Door-to-door temperature study protocol

You might consider Vaccine Vial Monitors that already track temperature exposures in the vaccine cold chain to to the point of use.

For further information see https://www.who.int/publications/m/item/vaccine-vial-monitor

Best regards.

Hi Gael

You could calculate the MKT temperatures of the vaccines during the journey and from that temperature look up the percent of life lost.

Let me know if you need further clarification.

Larry Schlussler PhD

Sun Frost

[email protected]

I once used RTMD s attached to distribution containers. Battery life was 3 days

There could be smarter ways

You can use WHO protocol (attached or in the link below)

Study protocol for temperature monitoring in the vaccine cold chain

https://apps.who.int/iris/handle/10665/70752

Yes, the WHO Protocol with the use of a continuous temperature recording instrument.
With UNICEF Peru we did it some years ago. If you want information my email is [email protected]

To all

You can use WHO protocol (attached or in the link below)

Study protocol for temperature monitoring in the vaccine cold chain

https://apps.who.int/iris/handle/10665/70752

Dear Erida, a million thanks, that's exactly what I was looking for. Have a nice day. 

Yes, the WHO Protocol with the use of a continuous temperature recording instrument.
With UNICEF Peru we did it some years ago. If you want information my email is [email protected]

Thanks Fabiola, I'll email you. 

best

Hi Gael and Erida

Study protocol for temperature monitoring in the vaccine cold chain

Dear Gaël,

Adding to the contributions of others below, the WHO protocol suggested by Erida is a great start. The WHO protocol is based on a study of 2011. In the past 12 years there have been a number of technology improvements and -innovations that can help automate many of the steps in the protocol.

Berlinger has a range of active temperature monitors (loggers) as well as passive temperature indicators. In the SmartView software all temperature data can be captured, stored, processed and analysed. Please use these links for detailed information:

https://www.berlinger.com/vaccines-temperature-monitoring

https://www.berlinger.com/cold-chain-management/cold-chain-data-logger

https://www.berlinger.com/shipment-monitoring-solutions/smartview-cold-chain-basic-module

The temperature data can also easily be exported to other tools or spreadsheets, which can be used to calculate the Arrhenius equation and do inventory management calculations (to mention two possible examples).

Are you interested mainly in the protocol (theory) for a door-to-door vaccination strategy? Or are you also interested to design a cold chain and temperature monitoring solution for the door-to-door (practical)? If you share some more details and requirements offline I’m happy to continue the conversation.

Kind regards, Hendrik

- Berlinger -

You might also consider new technologies for guaging the condition at the end of a vaccine's journey - I recently worked with these people https://www.mimicalab.com/ on their 'Bump' technology that's currently used to monitor and indicate the condition of perishable foodstuffs but could equally be used in the vaccine context - Unit price is currently too high to fix to every vial but could be considered for secondary packaging - let me know if you want an introduction to them - I'm sure they'd be happy to discuss.

Ian

SureChill

UP !

Dear colleagues,

Thanks all for your inputs. This is very much appreciated.

On the same line, do you know where to find the standards/norms in term of cold chain equipemnt for a door to door strategy.

To my knowledge we need 1 vaccine carrier for each vaccination team with 4 icepacks and 1 vaccine carrier for each supervisor with 4 icepacks. This is based on my experience but I would like to find some guidelines confirming this statement. 

Any idea? 

Warm regards. 

Yes Hendrik, you are right about the time when the protocol was developed.

What Gaël was requesting was the protocol, which as you mentioned is a good starting point. 

Then is up to Gaël to decide on the type of devices that will accompany vaccines and their resepective softwares.

Thank you for sharing the links.

Hi Ian

How would the info obtained from "Bump" technology be different than the info obtained from a VVM?

Hi Larry.

The idea with this tech is that the 'bump' is tuned to react to whatever is the contents. Essentially it reacts to being exposed to out-of-range temperatures in the same way that the vaccine does and it does the MKT 'calculation' by reacting more to a higher or longer excursion. The reading of the device is done in the form of a dimple or bump that is smooth when all is good but changes to a discernible bump when its gone off/been frozen. Does that make sense? 

Hi Ian

Dear Erida

It´s clear the protocol was written in 2003 but I think this study creates a little confusion because the graphics results in ANNEX 8 are out of the range of temperatures. I guess that the vaccine carriers and insulated containers didn´t have PIS.

The MKT is the tool used by laboratories, when whatever vaccine come to our warehouse, I turn off the dataloggers and when I read them on PC, the MKT is the more important value to decide the acceptation or not. But this MKT is not easy to following using in Province, district and health care because we have 26 differents vaccines, some freeze-dried, others liquid and in differents amounts, i.e. 0.5 ml, 5 ml, 1.5 ml, 1 ml etc. with different activation energy. In those links of the chain we used cold box and vaccine carriers with PQS (mandatory). If the icepacks are in the beginning of the heat transfer by latent heat the PQS garantee us the perfect condition of all vaccines inside it.

I thank the laboratories like Serum (VOP) and Pfizer (Prevenar) the VVM in its vaccines, it´s a great helpful.

Yes, Rafael,

and this is why I replied further on the discussion that now there are new WHO PQS temperature monitoring devices which provide also data on MKT and users can select the ones that they think are appropriate for their study.

Best regards,

Erida 

Hi Gaël, there are a few other publications that you may be interested in, especially the first one listed below. 

Temperature Monitoring Study Handbook
UNICEF (2017)
This is a supplement to the WHO protocol for Temperature Monitoring Studies (WHO_IVB_05.01.rev1) that Erida mentions above. "The handbook will facilitate the implementation of the WHO protocol by introducing practical tips, a generic work plan, data collection templates, and an Excel-based temperature data analysis tool."
Link: https://www.technet-21.org/en/knowledge-hub/main/2475-temperature-monitoring-study-handbook?Itemid=1758

How to monitor temperatures in the vaccine supply chain
World Health Organization (2015)
"This module describes the correct use of available temperature monitoring devices for routine monitoring of cold chain equipment performance, temperature mapping of cold chain equipment and implementation of studies to assess supply chain temperatures."
Link: https://www.who.int/publications/i/item/WHO-IVB-15.04

Temperature monitoring study: a fully documented process to detect weaknesses in the supply chain
World Health Organization, UNICEF (2017)
"Provides supply chain managers with examples of results from temperature monitoring studies that show evidence of the potential risks to vaccines in the supply chain."
https://apps.who.int/iris/handle/10665/272856

Hi Rafael

I was glad to see that MKT  temperature was being used. WHO in it's day/night PQS performance tests uses a single activation energy. I think all vaccines VVM2 to VVM 30 have the same activation energy, if there are other thoughts on this point please let me know. Knowing the MKT temperature for an excursion the performance of the cold chain equiptment could easily be evaluated. The loss of life for a particular vaccine type could be determined from the Arrenhenius graphs. This process could be automated, a microprocesser could calculate the loss for the excursion for a particular vaccine type, VVM7 for example. The percent of life lost would depend on the MKT temperature and the time length of the trip. To see the amount of life left for a particular vaccine vial, the density of the dot on the vaccine vial would give this information.

In Tanzania, Nexleaf and the Ministry there piloted a TREK project where a sensor monitors temperature and communicates to an app in a phone via Bluetooth.  Do ad long as one is within Bluetooth range, their phone will be able to monitor the temperature and pick excursions for alarms.