mSv = gamma specific constant (µSv m2 GBq-1 h-1) A = activity (GBq) D = distance from source Max body exposure (per year, professional worker) = 50 mSv Sources MUST be used within shielded environment (thickness >50 mm Pb), time of exposure must be minimised and distance maximised

  3. The quest for remote handling Lead shield + tongue Remote operation via swithches Look + handle Look(indirect) Sensing & reacting Sequencers Full confidence Blind trust

  4. 1985

  5. 2005

  6. Radiochemistry & Radiopharmacy

  7. Kit based synthesisers

  8. Synthesis stepsof FDG 18 18 18 18 O(p,n) F F F - 18 H 2 [KC(2.2.2.)]/orTBA / 18 O • SEPARATION F + AcO O AcO • SUBSTITUTION OTf AcO AcO O AcO OAc F 18 AcO OcA HO HO O • HYDROLYSIS HO 18 F HClorNaOH OH • PURIFICATION

  9. Separation of [18F]F- from [18O]H2O CLEANING PROCEDURE (30-40 minutes) Protected FDG formation Preparation of the modules (loading columns, reagents, solvents,etc) Hydrolysis START OF THESYNTHESIS Chromatographic purification Transfer of target water End of synthesis (35-40minutes) Fixed glassware synthesisers

  10. All transfers are pressure (helium) or vacuum driven Real time monitoring of temperature, pressure and radioactivity

  11. Handling of products for parenteral administration • Integrity of formulation must be preserved throughout the process • Preparation must be protected from microbial contamination • Processing may include: • Dilution to adjust radioactive concentration • Fractionation of bulk solution • Dispensing into vials • Final operation (non sterile) • Labelling • Packaging (shielded & shipping containers )

  12. Final product dispensing Class “C” Class “A”

  13. Raw material acceptance discard Raw material QC batch unreleased NO Passed Raw material QC NO Passed Production YES Dispensing YES Clean room operations Packaging Shipping batch released

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