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Frequently answered questions.
Q. What are the differences between medical thermo-containers and thermo-insulating packing from the polymeric materials?
A
The thermo-container is medical if it has such documents as:
— Thermo-container Operation and Maintenance manuals. It should includes technical characteristics, recommendations on preparing thermo-container (creation optimal temperature ranges) to transport thermal-labile medications from manufacturer to the ultimate user, warranty, manufacturer’s address. This document is developing by manufacturer of the thermo-container on base of results of acceptance test and engineering test in authorized institution by Ministry of Health;
— Registration Certificate (given by Ministry of Health) as the permit on application in medical practice;
— Certificate of Conformity (sustain the reliability of characteristics in the Operation and Maintenance manuals);
— Sanitary-hygienic Certificate (confirm the lack/presence of the harmful substance in the thermo-containers in the concentration that is not exceed the allowable standard).
Unfortunately no. So, it is the reason why it is possible to use in Cold Chain different thermo-insulating packing from the polymeric materials. Manufacturers of such packing are proclaim the opportunities of theses packing to maintain such temperature mode as (2-8) °C. But they do not give the recommendations on how to maintain practically that temperature mode. Such packing do not have above-listed documents and substitute booklet for the Operation and Maintenance manuals. So, they escape liability for the validity of the technical characteristics.
Unfortunately, yes. Despite of good structural practices, these thermo-containers were tested incorrectly because the Standard Methods of Testing for vaccine’s thermo-containers. If apply this Standard Methods of Testing on practice, it is possible to freeze medications during its packaging into thermo-container in case of application of frozen cooling elements.
You should make two steps:
1) To oblige all manufacturers of thermo-unstable products use equipment of temperature control in each thermo-container. It forced manufacturers and distributors use the thermo-containers, which could guarantee the target temperature mode from the moment of its supply to the storage till the moment of its acceptance of ultimate users.
2) To oblige all manufacturers to give the confirmation of maintenance of optimal and safety temperature mode.
The first step is to develop united methods of testing of thermo-containers for all governments. It should meet all current principals of Cold Chain and take into account the recommendations of thermo-containers manufacturers. To develop new united methods it is possible to use the correct items of the Standard Methods of Testing for vaccine’s thermo-containers approved by WHO/UNICEFF and suggestions of “Termo-Kont MK Llc.”. In the future these new methods should be passed to the all governments as regulation document, which should define the suitability of thermo-containers to vaccine storage and transportation.
The second step is to oblige all manufacturers of all types of thermo-containers to test their production in the laboratories authorized by WHO using that new methods.
The third step is to forbid the application of thermo-containers in the supply system of thermo-unstable medications, which are not tested.
The acceleration of this process is possible only in case of implementation in Cold Chain of thermo-indicators and devices of temperature control with accuracy of ± 0,5°C that could work in calendar and real time mode. The threat of derangement of vaccinal prevention regarding the growth of medications return because of temperature mode violations, forced manufacturers of thermo-unstable medications and Ministry of Health staff to take a serious view on Cold Chain requirements.
Q. What is the efficiency of temperature control on basis of chemical and electronic single-use thermo-indicators and multy-use electronic thermo-indicators and thermo-registers of documentary control?
A
I am take the view of the scientists and practitioners, believe that with application of chemical indicators (speed of color changes of indicating cells out of temperature mode (2-8)°C is from several hours till several days) to maintain the safe temperature mode is impossible.
Application of electronic single-use thermo-indicators with the accuracy of (0,5-1)°C and with discreteness not more than 30 minutes could give the positive effect only in case the temperature control out of temperature mode (2-8)°C is carry out with the usage of set of one-threshold and multy-threshold thermo-indicators.
At the same time the single-use chemical thermo-indicators could not give the reliable and necessary information for quality evaluation of medications, which were delivered with temperature violations. Application of such indicators gives the opportunity to manufacturer and clients to negotiate “in truth search”.
I would like to make a real-world example. It is about the official decision-making on thermal-unstable (2-8°C) medications acceptance, which were delivered to the final destination with temperature mode violations:
• The ultimate client refused to accept the medications and reported about that situation to the Direction;
• The Direction requested the information from the Quality Standardization Institution about the proposals on usage of that medications;
• Quality Standardization Institution don’t have the information about the dependency of medications quality out of temperature mode (2-8)°C made the request to the factory, which produced these medications;
• Factory, which don’t have the information about the dependency of medications quality out of temperature mode (2-8)°C could make two decisions (on the edge of losses regarding the contract default and resending the new lot of medications):
• Confirm the quality of delivered medications;
• Recommend the medications, delivered with temperature violations to the temporary storage and random lot of medications send to the repeated laboratory testing.
The first decision, at worst, could lead to the negative and unpredictable effects and, at the best, to the inefficient vaccination. It takes a lot of time to implement the second decision and it could cause the disruption of immunization schedule.
So, it is not know what decision would be made.
These shortcomings could be removed through the usage of thermo-indicators and thermo-registers of documentary control of temperature modes. It allows getting the results of registration in real time and calendar mode.
For example, the usage of thermo-indicator TI-2 (“Thermokont- MK Llc.”) allows getting the following information:
(a) Thermo-indicator workability at the moment of delivery to the final destination;
(b) Quantity and duration of the parcels, which were passed with violations of the temperature mode;
(c) Duration of registration;
(d) Results of registration from the moment of closing the thermo-containers to the moment of delivery to the final destination in the shape of graph and tables. It is possible to print this information and use as appendix to the Acceptance Certificate, confirmation of temperature violations.
Q. Is it possible to get the information from the “turned off” thermo-indicator TI-2?
A
In thermo-indicator TI-2 there is the protection from the accidental turning off. But if it is happened by reason of power source, you could get the information as you change the power source.
Q. What the accuracy of capillary and chemical indicators? Could we use it in the Cold Chain?
A
A. I offer you to look through the Certificate of Compliance of two indicators (ColdMark- capillar and WarmMark- chemical), that I have got from the one of distributors.
So, I’m sure that the application of such and similar indicators to control the temperature mode not only (2-8)°C, but and (0-10)°C is not reasonable.
Q. In the bullet 4.7 of the Methodological instructive regulations MY 3.3.2.2437-09 (from March, 01, 2009) are recommended the thermo-indicators that could record indices of time-temperature mode at a temperature of 45°C and at a time up to 48 hours. Could you please explain next questions?
1. Is the above pointed time-temperature regulations permit the acceptance of the vaccines delivered with temperature mode (2-8)°C violations?
2. Where could we buy the thermo-indicators and learn the Registration Certificate?
A
If take as a basis the Reference Manual “Medical immunobiologicals medications for prevention and treatment of infectious and other diseases” (which contains more than 80 official instructions on application the main vaccines, anatoxins, antybodies e.t.c.) it is clear that the main temperature mode regarding the preservation of vaccines initial quality is within the limits (0-10)°C. At the vaccine acceptance it is required to be guided by requirements on maintenance of temperature modes, which are pointed in the Operation and Maintenance manuals on each specific medication. If there is no special temperature modes and duration of its influence in Operation and Maintenance manuals that are required for the quality maintenance of vaccines during its warranty period or shorter period, all delivered vaccines should be returned to the Manufacturer.
To know where you could buy the thermo-indicators, you should refer to web of Roszdravnadzor (www. Roszdravnadzor.ru) or send them (1-14, Slavyanskaya, Moscow) letter of inquiry. They should inform you the name and address of Manufacturer, number of Registration Certificate and the permission to use their devices in medical practice. You have a right to request the copy of Registration Certificate.
Q. How could you explain the differences between recommendations in the “Operation and Maintenance manuals of thermo-containers” (Thermo-Kont MK Llc.) and in the bullet 6.7 of MY 3.3.2.2437-09?
A
During the thermo-containers testing it becomes obvious that it should be 3 points of control in the internal volume of thermo-container – under the cover, on the bottom and in the middle of container. The testing results show that it is enough to control only 2 points – on the bottom (the coldest area) and under the cover of thermo-container (the warmest area). Explain the thesis about the prohibition to control under the cover I cannot. You could know more exactly about it at one of the developers of MY 3.3.2.2437-09 (121002, Moscow, per. Sivcev Vrajek, 41 – director Medunicin Nikolay Vasilievich).
Q. What are your recommendations regarding the application of thermo-indicator TI-2 and working out six threshold disposable thermo-indicator TI-6-1?
A
If you apply the frozen cooling elements you should place the thermo-indicators under the cover and on the bottom of each thermo-container. The temperature mode on the bottom of thermo-container you could control with the help of thermo-indicator TI-2. The temperature mode of each lot of medications should be controlled by two thermo-indicators of documentary control. The remote sensor of the first thermo-indicator is placed on the bottom of thermo-container and another thermo-indicator’s remote sensor is placed under the cover. The thermo-indicator’s cases are placed in the special pocket of thermo-containers bags. In the second case the remote sensors are placed into the thermo-container through the special hole (advanced order).
Q. What is the rise in prices of one dose of vaccine on application of thermo-indicators (Termokont MK Llc.)?
A
Currently, the price of multy-use thermo-indicator TI-2 is five times as much the price to disposable thermo-indicator TI-6-1. It means that after the five shipments of medications the prices become equal. To define the vaccines rise in price at the initial purchase of thermo-indicator TI-2 it is required to compare the prices of vaccines, delivered in one container and the prices of thermo-indicators on one vaccine dose. For example, if in the thermo-container TM-52 are 2000 of doses and the price of two thermo-indicators TI-2 is 14800 rub the rise in price would be increase on 7,4 rub. This grow is 3,5% for vaccine “ENGERIX B” for adults and 1,1% for rubella vaccine. I believe, that it is reasonable “rise in price” for devices of temperature control, which allow evaluate the quality of thermo-unstable medications.
It is the answer for people, who are trying to avoid the responsibility for vaccines quality and declare about the high prices for thermo-indicators.
Q. Is it possible to secure the temperature mode not lower than 2°C placing the cooling elements and medications in the thermo-container that were cooled at the cooling room?
A
I believe not, than yes. You can find the recommendations on how to secure the temperature mode 2°C in the “Operation and Maintenance manuals”.
Q. What is your position to the firm standardization of temperature mode (2-8)°C for temperature-unstable medications?
A
On the one hand, if it is apply to medications that are delivering to the long-term storage it is reasonable temperature mode, but on the other hand, if to take into account that such temperature mode could not to guarantee none of thermo-containers manufacturer (except Termo-Kont MK Llc.), the vaccination of population in the remote distance from vaccines supplier would be near-zero. But it is contradict with reality. The exact answer we could get only in case of laboratory testing on time dependency of vaccines quality and quantitative data of environment. These testing are in interest of all participants of Cold Chain.
Q. When we could wait the appearance of new products of Thermo-Kont MK Llc?
A
at the present time we successfully finished the acceptance and technical checkout of thermo-container with manual adjustment of temperature mode. These thermo-containers are possible to use as heating and cooling chambers in the ambulances, storages, in the medical and preventive institutions, in the regions with hot climate (where solar battery could be used).
At the final phase of developing are the mini-thermo-containers for insulin and medical probes.
We developed the portable thermo-container with built-in thermo-indicator TI-2.
To the end of 2009 we are planning to launch the serial production of six-threshold thermo-indicator TI-6-1, and to the end of 2010 we hope to organize the serial production of four-channel thermo-register TE-4.
Q. What help do you need on Cold Chain improvement?
A
We cannot figure on our Government help regarding their reaction on our Cold Chain improvement proposals and creation the efficient system of documentary control of thermo-unstable medications. So, it is important that our wishes align with our opportunities. I believe, management of Public health or business representatives of foreign countries would take an interest in our products.
Q. Could we refuse your persistent Cold Chain improvement proposals?
A
Yes, of course, if the all vaccines and other medications, donor blood and its components, food and all kinds of medical probes would not depend on environment and real and climatic conditions.
Q. Why the thermo-indicators and thermo-registers of the multiple-use are not implemented in the Cold Chain taking into account their obvious advantage?
A
The main reason for this paradox is the major manufacturers, customers and distributors that are supply various types of the thermo-unstable medicine, donor blood and its components are disable to provide the temperature mode (2-8°Ñ) ±0,5°Ñ from a variety of causes. So, to avoid the responsibility they use the weak links in System of control of the fulfilling the requirements of current Regulations and choose the optimal ways to avoid the responsibility and to create a significant profit.
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