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This forum provides a place for members to ask questions, share experiences, coordinate activities, and discuss recent developments in immunization.
Discussions tagged VVM
Call for examples of country materials on VVM
Dear colleagues,
I am working on a new book project on VVM.
I would like to include examples of the following and shall be grateful if you could kindly contact me. Your help is much appreciated!
If you have any of the following, besides sending the material, I'd appreciate it if you could kindly explain and give a short background on the material you are sending (especially for photographs - where it was taken, when it was taken, what is the event, and who is the photographer)
Please reply to umit@kartoglu.ch
Description
Comments
VVM posters
Any poster related to VVM use. If you have the PDF file copy of the poster, I’d appreciate it if you could send it to me.
If you do not have any PDF copy of the poster, please make a photo of it and send the photo.
VVM training materials
If your country has any experience with running training sessions on VVM, either as a standalone VVM training or incorporated into any other training programme (e.g. vaccine management), I’d appreciate it if you could kindly share the material in PDF format with me. If you have it only in hard copy, and can spare one, please let me know, I can arrange a DHL pickup.
Photographs showing VVM in action
If you have photographs of health workers during immunization sessions that VVMs are visible on vials, I’d appreciate it if you could kindly send me a copy them. Please make sure that resolution of such photos should be minimum 150dpi and preferably 300 dpi.
VVM policy documents
I’d appreciate it if you could share PDF copies of your country’s any policy paper indicating VVM use.
With many thanks and all the best,
UMIT KARTOGLU
Type of VVM assigned to vaccines
Dear all,
Can any one explain how the decision is made as to which type of VVM is assigned to different vaccines, with examples? Are same vaccines manufactured by different manufactures assigned different type of VVM?
Thanks,
Chandralal
DIGITALLY MIMICKING THE ANALOGUE FUNCTION OF A VVM
Imagine that VVM’s do not exist. As an alternative a tiny electronic device could be developed which would record the temperature history of the vaccine vial. The device would be attached to the vial and graphically display the temperature history of the vaccine. If a health worker wanted to know how the temperature history of the vaccine would affect its life, how would they do it? This is essentially the same problem faced when trying to interpret the data obtained from a refrigerator or vaccine carrier data logger. Currently there is no analytic method to determine how temperature excursions affect the life of a vaccine.
VVM’s
A VVM may be thought of as an analogue device whose function is governed by the Arrhenius rate equation. The output of this elegantly simple device is a displayed dot of varying density. The density of the dot indicates the percent of life left in the vaccine. If VVM’s were not available the electronic device attached to the vaccine vial could use the collected data to calculate how temperature variations affected the life of a vaccine. This calculation could be done with the aid of the Arrhenius rate equation. The display of this device could mimic a VVM by displaying a dot of varying density to indicate how much vaccine life is left. However with digital electronics it may be more informative to display the number of days of life left. This same analytic tool could be used to interpret the data recorded on a refrigerator or vaccine carrier data logger. This would be a major step forward since there is no analytic method currently in use to determine how temperature excursions effect the life of a vaccine.
ALARM SYSTEMS
Knowing how temperature excursions affect the life of a vaccine can lead to more intelligent and responsive alarm systems. WHO recommends that an alarm is turned on when temperatures rise above 8C for 10 hrs. This recommendation could be misleading an alarm could be turned on when there are no problems and not turned on when there are serious problems. For example, for a 24 hours day an excursion to 9C for 11 hrs., then a return to 5C for 13 hrs. would turn an alarm on however this excursion would not lower the expected life of a vaccine. On the other hand if each day the temperature climbs to 20C for 9 hrs. in the afternoon, and than returns to 5C for the remainder of the day the alarm would not be activated, however the life of the vaccine would be cut in half.
A DIGITAL ANALYSIS OF TEMPERATURE DATA BASED ON THE ARRHENIUS RATE EQUATION WOULD HAVE THE FOLLOWING ADVANTAGES:
Simplified data interpretation: The analysis would show the effect of a temperature excursion in a simple to interpret form.
The severity of a refrigerator problem would be indicated which is a valuable piece of information for management.
Elimination of false alarms: Alarms would coincide with indication from a VVM.
More responsive alarm systems.
Reduced vaccine waste.
Data to show that outreach programs can be safely extended.
Simpler and less expensive designs for refrigerators without sacrificing vaccine life
These advantages could come to fruition if we simulated digitally what a VVM does in an analogue fashion.
Should we be confidently proud of the global improvements on immunization coverages? What can we do better to improve temperature monitoring in vaccine cold chain and ensure potent vaccines are usually used to vaccinate our clients?
nassor
In
Most of the countries now have improved immunization coverages and reach more children with vaccination, but we still need to monitor the potency of vaccines that are given on top of the high coverages we have achieved in many countries.
One of the biggest challenges when we talk about vaccine potency is the storage condition and to be more specific “the storage temperature”. Most of the vaccines are either heat or freeze sensitive and we need to monitor the storage temperatures more closely so that we can have potent vaccines given to the children and hence achieve higher coverages with potent vaccines.
There are several technologies that are currently applied in monitoring temperature of cold chain eg. VVM, Fridge and Freeze Tags, different types of RTM devices are now coming up. All this aimed at ensuring vaccines are stored in correct temperature to maintain potency. But, with all those devices the human component is not replaced and we still need someone to act upon the alarms or signs from those devices to ensure correct temperature are maintained all the time in vaccine cold chain.
Based on the field experiences (9+ years) in immunization program, I am still not sure if the closed vial wastage due to freezing for freeze sensitive vaccines reflect the reality. That means, I doubt there are many children who are probably receive vaccines which have been exposed to freezing. We are very good in monitoring heat exposure because of VVM and we have observed closed vial wastage due to VVM change reported but freezing exposure is very difficult to monitor especially in the scenario when the facility does not use temperature monitoring devices that gives freezing alarms. The actions taken following low temperature excursion at the facility level makes me more worried and I feel there is a need of looking at this issue with an additional eye.
Currently, many countries are getting into the new technologies of temperature monitoring but in some countries the coverage is still low. We may be proud of our improvement in the global immunization coverages but may be many of those kids are vaccinated with vaccines that are exposed to freezing. Being proud of the improvement of the global immunization coverages is good but we need to be confident that we have improved coverages with potent vaccines that are kept in recommended storage conditions. Use of modern technologies and innovations around temperature monitoring while working to improve immunization coverages is very important and this should off-course go hand in hand with behavior change on acting upon temperature excursion among those who are involved in vaccine cold chain.
True cases occurring in tertiary care centre’s - generating hidden immunization gap
Dear viewers
All of us are witnessing rapid multidimensional growth of routine immunization in the current decade. Keeping pace with the rapidly expanding / frequently changing schedule itself is a challenge faced by the service providers, more so in the private sector.
Pilot study revealed dangerously poor operational knowledge among the Medicos who are the current and would-be programme managers at various levels. This is conspicuously accentuated by the absence of an uniform vaccination schedule and vaccines with no Vaccine Vial Monitor (VVM) in the private sector.
We collected vaccination record cards of various private institutions, including Medical Colleges, providing vaccination services and found that no two vaccination cards are mutually matching either with IAP schedule or with National Immunization Schedule (NIS), whether essential vaccines of NIS or optional vaccines.
This is creating divided opinion in the community and the caretakers generally have lot of faith and strongly believe what they were advised by the super specialists in the super specialty hospitals at the time of giving birth and insist administration of vaccines as per the vaccination card they have from the private Institution.
India gives birth to ~2.7 core (27 million/270 Lakhs) live infants in a year. Even if 10% avail services from the private sector, absolute number is ~27 Lakhs per year in the country. Most of these children are from APL families (Above Poverty Line) – especially of Doctors / Nurses / Engineers / community leaders and the like who are deprived of receiving vaccines with known potency indirectly depicted by the VVM free of cost from the government. Though eligible, many are deprived of Mother and Child Protection Card [Tayi-card] in Karnataka and the vaccination data are not shared with the Government, even on sharing it cannot be “MCTiSed” = uploading to MCTS and making online.
Please find the attached with only 3 examples though this number is more than a million for the whole country. This is beyond the scope of “Intensified Mission Immunization (IMI)” as of now.
RI should become “peoples’ movement” as aptly iterated by the Honorable Prime Minister, which can address some of these issues to a large extent.
Solutions are with us – the deep lovers of RI, promoters of child health. Shelling out “my-self” from the “APATHY” itself is the first simplest and biggest step followed by empathy for the birthing children / future generation.
Doing right things properly at the right time and by the authorized persons itself are the easiest and the most gratifying social service in any field, more so in medical field, that too vaccination – providing quality life-saving services to the newborns and the children.
best wishes
Holla and the team
Close vial wastage at lowest distribution and service delivery levels
Dear Colleagues,
I trust this post finds you all very well!
I would be grateful if you could please provide (based on your experiences), the possible sources (misuse, VVM, expiry, breakage, etc.) and rate of occurrence of close vial vaccine wastage at the lowest distribution and service delivery levels?
Thank you in advance,
Hamadou
“CROWD TESTING” An Easily Implemented Method of Ice Pack Conditioning
Vaccines can tolerate temperatures above 8 deg C however temperatures below 0 deg C will freeze a vaccine and it will lose it’s efficacy. At temperatures above 8 deg C the life of a vaccine will be lowered but the exposure will not be catastrophic. For the most sensitive vaccine, VVM II, the life of the vaccine will decrease from 104 days to 99 days when exposed to 20 deg C conditions for one day. For a VVM7 vaccine exposed to the same one day temperature excursion the life of the vaccine will decrease from 650 days to 643 days. As Umit points out in a recent post [High Temperature Freezers], it is sometimes logistically difficult to get ice packs conditioned for an early morning departure. SDD freezers do not cool at night and as a consequence in the morning the ice packs are conditioned or close to being conditioned. Similarly, if an ice pack carrier is loaded with ice packs the night before a trip the ice packs will be conditioned or near conditioned the next morning. If the ice packs are not completely conditioned, they could be placed in the carrier earlier in the day to increase conditioning time.
[b]Crowd Testing[/b]
If a reader is involved in vaccine distribution this technique can easily be tested. In the afternoon, cold ice packs would be placed in a carrier along with a thermometer. The next morning the temperature of the carrier would be recorded and the ice packs examined. Water in the ice packs indicate that the ice packs are conditioned. It is most critical that the ice packs closest to the vaccines are fully conditioned. If the ice packs are not conditioned, repeat the experiment with the ice packs placed in the carrier earlier in the day. If, for example, the ice packs are conditioned 5 extra hours over the minimum conditioning time to reach 0 deg C, the consequence would be minimal. The length of time acceptable temperatures are maintained would be only reduced by 5 hours. Using “Crowed Testing” the effectiveness of this technique could be easily determined.
If you are involved in the distribution of vaccines, I would appreciate your help in evaluating this method. Please send your answers to the following questions to Tech Net
Name
Location
Date
Model of carrier
Number and size of packs in carrier
Ice pack freezer temperature
Number of hours in carrier over night
Average ambient night time temperature
Temperature of the carrier in the morning
Is there water in the ice packs?
Do you estimate more or less time is needed for conditioning?
Comments
VVM colour change as a continuous progression
Dan Brigden
In
WHO has just released a new infographic that summarises how health workers can use vaccine vial monitors (VVMs) to decide whether or not to use a vaccine vial. Most notably, it presents VVM colour change as a continuous progression, rather than as four distinct stages.
A VVM is a chemical indicator label attached to the vaccine container (vial, ampoule or dropper) by the vaccine manufacturer. As the container moves through the supply chain, the VVM records its cumulative heat exposure through a gradual change in colour. If the colour of the inner square is the same colour or darker than the outer circle, the vaccine has been exposed to too much heat and should be discarded.
The main purpose of VVMs is to ensure that heat-damaged vaccines are not administered. The VVM status is also used to decide which vaccines can safely be kept after a cold chain break occurs thus minimizing unnecessary vaccine wastage. In addition, VVM status helps the user decide which vaccine should be used first – a batch of vaccine showing significant heat exposure should be distributed and used before a batch that shows lower heat exposure, even if its expiry date is longer.
Please use the new infographic in guidance and training materials, and share widely. The infographic is available in English and French on the WHO website:
http://www.who.int/immunization/programmes_systems/supply_chain/resources/tools/en/index4.html
A VVM is a chemical indicator label attached to the vaccine container (vial, ampoule or dropper) by the vaccine manufacturer. As the container moves through the supply chain, the VVM records its cumulative heat exposure through a gradual change in colour. If the colour of the inner square is the same colour or darker than the outer circle, the vaccine has been exposed to too much heat and should be discarded.
The main purpose of VVMs is to ensure that heat-damaged vaccines are not administered. The VVM status is also used to decide which vaccines can safely be kept after a cold chain break occurs thus minimizing unnecessary vaccine wastage. In addition, VVM status helps the user decide which vaccine should be used first – a batch of vaccine showing significant heat exposure should be distributed and used before a batch that shows lower heat exposure, even if its expiry date is longer.
Please use the new infographic in guidance and training materials, and share widely. The infographic is available in English and French on the WHO website:
http://www.who.int/immunization/programmes_systems/supply_chain/resources/tools/en/index4.html
Differential conversion of Vaccine Vial Monitor - VVM
Dear viewers
In one of the Training of Trainers programme in 1990’s at Chennai, a resource person told that ‘ASA’ – Attention, Suspicion and Authority are the 3 important elements of any good surveillance.
Through high sensitivity, observational capacity, timely reporting often rare syndromes were discovered; new clinical signs innovated in the past. Lay reporting, rumor reporting, reporting any unusual events by the regular reporting centres were encouraged for adequate surveillance.
In the Feb 2016 Pulse polio, on booth day, Group D Mrs Mala regularly handling the cold chain observed and unusual event wherein VVM of a few vials rapidly converted and reached discard point between 4 to 6 hrs which she / we had not experienced in the past.
We were not able to find any visible / logical reason for this and shared with the MO / RCHO / State and the Centre – both the Govt and Development partners on same evening – 21 Feb 2016. We are indebted for the prompt response and the reply and now sharing with the TechNet viewers.
VVM’s and MKT Thermometers
Below are some examples of how an MKT thermometer could be used to to simpllfy temperature data analysis for the cold chain.
If the temperature in a refrigerator is 4 deg C for 20 hours then increases to 15 deg C for 4 hours, how will the vaccine life be affected?
- If this is a one day occurrence – should an alarm be set off to notify a repair person?
- If this temperature variation occurs everyday for a month – will it be problematic?
- If on a 24 day excursion the storage temperature is 4 deg C for 20 days and on the last the 4 days the temperature strays to 15 deg C, how would the vaccines be affected?
- If a manufacture builds a SDD refrigerator where the day-time storage temperature is 4 deg and at night the storage temperature increases to 15 deg C, would this be problematic? If this results in considerable cost savings, is this design a good idea?
Graphing data points of this temperature variation, 20 points at 4 deg C and 4 points at 15 deg C, how would you know if this excursion was a problem? Calculating the MKT temperature or using a direct reading MKT thermometer could easily answer these questions. For the example above, the MKT will be below 8 deg C so the temperature excursions to 15 deg C will have a negligible effect on vaccine life.
A direct reading MKT thermometer could be built which would give a continuously updated reading for the past 24 hours. This model could be used to notify a health worker that there is a problem with the equipment. The MKT thermometer would eliminate false alarms. A direct reading MKT thermometer could also look at the temperatures of the past 30 days to evaluate long term performance.
On an excursion a MKT thermometer could be set to start calculating at the beginning of a trip. In the previous example the MKT temperature at the conclusion of the trip the MKT temperature would be below 8 deg C, if the MKT is greater than 8 deg C, the Arrhenius graph such as the one attached could be used to see how the shelf life of the vaccine is affected.
According to Temp Time, a VVM manufacture, “Heat Marker is a patented mean kinetic temperature (MKT) indicator which follows the Arrhenius Equation.” In other words a VVM and an MKT thermometer both are governed by the Arrhenius Equation, one device has a numerical readout and the VVM has a readout which varies the brightness of a dot. Accepting the viability of a VVM is equivalent to accepting the viability of an MKT thermometer.
Some PQS tests are already using MKT temperature to measure the effect of temperature excursions. Widening the use of MKT temperature would simplify data analysis and in the long run reduce cold chain costs by incorporating more realistic guide for temperature excursions.
ECTC, CTC & VVM
Hi all,
I am quite new to the CTC adventure.
After reading the second draft of the WHO CTC guideline, now ECTC (I also wen through the first version and the discussion in Langen and Ottawa), several questions came to my mind, and I would be extremely grateful if some of the forum members can help me out with them
1- Now that the rigid time& temperature conditions of the CTC are only one of the extended temperature conditions eligible for re-labelling, can we assume that the stability studies conducted by the manufacturers when deciding the most appropriate VVM type to reflect their product decay (at 5, 25 and 37°C), can be used for a re-labeling purpose with 37°C as a max. threshold temperature?
2- For those of you who followed the CTC initiative from the beginning, what was the scientific ground to choose 40°C as a threshold, rather than 42, 45 or 37 for that matter? In many countries where MSF intervenes & where a CTC approach can have a great impact, ambient temperatures exceed 40°C during the hot season and can be below 37°C during the cold season.
Thank you beforehand for your answers and thoughts.
Alain ALSALHANI
Pharmacist, MSF
Buffered Temperature Chain
How about a Buffered Temperature Chain (BTC)?
Vaccines which are highly thermally stable can be distributed in the Controlled Temperature Chain (CTC). To be incorporated into the CTC the vaccines must be stable enough to be stored for 3 days at 40 deg C. There are very few vaccines which are this stable. If vaccines can be incorporated into the CTC there are numerous logistical and financial advantages. Since the infrastructure is much simpler and less expensive. Establishing a “Buffered Temperature Chain”, BTC could have many of the advantages of a CTC. The BTC would keep temperatures below 28 deg C.
Simple low cost methods could be incorporated to keep vaccines below 28 deg C. The expected life of vaccines of varied temperature sensitivity is given in the table below.
Category No. days to end point at 28 deg C
VVM 30 (High stability) 100 days
VVM 14 (Medium stability) 50 days
VVM 7 (Moderate stability) 25 days
VVM 2 (Least stable) 7 days
This data was derived from the Arrhenius graph showing Temperature Dependence. The graphs were obtained from “Temp Time” a VVM manufacture.
An Mean Kinetic Temperature (MKT) temperature of 28 deg C was choosen because it could be obtained passively by combining evaporative cooling, insulation and thermal mass in simple low cost coolers.
The VVM graphs are based on MKT temperature. The effect of temperature excursions could easily be monitored by a resettable direct reading MKT thermometer. Using a direct reading MKT thermometer simplifies data analysis. See Tech Net Post (http://technet-21.org/en/forums/vvm-mkt-equivalent-and-complementary-concepts/likes). Data is much easier to analyze when using a MKT thermometer rather than a data logger; the effect of temperature excursions can be seen from a single number.
The color change on a VVM is based on MKT temperature. The MKT thermometer could also indicate if temperatures strayed over 40 deg C which may be harmful to the vaccines even if the MKT temperature remains below 28 deg C.
If there is interest in the Buffered Temperature Chain, Sun Frost could provide direct reading MKT thermometers and temperature buffered storage containers. The containers could be built for portability or for use in a clinic.
Larry Schlussler, Ph.D.
Sun Frost
Sun Frost
VVM Checking Policy
ghulamtaqi
In
Can any one help me that is there any VVM checking policy/guideline available with WHO in between receiving and dispatching of vaccines.
APPLY NOW - WHO EPELA authentic e-learning courses on Pharmaceutical Cold Chain Management and VVM based vaccine management
Dear All,
WHO EPELA authentic e-learning courses are accepting applications for 2015 courses. Great opportunity for a lifetime experience...
http://http://epela.net/epela_web/index.php
PHARMACEUTICAL COLD CHAIN MANAGEMENT
2 February – 24 April 2015
4 May – 24 July 2015
7 September - 27 November 2015
The e-Pharmaceutical Cold Chain Management course invites participants to interact and learn within a sophisticated simulation of a pharmaceutical cold chain. For 12 weeks, participants and mentors travel virtually from one location to another, through different levels of the supply chain. In addition to the virtual visits to real facilities, the course includes short illustrated videos and reference materials about critical content. The most important learning opportunities are enabled via authentic tasks. These tasks are arranged mainly as group activities to promote collaborative learning. Self, peer, and expert review are important aspects of assessment within this unique learning environment. The course site offers participants tools to help them easily connect with other participants so they can discuss and work together as a team. Mentors provide timely feedback to all participants whenever necessary and are always ready to assist whenever participants need them. Following seven weeks of virtual visits, participants are introduced as a group to a real client so that together with their peers as consultants they analyze a real world cold chain challenge and make recommendations to the client regarding the client’s operation of the time and temperature-sensitive pharmaceutical products.
This course includes written (and audio-visual recordings by participants as well) individual and group assignments, discussions, self, peer, and expert review, and presentations. It has been designed as an asynchronous course, so participants do not need to be online at the same time to complete the tasks. However, there are some scheduled activities such as teleconferences (or Skype conferences) that require either a small group of participants or all participants to take part. There are no specific lectures and/or documents tied to assignments that must be watched and read, but participants are guided to review appropriate documents from the document library and view selected videos from the video library to support their learning.
Though designed as an e-learning activity, participants work with real vaccine vials to conduct shake test and participate in fun learning activities like scavenger hunt for sharpening their observation skills.
To view the course contents and introduction, please visit http://epela.net/epela_web/introduction.html
To apply online http://epela.net/epela_web/apply_online.html
VVM BASED VACCINE MANAGEMENT
26 January – 27 March 2015
20 April – 19 June 2015
5 October – 4 December 2015
The e-VVM based Vaccine Management course invites participants to interact and learn within a sophisticated simulation of a vaccine cold chain. For nine weeks, participants and mentors travel virtually from one level to another in the supply chain. The course includes short expert videos and reference materials about critical content. The most important learning opportunities are enabled via authentic tasks. These tasks are arranged mainly as group activities to promote collaborative learning. Self, peer, and expert review are important aspects of assessment within this unique learning environment. The course site offers participants tools to help them easily connect with other participants so they can discuss and work together as a team. Mentors provide timely feedback to all participants whenever necessary and are always ready to assist whenever participants need them. Following five weeks of virtual visits, participants are introduced as a group to a real client so that together with their peers as consultants they analyze a real world cold chain challenge and make recommendations to the client regarding the presented situation.
The course provides participants real VVMs to go through a series of experiments to understand their behavior.
To view the course contents and introduction, please visit http://epela.net/epela_web/evvm.html
To apply online http://epela.net/epela_web/apply_online_evvm.html
WHO SAID WHAT for EPELA AUTHENTIC COURSES
Anil Kumar CHAWLA - India
Facebook created a near perfect virtual environment for social interactions.
While attending WHO training programmes as a facilitator or participant, I always dreamed of such an environment for training activities so that I could avoid travelling when it is not possible. Alas! I missed so many opportunities because of the need of physical presence and compelling schedules.
With this "e-Pharmaceutical Cold Chain Management Course" and my "Test Participation" in it, I am happy that my dream is shaping up and coming true. E-course did not only fit the "Training Bus" into the computer but also our minds and body too.
Congratulation to Training Team for putting together such a wonderful e-course in the first attempt itself.
Andrea BERLINGER SCHWYTER - Switzerland
I would like to make a big compliment to the whole EPELA Team and Creators! The way it is set up is very easy, instructions are clear and I appreciated the direct links to the movies and documents which were relevant to fulfill a particular task. The library is amazing… really - you do not need anything more if you want to learn more about cold chain.
The videos are excellent and one of the biggest advantages of the course for me was, that – if I did not understand a sentence or an explanation, I was able to "rewind" and listen to it again. Just perfect and ideal for learning complex topics - in particular if English is not your mother tongue… pity that we cannot do that at other occasions in real life – perhaps less misunderstandings would occur J. I can only highly recommend the participation to this course for anyone who needs to get more knowledge and gain critical skills about cold chain issues in general – if you deal with vaccines - it is almost a must.
Andrey KUKHARENKO - Russia
I was lucky to become part of the e-learning course on Cold Chain Management in October-December 2013. It was my first experience of online training, but I was amazed how smooth and exciting the course was and how professionally it was arranged and executed. I am convinced that the course gave all of us a new insight in the most relevant issues of cold chain management and helped us to take a closer look at how the cold chain is structured and how it is to be managed. The course is designed as a friendly-user platform with a number of very well formulated authentic tasks, an extensive e-library and a package of extremely helpful video case studies and video presentations devoted to specific subjects. The course introduces the participants to a variety of practical tools, which help to approach the cold chain tasks and to tackle them in a more efficient and adequate way. I also appreciated the devotion of mentors to the course, who provided their feed-back, support and professional comment at all stages. I would recommend all professionals who seek to gain a more profound knowledge and expertise in cold chain management that they take this course and feel the incredible positive impact, which among other things reveals itself in tuning your mind at different angles of vision and seasoning your work with a set of very useful techniques and instruments of managing the cold chain. I cordially thank all mentors, designers and arrangers of the course for their outstanding job.
Hafidha OKBI - Tunis
This course gave me the tools needed to improve the cold chain management, it was interesting, excellent, and a very good opportunity to share experience and to learn from mentors and colleagues around the world. I really enjoyed and found it very useful, with a great use of practical case studies, videos, examples and discussions. The knowledge and skills of the mentors and standards of facilitation for the e-learning course were amazing. In summary, it was perfect, and exceeded my expectations and I hope to keep in touch with all mentors and participants in the future.
VVM & MKT Equivalent and Complementary Concepts
VVM’s and MKT are equivalent methods of measuring the effect of temperature variations on vaccines. VVM’s & MKT measurements can be used in a complimentary manner, the VVM’s give information on the life of individual vaccine vials. MKT measurements can be used to effectively measure the performance of equipment and the effect of short temperature excursions.
The MKT is defined as “A single derived temperature that, if maintained over a defined period of time, afford the same thermal challenge to a drug substance or drug product as would be experienced over a range of both higher and lower temperatures for an equivalent defined period. The mean kinetic temperature is higher than the arithmetic mean temperature and takes into account the Arrhenius equation“(Seevers, Robert H., Ph.D. "The Use of Mean Kinetic Temperature (MKT) in the Handling, Storage, and Distribution of Temperature Sensitive Pharmaceuticals. “Pharmaceutical Outsourcing (2009): 30-35. Web. 9 Oct. 2014.) The paper was referenced in the PQS type-testing protocol for solar powered refrigerators with rechargeable batteries (E03/RF04-VP.2).
The attached Arrhenius graph for a sensitive VVM-2 vaccine shows the relationships between temperature and vaccine life. The graphs are generated for vaccines of different sensitivities. If the vaccine is exposed to changing temperatures the MKT can be used in conjunction with the Arrhenius graph to determine the life of the vaccine.
For example, if a temperature sensitive vaccine, VVM-2, spent half its life at 5 C and half at 20 C its average temperature would be 12.5 C and the MKT would be 15.4 C. Under these conditions the Arrhenius graph could be used to determine the life of a newly produced vaccine is 40 days.
Direct Reading MKT Thermometer for Alarm Control:
With modern electronics a small device could be built to directly measure MKT. For example, the performance of a refrigerator in a clinic could be monitored to assure it is performing properly. The MKT could be measured for a 24 hour period. To obtain 24 hours of data a data point is recorded every 10 minutes. The data is updated every 10 minutes by measuring the current temperature and deleting the reading taken 24 hours and 10 minutes ago. The MKT would then be recalculated and displayed. This method would give a clear picture of the impact of temperature excursions, eliminating false alarms. If, for example, a refrigerator typically storing vaccines at 4 C experienced a 1 hour temperature excursion to 20 C the MKT temperature for that day would be 5.5 C and the excursion would not impact the life of the vaccines. In this case there would be no need to set an alarm off. If the vaccines are exposed to a 20 C temperature 2.5 hours the MKT temperature will reach 8 C. An alarm could then be set off. This technique would work equally well if the temperature varied during the temperature excursion. In a recent comment Oz Mansoor pointed out that a short temperature excursion can be of no importance and the inadvertent alarm should be avoided. The MKT temperature is an easy to interpret analytic method to determine if there is a potential storage problem.
There could also be a button on the device to display the MKT temperature for the past 30 days, so that performance could be evaluated for a longer period of time. An additional built-in alarm could indicate if the refrigerator temperature varied beyond some extreme high or low setting.
MKT Temperature and Vaccine Carriers:
Measuring the MKT temperature for a short trip would be helpful in evaluating the performance of a vaccine carrier and the impact of temperature excursions on the vaccines on an actual trip. For example, for a 6 day trip if the temperature in the carrier increased linearly from 4 C to 27 C the MKT temperature over 6 days would be 18 C. From the Arrhenius graph for a VVM-2 vaccine in stage 1 the vaccine should have a life of 28 days when stored at 18C. The trip should then not have a significant effect on vaccine effectiveness.
The use of an MKT thermometer would also be of value for the controlled temperature chain (CTC).
MKT Temperature for Testing Refrigerators:
The MKT temperature is currently being used for PQS testing to a limited degree. For solar powered refrigerators with battery storage it is used to measure the temperature of the refrigerator compartment during the day/night temperature test. Extending the use of the MKT to other tests such as the stable run test would have numerous advantages without sacrificing the efficacy of vaccines.
Suppose a refrigerator manufacturer is having a chest SDD refrigerator tested, and during the stable run test the temperature at the top of the storage area climbs from 4 C to 12 each night. To maintain the storage areas in the 2 C to 8 C temperature range they may opt to add a fan and ancillary battery to eliminate stratification. They may also opt to reduce the daytime running temperature to close to 2C to minimize the night time temperature excursions above 8 C. With the minimum temperature reduced it is more likely that under atypical conditions freezing conditions could be reached.
Assuming that each night the temperature increases linearly from 4 C to 12 C for 12 hours the 24 hour MKT would be 7 C. The performance of the refrigerator would then be the same as a refrigerator kept at an accepted constant storage temperature of 7 C. The additional proposed modifications (fans, ancillary batter, etc) would be unnecessary.
The consequence of not using the MKT temperature can be a more complex expensive and less sustainable product. Extending the use of the MKT temperature to other PQS tests would result in superior less expensive products without sacrificing performance or vaccine safety.
Sun Frost
Larry Schlussler, Ph.D.
INFORMATION NOTE: Vaccine vial monitor (VVM) assignments for different WHO-prequalified vaccines
WHO and UNICEF have jointly prepared an information bulletin which addresses varied implications of different types of vaccine vial monitors (VVMs), notably VVM category type 7 (VVM7) and VVM category type 14 (VVM14), on vaccines such as the Inactivated Polio Vaccine (IPV) and the fully-liquid Diphtheria-Tetanus- whole cell Pertussis-Hepatitis B-Haemophilus influenzae type b (DTP-HepB-Hib, commonly referred to as pentavalent). The note is directed to countries that are currently supplied by UNICEF Supply Division with these specific presentations of vaccine. The information is intended for WHO/UNICEF staff, as well as EPI managers or other partner agencies which support immunization programmes.
Both the english and french versions are attached here.
Both the english and french versions are attached here.
WHO/EPELA releases new videos on VVM
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Many thanks to Umit Kartoglu for sharing these videos with the TechNet-21 forum!
WHO/EPELA releases the most recently produced expert videos on VVM-based vaccine management. These videos are specifically produced for the new EPELA authentic e-learning course on vaccine vial monitor-based vaccine management. The new course will be offered for the first time from 27 January to 28 March 2014. If you are interested in the other courses in 2014, please visit [url=http://epela.net/epela_web/evvm.html]visit http://epela.net/epela_web/evvm.html
Both WHO and EPELA encourage others to widely use, share the videos and embed them in other websites. The following videos are now available publicly:
A year in the life of a vaccine: Kevin O’Donnell
[vimeo]58148553[/vimeo]
Kevin O’Donnell reviews the role of VVM and how it can be the answer to increase access and ensure quality of vaccine was not compromised due to unacceptable heat exposure.
Cold chain challenges everywhere: Simona Zipursky
[vimeo]58148554[/vimeo]
Simona Zipursky reviews the cold chain challenges to demonstrate that problems are both in developing and industrialized countries and questions whether VVM should also be the answer for both.
How does a VVM work?: Denis Maire
[vimeo]58747176[/vimeo]
Denis Maire summarizes the technical characteristics of VVMs and explains how they work.
Interpretation of VVM in relation to other temperature monitoring devices: Umit Kartoglu
[vimeo]58156915[/vimeo]
Umit Kartoglu reviews temperature monitoring devices used in a typical vaccine cold chain and analyses how the readings relate to each other when there are more than one device at a particular point. This analysis is done from the VVM perspective.
Using VVM as a stock management tool: Umit Kartoglu
[vimeo]58161022[/vimeo]
Umit Kartoglu reviews the requirements for product arrival, storage and dispatch and analyses the role of VVM in effective stock management for each step. Special emphasis is given to the relation of VVM and expiry date in illustrating how VVM over-rules earliest expiry first out principle.
Vaccines beyond the cold chain: Simona Zipursky
[vimeo]58148555[/vimeo]
Simona Zipursky reviews the studies on taking vaccines beyond the cold chain all published in peer-review journals and comments on how VVMs could be instrumental in these operations.
VVMs getting smarter: Umit Kartoglu
[vimeo]58161023[/vimeo]
Umit Kartoglu reviews the recent changes in integrity and location of VVMs and the new message VVM is giving whether a vial containing multi-dose vaccine following opening can be kept for a subsequent session or not.
VVM use at the most periphery: Serge Ganivet
[vimeo]58680045[/vimeo]
Serge Ganivet reviews the VVM use at the most periphery through different examples and brings new perspectives on how to make best decisions based on the expiry and VVM readings.
Vaccine Vial Monitors (VVM)
Project Optimize is seeking real-life stories of how vaccine vial monitors are making an impact in the field. If you would like to share your story, please reply to this forum post.
Dont hesitate to also post photographs if you have some
Thanks in advance
Michel Zaffran
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