Regulatory Open Forum

Are you aware there is already a very active thread on the topic of the vaccine?

Regardless, I'm not sure about the dry ice.  North Carolina released its draft (148-page) distribution plan and the only reference to dry ice I noted in it (not having read anything close to 148 pages, but searched for some key terms) was for disposal of hazardous waste.  I understand our governor had a press conference at the time the draft was released and said our hospitals are prepared to store the Pfizer and/or Moderna vaccines.  Not sure if he explained how, or even if he knows.  I think our hospitals might well be equipped for this, but outside the hospital setting...we'll see.  Nursing homes may prove to be a challenge.

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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Hi Julie,

Yes, it is not necessarily  storage at hospitals that is the issue..they have ultra-low freezers yes (larger ones do).  Dry-ice for shipment is the issue.

Ironically the discussion is now about distribution to grocery stores who may have those freezers, said one report I heard. We had them in my old GLP test facility for storing test tissues and other items needing long term storage. 

A boom  for us here in the Midwest ramping up ethanol? And ammonia will start up again , but we are not planting until April. ...

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Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
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Original Message:
Sent: 05-Dec-2020 11:28
From: Julie Omohundro
Subject: The Pfizer Vaccine

Are you aware there is already a very active thread on the topic of the vaccine?

Regardless, I'm not sure about the dry ice.  North Carolina released its draft (148-page) distribution plan and the only reference to dry ice I noted in it (not having read anything close to 148 pages, but searched for some key terms) was for disposal of hazardous waste.  I understand our governor had a press conference at the time the draft was released and said our hospitals are prepared to store the Pfizer and/or Moderna vaccines.  Not sure if he explained how, or even if he knows.  I think our hospitals might well be equipped for this, but outside the hospital setting...we'll see.  Nursing homes may prove to be a challenge.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

I offer my post from November 30th's RAPS Regulatory Exchange:


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John Willenbrock
Technical Manager, FDA
Jamestown NC
United States
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Original Message:
Sent: 05-Dec-2020 08:19
From: David Steinberg
Subject: The Pfizer Vaccine

There is a major issue with  the vaccine that needs significant planning. It must be stored at -94 degrees F (or as we say -70 degrees C). To store this you need special "freezers" and significant amounts of dry ice, Since late April , dry ice has been on  allocation and very short supply. This was before the news about the vaccine, the production of dry ice dropped.

Dry ice is mostly made from liquid carbon dioxide. This is obtained as a by-product of fuel ethanol and also manufacturing of ammonia. Many plants are shut down for lack of demand mostly due to the economic effects of the Covid-19 virus.

At the same time demand for dry ice increased for shipping temperature sensitive foods to consumers as they were not shopping in stores but having home delivery.

 

END OF YEAR HOLIDAY CLOSURE: We will be closed Thursday, December 24th through Friday, January 1, 2021 to spend some much needed time with our famili es.  We look forward to assisting you with your regulatory consulting needs in the new year!

David C. Steinberg, FRAPS
President
 

SteinbergAndAssociates.com
Office: 973-907-7561

 

                  

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