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