Moving Equipment

[Brenda K Hutson]

Later this year, we will be moving into our new Hospital (built right next to our current, old one). The "current" Management actually suggested we tape the refrigerator doors closed, with the blood inside, and just move the equipment to the new Hospital!

Ok, now that I am over that shock, I know what I have done at previous Institutions when we have moved the Lab, but would like to know what the regulations/guidelines are for moving refrigerators, freezers, centrifuges, cellwashers, etc.; in other words, what checks are performed once the equipment (without blood products in it ) is in the new Lab, prior to using it?

I would greatly appreciate any and all feedback!

Thanks

Brenda Hutson, CLS(ASCP)SBB

[Alternatives]

Hello Brenda,

You will need to do a change control on your validation to evaluate and document impacts of the moving on your equipment. For your IQ, it concerns new location of your equipment and electricity. Regarding OQ, you will need to realize a new mapping of your refrigerator and check your alarms with your monitoring system.

Of course do not move your refrigerator with the blood inside as you will have cold chain failure for sure! Tape is not the solution, maybe transfer your blood products into another refrigerator during your moving.

Hope it will help,

Benoît

Edited January 22, 2009 by Alternatives

[bxcall1]

Make them buy you new refrigerators for the new Blood Bank!

Then you can validate the new ones before moving your stock into them. If you do it right the refrigerators can be part of the building budget instead of coming out of your capital budget.

That's the plan I have, as we will be moving in a couple of years to the as yet not completed building.

I actually put in a capital budget request for new refrigerators for when we move and was told thay they already are a part of the new building budget...lucky me!

[quint]

Make them buy you new refrigerators for the new Blood Bank!

Then you can validate the new ones before moving your stock into them. If you do it right the refrigerators can be part of the building budget instead of coming out of your capital budget.

That's the plan I have, as we will be moving in a couple of years to the as yet not completed building.

I actually put in a capital budget request for new refrigerators for when we move and was told thay they already are a part of the new building budget...lucky me!

Agreed

[nsarris]

Benoit,

This thread was posted a while ago so I hope you are still around !

Just in reference to the requirement in OQ to re-mapping after relocation of refrigerators, is this actually specified in any standard or code ?

Nick Sarris

[Alternatives]

Benoit,

This thread was posted a while ago so I hope you are still around !

Just in reference to the requirement in OQ to re-mapping after relocation of refrigerators, is this actually specified in any standard or code ?

Nick Sarris

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

[Karen Olsen]

Make them buy you new refrigerators for the new Blood Bank!

Then you can validate the new ones before moving your stock into them. If you do it right the refrigerators can be part of the building budget instead of coming out of your capital budget.

That's the plan I have, as we will be moving in a couple of years to the as yet not completed building.

I actually put in a capital budget request for new refrigerators for when we move and was told thay they already are a part of the new building budget...lucky me!

This is exactly what we did!! Had our new one (purchased on capital) up and running with all QA completed. Then we moved the blood to that refrigerator. And then moved the older refrigerators in. Permformed all QA on those and then separated the blood out as prior to the move. It really worked very slick! Yes, we performed all QA on all instruments after the move. I moved one workstation over ahead of time and had all QA done on D day. Then with blood in the refrigerator and a workstation up and going, I had one Tech move into new area with out even a hipcup! Went very smoothly!

Good Luck!

[nsarris]

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

Benoit,

Really appreciate your feedback.

The new Environmental Monitoring System at the new site will be fully validated. I just wanted to confirm if there were any regulatory requirements to fully re-map the relocated refrigerators. I have discussed this with various refrigerator suppliers and they all agree that provided the new location has similar ambient environmental conditions then the refrigerator should perform the same. The only issue they had was possible transit damage, hence some level of OQ would still be required. But the thermal profile inside any refrigerator would only be influenced by the internal fan, shelving layout or content layout. Hence the hot/cold spots should not move due to a relocation. I am suggesting perhaps a limited temperature mapping be undertaken to confirm that the existing hot/cold spots are still within the required parameters, which would be incorporated into an OQ.

Nick Sarris

Red Cross Blood Service Melbourne Australia

[Alternatives]

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

[Malcolm Needs ☆]

Benoit,

Please, please, please can you be my Quality Manager???????????!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

[Alternatives]

Benoit,

Please, please, please can you be my Quality Manager???????????!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

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