jeudi 20 septembre 2007
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POST 01160E : QUESTIONS ON CCM CARDS Follow-up on Post 01155E 29 september 2007 ________________________________ The following contribution is from Ãœmit Kartoglu from WHO in response to Nihal Babalioglu’s request. I apologize to Nihal for having addressed her as him... ________________________________ Dear Dr Babalioglu, I am not clear whether this is a theoretical question or it comes from an experience that you are facing a problem. So, my comments that are conceptual in nature may not be fully applicable to what you are looking for. The World Health Organization publishes the Guidelines on International Packaging and Shipping of Vacccines (WHO/IVB/05.23). This document is produced mainly for UN procurement agencies, but is also widely used by self-procuring countries in procurement agreements. If your question is not a theoretical one and comes from an experience, I do not know whether in that particular procurement agreement Turkey has used the above mentioned document as a contractual obligation. In many cases, self-procuring countries refer to WHO guide as a whole, but we also know in some cases, countries amend this document and request for additional things. Therefore my comments apply only to what WHO recommends. 1. With its 2005 edition of the above mentioned document (published in December 2005), WHO recommends use of 10-day electronic devices in international shipments. Vaccine cold chain monitor cards are only recommended in exceptional circumstances such as the use of dry-ice since the batteries of the electronic devices do not function at such extreme low temperatures. When it comes to CCM cards, WHO recommends inclusion of ONE card per shipping carton. Not knowing the type of Hib vaccine you are referring to (is it liquid or freeze-dried), it is difficult to comment whether use of CCM can be easily justified. In the past, WHO used to ask for more than one CCM card. However, this was not done with the reason to monitor different parts of the shipping carton, but mainly to have more CCM cards for the box and use them with the split shipments from the primary store to lower levels. Multiple CCM cards used to come located in the same place in the box. Since the great majority of countries open the shipping cartons to store vaccines with secondary packaging, multiple CCM cards were mixed up and lost in many occasions. This practice is no longer recommended. 2. I am sure you are asking regarding the reliability of a CCM reading vis a vis the content of the shipping carton and not questioning the reliability of the CCM card. In a shipping carton that is 153 litres in size (in your example) there will always be temperature differences from bottom to top and from left to right depending on the heat/cold source of ambient as well as coolants used in the shipping carton. If the temperature variation is high, two devices placed at different locations in the shipping carton may not produce the same results. However, this is very unlikely with the CCM cards. Because, Monitormark (the temperature strip in CCM) is a cumulative indicator, and for example it takes 3 days for A window to become blue if the contents of the box are exposed to temperatures say at 12 degrees C. It is very unlikely that such temperature variation could happen in a box and one CCM would show no coloration while the other shows A blue (unless you make an experiment and heat the box from the bottom and cool it from the top at the same time). In CCM there is also another issue that is the human factor. Prior to its activation and use CCM cards must be placed in a cool environment of less than 5 degrees C for a period of at least 2 hours. Also the surface to which the MonitorMark is attached must be below 9 degrees C. In the cases of this not being done, the strip naturally will be conditioned to room temperature (approximately 20 degrees C) and as soon as the device is activated, coloration of the first window will start (but again, it takes approximately 2 days for A window to become blue at 21 degrees C). If one CCM conditioned to cool temperatures as recommended and one other kept only at room temperature (not conditioned) are used in the same box, different coloration will be seen as a result of non-compliance. If the issue is that you have requested more than one CCM card in a shipping carton, unless you specify the location of these cards, vaccine manufacturers will place them together in one place. In this case, you will have the same readings. On a similar issue, my experience with rejection of shipments based on the number of temperature monitoring devices (in particular with CCM) is as follows: If no CCM card is included, the recipient party rejects the shipments since no one could tell whether the vaccines have been exposed to unacceptable temperatures. Testing vaccines is both time consuming and an expensive practice. It should also be justified with the number of doses in question. If a country requests say 2 CCM cards to be included in one shipping carton, and the manufacturer places only one, the usual practice is to WARN vaccine manufacturers regarding their contractual obligations. Legally this may be a contractual violation (you asked for 2 and they provided 1), in terms of temperature monitoring - technically there is no additional value of having two CCM cards in one box, therefore nobody rejects the shipment in such cases. But communicating with the vaccine manufacturer with the contractual obligations is important to prevent such cases occurring again the future. Hope this helps. Dr. Umit Kartoglu Scientist FCH/IVB/Quality Safety and Standards ______________________________________________________________________________ All members of the TechNet21 e-Forum are invited to send comments on any posting or to use the forum to raise a new discussion or request technical information in relation to immunization services. 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