TL;DR
Vial breakage is usually a conveyor belt misalignment, a guide rail set too narrow, or a vial handling star wheel timing fault. Check guide rail spacing and star wheel timing first.
What you might see
- broken vials found on the filling line conveyor
- vial jam alarm at the in-feed or out-feed star wheel
- glass fragments in the fill zone
- increasing breakage rate on narrow or tall vials
Likely causes
Guide rail set too narrow for the vial diameter, clamping and cracking vials
Star wheel timing out of sync with the conveyor belt speed, causing vials to collide
Conveyor belt misalignment causing vials to tilt and contact the guide rail
Vial lot dimensional variation outside the handling system tolerance
Required tools
- Calipers for guide rail measurement
- Glass fragment collection kit (validated)
- Star wheel timing reference procedure
- Rail adjustment tools
Safety first
- Glass fragments from broken vials can contaminate the product. Follow the glass breakage SOP and quarantine all potentially affected product.
- Use cut-resistant gloves when removing glass fragments from the conveyor.
- If the broken vials contain injectable product, treat the area as a chemical or biological spill per site EHS procedure.
Procedure
- 1
Stop the line immediately and remove all broken glass fragments from the conveyor and fill zone. Use a validated glass removal procedure.[1]
- 2
Quarantine all product from the last 30 minutes of production before the breakage event for a glass contamination investigation.
- 3
Measure the guide rail gap at the in-feed, fill zone, and out-feed with calipers. Compare to the specification for the vial diameter.
- 4
Adjust the guide rail to the correct spacing using the rail adjustment handles. Verify by passing 10 empty vials through slowly by hand.
- 5
Check the star wheel timing by running the machine at low speed with no product and watching the star wheel pocket engage each vial position on the belt.[1]
- 6
Adjust the star wheel phase if the timing is off, following the phase adjustment procedure in the maintenance record.
- 7
Run 50 vials through at 50% speed and inspect for any vial-to-rail contact marks. Accept the line only when no contact marks are present.
Sources
Bosch / Syntegon Syntegon FXS / FLS Vial / Syringe Filling Line general technical documentation, Bosch / Syntegon
Syntegon FXS / FLS filling line general glass handling and conveyor procedures (general)
More guides for Bosch / Syntegon Syntegon FXS / FLS
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Stopper insertion faults are usually a stopper bowl jam, a worn insertion finger, or a stopper that is too sticky or too hard for the inserter setting. Check the bowl and insertion force first.
Stop fixing the same fault twice.
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