complete and concised topic

1. NUCLEAR PHARMACY

2. FORMULATION OF
RADIOPHARMACEUTICALS
 READY TO USE: Don’t demand any of the preparatory steps and are available in
ready to use form. e.g.
 Iodine -131
 Galium-67
 Iodine-131 incorporated radiopharmaceuticals.
• INTENDED TO BE FORMED : They require the radio- labeling technique
whereby a radionuclide is tagged with a pharmaceutical moiety.

3. Continued….
 Technetium-99 is most widely used for this radiolabeling techniques because of its
ideal physical properties.
 Its has half life of about 6 hours which is suitable for radiopharmaceutical
investigation .
 Its is used in preparation of wide variety of radiopharmaceuticals which have
different biological fates and used for diagnostic purposes.

4. TECHTENIUM GENERATOR
 Used for formulation of radiopharmaceutical.
 Contain parent nuclide,molybdenum-99 alumina Column.
 Mb-99 decays to Tc-99.
 On passing through the column ,normal saline solution carries only Tc-99 as
sodium pertechnetate form. This collection is called elution process.
 Mb-99 continues to decay to Tc-99.

5.  After 23 hours another elution with sodium chloride solution is possible.
 Process can be repeated daily until one week when the yield of sodium
pertechnetate becomes inconveniently small due to low levels of decay of Mb-99.

7. FORMULATION PROCESS
 The most common procedure is to use a single sterile, freeze dried and rubber
capped vile also called kit.
 Preparation is achieved by single step addition of sterile sodium pertechtenate to
the kit according to the manufacturer’s instructions.
 Equivalent volume of gas is withdrawn from space above the solution, before
withdrawing the syringe from the vial.

8.  Manufacturer specifies the minimum and maximum range of activity that
can be added into a particular kit.
 Vial is shaken to dissolve the contents.
 Aseptic conditions are applied throughout the procedure to maintain the
sterility of final product and to ensure the adequate protection of operator
from radiations.
 Because of their shorter half life ,radiopharmaceuticals are not batched in
the same way as traditionally compounded

9. sterile preparations (CSPs)-they are prepared and administered within 18-24 hours
after compounding.
 Additionally, while radiopharmaceuticals must confirm to the standards for low-risk
level CSPs, some exceptions have been graduated due to the inherent nature of
radioactive agents.

10. QUALITY CONTROL
 QC is the area of pharmacist. since, these medicinal products are intended
to be administered to the patients therefore they are expected to have
same degree of quality and safety as other pharmaceuticals.
 All ingredients and the final product must meet all the legal, statuary and
quality requirements.
 After a long period of continuous satisfactory testing ,the
radiopharmaceuticals lab can be confident about the product being
dispensed.

11.  Qc tests are performed on retrospective basis and done for sterility of
products.
 Recently the limulus amebocyte lysate (LSA)test is considered merit for
pyrogen testing of RP which gives an instant result. Limulus amebocyte
lysate (LAL) is an aqueous extract of blood cells (amoebocytes) from
the Atlantic horseshoe crab, Limulus polyphemus. LAL reacts with
bacterial endotoxin lipopolysaccharide (LPS), which is
a membrane component of gram-negative bacteria. This reaction is the
basis of the LAL test, which is widely used for the detection and
quantification of bacterial endotoxins.

12. DISPENSING
 Already prepared RP can be prescribed anytime.
 Physician provides necessary information to pharmacist regarding dose
and time of administration and pharmacist makes necessary calculations.
 Calculated radioactivity containing material is transferred from stock
container and placing it in a paper cup within a lead container is ready for
administration.
 Label is affixed .

13.  For radiopharmaceuticals requiring preparation as list is furnished to
radiopharmacist a day prior to administration.
 Radiopharmaceutical is prepared, placed in lead container and label is
affixed bearing:
o Name of radiopharmaceutical
o Total volume in the vial
o Activity measured at that specific time
 Container carrying the kit is transported to the injection area .

14.  Dose required for the patient is calculated, appropriate volume is filled in the
sterile syringe
 The activity present in the syringe is measured and recorded before
administration.

15. OTHER AREAS OF
RADIOPHARAMACEUTUICAL INTEREST
 Radiopharmacist should have information other areas of radiopharmaceutical
interest other than the basic principles.
 Two of them are mentioned below:
 Radiation protection
 Good radiopharmaceutical practices

16. RADIATION PROTECTION
 Safekeeping of workers from hazards of radiation by :
 minimizing radiation exposure
 Preventing spills and spread of contaminants outside the library
 Sensible use of time
 Keeping distance from the source of radioactivity
 Proper sheilding

17. SYMBOLS FOR WARNING

18.  All the members of department are responsible for their own protection as well the others
protection from radioactive exposure.
 Know the rules, area designation and signs set for handling of radiopharmaceuticals.
 Confined to assigned area and duty.
 Radioactivity task should be performed in isolated area and by keeping the radioactive sources
behind the lead glass shielding .use proper safety clothing and glasses .
 Perform so that there is ideally minimum waste .

19.  Avoid carelessness i9n handling materials and do not splash, splatter and
spill radiopharmaceuticals.
 On completion of procedure wash the hands.
 The containers containing more then 3.7MBq of activity should not be
picked by hands from more than a few seconds. for longer time always use
forceps.
 Avoid unnecessary movement of radioactive material, transport material
carefully in trolly or tray lined with disposable cloth.

20. RADIATION PROTECTION &
WASTE DISPOSAL

21. Radiation protection
 It is safekeeping of workers from hazards of radiation by minimizing radiation exposure of the worker to a level as low
as reasonably achieved (ALARA)
 Use of MPI (Myocardial perfusion imaging) should be governed by the principle of ALARA. Continuing
advancements in nuclear imaging are aimed at improving image quality while lowering the dose of radiation given to
patients during imaging tests. Patient radiation exposure depends on the type and dose of radiopharmaceutical, and
the radiation dose may vary considerably depending on patient weight.
 In obese patients, the risk associated with a high radiation dose may outweigh the benefits of SPECT MPI, so other
imaging modalities may be considered.
 In lighter-weight patients, reducing the radiation dose may preserve image quality while reducing radiation exposure.
Generally, Tc-99m-labeled radiopharmaceuticals offer lower patient radiation exposure.
 Achieved by preventing spills and spread of contamination outside the laboratory.
 Sensible use of time, distance and shielding by means of lead.
 The time spent in radiation area, intensity of radioactivity, distance from radiation sources and shielding are basic
elements of safety.

22. Time:
Radiation dose for a worker g=having particular dose rate would be directly proportional to the amount of
time spent.
Distance:
Increasing distance has dose reduction effect because radiation intensity decreases by square of distance
from radiation source. A direct contact with radioactive source should be avoided by any available means.
shielding:
Material capable of absorbing large proportion of radiation are used for shielding, Lead Plastic or glass.
Intensity:
Hazard increases with the intensity of radioactive source so for safety reasons, it is not recommended to
work unnecessarily with high strength of radioactivity.

23. Waste Disposal
 Short lived RPs: Used syringes, contaminated papers are disposed of like other
solids or dry wastes. These are emptied into central shielded waste container for
disposal. After 10 half lives the material is disposed of as ordinary. Water
dispersible must be poured in sink with copious flow of water.
 Long lived RPS: these are transferred to authorized commercial firms that bury
them at approved sites. Each shipment of radioactive waste is classified,
packages, marked and labelled mentioning an identity, activity and volume of the
radionuclide and names addresses phone no.s of the slender generator of wastes
and the receiving authority.

24. GRP: GOOD RADIOPHARMACEUTICAL
PRACTICES

26. Good radiopharmaceutical practices
(GRP)
 Good radiopharmaceutical practices are guidelines designed, documented and implemented for
protection of workers, patients and admins. Of safe and appropriate RPs.
 It is concerned with ;
 Personnel: Must be qualified and specially trained
 Premises: Design, location and architectural orientation
 Minimal public access, equipment calibration
 Proper storage, handling, disposal and processing of RPs.
 Air pressure must be lowered and protection from environmental contamination
 Sterile products working zone must comply with environ. Requirements for sterile products

29. Personnel:
 They should be well educated, trained according to the situation.
 They should have proper and detailed information about the product and about the use of the
product.
 They should have appropriate training on Quality control, preparation and particularly on radiation
protection.

30. Premises and equipment:
The premises must be designed to fulfill the requirements of production, quality
control and environmental control.
The design of the radio pharmacy vary from designated bench in department of
pharmacy. Its location and design must be specially designed according to the
protection of personnel from radiation hazard, avoidance of contamination of work
area and the clean air circulation.
The whole area should have minimal access to public and the patients in order to
safekeeping radiation hazards , proper storage capacities and disposal system for
radioactive waste.

31.  The radioactive products should be stored, processed, packaged and controlled in self contained facilities. The
equipment used for manufacturing should be reserved exclusively for radiopharmaceuticals.
 Air pressure should be low where products are exposed to environment. And its also necessary to protect
product from environmental contamination.
 Sterility of products depends on sterility of environment so sterility should be maintained in working area.
 A periodic sanitation program should be designed and implemented
 Contamination levels and radiations limit should be monitored at regular intervals.
 The area should be cleaned with antiseptics or detergents.
 Proper ventilation should be available to the area.

32. Preparation:
 Production of different products should be avoided in same station at same time in
order to minimize risk of mix up.
 Process of validation, in process controls, monitoring of process parameters should be
performed. All tests of product should be completed before use.

33. Quality Control:
 QC is the area of pharmacist. Quality of the product is essential to the correct interpretation of the
results of the investigation, or the delivery of the correct therapeutic dose, so that quality assurance and
quality control testing form an important part of the responsibility. There is considerable scope for
research and development in the field of radiopharmaceutical science.
 All ingredients to final product itself must meet all the legal, statuary and quality requirements.
 It is performed on retrospective basis and are done for sterility and pyrogencity of products. Limulus
Amebocyte lysate test is considered for pyrogen testing.
 GRP Requirements: When products have to be displaced before all tests are competed, this doesn’t
obviate the need for a formal recorded decision to be taken by the qualified person on the conformity of
the batch, In this case there should be a written procedure detailing all production and quality control
data which should be considered before the batch is dispatched. A procedure should also describe the
measures to be taken by the qualified person if unsatisfactory test results are obtained after dispatch.
 Unless otherwise specified, reference samples of every batch should be retained.

34. Dispensing:
 The physician provide necessary info. Regarding dose and time of administration.
 Pharmacist makes necessary calculations
 Calculated radioactivity containing volume is transferred from stock container and
placing it in paper cup within lead chamber is ready for admins. To patient.
 Label is affixed prior dispensing.
 RPs that require preparation, a list is furnished to radio pharmacist one day prior
to their administration.

35. Equipment Caliberation:
 It should be done on weekly basis atleast.

36. Documentation and record keeping:
 Receiving all the RPs, kits and generators.
 Various stages of preparation dispensing of radiopharmaceuticals
 Maintenance of premises
 Results of test procedures
 Issue of finished preparations.
 Activity dispensed to patients
 Preparation of master procedure specifications and QC procedure as reference.
 Records must indicate life history of incoming RPS material from delivery to final disposal, it helps
future panning.
 Revision of documents periodically in the light of current experience and developments in the field
but after a satisfactory validation and should be authorized by help of head of the unit.