TechNet-21 - Forum

This forum provides a place for members to ask questions, share experiences, coordinate activities, and discuss recent developments in immunization.
  1. Michel Zaffran
  2. Supply chain and logistics
  3. Wednesday, 26 August 2009
Today, most vaccines are licensed for storage between 2-8°C, regardless of their true stability. While there are some vaccines that do need to be kept at this specific temperature range, studies have shown that most vaccines are able to withstand higher temperature ranges for a specific period of time and that keeping them at 2-8°C puts some of them at risk of freeze damage. This isn't to say that vaccines should not still be stored at 2-8°C, but that if the vaccine is in fact stable enough to allow, for example, storage at 25°C for 30 days, that the product's license should reflect this so that countries have the option to use it as such if they wish. Looking at alternative temperature storage for vaccines has many advantages, chief amongst them: • Taking full advantage of the real stability of vaccines to improve coverage by reaching out to remote populations beyond the reach of the current cold chain • Increasing efficiency and effectiveness of immunization services to new target groups and in campaign/pandemic situations • Protecting freeze-sensitive vaccines • Facilitating the integration of the immunization supply chain with those of other health care products There are many regulatory and programmatic challenges that will need to be addressed before storing certain vaccines outside of the 2-8oCdegrees becomes a feasible practice, however one of the first issues to tackle is what we call this new storage/transport arrangement. While many options have been proposed, we'd like to get input and opinions from as many people as possible before choosing an official term. Some suggestions thus far have included: Out of the cold chainFlexible cold chainControlled ambient temperature storageHigher temperature storage[/ol] Please help us find the best term possible! Michel Zaffran Senior Adviser & Project Optimize Director
Michel Zaffran Accepted Answer
Many thanks to the many readers who have provided feedback and input. My colleague Steve McCarney of PATH has consolidated all the inputs received into a background document that was presented at the last WHO Technology and Logistics Advisory Committee (TLAC) meeting in September. We are proposing that the terminology "Controlled Temperature Chain," (CTC) be now used to describe storing and transporting vaccines beyond the 2-8 degrees Celsius temperature range, as appropriate to each vaccine's stability profile. A copy of Steve's document and summary of the process used to select this term can be found in the TechNet library at the following link. http://e2ma.net/go/2521572730/2299581/86614148/32403/goto:http://www.technet21.org/Tools_and_resources/technet_documents.htm regards
  1. more than a month ago
  2. Supply chain and logistics
  3. # 1
TechNet Admin Accepted Answer
Admin
Dear all, This is my first time in Technet21, and I am very pleased to vote my favorite option. Regarding the names I suggest: "COOL CHAIN". The temperature of 25°C is very close to cool temperature and the word chain remains as the process (way) from harvest to the consumer. Best regards. Luciano Agonigi
  1. more than a month ago
  2. Supply chain and logistics
  3. # 2
TechNet Admin Accepted Answer
Admin
I think that it is important to distinguish between vaccines that can tolerate freezing, and those that can't. Rather than introduce a new name, I would try for something simple that can be easily understood such as: "Keep cool, do not freeze" for freeze sensitive vaccines "Keep cool" for freeze insensitive vaccines. Steve Zweig
  1. more than a month ago
  2. Supply chain and logistics
  3. # 3
TechNet Admin Accepted Answer
Admin

Sir, I feel that it is more appropriate to call these vaccines as thermostable vaccines the others are thermolabile vaccines. This is just a developmental phase and it should not take away the basic vaccination procedures and its importance. Nagaraj

  1. more than a month ago
  2. Supply chain and logistics
  3. # 4
TechNet Admin Accepted Answer
Admin

Hello everybody I think this new method of vaccine storage and transport may be named Heat Flexible Vaccine Storage and Transport System as the vaccines can withstand varying degrees of heat thanks Dr Murtada A ABDELMAJID

  1. more than a month ago
  2. Supply chain and logistics
  3. # 5
Alejo Bejemino Accepted Answer
Dear Michel, During my consultancy assignments, I found out that large quantities of vaccines were wasted by either heat exposure or freezing. Vaccines damaged by heat exposure could be easily detected by the use of VVM whereas those vaccines damaged by freezing could not be easily detected. The possibility of administering freeze damaged vaccines then was high. Most of the health centers did not have the freeze indicator in their refrigerators and transport boxes, making it difficult to determine whether vaccines were exposed to freezing or not. Considering that some of the EPI vaccines can now be stored outside the +2/8⁰C range and many new vaccines coming in the pipeline, I suggest that the designated name for this out of range storage temperature should be specific for the types of vaccines. I suggest either of the following names: Storage Temperature below & above +2/8⁰C Range or Storage Temperature Limit or Vaccine Temperature Limit. It is more useful if the following label could be printed in each vial of vaccine: For vaccines sensitive to heat such as OPV, MEA, BCG etc. the label could be: -25⁰C [+2/8⁰C] +25⁰C Similarly, for vaccines sensitive to heat and cold such as DPT-HepB, TT etc. the label could be: +1⁰C [+2/8⁰C] + 35⁰C The number preceded by a positive sign on the right of the +2/8C range specifically indicates the maximum temperature limit and the number preceded by a negative/positive sign on the left indicates the minimum temperature limit. These additional labels on the vial could increase cost of the vaccine but these could also build up the confidence of field staff and help them in ensuring that vaccines are not exposed to freezing or high temperature. This new change in the vaccine storage temperature will also result to a low refrigeration cooling requirements for a high vaccine storage space capacity. Hope this is useful. Best regards, Alejo H. Bejemino Cold Chain Consultant No. 1 Hamada Road Baguio City, Philippines Res. Tel.: +63 74 442 2254 Mobile: +63 919 510 3669 Email: [email=albejemino2001@yahoo.com]albejemino2001@yahoo.com[/email]
  1. more than a month ago
  2. Supply chain and logistics
  3. # 6
TechNet Admin Accepted Answer
Admin
The text printed on a label and or carton is governed by requirements stated in respective pharmacopoeiae and Rules under Drugs Act or a similar regulatory document. It may be easy for the regulators to accept or modify requirements if we suggest ' RT stable ' for storing and transporting vaccines outside of the 2-8C range. RT (Room Temperature) is defined in the pharmacopoeiae. Technet21 is a good forum, truly. Harshavardhan
  1. more than a month ago
  2. Supply chain and logistics
  3. # 7
TechNet Admin Accepted Answer
Admin
Friends, Yes, the word COOL seems most apropriate and acceptable. While denoting need to have low temperature, it also removes the chill of cold. Rajesh,India.
  1. more than a month ago
  2. Supply chain and logistics
  3. # 8
Moderator Accepted Answer
Admin
Michel, All, This could be called "hold chain" to refer to that which is held, stored and monitored. The name similarity would have the benefit of uptake and continuity of concept. Still catching up so maybe this has been said. Regards, Marcia.
  1. more than a month ago
  2. Supply chain and logistics
  3. # 9
TechNet Admin Accepted Answer
Admin
Hello, my suggestion would be: extended (expanded)temperature range vaccine (optionally with from:to C) lets keep on thinking best wishes Klaus
  1. more than a month ago
  2. Supply chain and logistics
  3. # 10
TechNet Admin Accepted Answer
Admin
Julie- Sounds a cool name- but may be difficult to translateinto other UN languages Jules
  1. more than a month ago
  2. Supply chain and logistics
  3. # 11
TechNet Admin Accepted Answer
Admin
I think we need to keep the "Cold Chain" part, to indicate that vaccines will still be part of the controlled system of management and transport that characterizes a well-functioning cold chain. However, I think we also need to include the concept of flexibility. Thus the idea of "Flexible Cold Chain" seems the best. To avoid it being too long, we could use "Flexichain." Best, Julie
  1. more than a month ago
  2. Supply chain and logistics
  3. # 12
Moderator Accepted Answer
Admin
Dear all I am making a close follow up of names - I support Ranjit A word COOL CHAIN Also your two suggestions are valid Chris Kamugisha
  1. more than a month ago
  2. Supply chain and logistics
  3. # 13
TechNet Admin Accepted Answer
Admin

Could we have an outside the box name as "Life Chain" or "Safe Chain" or "Vital Chain"?

  1. more than a month ago
  2. Supply chain and logistics
  3. # 14
Moderator Accepted Answer
Admin
31.8.2009 Dear Technet Moderator, Re.: Selecting a term for : "Storing and Transporting Vaccines ..." I suggest CALT, which stand for "Controlled Ambience Limited Time" I am very happy that the possibilities for storing and transporting vaccines outside the 2-8 degrees celsius range are again being considered in Technet Forum. In Technet Forum, posts 01214E and 01254E I raised for the first time (1.5 years ago) the possibility of keeping vaccines for a limited time in a higher temperature range than the actual one, referring to Annex # 1 in the WHO publication: "Temperature Sensibiliuty of Vaccines", and pointed out, how much the cold chain could be simplified by doing this. At that time I called it "Easy Cold Chain". There were no response to my suggestions (temperature range and term) at that time. Since then I have in cooperation with Soeren Spanner, my TLAC colleague, prepared a paper that describes in detail, how such a change could be implemented in a way that will at the same time offer thermal security, and a lot of space to cater for the new vaccines that will require much more space. We were given the opportunity to present it as a "discussion" paper in the March 2009 TLAC meeting , and will present it in a formal version in the next TLAC meeting in September. We hope that after the September TLAC meeting we can publish our paper in TECHNET Forum. A change to a larger temperature range will require a lot of advocacy and a huge amount of training in vaccine handling, but will also imply huge advantages, and not only economic ones. Best regards, Mogens Munck P.S.: TLAC has been disbanded, the September meeting will be its last meeting.
  1. more than a month ago
  2. Supply chain and logistics
  3. # 15
TechNet Admin Accepted Answer
Admin
Suggestion: Vaccine Control Chain
  1. more than a month ago
  2. Supply chain and logistics
  3. # 16
TechNet Admin Accepted Answer
Admin
Initially we were using the term "fast chain"How about we say "Briefcase vaccines"?We know that briefcases are used by men and women in all conditions and at ambient temperatures- at least most of the time. F. O.
  1. more than a month ago
  2. Supply chain and logistics
  3. # 17
Toryalai Hart Accepted Answer

I thought that the term "cool chain" used by the optimize group was excellent. Not necessarily cold, but still cool.

  1. more than a month ago
  2. Supply chain and logistics
  3. # 18
ousmane dia Accepted Answer
Before considering the extreme range of temperature 25C, I rather suggest that we try as much as possible to store these vaccines in a storage space with AIR CONDITIONNING or in the office of the the manager of the health facilities, some of whom have AC . This can increase the storage time to over 30 days. Otherwise I am afraid to see AMBIANT (25C) being the first insteed of the last acceptable alternative, with the possibility that healthworkers can inadvertantly allow the vaccines under this temperature more than 30 days. Considering "controlled" to mean "monitored", this would apply to both inside and out of the cold chain storage. This does not exclude the fact that we need to maintain temperatures low at the storage environnement when ever possible. Based on that I suggest that we use Controlled Air Conditionned Storage Facilities without AC should not be given vaccines stocks for more than 30 days to allow them the possibility of using ambiant temperature in case of cold chain failure. Ousmane Dia Senior Logistics and Operations Manger JSI Washinghton
  1. more than a month ago
  2. Supply chain and logistics
  3. # 19
Michel Zaffran Accepted Answer
Thank you for your comments I suppose that there are two different sets of discussions that we would like to have: 1. A discussion on the programmatic issues related to the use of vaccines in a controlled environment different than the 2-8°C to which your comments and others before are contributing 2. the discussion which I have initiated on calling for suggestions of what name shoud we give to "storing and transporting vaccines outside of the 2-8°C range" since the words "Cold Chain" would no longer apply We will be asking the Moderator to create these two streams of discussions. regards Michel Zaffran
  1. more than a month ago
  2. Supply chain and logistics
  3. # 20
TechNet Admin Accepted Answer
Admin

The issues are to be looked differently. The longevity of the thermostable vaccine v/s routine vaccines that can survive higher temperatures and being effective for say 30 days, etc. In field practice some thing else happens - the most dangerous thawing - frequent heating and cooling which destroys the vaccine in a shorter period. Temperatures exposed at various places could be different. So temperature recommendations prescribed are optimal ones and shelf-life is described. What is probably discussed as I understand is the stability despite some amount of thawing that could protect the vaccine. Nagaraj

  1. more than a month ago
  2. Supply chain and logistics
  3. # 21
egyptianmoh Accepted Answer

Dear Mr. Zaffran, Dear All,

I am very pleased to get in touch with you. Actually, It is my first participation in the TECHNET21. Regarding the names, I suggest "controlled temperature storage and transportation". It will be controlled since the temperature is monitored as I understand. "Ambient" is not a good idea since some references define ambient temperature with the range from 20 to 25 degree C. I think the other terms may have false implications of non controlled storage. This was what exactly happend with me when I first read about "out of cold chain". I thought that the cold chain was failed and the product was spoiled. "Flexible cold chain" is not appropriate from my point of view since it is no more cold.

Kind regards, Mohamed Mohamed Refaat MohamedInspector Pharmacist, Biological Products InspectorateCentral Administration for Pharmaceutical Affairs, Ministry of Health21 Abdel-Aziz Al-Soaad St., Manial Al-RoddaCairo, 11451 - EgyptTel: ++202 2368 4381 - ++202 2368 4288Fax: ++202 2368 4194Mobile: ++2 012 04 08 258E-mail: egyptianmoh@yahoo.com

  1. more than a month ago
  2. Supply chain and logistics
  3. # 22


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