Inappropriate Dad Jokes (Cleaning)
What is the molecular formula for Hydrogen Peroxide?
H2O2
List every location where personnel micro plating occurs.
Top of the head, chest, fingertips and palm of both hands. (Both wrists and lower legs for gown certification, optional answer).
Currently, what are the five primary cleanroom classifications at the Michelle Facility?
RNC, CNC, Class 100,000, Class 10,000, and Class 100.
What does CFR stand for?
Code of Federal Regulations
What website under the Exela Managed Bookmarks is used for reporting safety incidences and close calls?
Gensuite
How often do you sanitize your hands in a controlled environment?
Every time you switch to a different task, touch something, document, change gloves.
What is the minimum amount of CFUs needed for an action level excursion when personnel monitoring in a Class 100 space?
One
What is the current date format we print on IV bags?
YEAR/MO
What does contemporaneously mean?
Performed concurrently, at or nearly at the same time.
What does BMRAM stand for?
Blue Mountain Regulatory Asset Manager
What does CNC stand for?
Controlled Non-Classified. A room where air is filtered to reduce contaminants below normal environmental levels but isn't formally designated with a Class or Grade.
What is the form used when transporting QC Micro samples to the lab from Michelle?
FORM-001023: QC Sample Transport Form (FRM-000832 Veeva)
What does HEPA Filter stand for?
High Efficiency Particulate Air Filter.
What are the four acceptable error codes allowed for error corrections?
CE - Calculation Error
TE - Transcription Error
SE - Spelling Error
DE - Date Error
How often are media fills required for a person to maintain aseptic qualification?
Once a year
What is the Veeva document number for the Cleaning and Sanitization of Manufacturing Cleanrooms SOP?
SOP-000006
If a gowning certification lapses for less than 30 days, what must occur to re-certify?
Gowning certification must occur with only one testing occasion instead of three.
Where are the two main places you can go to search for SDS sheets?
The internet and the SDS bookmark under the company managed bookmarks tab.
When may red ink be used when documenting on GMP documents?
When grading quizzes or redlining a document for changes.
What does SAP stand for?
Systems, Applications, and Products.
How does a sporicidal agent vary from a disinfectant?
A disinfectant kills microorganisms whereas a sporicidal agent destroys nonliving spores formed by microorganisms.
What is a pyrogen?
Any substance that is able to cause a fever upon entering the blood.
Name at least 15 departments in Exela.
Examples:
QA - Batch Review
QA - Operations
QC - Chemistry
QC - Microbiology
R&D
Tech Services
Operations - P&L
Operations - Inspection
Operations - Fill
Technical Writers
Facilities
Maintenance
Engineering - Process/Automation
Metrology
Operations Excellence
Materials Management
IRMI
Project Management
Sales
Finance
Procurement
Security
List at least 8 sections in a typical Exela Batch Record.
Examples:
Product Information
BOM
Dispensing
Compounding
In-Process Testing
Bulk Solution Sterile Filtration
Filling
Terminal Sterilization
FDP Sampling
Inspection
AQL
How long does Exela retain manufacturing records?
8 Years