M_Allan

Again, even on the new site, there is a lot of advertisement going on, to promote a system, as in this post. I can only say. Try a system, before you buy a system. Let your QA and IT department check the system, and then make the decision. As always, the Rees system pops op as #1, because their sales people are very aggressive, and they still promote themselves as #1. I have to admit. The Rees system is not bad, but, you have to keep in mind, that this company will tie you, with hands and feet, to stay with their support and service. You should check the person that is involved in the purchase. Bribe is not on-common. Once you signed, there is no escape, and you need an expert to pull you away from the " Rees " grip. I do not want to mention any specific customers, but they had to deal with these situations. Another problem that still occurs, is the fact, that blood banks need to operate at the same standard as the pharmaceutical industry. The pharmaceutical industry has a lot more money to throw out of the window then the blood banks. The Pharm industry is not interested in quality, but only in a company that can cover their " ass". To be compliant, bloodbanks have to pay, just because the pharm industry is willing to pay the bucks, to point the finger at somebody else. Two different trades, with a complete different goal. If you want to buy a monitoring system, consult an independent expert ( hard to find ), and take care, he is responsible for the audits.

Hello Mr. Jones, Oh No! Yet another system! I just had a look at their specs, and the way I see it, nothing new. To me, just the same car, painted different. They claim, you need no software, and no server. You need to store your readings somewhere, and if a memory-bank breaks down, you need to have a backup...correct. Settings, user info etc. etc. also need to be stored somewhere. No backup...... have fun. And, a web-based application is not really that new. Marc

Hello RR1, You are right, but I think, the critical temperatures in regards to the stability of the samples and units are more important, and that is were a couple of degrees difference can cause a lot of problems. Marc

And, yes, Another important issue is the hysteresis of the fridge or freezer. As you see in my avatar to the left, this is a graph of a fridge. Every fridge or freezer does the same thing. The compressor switches on and off, and depending on the quality of the thermostat and compressor, the temperatures can fluctuate a lot. Sometimes even, for an extended period of time, the fridge might freeze, or go above the maximum limit. This is hard to monitor with a standard thermometer, and I think, it would be wise, to, at least, once every 2 months, use an electronic thermo-logger, that will show you these fluctuations, and if it runs within the accepted temperature fluctuations. Especially, when a fridge has been closed over night, the temperature usually goes down a lot, and I have seen plenty of fridges, that you could better use to make ice-cream. Marc

Interesting topic, but one important thing nobody mentioned. All samples or units in a fridge or freezer need to be stored within a certain temperature limit. It is not only, that temperature fluctuates because of air movement, there is also a permanent difference in temperature in different locations of the fridge or freezer. Usually, I notice, that many people place a thermometer in the front of the fridge, so they can easily take the reading. Most of the time, the temperature in the front of the fridge, can be many degrees higher then in the back. It is of importance, to map a fridge or freezer, to pin-point the difference in temperatures in several locations. If you located the coldest and hottest spot in a fridge, you could place a thermometer or monitoring system probe there, and by taking the readings, you have a certainty, that the rest of the fridge, is within these two readings. For a freezer it is easier, since it is only really important what the highest temperature spot in your freezer is, so one thermometer/probe would be enough. Marc

Yes Tadpole, Here we see again. A -80 Freezer can work perfect in Canada, but can fail in Bahrain. A particular Box can fail with you, but works fine within specs in Norway. Work out the variables, and write your own PQ according regulations. Marc

Eoin and Malcolm, Sometimes, misunderstandings happen. Especially when writing on a forum, especially, because English is second to me. Maybe, it is also, the way I look at the monitoring market today, that makes me a bit aggressive towards monitoring manufacturers. Few started, making a fortune on the new market years ago. Because they had a monopoly, they could get away with almost anything. The way they prepare there paperwork, they walk away without being blamed, and with enough money where plenty of customers have been bribed, and told it was going to be fixed in the next update. For most monitoring system manufacturers, the money is in the pharmaceutical sector. To deal with regulations, also blood-banks have to play the game, and usually end up having to buy a similar system, like the pharm. industry does. Usually overkill, money-wise, and most of the time, not according the regulations they have to deal with, but the manufacturer says..it is all fine. Unfortunately, I have to say, that most garbage systems come from the U.S. Everybody is trying to make a lot of bucks. Just like Microsoft. Invest 1 million in the product, and 10 into getting people crazy enough to buy it. As I call it " the on the fly dilemma " In regards to Environmental Monitoring Systems, we really have to ask ourselves if, what we buy, is worth buying. As a complete "odor and colorless" person, I have been testing about 10 different systems. Which way you go, it is always a compromise. Only few are honest. It is like most companies in this world, the moment they grow big, they get corrupt. For a lot of companies, a large portion of their budget goes into re-validating their monitoring system. I noticed, that the smaller ones have the drive to do everything according the book. They try to sell there product without the errors their opponents have. Many things about monitoring systems are doubtful. Specifications on Sensors. Do you have them on paper ? Validation on software upgrades. Have you seen them ?? CFR 21 Part 11 Compliant, the sales person says. This is not possible !!!! See FDA. How does Hard and software validation work ? Few end-users know. and many....many...more. O, yes, it is easy to say if something goes wrong. Just see who we can blame. I think it is more important, that everybody takes the responsibility for his own actions, which rarely happens. There are only a few companies, that were able to blame an Env. Mon. System Manufacturer, and make them pay for their errors. Very few !! This is a big problem, end-users have to deal with. I could fill a book with problems regarding, because I am a #1 in dealing with these issues, and trying to solve problems. Interesting ??? Yes !! Marc

Eoin, I did not see, anywhere in this topic, that Mabel is using a "R" system. That is why I did not understand why you came up with it. You write: "Also this is not a forum for manufacturers, it is for med scientists / techs to discuss matters" Correct, but there are still several manufacturers that try to promote their system, and their Validation protocols. There was another discussion on manufactorers Validations in a topic, and what they are worth to us. That is why I mention the PQ protocol, designed by independent soft & hardware people, including tests to reveal the errors in the system, and what impact these have on bloodbank regulations. You probably understand my remark now. Regards, Marc

Dear Eoin, I think it is up to Mabel, to tell us what kind of system she is using, and not necessary to mention the "R" system, unless you have a PQ written for this particular system, and it is not your intention to promote it. Everybody that has a "R" system, has a validation protocol for that system designed by the Manufacturer, and does not need a Validation protocol, since they can reproduce the tests from that document. Marc

Dear Mabel A Validation Protocol is system specific. Depending on the systems features, certain tests are performed, to test the correct functionality. For the end-user, it is important to perform a PQ ( Performance Qualification ), this, to test if the system is working according manufactor specifications and regulations in their specific environment. If the monitoring system has been validated by the manufactor before, you can use their Validation scripts, to perform the Validation, and perform extra tests to see if the system is really running accordingly. What kind of system are you refering to, maybe I can be of help Marc.

Benoit, That is a very impressive list. Important is, that no vendor can claim that his or her software products are certified Part 11 compliant. A vendor, instead, can only say that he has all of the Technical Controls for 21 CFR Part 11 compliance built in to his product. If they work correctly....... that is another question. I think, that it is important, as I mentioned before, to let a vendor install a demo unit, and have your QA and IT test the system in depth. Marc

Jeanne, That is a wonderfull story.... and OOO so typical. It happens to me during PQ's all the time, but This also shows, that the alarming should go off in the section where the fridge is. If a fridge in the Blood dispensing unit goes in alarm, it should alarm or phone in that area first, and not in the Lab, for example. I love the game, setting of an alarm, and wait, for somebody to show up....if at all. Thanks, Marc

Adiescast, You are right, that changes the situation a lot, and makes tracebility a lot more difficult.

Not that I want to scare people, but it is always interesting to find out, what is found during inspection. Here are two horror stories. First time, looking at a stone-age fridge with the brand "blood-bank", I asked one of the staff, if they are using this fridge to slowly de-frost their units ??!! She answered, but…it shows + 4ºC on the monitoring system, so what do you mean with de-frosting? Yes, when we checked the temperature close to the monitoring probe, it was close to that temperature, but the bottom half of the fridge was -4ºC. Here it shows again, how important it is to, at least when the fridge is installed it should be mapped, and shame on the company that installed the probe.:mad: Another one: Freezer -20ºC, so full of urine samples, that the door was taped shut with Duck-tape, to keep it closed. At the same time, this company was in the process of installing a monitoring system, but was not set to alarm yet. Two days in the process, I looked at some graphs, and noticed that this freezer was running on +10 to +15 for the last two nights. During the day it was within the limits. What happened At night, because of the high temperature in the room, the tape loosened, and the door popped open. In the morning when "a Lady" got a badge of samples out of the freezer, she re-attached the tape. ???!!! Do I need to say more Do you like more of these stories…….just ask…….and have fun. Marc

Hello Brenda, Since they have to be cleaned regularly, this could be the right time to do a visual inspection. A validated cold box, can be invalid in a day if damaged. As long as the lid/seal, outer shell and inner shell are intact, we can assume, the insulation layer, usually foam, is intact as well. If the inner or outer shell are punctured, liquid can enter, and will affect the insulation and it will decay after a while. If in doubt, compare the weight of a new and old box, to see if there is water between the layers. Also dents will compress the insulation layer, and change the characteristics. Since the insulation, when intact, does not really change its insulating properties, I think, it is "overkill", to Validate them more then once a year. Marc

Hello Shadya, With manipulation, do you mean transport / storage ? Marc

Dear Brenda, I am in the temp. monitoring field QA/PQ/SOP's for many years, and I know, it is really hard to come up with a perfect, water(blood)-proof, solution. Units are handled more then once, and only the SOP for handling will guarantee the units being in range. during handling. To my opinion, there should be no difference between storage or transport in regards to temp. monitoring. I do agree, that a color indicator on the units is a good solution to show that a unit has been out of range. Bulletproof. But an indicator does not prevent it from happening. Delivering units, to find out that the dots are red is rather frustrating. Also, if a fridge, freezer or box is validated, this does not automatically mean, that they are infallible. That is why we have monitoring systems. Continuous monitoring will also show defects before they brake down completely, and prevent the worst. As you mentioned, the things that happen in O.R. , the question is, how far the responsibility goes for the Bloodbank. Once delivered in good order, it is up to the recipient how they handle the units to my understanding. But, I think, that these issues will keep us busy for the next hundred years. Marc

I think, swede found a good way to be able to use the monitors straight away, by storing them on " working temperature ", so they can be used immediately. One of my concerns with, lets call them " sentinels ", like Safe-T-Vue and Hemotemp, is, that there is no data collection or traceability that can be filed. The other one is, the low temperature limit, that is not indicated by certain "sentinels". So how can we prove that units have not gone below a certain temperature. If this would be 100% FDA proof, you might as well put a Safe-T-Vue or what ever, in every one of your fridges, and as long as they indicate "white", your Units are fine, and you do not need an expensive monitoring system?! To my opinion, the best way of monitoring transport, is with a small electronic logger, that logs time and temp, and where the data can be filed with the rest of the monitoring data, so to create a waterproof traceability route. Correct, the loggers can be stored in a fridge, to achieve fast correct readings when placed in a cooler box, and prevent unnecessary out of range readings.

Dear dherbert. If you have spare probes for your monitoring system ( I presume wireless), you could write an S.O.P. , how a non technical employee, could insert the probe, to continue monitoring the device, in case a probe goes bad. ( Spare probe "X" inserted in fridge "Y" at time "Z", at same location as existing defective probe. Insert probe lead through door-seal, and set alarm limits correctly. Write comment in software ( CFR 21/11) ) Later, a technician can install the probe properly, and re-programme it to the correct settings. At least, there is proof of correct monitoring. In most wired monitoring systems, you cannot just change the probe, since it needs to be calibrated to the hard and software of the system as well. When you have a wireless system, you can have several calibrated spare transmitters, with probes programmed in the system, on "standby", to replace the defective transmitter including probe. You cannot swap the probe on the transmitter, since this will void the calibration. In regards to standard thermometers, I can only say, that, to my opinion, these are useless. If the reading from the thermometer is taken with an interval of "say", 4 hours, It is always possible, that the fridge has been out of limit for extended time, without somebody knowing. This usually happens when somebody does not close the door properly, and the next person that enters the fridge say, 3 hours later, does close it firmly. When the reading of the thermometer is then taken, the temperature looks fine, but in fact, your samples could be ruined. A small logger could be an alternative, but a spare wireless probe will save you a lot of paperwork, since everything will be dokumented in the systems log. Hope, again, that this is of any help. Marc

Hello Hodag, Buy...buy...buy... is easy. They already have coolers, so let people validate what they have, if possible. And..... even Thermosafes have to be re-validated after 1/2 or 1 year, or in case damaged. It would be nice, if certain people on this forum would not just try to promote their products. No offence.

One thing I forgot to mention, is the fact, that using wet ice for transport is not optimal, unless the ice is seperated from the blood so it cannot touch the samples.

Validation of small coolers has to meet the following criteria: Whatever media is used to cool the contents, we have to prove that it will stay within certain limits during transport. Wet Ice in this case is ± 0 ºC as long as the Ice is melting. Just above the bloods freezing point. Once molten, the temperature will rise. To validate the cooler, we also need to know, the maximum time it can be in transport. Better insulation means longer temp. stability. Another variable is the exposure to ambient temperature. Now, to validate the cooler. Insert a documented amount of wet ice in the cooler box. More Ice, means longer stability. Insert a calibrated "logger" where the samples are going to be stored. Place it in a room that mimics the maximum exposure temperature during transport. Leave it exposed for the maximum time the cooler could be in transport. Next, take the readings from the logger, to prove, the cooler contents stayed within the limits. Document these findings with the coolers operations log, and depending on visual damage repeat this whenever necessary. Usually, if no damage to the box is visible, once a year. Damaged insulation can shorten the temperature stability of the box. This can be easily checked, by pressing the inner lining of the box, and to see if there is any play between the lining and the internal foam. Now, the SOP for transport could be as followed. This could be used for any blood transport. Blood samples removed from equipment "X" at " Date and Time". Actual temperature can be retrieved from monitoring system Blood samples delivered at "Y" at " Date and Time" in box "Z". ( Signature ) Data from logger "A" that was with the transport will be added to transport log file, to prove temp. stability. I have been testing the Elpro Libero Logger, and this little device could be perfect for the job. After delivery, it will give you a pdf with the readings or a graph, and this can be filed with the transport documentation. Hope, this can be of help.

For Mabel Adams and adiescast, I can say the following. Rees is that expensive, because he has a nice portion in large Pharmaceutical companies. These companies pay "big bucks", so you can understand, that it is impossible for them to work with different prices for the blood-banks. Sooner or later people would find out. True, certain systems could be a lot cheaper if you look at the material used. Selling sensors that cost the vendor ± $150.- for ± $650 is not an exception. True, the Rees Human Interface is very good. Any person can operate it within no-time, and the option to operate the software from a touch-screen is working very well, especially in blood-banks. Another company called Amega Scientific, has a similar interface, and is a lot cheaper. Also their hardware is more up-to-date, where Rees is still using their old-fashion hardware. Still working fairly well, but almost obsolete. They should really do something about that, if they do not want to loose their portion of the market. Yes, both systems have their shortcomings that certainly should be improved, but they function. It is all up to the user, and how much they want to spend. As other members were refering to in this Topic. Let them install a demo unit, and let your IT and QA test the system, and then decide. Once bought, you are stuck with the equipment for many years.

Dear Alternative, It is nice to see you try to promote your system, but there are certain things, I would like to know. What kind of wireless sensors are you using ? Random send or duplex ? I do not see a possibility to let the system call a phone and generate a voice message ? There are many lab. experts on this site, that now little about all the systems that are on the market, so give it a go.....and let us know ! Marc

Matt, You are absolutely right. I mentioned this before, and I have seen this more often myself. IQ/OQ done by vendors is only to make their system look good. I prefer to see it as an installation check, not a validation. I do not see it as being forced by the vendor to get their software validated. It is more, that they do a bunch of checks, to show, that their system is working, according their standards ! For every piece of equipment/software, I sure believe it necessary to perform a PQ. Since I have a lot to do with PQ's, Hard & Software, on different systems, I can tell you, that I encountered numerous 21 CFR 11 incompatibilities as well as hardware that is in no way FDA compliant. Last but not least, it is also these regulations that are not full-proof. I cannot, go into detail on systems from different vendors, because there are more then one, I know inside out, and this would create a very big storm. Do understand. In this kind of business...... it is all about money, and nothing else. As I said. Ask the vendor to install a demo unit, and test it........ to the max. Have fun, Marc