Gowning and Cleanroom Rules
Is loose jewelry or piercings, fake eyelashes or dangling earrings allowed on the production floor? Is food, gum, candy, beverages, or tobacco products are allowed within the locker rooms or CNC production or office areas?
NO! Absolutely NOT
What does ASIM stand for?
Automated Syringe Inspection Machine
Is it optional to reference SOPs?
NO! You should always utilize your SOP when executing a task/process.
What is PMX?
-PMX is the system that it utilized to access our Batch Record.
What should you do if you notice a rip in your gowning, hairnet, or beard cover?
Immediately replace the damaged protective apparel.
What does PPE stand for? What PPE is required when operating the ASIM?
- Protective Personal Equipment.
- Safety glasses, bump cap (when entering inside the ASIM), nitrile gloves, and cut resistant gloves (when handling broken glass).
Will you utilize the ASIM Operations procedure to clear ASIM alarms?
NO! You will utilize the ASIM Alarm Response procedure to clear ASIM alarms.
What is the difference between "End of Batch" and "End of Section?"
-End of Batch is ending the entirety of the batch,
-End of Section is ending the current FO (Filling Order).
Name the PMX Work Center for ASIM
- SL4ASIM
Are you allowed to have personal medications / cosmetics / lotions stored in the street side lockers?
YES! Personal medications / cosmetics / lotions are only allowed to be stored in the street side lockers and cannot be stored in Parenteral controlled environments.
What are the 3 different Alarm Types and their differences?
- Error Alarms are the highest critical type of alarms on the ASIM and will stop the machine and require an operator response and comment to prevent impact to product.
- Warning Alarms are the second highest critical type of alarms on the ASIM and will not impact product. A warning alarm may cause an automated response from the ASIM.
- Info Alarms are the lowest critical type of alarms on the ASIM and will not impact product.
Who do you report a GMP concern to first?
- Any GMP/SOP concerns should be escalated to your Lead and Supervisor.
What tubs get removed for QA Pop End?
The last 3 inspected tubs get removed for QA Pop end samples.
Can you skip steps within the PMX Ticket?
NO! You have to complete PMX Ticket in chronological order.
Are you allowed to reuse gowning apparel?
YES! If returning to CNC area on the same day, remove gowning garments and place them in CNC side locker.
What does an operator need to do on the Inspection Module HMI after the Alignment Kit is complete and again after the Functional Kit is complete?
Reset the Trend Counters
What procedure will you use to relocate pallets from a specific floor location?
RTP-PRD-PMX Mobile Paletti Overview
What needs to happen prior to account for pallets?
Ensure the outgoing undetermined, QA Pop sample material TU(s) and good material TU(s) are created and sent back to ASRS
What is the purpose of a 'Log Event' in PMX?
- A 'Log Event' allows the operator to document any mistake or inaccuracy made when recording or inputting data into PMX.
What is the purpose of the yellow demarcation line in the locker rooms?
To distinguish between the CNC side and the unclassified side of the locker room.
How many syringes are in the Alignment Kit? How many syringes are in the Functional Kit? What color are the RNS tips in each kit?
Alignment Kit contains 15 good syringes with yellow-marked needle shield tips.
Functional Kit contains 15 syringes: 8 good syringes- 4 with needle shields marked in blue and 4 with needle shields marked in white. 5 with needle shields marked in orange. 1 with the needle shield marked in red. 1 with the needle shield marked in green.
You are running ASIM and need to print an Undetermined and Sample label. Which printers would you use? What color are each label? Which SOP will you use to ensure the correct printer and label was used?
-Undetermined labels get printed from Printer 142 and Sample labels get printed from Printer 141.
-Undetermined labels are yellow and Sample labels are blue.
-RTP-PRD-VI Labeling Process.
What is the difference between Line Inspection and Line Clearance? What is the purpose of both?
- Line Inspection ensures the equipment and workstation(s) are clear of all previous products or product materials, documents, and that the equipment is clean and suitable for use.
- Line Clearance is the process of removing all the completed batch specific materials from the line and area.
- The purpose of both is to ensure there is no product or material from the previous batch on the line.
What does it mean when PMX says you are locked out of a step?
- PMX will lock a procedure step until it is completed to prevent data from being overwritten by another user.