potpourri
Novo Nordisk goes by __ essentials
10
What is the PPE required while the line is running entering room 1034 and 1036?
1034: Blue scrubs, eye protection, hearing protection, and gloves
1036: Frock
What are the challenges on the labeler machine?
Detection of Label ID
Label Prescence
Dynamic Data
what is your virtual lock and key at Novo Nordisk.
Initials and password
The process of clearing a specific machine of material/product is called
Running empty
In the fill room, "speed outfeed conveyer area 2" controls which function?
Tablet feeding
According to JI Q0363059, in room 1036 where is the starting point of a line clearance done in the fill room?
Incoming pass-through and bottle infeed
At the ____ machine you are required to use an outlining tool to perform the vision challenge
USP
In tulip, while logging for completion of semi-annual clean it is considered a _______ entry
Room
The batch stop will not pass through a machine until which process is completed
Run Empty
A batch campaign time is how many days?
19 Days
How often is a scale check required?
Weekly
Where are challenges being documented for completion?
SAP and Pas-X log book
In tulip, while logging for completion of drain sanitisation it is considered a _______ entry
Equipment
_____ total line clearances are needed to proceed with starting a batch
4 line clearances
If there are 60,000 bottles required in a batch. There will be ____ samples required
6
During the tablet dumping process, after opening the plastic tablet bag...the next step in the process is
Checking the debossing of the tablets
How often are challenges required to be performed?
Monthly
When you are doing manual take-out at the beginning of the batch, what description do we use when the take-out is above target for the order?
Quantity acceptable
If a batch is released and ready to start in PAS X, what will show for the SFO (shop floor order) status? What does it show if it is started?
"RFP" "S"
If a work order is opened in the middle of a batch where would it be documented.
Pas-X
During a stability batch. how many times do collect stability samples need to be collected? What point in the batch are these stability samples collected?
Beginning middle and end of a batch. 3 sets of samples pulled.
Explain the checkweigher challenge at the USP machine. What are you checking for? What is the process?
Checking the USP for detection of a missing leaflet. Remove a leaflet from the cartoner machine. View the too light statistic on the checkweigher statistics value page. Confirm the carton with the missing leaflet was ejected to the faulty weighing eject bin. Verify the too light statistic increases by 1 value
Following a jam in the fill room, which JI is used to document the clearing of the jam in Pas-X?
Q0364489
When is a batch considered back-to-back?
There is no work order open
The line is not left unattended