Plasmapheresis Validations

[spavlis]

Our donor center is interested in starting a plasmapheresis program.

Does anyone have any information or suggestions on how to perform validation studies for plasmapheresis?

Any help would be greatly appreciated.

thanks

stephanie:)

[PSanai]

The vendors of apheresis equipment have sample validations available that you could use as a starting point. You'd need to revise them to fit within your validation process.

The validations performed on new apheresis equipment at my blood center consists of (shortened version) IQ= installation of the machine by the vendor. OQ = writing, approving and training the procedures for the process and finally PQ= collecting X amount of products and checking to see if the products are suitable for transfusion. In the case of plasmapheresis the PQ would check to see if the actual volume of the product is within 10% of the tageted volume.

Good Luck!

[spavlis]

Thanks, the vendor did have a sample validationwe could use.

The one lingering question is " How many plamsa collections do we need to collect to be successfully validated?" The vendor was great in describing how to validate plasma collections on the machine, but convienently left out how many to collections we need to perform.

Any suggestions on how many successful plasma collections make us validated?

stephanie

[PSanai]

That is a very good question with no easy answer. Typically at my blood center, this decision is made in conjunction with QA. We'd consider the number of machines being installed. Another factor is if this is a new process or just adding machines to an exsisting process. Obviously, we'd require a larger number for the validation if process is new. Your vendor rep could tell you what other blood centers have done. You might consider selecting a number and contacting your CSO at the FDA and asking if they consider the number adequate for this validaton.

My guess is that we would require at least 10 procedures per machine. Any procedure stopped early due to VP problems or donor reactions would not count in the 10 (or whatever number you select.)

Hope that helps!

[Debbie]

The numbers you would want to do is TOTALLY dependent on you and your QA. You are validating a process, not a piece of equipment, so you don't want to go down the "per machine" route. You simply want to validate the process, and ensure that each piece of equipment is included in that number.

Plasma never fails QC, it's an easy collection, with minimal QC - so you don't need to make the validation extreme. I've seen most people go with the standard "20". Since the new guidance for platelets, and the FDA focus on scan statistics... you may want to consider more along those numbers. Since that's "Guidance" and not "Code" - it's optional... so if you want to go with 20 collections, I think you could make an easy argument for it.