Nomenclature
What "TFF" stands for
What is "Tangential Flow Filtration"?
What is the soil expiry of the Final skid following a production lot?
19 hours after post-process rinse is complete
Which of the samples taken during UF/DF are urgent and require QC results prior to proceeding?
1. The sample following recovery but prior to final formulation
2. The sample following final formulation, prior to PS80 addition
**What would happen if someone neglected to press the stop button following replacing the 620 Bioprene tubing element in PU-5513?
The system would probably throw an error code slash alarm and not allow you to proceed?
If the temperature of the water is high, will that result in increased or decreased flow of water through the permeate line?
Increased flow
The definition of "ultrafiltration"?
What is, "Concentrating your product into a specific concentration range, calculated in the batch record and SOP"?
Where on the SK-5510 do you take the different samples during the whole UF/DF process?
Post-EQ offline pH sample? Permeate line
Everything else: NovaSeptum sampling assembly on the retentate(?) line
What criteria when met, require the installation of new cassetttes?
Cassette filters about to exceed 19 cycles OR NWP test value falling below 72% of the inttial NWP test
What would an absorbance reading greater than, idk, zero, on the permeate line indicate? Next steps?
Unless the UV meter is just acting up, this indicates protein leaking through the cassettes and going down the drain. Probably the system would throw an alarm, also hold if it gets to like 0.5Au?
Why does the B0114 buffer have stricter standards than the other buffers we use in Purification? (like having to attach the IT receipt to the BR)
Because, as the DF buffer, B0114 is the buffer that actually goes inside patients
The definition of diafiltration?
What is "A form of tangenial flow filtration in which one buffer in a solution is exchanged for a different buffer"?
What is/are the sanitizing agent(s) used when cleaning the UF/DF skid?
What is the skid stored in?
HWFI and B0672A
B0102
When new cassettes are installed, which other items must also be replaced?
The 620 Bioprene tubing element in the pump
The adaptor gaskets
The adaptor plates
During the pre-use IDU Integrity Test recipe, the integrity test fails. What should operators check when troubleshooting?
1. Is pressure gauge 551-PCV-39 set to the 15 psi? (p.s. does PCV-39 control the pressure in the holding tank or what?)
2. Are there any leaks in the system? (check the whole skid)
Product volume = 27.6L following concentration. Calculate the minimum volume of B0114 needed to continue operations
NLT 329L of B0114 + a few extra liters
"Volume required is 10.1x (the volume of product in the tank + 5 L for the skid hold-up)" PLUS volume required for holding tank to reach NLT 35?L
During UF, what material is passing through the permeate line? What passes through the retentate line?
Permate line: Whatever buffer the Phenyl eluate was sitting in (in this case B0104/B0105 mix)
Retentate line: Product (in buffer) that passes past (*not* through) the cassettes and back into the holding tank
The title of SOP-103821
What is "DNA/Viral Filtration and Formulation?"
When is the cassette integrity test performed? When is the NWP test performed?
Integrity test occurs prior to a production lot. NWP occurs following a production lot
What would be the result if the hydraulic pressure on the skid was too low? Too high?
Cassettes could fail the integrity test. Product could leak out of the cassettes into the permeate line?
Cassettes could be damaged? Or flow to the permeate line could be too slow and DF could take forever?
Why is ultrafiltration always performed *before* diafiltration?
So you don't have to use as much DF buffer. If you didn't concentrate your product down first, you'd have to use like 7 barrels of B0114!
State the acronym and definition of "TMP"
"TransMembrane Pressure". "The driving force behind the separation process of tangential flow filtration. The average applied pressure from the feed to the filtrate side of the membrane."
The title of SOP-104123
What is "Operation and CIP of the UF/DF Skid"?
What things on SK-5510 is regulated by CDA pressure?
What is regulated by hydraulic pressure?
Opening and closing valves on the skid. Also later doing recovery from the skid and air purge
The power unit holding the cassettes in place and preventing cassette leakage
**What would an NWP test below the "72% of initial NWP" indicate?
The cassettes have not been sufficiently cleaned following the CIP recipe. This is to be expected once the cassettes have been used for many production runs. If NWP fails, cassettes will need to be replaced prior to the next production run (right?)