SEPAX
Is a file generated when eSTOP is selected
Yes
A ___ Ticket should be submitted to report a safety incident
Sphera
What reagent do we use to wipe pipettes?
IPA
If no FACS for XLP day6 is it a deviation?
Yes
Are kits wiped with IPA or Steri Perox?
Steri Perox
During purge mode.
What orientation should the chamber be to while pumping to allow for recovery of entire volume of cells
inverted
If an emergency injury occurs where do you need to call
911
If a bottle or wipe is found unlabeled who gets the deviation? Is it major or minor?
The supervisor or lead on the floor for the suite. Minor
Who is the supervisor for QA BH Days
Vu Chau
Does the CRF passthrough get wipes once a day, once per shift or after each item is passed through? What reagent?
Once per SHIFT, Steri Perox w/ 5 min contact time
During the purge mode protocol.
The clamps leading to the ______for purge will remain open.
The designated bag ( Either input or output bag )
What is the evacuation are for MFG?
Evacuation Zone 1
When wiping materials on a materials staging table. Do you move the item across the demarcation line.
a. After applying appropriate disinfectant
b. After applying disinfectant and waiting contact time
A. After applying initial appropriate disinfectant
What do we risk if we don't comply with our procedure?
FDA Shutdown
Do you need to wipe the cart before use? If yes, what reagent and do you need to wait contact time?
Yes, 70% IPA, 3 min Contact Time
When do we discard the SEPAX kit
At the end of the process day
What do you do if you're in CRF and the O2 alarm goes off?
Evacuate through the nearest doors, even if its not a common exit. Do not go back in to save anyone.
Are labels wiped with IPA or Steri Perox
IPA
What Country will be auditing us next?
South Korea, February 2025
When wiping in aph do you wipe the container, the bag or both?
Both with 70% IPA
What does the "M" dip on the SEPAX graph mean?
Part of the volume inside the chamber was sent out to rinse either the input bag or output bag.
What do you do if there is a fire inside ISO7?
Stop all operations no matter what, exit immediately with owning, do NOT try to gown out.
Does the back pass through need to get wiped once a day or after each time something is passed out?
After each item,with Steri Perox with contact time
( Also need to wipe timer and wait contact Time before using timer)
What is the difference between a deviation and a process comment?
Deviation: A confirmed departure from an approved procedure, process, or established standard for cGxP operations.
Process Comment (PC): Also known as an Event Comment. An entry or note annotated in GxP source documentation that describes an event.
Where is the probe taped and how is the cassette placed before placing a bag into the CRF for cooling.
On the cassette, with bag pressure on top of cassette before placing into CRF slot