Area 2 Filling Process
Area 3 Filling Process
Good Documentation Practices
Know Your Support Groups!
Aseptic Technique
100
One difference between Area 2 Lyophilizer and Area 3 Lyophilizer is the number of shelves found in each area. Whereas Area 3 has 13 shelves, Area 2 has this many.
What is 26?
100
This rarely-filled product is filled into a 15cc vial configuration.
What is Ocrelizumab (or 2H7)?
100
This is the GSP which provides guidance on Good Documentation Practices.
What is GSP005?
100
An outfeed elevator overload alarm in Area 2 Vial Washer.
What is "Fill Specialist"?
100
This SOP details the standard/acceptable practice of aseptic technique/cleanroom behavior.
What is SOP 1640.004?
200
In Area 2, these two products are filled in multiple configurations.
What is Avastin (6cc/20cc) and Rituxan (10cc/50cc)?
200
The approximate time, in days, of an Activase 100cc Freeze Dry Cycle.
What is four days?
200
When considering correct labeling on an Area 2 Lyo Batch report, there are three items required for proper documentation.
What are: 1)Lot Information 2)Page Number 3)Operator Initial/Date
200
Filler Door Sensor #16 reads "OPEN" when in fact the Door itself remains "CLOSED".
What is "Automation"?
200
These interventions are not categorized in SOP 600.342 and therefore require a DMS.
What is a Supplemental Intervention?
300
Area 2 Capper has this feature which distinguishes itself from Area 3 Capper.
What is Spring Pressures (over Process Air)?
300
Provide the tag name for this sensor which measures non-viable particulates per SOP 1670.013.
What is AT?
300
The proper action taken for unused FNs with no data recorded.
What is discard?
300
A leaky pump (#2) discovered in Area 2 during product transfer for Rituxan 50cc.
What is "MSAT"?
300
SOP 600.342 requires that following an intervention, technicians are to remove vials within this distance on either side of the intervention.
What is THREE feet?
400
Per SOP 1630.026, during loading operations, what must be pressed prior to the last shelf reaching 80%?
What is "Stop Outfeed End Phase"?
400
Activase 100cc, which formerly used an 8-pump configuration, now uses a 4-pump configuration in effort to mitigate which issue/defect/phenomena?
What is product splashing/extreme splashing/product on stoppers?
400
Control Printing is required for this type of form used for filling operations.
What is/are QC (or EM) forms?
400
These two Groups are notified when the Velocity Sensors inside the cleanroom are malfunctioning during a fill.
What are EQA and Instrumentation?
400
For an Area 2 Fill: The maximum duration (in hours) and the maximum personnel allowed inside 8316.
What is 32 and 6?
500
Filler Z-Bars: When are they installed, what is their purpose, and what product/configuration is it used on?
1. During Changeover 2. To help actuate filler pumps to its full capacity 3. Rituxan 50cc
500
For the Area 3 Lyo, this designation/label for shelf height must read at less than or equal to 1.0mm on the Lyo HMI, per SOP 1670.025.
What is ZT1?
500
Technicians AB and CD are working on fill checks inside an Area 3 Fill. Technicians AB and CD weigh out the first vial of the fill check. It reads "55.01g". Technician AB documents Gross Weight as "45.01g". Technician CD, acting as verifier, observes the inaccurate documentation. Detail the proper steps required to address this issue. (Hint: Be as detailed as possible)
1. Cross out the incorrect entry. 2. Initial/Date for Operator/Verifier 3. Input the correct entry as given through the scale 4. Write a process comment providing what was observed and what actions were taken- explain the crossout!!!
500
These three groups are notified in the event of a HEPA failure inside the cleanroom.
What are EQA, Facilities (UOME/PEME/TSS), MSAT?
500
Per SOP 1640.004, in Areas 2 and 3, this is the only location where vial rejection is NOT ALLOWED
What is "On Autoloader Table and Infeed"?
M
e
n
u