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Double bag platelet and extending expiration date


LabCat

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What is the standard that allows the expiration date to be extended on a double bag unit of apheresis platelets?

Example: unit expires 09/03/2016 23:59. Order to transfuse is received at 20:00 09/03/2016. Contents of one bag are poured into the other bag while keeping the system closed before unit is issued. New expiration date is 09/04/2016 20:00.

How does pouring the contents of one bag to another modify a product's expiration date?

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Combining them makes the expiration shorten to 24 hours.  Of course, if the product already was going to expire in less than 24 hours the shorter expiration would apply.  Don't lengthen it!  ARC requires the expiration be shortened when the bags are combined but another blood supplier I have used said that was internal ARC policy, not a requirement.  The reason they are in two bags is that the bags are oxygen permeable and that large plasma volume requires more surface area for sufficient O2 transport.  These would be units they had hoped to make into 2 platelet products but the platelet count wasn't high enough for two.

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23 hours ago, Mabel Adams said:

Combining them makes the expiration shorten to 24 hours.  Of course, if the product already was going to expire in less than 24 hours the shorter expiration would apply.  Don't lengthen it!  ARC requires the expiration be shortened when the bags are combined but another blood supplier I have used said that was internal ARC policy, not a requirement.  The reason they are in two bags is that the bags are oxygen permeable and that large plasma volume requires more surface area for sufficient O2 transport.  These would be units they had hoped to make into 2 platelet products but the platelet count wasn't high enough for two.

 

11 hours ago, Smarty pants said:

the maximum volume depends on the device the product is collected on. That is how the FDA clears the product. I know that the Trima max 400mL. I think Amicus' maximum volume is dependent on the yield of the platelet.

I was always under the impression it was based on the manufacturer instructions of apheresis equipment/platelet containers. They have yield and volume constraints the products need to fall within.

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Quality guy.... are we saying the same thing? 
The Trima platelets have a volume of 400 mL (max yield <5.2) per bag.  Their product bags are more clear and pliable. 
Amicus has a more detailed yield/ volume ratio (The volume depends on the yield, they have a table your supplier could provide you.  If they yield is "x" the volume needs to be between "y" and "z").  I know their bags have a more "milky" color and hold their shape a bit more, less pliable.
If that helps at all.

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The other supplier was quite a number of years ago, but I'm sure it could be that the 24 hour outdate after pooling requirement was instrument specific and didn't apply to their instrument.  They made it sound like the product having to be split into 2 bags was universally required, but changing the expiration after pooling was not a standard requirement.  Again, that might have been true of their apheresis machine's bags only.

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