House Keeping
How is the lab cleaned? How do you make VIREX?
Virex bench tops and hoods
IPA Hoods
VIREX 1mL per 256mL water.
Where do you find your SOPs?
R://
QA Control View Only
Current SOPs
How do you properly serial dilute from a 1:10 initial dilution.
1mL into 9mL
or
10mL into 90mL
What is the proper format for dates
mm/dd/yy
Evacuation location for Fire?
Back of the building by the dumpsters
What is the proper location for biohazardous materials?
Autoclavable designated area on benchtop
Nonautoclavable designated biohazard bin
What SOP would you find cleaning procedures?
700M0120
Name the color tape and corresponding day
M-Yellow
T- Orange
W-Red
TH- Blue
FRI-Purple
SAT- White
SUN- Green
What is the proper way to correct an error?
Single cross out line, describe reason for correction, initial and date.
Name Proper PPE standards
Safety Glasses
Lab Coat
Hair/ beard net
closed toed shoes
appropriate cuff length gloves
All equipment is tagged by QA department. There are calibrations/ verifications that are conducted to ensure working conditions are met before testing.
i.e., daily balance verification
How do you know if you are qualified to perform the method?
Training Matrix- broken into Families each method should be assigned to a family.
How do you assign expiration date to prepoured plates
30 days from pouring unless expiration on label comes before.
When conducting testing at what point in the procedure should you document your weight?
at time of weighing.
On the weekends- what is the proper procedure for being in the building
Personnel is to sign in using the weekend log in the front lobby
Where should all pending QC media be stored?
In Media or Pending QC area in Lab.
What SOP relates to EM and what is the purpose?
700M0100- monitor the environmnetal conditions in the lab to ensure there is not heavy microbial activity that could impact the testing.
What is the purpose of an in process air plate?
to monitor the environment inside the BSC during testing
What is the purpose of documenting everything that happens during a test?
Provide the client with accurate results and maintain data integrity.
If you didn't document it- it didn't happen.
When performing a new task what can you do to make sure you are being safe?
perform 2 min for my safety- MAIA app
How do you perform deep cleaning procedures? How often is this done?
Hoods are taken a part and cleaning thoroughly with VIREX and IPA.
Drawers are emptied and cleaned with Virex and IPA
Quarterly
How do we deem media acceptable for use?
Every batch of media goes through a QC process
What ISO accreditation are we trying to receive?
ISO 17025 is the international standard that sets out the general requirements for the competence, impartiality, and consistent operation of testing and calibration laboratories. Most labs must hold accreditation to this standard in order to be deemed technically competent
What does ALCOA stand for?
Attributable
Legible
Contemporaneous
Original
Accurate
If you feel unsafe, what can you do?
STOP WORK Authority