APS
What does APS stand for?
Aseptic Process Simulation
What is considered Unload start time?
When the vial pack leaves exits the chamber
What is the first step of Rinser Teardown?
Draining and blowout procedures
SOP for SKAN Isolator operations
017536
What does AC stand for?
Area Clearance
What is the purpose of an APS
To test if the line can produce sterile product
When must tray off conduct a seal check?
At the end of every shelf
When must recirculation filters be replaced?
If after drying they are 1g or more over initial install weight
How many loading zones do the Fill and Lyo isolator have?
12 zones
What does BAS stand for?
Building Automated System
Required amount of APS to be ran each year
2
For reverse conveyance unloads what crucial step must be done before the slot door opens?
Ensuring NLT 2 hour particle count monitoring has been completed
During guided setup, after installing how many grippers will it ask you to move to format change to reposition the turret to allow install of the rest of the gripper blocks?
Grippers 1-6
What zone is loaded separately from the rest?
Zone 5
What does API stand for?
Active Pharmaceutical Ingredient
Minimum number of acceptable media vials required for APS
NLT 10,000
What intervention is used for removal of vials on the Lyo loading conveyor?
R1.6
What is Tunnel night mode used for?
To reduce temperatures and energy if the tunnel will not be used for an extended period of time while keeping pressure the same to ensure sterility is kept
What machines must give SKAN ready signals before Deco can start?
Filler, Tunnel, and CLU
What does CCI stand for?
Container Closure Integrity
What are the Filling Aseptic Process Simulation qualification interventions
R1.1/R1.2, R2.1, R3.1/R3.2, R4.1, R5.1, R8.1, R1.7, R7.1, R8.2
At the beginning of an unload, what must the oversealer and tray off operators do for the Lyo to start unloading the first rows?
They have to both start their machines and ensure they have ran empty
What process is used to ensure tunnel cool zone is sterile?
Cool zone sterilization (CZS)
During Deco cycle if errors occur that may pose danger to operators, the isolator will move into what mode?
EMERGENCY MODE
What does IPC stand for?
In Process Control