Radiopharmaceutical Production Filter integrity test STOP Filter Integrity

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Radiopharmaceutical Production Filter integrity test STOP

Radiopharmaceutical Production Filter integrity test STOP

Filter Integrity Test • • The filter integrity test is one of the most

Filter Integrity Test • • The filter integrity test is one of the most important tests that are carried out on the final product. A satisfactory result from this test gives assurance that the final product is sterile and therefore acceptable for human use. Contents • Acceptance Criteria • Discussion • Procedure • Example SOP

Filter integrity test Radiopharmaceutical Production QC Tests Filter Integrity Test Contents Acceptance Criteria Discussion

Filter integrity test Radiopharmaceutical Production QC Tests Filter Integrity Test Contents Acceptance Criteria Discussion Procedure Example SOP STOP Acceptance Criteria: The membrane filter integrity test is not mentined in the International Pharmacopeia. However, it is a requirement of GMP guidelines on aseptic processing using final sterilizing filtration. It is highly recommended that this test is performed prior to release of the product.

Filter integrity test Radiopharmaceutical Production QC Tests Filter Integrity Test Contents Acceptance Criteria Discussion

Filter integrity test Radiopharmaceutical Production QC Tests Filter Integrity Test Contents Acceptance Criteria Discussion Procedure Example SOP Discussion: Although this test is not required by the International Pharmacopeia, the fact that the sterility test results will not be available when the radiopharmaceutical is injected, assessment of the filter integrity using bubble point or pressureretaining test represents an appropriate indication of the performance of the aseptic processing and sterility of the product. Therefore, it is highly recommended that the filter integrity test be performed after dispensing and prior to release of the FDG product batch. It must be emphasized that the filter integrity test does not replace the required sterility test. STOP

Filter integrity test Radiopharmaceutical Production QC Tests Filter Integrity Test Contents Acceptance Criteria Discussion

Filter integrity test Radiopharmaceutical Production QC Tests Filter Integrity Test Contents Acceptance Criteria Discussion Procedure Example SOP STOP Procedure: Connect to a three way valve a 50 -60 cc syringe, a pressure gauge (reading >60 psi), and the filter being tested. (If using a vented filter, block the vent hole with a drop of oil). At end of the filter, attach an extension tube, other end of which is dipped in a beaker filled with water. As pressure is applied by pushing the plunger, record the pressure reading when continuous stream of bubbles is formed in water. Nominal pressure reading for an intact filter is >45 psi.

Example Procedure Radiopharmaceutical Production Vented filter procedure Filter Wetting: The filter must have been

Example Procedure Radiopharmaceutical Production Vented filter procedure Filter Wetting: The filter must have been thoroughly wetted prior to testing. Using it for final product filtration wets it adequately. The vent should be closed with mineral oil QC Tests Filter Integrity Test Contents Acceptance Criteria Discussion Mounting the Filter: Mount the filter in the Bubble Point testing apparatus. There is a female Luer fitting on top of the bubbling chamber (Picker vial with water in it) and a male Luer fitting on a 1/8" line for the gas supply. Procedure Example SOP Initial Pressure Test: Turn V 2 to "Test" and then turn V 1 to "Low. " This will apply a pressure of 35 psig to the filter. Observe that there is not a stream of bubbles exiting the filter. A single bubble or two is quite acceptable as the gas pressure forces the filter to deform slightly. Find the Bubble Point: Turn V 1 to "High" to slowly increase the pressure to the rated bubble point of the filter. Note the pressure at which the filter begins to pass a steady stream of bubbles. Record the bubble point pressure in the batch record. Technically the filter passed the manufacturer specifications when it held ≥ 32 psig. STOP

Example Procedure Radiopharmaceutical Production Unvented filter Procedure Filter Wetting: Wet the filter with the

Example Procedure Radiopharmaceutical Production Unvented filter Procedure Filter Wetting: Wet the filter with the appropriate fluid, typically water for hydrophilic membranes or an alcohol/water mixture for hydrophobic membranes. QC Tests Filter Integrity Test Pressurize the system to about 80% of the expected bubble point pressure which is stated in the manufacturer’s literature. Contents Acceptance Criteria Slowly increase the pressure until rapid continuous bubbling is observed at the outlet. Discussion Procedure Example SOP – – – A bubble point value lower than the specification is an indication of one of the following: fluid with different surface tension than the recommended test fluid integral filter, but wrong pore size high temperature incompletely wetted membrane non-integral membrane or seal Link to Demonstration STOP

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