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Bonni Hazelton

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  1. Our facility is FACT accredited and just for consistency, we have completed forms for both HPC processing and for our flow cytometry department. As mentioned above, a great learning tool, and also some feedback as to what changes might improve the forms.
  2. AABB has on its web site Publication #06-03 that refers to the ISBT 128 requirements. I have verified with the Regulatory Affairs department that the last bullet point of this memo is correct. If you are working only with HCT/Ps that are either autologous or related allogeneic (classified as 261 products) you are NOT required to implement the ISBT 128 labeling. If however you start using 251 products (e.g. unrelated allos) you will be subject to compliance with ISBT 128 within 60 days of implementing the new treatment.
  3. I agree that the mind set has been "...frozen is frozen". I think there may be a problem with the use of dry ice (-80 C) for stem cells that are required to be stored at temperatures below -120 degrees C (those containing DMSO as the only cryoprotectant). A combination of DMSO (5%) and hetastarch (5%) used in the cryopreservation of stem cell products does, however, allow for storage at -80C and therefore could be shipped/transported to bedside on dry ice. Igloo coolers are very resilient and can also be set up to tranport stem cells to the bedside in liquid nitrogen vapor. Validation indicates that the conditions we use can hold <-120 C for over 3 hours during an infusion event. We have used liquid nitrogen in some of our Igloo coolers for over 10 years and they are still not cracked and hold temperature well. SAFETY PRECAUTIONS must be carefully addressed when setting up for this type of transport! I don't think transport of -120 frozen products at -80 is an acceptable practice.
  4. I think your program director is requesting the correct follow up. Although you have multiple references re: the engraftment, the final piece of your validation should be engraftment using cells manufactured and frozen under YOUR conditions. I assume you are freezing aliquots of the products along with the units in both freeze conditions. Although these will never completely and accurately represent the product in the bag, they are a good monitor of the quality of the product. In the situation where you freeze using both methods, they can be checked for viability and compared subsequent to cryopreservation but prior to infusion. You may have done this already, but if not it would add to your validation. The ultimate end point for using cells frozen in this fashion is acceptable time to engraftment. The plan to infuse the "dump" frozen product and monitor the patient's engraftment is great, but due to the possibility of patient/HPC differences you may want to extend that to 2 or 3 patients. (Just a thought) Bonni
  5. I am actively working as a consultant in preparation for FACT accreditation for three programs. I can provide references as necessary. Our first program accreditation by FACT was finalized in September 1998. My position for the last 15 years has been Laboratory Director of the HPC processing laboratory. I am also an active FACT inspector and AABB assessor for Cellular Therapy programs. contact: bhazelton@biocellutions.com
  6. Are there any exceptions for the FDA ruling regarding the implementation of ISBT Code 128 for all blood products within the next couple of years? I am the Director of a low-volume progenitor cell processing facility. We support only one program and process HPCs for approximately 30 patients annually. Our facility does not provide/process any other blood products. Is there a source where I can find more detailed information regarding the FDA ruling?
  7. You can use a number of methods to verify the holding temperature of the LN2 dryshippers. 1-If you have a monitor with a thermocouple for temperatures as low as -120 degrees C (the temp you will need to maintain in transit) and associated printer you can use it to record the temperature of the charged shipper every 4 hours. The length of time it takes for the temp to go above the -120 degree C mark, becomes your "holding time". For shipping, that time should be decreased by at least 24 hours for safety (we decrease by 48 hours to leave time for redirection of mis-shipped specimens!) 2-If you do not have the above equipment, CryoGuard M120 (Controlled Chemicals Inc.) temperature monitor can be used in somewhat the same fashion. This would require manual monitoring and recording and would also necessitate the opening of the shipper. Check the status of the monitor at set intervals (eg 4 hrs) and document (green= still below -120/red above -120). Using the same criteria as above, set your "holding time". 3-The weight of the shipper can also be used to monitor holding time by measuring the weight of the shipper at each step in procedure #2. First, weigh the completely empty chamber prior to charging. Weigh the chamber at the start of the procedure (full) and at each subsequent time point. What you should see is that as long as their is nitrogen in the shipper (wieght is > empty weight) the temperature will hold. After validating and documenting this you can use the weight of the shipper not only to verify the holding time but also to ensure proper temperature at the receiving end (eg weight at time of receipt). With all the verifications of holding time, do them routinely as when the shippers get "bounced around" during transport the vacuum can be lost very rapidly. You would probably notice changes during charging if there is a problem.
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