Packaging Flashcards
Tell us High speed packaging line controls
Why is pin hold detection important?
(this was in response to me talking about a pin hole detector being one of the controls on the line)
You are changing your PIL – can you talk through how this would be managed?
There was a rogue tablet found which was blue in color after the manufacturing of 4 batches of white tablets.
This led to discussion about line clearance packaging machine challenge testing.
You received a complaint regarding a batch of sachets. Complainant stated that the pack contains white powder instead of the normal granules. What do you do?
R&D manager tells you they want to pack an IMP and placebo for stage IV clinical trial on high speed packing line used for commercial, what do you say?
- What are the controls on a high speed packing line?
Rogue tablet found on packaging line. It is aspirin, found during packing salbutamol. Aspirin last manufactured 2 batches back. What do you do? Different shape and colour. Would you contact DMRC ?
An operator tells you that they just focus a blister pack with an empty pocket, what do you do?
What controls are in place on a high-speed packaging line?
Your operators on your high-speed packaging line come to you with a problem that tablets are twinning? What does that mean? What would you do about it?
What are the risks of twining??
What are controls on the line?
While certifying a batch of commercial product you notice that the braille does not match the pack strength (braille – 50mg, pack 25mg). What are you concerns and what do you do?
Investigation revealed that the problem was with the artwork approval process.
Talk through the artwork approval process and indicate where this issue could have been identified and prevented.
Where would you find the requirements for braille on packaging?
What standard is required for braille?
Drug name and strength have already been mentioned, what other information would a blind consumer need to know?
Can you describe a high speed packaging line and the controls you would expect to see in place?
What are the controls on high speed packing line?
During engineering maintenance 6 pink rogue tablets are found struck in the hopper and the position is just above the web. The maintenance schedule is every 6 months. The first batch manufactured after maintenance is pink tablets and rest of the batches are white tablets.
What is CCIT and how do you perform it?
Model Answer:
Container Closure Integrity Testing (CCIT) ensures the container (e.g., vial, prefilled syringe) maintains sterility over shelf-life. Methods include:
• Dye ingress
• Vacuum decay
• Helium leak detection
• High-voltage leak detection (for liquids)
Tips:
• Mention it’s a GMP expectation for sterile products (Annex 1 and USP <1207>).
• Essential for sterility assurance and product quality.
What are critical parameters to validate for a high-speed double-blind packaging line?
Model Answer:
• Speed control: Packaging line speed and reject mechanisms.
• Segregation: IMP vs placebo—prevent cross-mix.
• Line clearance and reconciliation: 100% checks, especially between arms of the study.
• Labeling: Blinded labeling accuracy and verification.
• Vision systems: To detect label presence, orientation, integrity.
• Weighing: If placebo and active differ in weight, use automated check-weighing.
Tips:
• Highlight importance of blinding integrity.
• Mention that validation includes mock runs simulating full study batches.
