Problems on this page:
Fill volume out of tolerance
Hits OEE: Quality
Symptoms: In-process weight checks drift high or low, or reject more vials than usual.
Pump or dosing settings drifting
Check the dosing settings against the batch record and recalibrate the pumps as the procedure describes.
Air bubbles in the product line
Prime the line fully and check the connections on the suction side for small leaks.
Pump tubing or piston worn
Replace peristaltic tubing or piston parts on the schedule the maker sets, not only when weights drift.
Product temperature or viscosity changing
Keep the product at the temperature the process was validated at.
Prevention: Fill weight trend charted for every batch so a drift is seen before rejects rise.
Stoppers missing or not seated
Hits OEE: Quality
Symptoms: Vials leave the stoppering station without a stopper, or with the stopper raised or tilted.
Stopper bowl feed jamming
Check the bowl and track for stuck stoppers and the vibration setting for the stopper type.
Stopper siliconisation outside its range
Check the stopper batch against its specification, since it changes how stoppers slide.
Stoppering head height or alignment off
Check the head setting against the vial format and its change parts.
Vial height or neck varying
Check incoming vials against their drawing.
Prevention: Stopper presence checked by the inspection system with its challenge test at start-up.
Vials tipping or breaking
Hits OEE: Availability
Symptoms: Vials fall over at the infeed or transfer points, or broken glass stops the line.
Change parts not matching the vial format
Check that every star wheel and guide is the set for this vial size.
Too much pressure on the infeed table
Reduce the back pressure on the accumulation table.
Timing between stations off
Check the transfer timing as the maker describes.
Glass defects in the incoming vials
Inspect the vial batch and raise defects with the supplier.
Prevention: Broken glass recorded and cleared under the line clearance procedure, with the cause noted.
Environmental monitoring excursion
Hits OEE: Quality
Symptoms: Particle counts or microbial results in the filling zone exceed the action level.
Glove or sleeve breach
Handle the excursion under your site deviation procedure and test the gloves used in the period.
Airflow disturbed in the critical zone
Check the airflow and pressure readings and any change to equipment layout near the filling point.
Too many or poorly performed interventions
Review the interventions in the period against the approved list and the operator training.
Gap in cleaning or disinfection
Check the cleaning records for the room and the isolator or barrier.
Prevention: Monitoring trends reviewed per batch, with interventions recorded as they happen.
Glove integrity test failing
Hits OEE: Availability
Symptoms: The glove tester fails a glove port, and filling cannot start or continue.
Glove worn or punctured
Replace the glove following the procedure, and look at what may have caused the puncture.
Glove fitted incorrectly to the port
Refit the glove and repeat the test.
Tester seal or adapter leaking
Check the tester seal and its own leak check.
Glove past its replacement date
Replace gloves on the fixed interval, not only after a failure.
Prevention: Glove test results logged per port with the glove fitting date.
Product dripping or splashing at the needle
Hits OEE: Quality
Symptoms: Drops form on the needle tip, or product splashes onto the vial neck.
Suck-back setting too low
Adjust the suck-back so the needle does not drip between vials.
Needle position too high or off centre
Check the needle depth and centring for the vial.
Dosing speed at the end of the fill too high
Slow the end of the dose so product does not splash.
Damaged needle tip
Replace damaged needles.
Prevention: Needle condition and position checked at each set-up.
Weigh station stopping the line
Hits OEE: Performance
Symptoms: The in-process weigh station stops the machine with false rejects.
Weigh cell not calibrated
Calibrate the weigh cell with certified weights.
Vibration or airflow disturbing the balance
Check what is touching or blowing on the weigh cell.
Tare values wrong for the vial batch
Re-tare with vials from the current batch.
Sampling set more often than needed
Check the sampling frequency against the batch record.
Prevention: Weigh cell verified at start-up of each batch.
Crimp caps not secure
Hits OEE: Quality
Symptoms: Caps can be turned by hand, show creases, or the crimp skirt is uneven.
Crimp pressure or roller setting wrong
Set the crimp for the cap and vial format and check it with the approved test.
Crimp rollers worn
Replace worn rollers.
Cap specification changed
Check incoming caps against their drawing.
Stopper not fully seated before crimping
Fix the stoppering step first.
Prevention: Crimp quality checked on samples at set intervals.
Decontamination cycle failing
Hits OEE: Availability
Symptoms: The isolator or room decontamination cycle aborts or fails its indicators.
Humidity or temperature outside the cycle limits
Check the room conditions before the cycle starts.
Load or layout different from the validated one
Load the isolator as the validated pattern shows.
Sensor out of calibration
Calibrate the cycle sensors on schedule.
Leak in the isolator or its ducting
Run the leak test and find the leak before repeating the cycle.
Prevention: Cycle records reviewed after every run, with failures investigated before the next batch.
Guidance only. Always follow lockout/tagout and your site's safe-work procedures, and verify against OEM manuals before acting.
Related equipment guides: filling machine · capsule filler · freeze dryer · autoclave · vision inspection · ampoule filling machine
Stop the same fault coming back
Recurring aseptic vial filler stops usually trace to a cause you cannot see by hand. The partner we recommend is Fabrico: it tracks OEE and downtime live from PLCs, IoT sensors or AI cameras; where cameras are fitted, the video of a stop sits next to its machine data so the cause can be reviewed; and a technician opens the work order from the stop in the same system. Data is hosted in the AWS EU region, and Fabrico and the company behind it hold ISO/IEC 27001, ISO/IEC 20000-1 and ISO 9001.
Book a Fabrico demo
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Related tools: full troubleshooting directory · OEE calculator · downtime cost · MTBF / MTTR · glossary
Methods that cut recurring stops: the six big losses · root cause analysis · preventive vs predictive maintenance · TPM · SMED & changeover