HPLC PRESSURE DROP
During batch file run after five std. Run pressure drop occurs due to which shift in RT. How can we file an incident report. What reason and explanation and remedies we file
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Is there any source of leak detected ?
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✅ Incident Report – HPLC Pressure Drop & RT Shift
1) What happened (Incident Description)
During a batch sequence, after the injection of five standards, a sudden pressure drop occurred in the HPLC system. Following the pressure drop, a shift in retention time (RT) was observed for subsequent standard injections and samples. The batch was stopped, and the issue was investigated.
✅ 2) Probable Cause(s)
A) Partial blockage dislodged → sudden flow increase → pressure drop
Sometimes a partially clogged column, guard column, or inline filter gets cleared suddenly.
When the blockage clears, backpressure drops and retention times shift to lower RT because of increased actual flow.
B) Leak in the system
A loose fitting, worn ferrule, or micro-leak in pump head or column inlet can reduce pressure.
Leak causes unstable flow → RT shift.
C) Pump malfunction / air bubble
Air bubble entering pump head reduces pressure and flow.
Causes inconsistent RT.
D) Mobile phase composition shift
Sudden change in gradient accuracy due to pump mixing issue.
Leads to RT drift and pressure change.
✅ 3) Explanation (Technical Justification)
HPLC pressure is directly linked to flow resistance across the column.
A sudden pressure drop indicates reduced flow resistance, typically due to:
Clearance of blockage,
Leak formation, or Pump instability.
Retention times shifted because the actual flow rate changed even though set flow seemed unchanged.
This directly impacts chromatographic performance and validity of the batch.
✅ 4) Remedies / Corrective Actions (CA)
You can list these:
1. Checked entire fluidic path (inlet filter → pump → mixer → injector → column → detector) for leaks.
2. Tightened all fittings and replaced worn ferrules.
3. Purged pump thoroughly to remove air bubbles.
4. Flushed column with strong solvent (e.g., 100% organic) to remove particulate blockage.
5. Cleaned / replaced guard column or inline filter if excessive debris was found.
6. Verified flow rate accuracy using a volumetric flask test.
7. Re-equilibrated column and re-injected system suitability standards.
8. Ensured no further pressure fluctuations before re-running batch.
✅ 5) Preventive Actions (PA)
Regular cleaning of inline filters.
Scheduled column maintenance (backflushing if allowed).
Strict filtration of mobile phase & samples through 0.22 µm filters.
Routine pump maintenance (seal wash, piston seal inspection).
Daily leak check before starting
1) What happened (Incident Description)
During a batch sequence, after the injection of five standards, a sudden pressure drop occurred in the HPLC system. Following the pressure drop, a shift in retention time (RT) was observed for subsequent standard injections and samples. The batch was stopped, and the issue was investigated.
✅ 2) Probable Cause(s)
A) Partial blockage dislodged → sudden flow increase → pressure drop
Sometimes a partially clogged column, guard column, or inline filter gets cleared suddenly.
When the blockage clears, backpressure drops and retention times shift to lower RT because of increased actual flow.
B) Leak in the system
A loose fitting, worn ferrule, or micro-leak in pump head or column inlet can reduce pressure.
Leak causes unstable flow → RT shift.
C) Pump malfunction / air bubble
Air bubble entering pump head reduces pressure and flow.
Causes inconsistent RT.
D) Mobile phase composition shift
Sudden change in gradient accuracy due to pump mixing issue.
Leads to RT drift and pressure change.
✅ 3) Explanation (Technical Justification)
HPLC pressure is directly linked to flow resistance across the column.
A sudden pressure drop indicates reduced flow resistance, typically due to:
Clearance of blockage,
Leak formation, or Pump instability.
Retention times shifted because the actual flow rate changed even though set flow seemed unchanged.
This directly impacts chromatographic performance and validity of the batch.
✅ 4) Remedies / Corrective Actions (CA)
You can list these:
1. Checked entire fluidic path (inlet filter → pump → mixer → injector → column → detector) for leaks.
2. Tightened all fittings and replaced worn ferrules.
3. Purged pump thoroughly to remove air bubbles.
4. Flushed column with strong solvent (e.g., 100% organic) to remove particulate blockage.
5. Cleaned / replaced guard column or inline filter if excessive debris was found.
6. Verified flow rate accuracy using a volumetric flask test.
7. Re-equilibrated column and re-injected system suitability standards.
8. Ensured no further pressure fluctuations before re-running batch.
✅ 5) Preventive Actions (PA)
Regular cleaning of inline filters.
Scheduled column maintenance (backflushing if allowed).
Strict filtration of mobile phase & samples through 0.22 µm filters.
Routine pump maintenance (seal wash, piston seal inspection).
Daily leak check before starting
