Cleaning of Manufacturing Areas
Prior to cleaning in a Grade B / A environment, what should you make sure of before starting the clean?
C. Tulips are off / capped
What does LWS stand for?
Lighthouse Worldwide Solutions
What is a mistake in which a person transfers information incorrectly from the original source onto a second document?
Transcription Error
When adding items, components, etc into the RAB, what method do use to perform these functions?
Doctor/Nurse Method
What button has to be pressed on the HMI before the machine will have power to run?
Control Voltage
When performing a clean that involves cleaning of the ceilings and walls; Can the same mop be used to clean both the ceilings and walls?
Personnel Monitoring
What error codes are we allowed to use at Exela?
TE, CE, SE, DE
When should you be removing the trash and replacing it with a new bag? (percentage)
80%
What is the segment on the machine where the needles are routed through called?
Peristaltic pumps
What kind of wipes are only permitted to be used inside grade B/A environments?
Non-Linting Wipes
What is the term called for when the pressure drops inside the cleanroom?
This U.S. agency enforces cGMP regulations to ensure the safety and efficacy of pharmaceutical products.
FDA
How often should someone be spraying their hands/wrists when inside the cleanrooms?
When should you not spray them?
Before and After performing task; or intermittently if not performing tasks.
Prior to personnel monitoring.
What settings must be checked/changed prior to initiation of SCADA?
Fill Parameters
When cleaning equipment, which of the following isn't considered equipment?
A. Tables
B. Shelves
C. Door push buttons
D. Panel box for rollup door
C. Door Push Buttons
What is the minimum suggested time for doors to remain closed before being re-opened?
1 min
What is it called when someone doesn't perform/verify a step on documentation?
Omitted data
What must you avoid doing if you're working inside the RAB other than avoiding leaning to far into the machine?
Talking while inside the RAB
What is the part called that transitons stoppers from the linear track?
seperating lock
What does a quarterly clean consist of and what agents are used?
Perform Bi-Monthly Tasks with sterile filtered WFI
then perform bi-monthly tasks with sporklenz and IPA, including ceilings
What does HEPA stand for?
High Efficiency Particulate Air
Beginning from left-top-right, What are the hazard diamond numbers for:
IPA
H202
Sporklenz
Vestasyde
1-3-0
1-0-1
2-0-0
3-1-0
When do you not have to perform personnel monitoring?
When entering for a clean
What is the process on the HMI once micro sets their plates in the RAB?
Operator-EMS-Actual values MAS