Cleaning Requirements
This system is used to document weekly and monthly cleaning activities for packaging lines.
What is PMX?
Devices found outside the product flow must be processed as this.
What are rejects?
Unlabeled devices are placed here before reintroduction.
What is the blue recovery template?
This PMX feature is used to document GMP waste drums.
What is TrashTrackr?
This is the classification of the packaging area?
What is Controlled Not Classified (CNC)?
Full reject bags and partial reject bags are labeled with what colors?
What is white for full, yellow for partial?
After one hour of continuous de-labeling, this ergonomic precaution is required.
What is a ten-minute break with no use of hands, wrists, or forearms?
This must be done if a value or barcode number needs to be corrected in Trash Tracker.
What is use the Edit function?
What is the correct method for making corrections to hard copy GMP documents?
What is CLIDE: Correct, Line-out, Initial/Sign, Date/Time, Explain?
If cleaning is not performed within the required timeframe, this happens to batch processing.
What is PMX blocks new batch processing until cleaning is documented?
Before removing GMP waste drums from the line, what two tasks must be completed?
What is Final Accountability in PMX and documentation in Trash Tracker?
The same operator must perform these three actions for each device reintroduction.
What are inspection, movement, and reintroduction?
This is the function used to add clarification statements or additional details in PMX.
What is "Create Log"?
This document must be referenced for chemical-specific safety precautions during cleaning.
What is the Safety Data Sheet (SDS)?
This is the maximum number of devices that can be placed in a reject bag.
What is 50?
Before reintroducing a device tray, this must be confirmed on the HMI.
What is the Reintroduction Type is set to "Reintro"?
What is the preferred date format for GMP documentation?
What is DDMMMYYYY (e.g., 13MAR2022)?
This is the required head protection when crossing the plane of equipment during cleaning.
What is a bump cap?
This must be done to case labels before discarding rejected cases.
What is deface with a permanent marker?
What is the maximum number of labeled devices that can be reintroduced at a time on the accumulator clip chain?
What is 10?
This must be done when blank spaces are not omissions in documentation.
What is indicate "N/A" or "End of Data" with initials and date?