Alternatives

Hello Kirkaw, Would it be acceptable for you to have them verified only? I mean that your thermometers to be compared to a standard, and a certificate edited, showing that its accuracy is acceptable and within a certain limit. That would be my only suggestion, as I am not certain if a company could compensate a thermometer that is not theirs...It should also depends on the model you have.. Benoît

Hello Marcia, Usually, calibration should be done once a year. Calibration is not only comparing temperatures of your device to a standard. You might want to adjust your thermometer, and have its temperature compensated (temperature read +/- gap discovered during your calibration). I would suggest you to ask directly your provider. Most of them offer this service, and provide you a certificate of calibration. There are several standard around the world. NIST is mostly recognized in North America. hoep this helps, Benoît

Hi all, I would like to get your opinion and help, about how do you calibrate your temperature/humidity/pressure sensors you use when you monitor your thermal equipments and facilities. I heard and see different approaches in hospitals. A sensor for me, is like a watch. With time, data have to be adjusted, and that's the objective of a calibration. Once a year minimum. When I calibrate sensor, I compare the temperature of the sensor in a bath, with a more accurate and precise thermometer (NIST) on several points across it range (minimum of 2). They are always small differences between both, so I calculate the difference on each point, and then adjust my sensor accordingly. This way, sensor could display a temperature on the software, after this adjustment. I edit a calibration certificate for each logger. I've seen a different approach: the hospital use another NIST and calibrated thermometer (same accuracy/precision), place it inside the equipment, next to the sensor to be verified, and compare data between both. The only certificate of calibration available and edited is for the NIST thermometer. What's the best way to do it in term of regulatory requirement and quality? If the verification only is acceptable: - How do you determine for how long you have to compare data? - Knowing that the temperature inside an equipment is not homogenize everywhere, how do you determine that it does not impact the difference that you might have between 2 readings? - Do you have to use same kind of logger (electronic Vs glycol for example) as it could explain differences between both of them? Except being a NIST thermometer, how do you choose one and not another? - If you find differences, do you then calibrate the sensor to adjust it? As far as I am concerned, I do not consider the latest, being a calibration, but a verification. Verification let too much place for approximation, and in case of cold chain failure and major incident, it's easier to have a scientific and legal rational when you calibrate them. Furthermore, in case of differences after a verification, only solution is to calibrate the sensor, so double the work and the cost. What's your thought about it and do you know what the regulation request? Thanks in advance! Benoît

Hello, I think David is right. What is your tolerance to risk and the impact on your products if temperature goes out of its range during the inbetween time? If you are investing time, money, new procedures...into a new monitoring system, why keeping your old one? They are many monitoring system that have a sampling rate lower (every minutes, 5 mns...). Isn't it redundant to keep 2? And yes, as David said, the more sensors/systems you will have, the more chance of having different temperature you'll get as accuracy/resolution/calibration/type of sensor/location... could be different. That's just my opinion... Benoît

Hello Beth, I concord with Adiescast...a standard configuration does not exist, and there is no "best way". However, some methods could be easily defined, and then be qualified upon your reality. Most important factors to take into consideration is payload size, length of transportation, and external temperature. In all cases, do not use frozen gels in direct contact with products you want to keep refridgerated. I don't think using paper paper or thin carbon would be recommended to separate frozen gels from your products...They will become wet and create humidity very fast... Method you could test is maybe using a sandwich method...a frozen gel at the bottom, then refridgerated, your product, another refridgerated gel and a fozen one...But again, it will depend of many factors, plus size of your cooler... For your tests, do it at min and max payload as results could be different... Ben

Unfortnunatelly I moved from Europe to the other side of the Atlantic!! But I always had London and UK in mind, as I spent a lot of time there for vacation! Benoît

Hello Nick, I don't know any requirement either rational to do a re-mapping when you move your equipment. If the environment is the same, it will not affect the performance of your equipment. As I said, I will just suggest a change control to document this move, the monitoring system (alarms, reading, connexion), confirm environment is the same...etc. If you want to make sure that no damage during the transit has affected the equipment, you could do a limited one during 24 hours with a couple of data loggers. Benoît

Hello Nick! Yes still here! As during the initial validation of your monitoring system, you will have to document and to include in your protocol and tests, location of your equipments, how they are connected...etc...if you move it, this information will no longer reflect your new reality. Furthermore, if you use a wireless system, you'll have to test your reading, alarms and connection, to make sure the new location allows a good signal transmission. There probably many references, but you could look to this one from the FDA: "Blood establishment Computer System Validation in the User's facility". If you google it, I think it comes in first results. "Validation after a change: Due to complexity of blood establishment Computer systems and BECS, a small local change may have a significant global system effect. When any change (even a small change) is made to the software on the blood establishment computer system, a validation analysis should be conducted, not just for validation of the individual change, but also to determine the extend and impact of that change on the entire system. Based on the analysis, you should then conduct an appropriate level of software regression testing to show that unchanged but vulnerable portions of the system have not been adversely affected. Appropriate regression analysis and testing provide the confidence that the system is validated after a software change. We recommend that you perform regression testing, when indicated by your analysis, by re-running test cases that previously passed." Hope that helps! Benoît

Sorry, I have made a mistake and post this new thread above under an old inactivate profile...That's what happens sometimes when you have tons of ID and PW to remember! Benoît from Alternatives

Lounging, there is a market place section where all your products, could be advertised. I don't think your post is very constructive in this debate...

Yes, I am totally agree with you...but as far as I am concerned and after having worked with many hospitals, there is a huge difference between pharma and hospitals. USP1079 is a very clear regulation, as well as PDA report 39, Guidelines 0069 from health Canada...in pharma industry. In hospitals, except sometines for some centers, not every equipment has been qualified with an IOPQ. Temperature profile are not used to qualify packaging system. ISTA profiles neither...etc. I mostly speak in hospital of AABB, JCAHO, WHO, FACT, Z902-04...But, yes, definitely, all pharma regulations, even if they are not in force in hospitals, could be a great source of inspiration ! Benoît

Does USP 1079 only focus on pharmacopeial preparations and regulates pharma industry not hospitals and blood centers?

Hello Mabel, Advices I could give you. First, depending the size of your cooler, don't hesitate to use several data loggers placed at the top, at the bottom, and centrally; temperature might not be homogen everywhere if it's a big trolley cooler. Then, the closest they will be from your product, the more accurate recorded data will be. Don't use a bag or do not wrap your data logger. Indicate on the box that it's monitored by x number of data loggers. Benoît

Hello, I am questioning about something...All your hospitals probably have monitoring systems already in place to monitor 24/7 some of your fridges, freezer...etc. Why don't you add some sensors into your reagent fridge to monitor it in real time? That's probably not a huge investment as solution has already been installed. Taking twice a day does not show you what happened where you were not here, and does not prove you did not have any excursion. A Min Max only tell you that you have been out of range, and I don't think it's proactive, as if you see you were below or over your limit, I suppose you can't use your products anymore. And there is a cost involved for cold chain failure. Every fridges have some defrost cycle. Some of them are higher than others. Placing some data loggers inside during 24 or more, will show you all these cycles and temperature homogeneity inside your fridge: for example, solution is sometimes to readjust your set point to be back within your allowed range. Regulation could not be requesting you alarms, but will request you actions case of excursions. I think the cost of cold chain failure (in term of $, but also quality, time...etc) is higher than having a good knowledge of your equipment and be proactive. You want to manage exception, not excursions. And many vendors of monitoring systems have highly increased their technology and decrease their costs too. What do you think? Benoît

Good question! Something that is done in pharma industry and might be implemented in an hospital; As there are no regulations on the number of sensors to be placed into a equipment, solution is firstly to perform a mapping of your fridge or equipment in order to determine hot and cold spot. Under protocol, and regular business hours (with door opening), it will show you how homogen is the temperature inside your fridge. Pharma companies then select their hot and cold spot where temperature sensors will have to be placed (this is a requirement). So the number of probes will depend of disparity of temperature inside your equipment. What do you think? Benoît