Quantities
1
What does TFF stand for? Do we use it in our UF/DF process?
Tangential flow filtration, yes.
Where do you pull permeate and retentate samples?
Permeate-on the skid and retentate- bag
What could happen if air is introduced into the LevTech?
Foaming and protein loss.
How can excessive foaming impact the product?
Could damage the product.
How many ports are there on the transfer panel?
Throughout UF/DF, when do we perform an airpurge?
During manifold flush
What should the air regulator be set to?
30psig
The retentate bag's weight keeps slowly dropping although nothing is running.
Observe bag for leaks. Check sampling manifold for any open ports. Observe scale for abnormalities. Escalate.
High TMP could indicate what? Low TMP could indicate what?
High: Cassettes are clogging Low: cassettes are compromised.
How many pressure sensors should there be on the UF/DF skid?
4
Prior to starting the product transfer, what needs to be done?
Filter needs to be flushed, retentate bag samples must be pulled, and gross weight is obtained.
How many ports are there on the skid and what is each one used for?
4- WFI, Sani, Recovery, and Re-circulation
During product transfer, the flow is very slow and the transfer is taking longer than usual, what should I do?
Hardening of tubing during process
Ensure flow path is open. Escalate.
From start to finish of the UF/DF process, how many times is SoloVPE utilized for protein concentration?
What happens during UF and what happens during DF?
UF- Concentrating down
DF- Buffer exchange
What final pressure should the cassettes be torqued to?
1700-1900psi.
Most likely, you will have to re-perform a new sample but this time let the line flush to drain longer. Follow tree in SOLO SOP.
During transfer, pump is not ramping to set point.
Escalate.
How long is the pressure hold during the pressure test?
5 minutes
What criteria is used to separate components in a liquid solution?
Molecular size or weight.
What is TMP and why is it important?
Transmembrane pressure which is the pressure difference between the two sides of a membrane. It ensures protein retention is maximized without damage or loss of protein.
When starting recovery, you get this prompt "Calculated post recovery concentration = ___. Target post recovery concentration = ___. Selection (1) to proceed with calculated concentration. Select (2) to return to previous prompt.
Escalate to supervisor and potentially process leads.
What could happen if the bottom diaphragm of the skid is not tightened properly?
Since the first thing you run through the skid is WFI and that part acts as a valve, it could gush out instead of flowing straight through the skid.