Radiopharmaceutical Production

Quality Control Testing

Visual Inspection

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Visual Inspection

• The radiopharmaceutical should be inspected visually to check for the color and presence of any particulate matter.

Contents• Acceptance Criteria• Discussion• Procedure

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Radiopharmaceutical Production

QC Testing

Visual Inspection

Contents

Acceptance Criteria

Discussion

Procedure

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Acceptance CriteriaAcceptance Criteria: The product should be clear, colorless and

free from particulate matter. The test should be completed on every batch prior to release of product.

Procedure: Hold the test sample in the path of a strong light beam and against a white and a black background to inspect colour and presence of particulate matter. For sake of radiation protection, the vial content is viewed through a leaded glass. Non-tinted glass or indirect viewing using a mirror or video camera is preferred to eliminate the possibility of false observation of colour in the solution.

Radiopharmaceutical Production

QC Testing

Visual Inspection

Contents

Acceptance Criteria

Discussion

Procedure

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DiscussionDiscussion: A slight yellow color in the preparation is acceptable

according to IP and Ph. Eur. specifications due to the fact that the sample is often viewed through tinted glass. However, experience shows that FDG preparations are generally colorless. Therefore, ‘slightly yellow’ color in the product should be treated with caution as this occurrence indicates the likely presence of impurities arising during manufacturing.

Visual inspection is a measure of the process performance. Presence of particulate matter in the product indicates possible failure at various stages of manufacturing including:

• failure of the sterilizing filtration, • inadequate cleaning and control of glassware and components, • inadequate environmental control during assembly of reagents

in pre-installation stage, and perhaps • operator error.

Radiopharmaceutical Production

QC Testing

Visual Inspection

Contents

Acceptance Criteria

Discussion

Procedure

STOP

ProcedureNote: A closer visual inspection may be performed on the reserve

sample several half-lives post-production.

Procedure: Hold the test sample in the path of a strong light beam and against a white and a black background to inspect colour and presence of particulate matter. For sake of radiation protection, the vial content is viewed through a leaded glass. Non-tinted glass or indirect viewing using a mirror or video camera is preferred to eliminate the possibility of false observation of colour in the solution.

Link to demonstration

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