[11C]PBR28 FOR INJECTION: RADIOPHARMACY TEST RESULTS
PET Radiopharmaceutical Sciences Section,Date of review: 08/19/05
Molecular Imaging Branch,
National Institute of Mental Health,
National Institutes of Health,
Bldg. 10, Rm. B3 C338,
Bethesda, MD20892
Approved by: ______Initials______Date:______
Victor W Pike, Ph.D., Chief, PET Radiopharmaceutical Sciences, NIMH
Batch # PBR- _____ Date:______
- Completed vial label
Attach completed vial label to this form.
- Pyrogen Test (note: [11C]PBR28for Injection may be released for human administration before completion of this test)
Test Record
Reagent vial (Cape Code®) / Lot # / Expiry date / Catalog #Positive control endotoxin
(0.2 mL/vial and contains 0.1 ng/mL of endotoxin) / ______/ ______/ PC010
LAL single test vial.
Sensitivity 0.25 EU/mL / ______/ ______/ GS250
Control standard endotoxin / ______/ ______/ E0005
Pyrogen-free dilution tube (12 x 75 mm) / ______/ ______/ TB240
Sterile Saline for Injection USP; American Pharmaceutical Partners / ______/ ______/ 401694C
Sterile Water for Injection USP; American Pharmaceutical Partners / ______/ ______/ 401753C
Procedure:
-Run each sample in duplicate: label vials 1 & 2 for positive controls; 3 & 4 for negative controls; 5 & 6 for sensitivity test; and 7 & 8 for test samples.
-Turn on heat block and confirm temperature setting is 37 °C.
-Wipe each vial stopper top with alcohol swabs.
-Label 0.9 % saline container as “PBR28 pyrogen vehicle blank.”
-Using a clean tuberculin syringe (0.5 mL size), place pyrogen vehicle blank (0.2 mL) in each of the negative control tubes (#’s 3 and 4).
-Take 0.5 mL of final formulated [11C]PBR28 and dilute with 0.5 mL of sterile water using a pyrogen-free test tube.
-Using a clean tuberculin syringe (0.5 mL size), place diluted [11C]PBR28 (0.2 mL) in each of the test vials (#’s 7 and 8) and the positive control tubes (#’s 1 and 2).
-Confirm that the Control Standard Endotoxin (CSE; typically 500 EU/mL) diluted with sterile Water for Injection (USP), is less than 1 month old. If more than one month old, reconstitute a new control standard endotoxin by adding sterile Water for Injection (USP; 10 mL) to the Control Standard Endotoxin vial. (Vortex for 30 s to ensure complete homogeneity.)
-Perform a serial dilution to this CSE stock solution using sterile Water for Injection (USP) such that a 5 EU/mL solution in a sterile vial (10 mL size) is obtained. Label this vial as “CSE diluted 5 EU/mL” and record the date of preparation on the label.
-Take the CSE 5 EU/mL solution (0.1 mL) and add this aliquot to each sensitivity test vial (#’s 5 and 6). Add sterile water (USP, 0.1 mL) to each sensitivity vial.
-Gently mix all contents of all vials and incubate at 37°C for 60 min.
-Check for gel formation by inverting the vial 180 in one smooth motion.
-If gel collapses the test is negative.
-Return CSE stock and diluted CSE solution to refrigerator when not in use.
[11C]PBR28 batch #: ______Date of test: ______
Start time of incubation: ______
End time of incubation: ______
Results
Vial # / Test Vial / Results1 / Comments1 / Positive control
2 / Positive control
3 / Negative Control
4 / Negative Control
5 / Sensitivity Test
6 / Sensitivity Test
7 / Sample
8 / Sample
1 (+) = gel formation, (-) = no gel formation; test sensitivity < 2.5 EU/mL
Does pyrogen test results show < 2.5 EU/mL?
Circle one: Yes or No
Initials of person performing assay: ______
- Sterility (note: [11C]PBR28for Injection may be released for human administration before completion of this test. When practical, a sample for sterility testing should be submitted one day after [11C]PBR28production/human administration. In the case of [11C]PBR28that was produced on a Friday or a workday preceding a federal holiday, sampling and submission of the sterility test sample should proceed on the next federal workday.)
Procedure:
-Residual [11C]PBR28for Injection contained in the dose vial (10 mL size) is stored in a lead container in hot cell 4 for at least 6 h after end of synthesis.
-The vial is removed and the absence of radioactivity in the vial is confirmed by holding the vial next to a GM meter with pancake detector.
-The vial is carried to the laminar flow hood and the hood is sprayed down with isopropanol and the laminar flow fan is turned on.
-Record the lot # and expiration date of each of the Bactec vials.
-Yellow vial (anaerobic) lot #:______expiration date: ______
-Blue vial (aerobic) lot #:______expiration date: ______
-The caps of the aerobic and anaerobic Bactec vials are removed, and the septum tops of the Bactec vials and decayed [11C]PBR28 vial are wiped with a sterile swab and allowed to air dry. Using aseptic technique a minimum of 200 L of the decayed [11C]PBR28 for Injection is removed from the original dose vial and added equally to the anaerobic (ca. 100 L) and aerobic vials (ca. 100 L). Note: For the Bactec sterility testing method, vials should be inoculated and submitted on the same day.
-Using a permanent marker, record lot # of decayed radiopharmaceutical and date of submission on the two blank lines of each of the Bactec vials. Do not write on barcode/peelable barcode of the Bactec vials.
-Fill out the “Request for Sterility test” form and submit the sample and form to the NIH Clinical Center Microbiology Lab. Retain a photocopy of the form and attach to this form until sterility test results come back.
-Attach completed sterility test results to this Radiopharmacy Form. Photocopy of submission form may be discarded upon receipt of sterility results.
-In Case of Positive Result. If growth is reported: a) notify the PI; b) ask for the identity of the organism from the microbiology lab; c) file report on the investigation and follow-up results in the GMP investigations file.
Is the [11C]PBR28 for Injection sterile?
Circle one: Yes or No
- Radionuclidic Indentity
Has radionuclidic identity been performed < 12 months ago?
Circle one: Yes or No
List date of radionuclidic identity test and results of test.
Date: ______Results: Pass or Fail
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