Outcome 6 Flashcards

1
Q

what two things do you before performing qc?

A
  • visual inspection for colour and clarity
  • calculate assay
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2
Q

during a visual inspection, what must the eluate look like?

A
  • colourless
  • clear
  • free of particulates
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3
Q

why is it important for the eluate to look that way during a visual inspection?

A
  • should indicate free of foreign material which could be harmful to patients
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4
Q

why is radionuclides purity important? what is it in regards to?

A

in regards to Mo-99
checking to ensure that there isn’t any Mo-99 in the eluate which can increase patient’s radiation dose

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5
Q

what three things do we do to test for radionuclidic impurities in the generator eluate?

A
  1. molybdenum breakthrough test
  2. phenylhydrazine test
  3. MCA method
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6
Q

what is the mo-99 breakthrough test?

A
  • testing to see if there is Mo-99 in the eluate
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7
Q

how do we perform the mo-99 b. test?

A

by the use of special moly breakthrough lead pigs which allow for the mo-99 photons to not attenuate which will allow for the dose calibrator to give readings of mo-99

(has different thickness which attenuates the tc-99m gamma rays)

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8
Q

what is the mca method?

A

analyzing a sample in an mca to look for energy peaks from other radionuclides other than tc-99m

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9
Q

what is the drawback of the mca method?

A

must only use a very small sample of eluate in mca

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10
Q

what is the radionuclidic impurity limit?

A

<0.15 kBq Mo-99/MBq Tc-99m at time of administration

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11
Q

what happens to the ratio of Mo-99 to Tc-99m as time passes?

A

ratio increases over time as Mo-99 decays slowly and Tc-99m decays quickly

(think tc-99m will be smaller therefore ratio is increasing)

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12
Q

how do you determine expiration times for eluates?

A

mo-99 breakthrough results or 12 hr max exp time

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13
Q

if the moly breakthrough value is ______ at the time of elution, your eluate can be used until _____.

A

=<0.042
12 hrs expiry time

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14
Q

what type of contaminant are we looking for when testing chemical purity? why is it important?

A

Al3+, it can interfere with the attachment of the radionuclide to the pharm. (radiopharm. labelling)

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15
Q

how do we determine chemical purity?

A

ATA - Orin tricarboxylic acid test

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16
Q

what is the limit for the ata test?

A

10 ug Al3+/ml of eluate

17
Q

how do we determine the concentration of aluminum in the eluate?

A

compare the standard known to contain a concentration of al3+ equal to the limit

18
Q

what is a PASS for an ata test?

A

when the eluate is less pink than standard

19
Q

what is the acceptable range of pH for the eluate?

A

4.5-7.5

20
Q

why is pH important?

A

pH affects labelling

21
Q

what is done if the qc fails?

A

repeat the qc procedure and if it fails again, discard the eluate, then repeat elution – if failed again, contact manufacturer

22
Q

What are the four moments of hand hygiene?

A
  1. Before contact with patient or patients environment
  2. Before clean/aseptic procedures
  3. After body fluid exposure risks
  4. After contact with patient/patient’s environment