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TechNet-21 - Forum

This forum provides a place for members to ask questions, share experiences, coordinate activities, and discuss recent developments in immunization.
  1. Narayana Holla
  2. Programme management
  3. Sunday, 11 July 2021

Dear viewers

We really do not know as to we are right or wrong in asking the following queries as we are facing this situation for the first time in the last 40 years as we never used vaccine which requires minus temperature for storing and shifting before administering at the planning unit level. We have many more queries, but sharing only the following for the time beeing. 

All experts in this field, especially the manufacturers can kindly respond for providing quality service to the esteemed beneficiaries. 

                                                 Queries on Deep Freezer [DF] at the vaccination center at the Facility 

1. What is the temperature range recommended for storing in the DF? 

2. What minimum "cold hold over time" is expected below permissible upper limit of the range for that vaccine in hours if power fails? 

3. Should the deep freezer also be lined with Ice-Lining like that of Refrigerator [ILR]? If yes should it be with icepacks filled with water as thermal buffer or nonfreezing gel? If there is no ice-lining, how many packs & which size packs are recommended to be placed in the cabinet - say 50% space for vaccine, 10-20% for ice-packs, 30 to 40% free space for air circulation or which proportion the company recommends? Often the entire storage pack is totally frosted: stony hard, unable to open the carton and remove the vaccine vials / ampules: which may break in the deep freezer itself causing loss to the buyer unless compensated by the company - say buy 100 get 20 to 25 free. 

4. How often de-frosting is recommended and where to and how to transfer the vaccines to alternate cold chain equipment? Non electrical or Electrical? Within how many seconds / minutes?  

5. What type of temperature logger is recommended inside the DF? One which can continuosly display outside mounted on the wall / transmits data through SIM which the supplier can access 24 x 7 / data logger with USB…..? 

6. At what minimum and maximum temperature beeps are expected? [below  -25 0C        higher than -15 0C] 

7. What is the optimal packing unit for keeping vaccine in the DF? [Cluster of how many secondary packings:50/100/200/300...] 

8. What process is recommended for removing secondary packing from storage packing and individual vials / ampules from the secondary packing placed in the DF? 

9. Within how many seconds / minutes process mentioned in 8 are to be completed? 

10. In which container / tray & at what temperature the secondary packing units / vials / ampules are to be carried to the session site [away from the cold room by say 50-150 mtrs]; how to record and document the temperature from removal from the DF to administration to the candidate with documentary evidence? 

11. How to thaw:- allowing it to liquefy on its own on the vaccination table in its trough / gently roll between the palms at 37 0    

12. Towards the end of the session if less than 5 doses are needed what procedure is to be followed? [say 3 more than 100] or how to pull out only 1 to 4 doses from the DF 50 to 150 meters away from the session site?

13. Is a Vaccine Carrier recommended - the brand item in any vaccination session? If so, what size? 1.7L /2.9L / 5L; small ice pack / Large icepack; conditioned [ice-pack at 0+0C] / unconditioned [sub-zero] / with water as thermal buffer or non freezing gel?

14. What should be the temperature within the vaccine carrier if point 13 is recommended: between minus 25 0C & minus 15 0C? 

15. Will the manufacturer can share a CD explaining all these and any further step to step activity from receiving the vaccine from the manufacturer till disposal of the cut ampule / opened vial for maintaining universal uniformity including how to provide documentary evidence.

Some questions may look silly but are operationally very important for us. I hope one or more may reciprocate especially the manufacturers of the vaccine with end to end CD for recuurent training of multiple batches.

with great expextations

KVG Team

 

 

 

 

 

 

Pat Lennon Accepted Answer

I agree this is an important topic and appreciate the information provided by the community. Yogesh, thanks for sharing the performance details of the cold boxes as this information may not be easy for most people to find and it is useful for planning.

In suport of Yogesh's points raised above regarding the Pfizer-Biontech vaccine, our colleagues at WHO recently released this training guidance available here on TechNet: Handling, storing and transporting Pfizer BioNTech COVID-19 Vaccine COMIRNATY® (Tozinameran) (technet-21.org)

Thanks,

Pat

  1. more than a month ago
  2. Programme management
  3. # 1
Yogesh Bhamare Accepted Answer

First of all,I would like to Thanks to Narayana Holla,for raising such an important quries on valid points.Also Grateful to RAFAEL HERNAN RIVERA & Pat Lennon for the responses.

Just to add on,seeking guidance on following....

Pfizer Vaccine can be stored at refrigerated temperatures for up to 1 month (31 days).Any time used for transport counts against the 31-day time limit for storage at these temperatures.PQS enlisted Cold Boxs are the qualified container can be well taken into use for vaccine transportation,as do have long hold over time (with conditioned icepacks),which ranges much more than 12 hours,i.e.90 hours to 130 hours (if lid not opened & depends on product to product)

CDC guidelines published suggests Pfizer Vaccine Transportation in a refrigerated temperature: Between 2°C and 8°C (36°F and 46°F) for up to 12 total hours (in a portable refrigerator or qualified container/packout).However, in some countries,because of geographical terrain,transportation time may exceeds beyond 12 hours or in some cases it will be required to shift vaccines from larger cold boxes to small cold boxes for its further transportation to LD point,which also extends the duration for vaccine transportation. 

So any scientific reason/logic for restricting the transportation period upto 12 hours,if it is there,then please let us know about.

Thanks,

Yogesh

  1. more than a month ago
  2. Programme management
  3. # 2
Narayana Holla Accepted Answer
 
Dear Rafael Sir
 
Myself and my team are very greatly thankful to you for the specific responses to specific questions for a specific vaccine. It has taken us to a new horizon altogether.
 
With best regrds
Holla n Team
  1. more than a month ago
  2. Programme management
  3. # 3

Dear Holla

I´l try to answer your questions about Pfizer/BioNtech

1. What is the temperature range recommended for storing in the DF?  -60°C to -80°C

2. What minimum "cold hold over time" is expected below permissible upper limit of the range for that vaccine in hours if power fails? The setpoint of ULT is near to -75°C, in 1 hour without power the raise of temperature was 3°C, then the upper limit will be expected in 5 hours.

3. Should the deep freezer also be lined with Ice-Lining like that of Refrigerator [ILR]? If yes should it be with icepacks filled with water as thermal buffer or nonfreezing gel? If there is no ice-lining, how many packs & which size packs are recommended to be placed in the cabinet - say 50% space for vaccine, 10-20% for ice-packs, 30 to 40% free space for air circulation or which proportion the company recommends? Often the entire storage pack is totally frosted: stony hard, unable to open the carton and remove the vaccine vials / ampules: which may break in the deep freezer itself causing loss to the buyer unless compensated by the company - say buy 100 get 20 to 25 free. 

The ULT has a vacuum chamber, no needs icepacks. All the compartments can be totally filled with vaccines, because the evaporator is in all the walls of the equipment. 

4. How often de-frosting is recommended and where to and how to transfer the vaccines to alternate cold chain equipment? Non electrical or Electrical? Within how many seconds / minutes? The defrosting depends of the humidity of the air around the ULT, depends of the how many times it´s opened the door, and the manufacturer. When the inventory of vaccines is low in the period, the vaccine is transfer to another ULT while the main is defrosting, the filter is cleaned and is done the maintenance. Other option is to have dry ice 20 Kg per 11.700 doses in a cold box and to transfer the vaccine, depends the quantity of vaccine.

5. What type of temperature logger is recommended inside the DF? One which can continuosly display outside mounted on the wall / transmits data through SIM which the supplier can access 24 x 7 / data logger with USB…..? the first, with internet and you can see the temperature in your cellphone. Some ULT has the USB port to discharge the values.

6. At what minimum and maximum temperature beeps are expected? [below  -25 0C   higher than -15 0C] below: -80°C and higher than -60°C.

7. What is the optimal packing unit for keeping vaccine in the DF? [Cluster of how many secondary packings:50/100/200/300...] Each secondary packaging has 195 vials with 1.170 doses.

8. What process is recommended for removing secondary packing from storage packing and individual vials / ampules from the secondary packing placed in the DF?  The labs give the process, never retire the individual vials of the secondary packing in this temperatures you can do it but is not good.

11. How to thaw:- allowing it to liquefy on its own on the vaccination table in its trough / gently roll between the palms at 37 0C. To thaw inside the ILR between 2°C and 8°C the vials must be out of the secondary packaging to accelerate the process. 

12. Towards the end of the session if less than 5 doses are needed what procedure is to be followed? [say 3 more than 100] or how to pull out only 1 to 4 doses from the DF 50 to 150 meters away from the session site? Each vial has 6 doses, and at the end of the cold chain (i.e. the last 31 days) the temperature must be between 2°C and 8°C. never in DF.

13. Is a Vaccine Carrier recommended - the brand item in any vaccination session? If so, what size? 1.7L /2.9L / 5L; small ice pack / Large icepack; conditioned [ice-pack at 0+0C] / unconditioned [sub-zero] / with water as thermal buffer or non freezing gel? the same carrier vaccine used for other biologicals, the best size is 2.5 liters to 180 shots but wherever it´s fine.

14. What should be the temperature within the vaccine carrier if point 13 is recommended: between minus 25 0C & minus 15 0C? between 2°C and 8°C.

Best regards. 

 

 

 

 

 

 

  1. more than a month ago
  2. Programme management
  3. # 4
Narayana Holla Accepted Answer

Dear Pat 

Thanks for the response. I will go through the references / links for more details. 

wirh regards

Holla n team

 

  1. more than a month ago
  2. Programme management
  3. # 5
Pat Lennon Accepted Answer

Dear Dr. Holla - I won't be able to answer all your detailed questions but I hope the information below is helpful.

WHO PQS provides performance requirements for cold chain equipment that includes freezers - both water pack and vaccine freezers. Vaccine freezers were primarily used for storage of oral polio vaccine in case India has any guidelines on OPV storage and handling that could be helpful to you. One reason PQS differentiates between vaccine and water pack freezers is because there is concern that placing warm water packs next to vaccine would result in localized warming inside the freezer which could potentially reduce shelf life of the vaccine.

The freezer performance specifications can be found here: https://apps.who.int/immunization_standards/vaccine_quality/pqs_catalogue/catdocumentation.aspx?id_cat=17

A list of PQS prequalified freezers and refrigerators is here: https://apps.who.int/immunization_standards/vaccine_quality/pqs_catalogue/categorypage.aspx?id_cat=17

Some of your questions above are covered in the freezer equipment specifications.

For the freezer temperature logger I would reccomend one with a temperature probe that goes inside the freezer and the data logging and display sits outside the freezer to make reading temperature and accessing data easier and to reduce door openings. 

PQS has a list of prequalified temperature monitoring devices at the following link but I'm not aware of freezer specific devices: https://apps.who.int/immunization_standards/vaccine_quality/pqs_catalogue/categorypage.aspx?id_cat=35

Some of your questions about vaccine packing and handling time will be dependent on the thermal stability of the specific vaccine in question so are best answered by the vaccine developer. I'm not aware of a vaccine that is required to stay frozen durning an immunization session. Typically COVID vaccines are allowed to be thawed at 2-8C before use - but confirm with vaccine developer directly.

Thanks,

Pat

  1. more than a month ago
  2. Programme management
  3. # 6


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