OPERATION OF COMPRESSION MACHINE IN PHARMA [PICTORIAL]

1. Objective

• Compress granules/powder into tablets of consistent weight, hardness, thickness and appearance
• Maintain GMP, safety, and data integrity throughout operation

2. Pre-Start Checks

Before touching START:

1. Line clearance
   • Previous product removed; area cleaned.
   • BMR, status board, “CLEAN / READY FOR USE” tag verified.
   • QA line clearance done (if required).
2. Material verification
   • Correct product name, batch no., strength.
   • Right granules/blend, right lubricant stage completed.
   • Sieving/milling steps completed as per BMR.
3. Machine checks
   • Dies and punches: correct tooling size & shape, clean, no damage.
   • Turret area clean, no leftover powder.
   • Guards, interlocks, emergency stop working.
   • Lubrication done as per preventive maintenance (no oil near product zone).
4. Documents
   • BMR/BPR available at machine.
   • In-process test formats available (weight, hardness, friability, thickness).

3. Setting up the Machine

1. Install tooling
   • Fit correct die set and punches (upper/lower).
   • Tighten as per SOP; rotate turret manually to check free movement.
2. Adjust basic settings (initial)
   • Fill cam / weight adjustment: approximate starting tablet weight.
   • Compression force / main pressure: start low.
   • Pre-compression (if available): set mild pre-compression.
   • Tablet thickness: initial setting with feeler gauge/scale.
3. Feeding system
   • Check hopper and feed frame/force feeder—clean and assembled correctly.
   • Ensure dust extraction connected and functional.

4. Trial Run & Optimisation

1. Run without product
   • Jog/slow run to confirm smooth motion, no abnormal noise/vibration.
2. Introduce small qty of blend
   • Start at low speed.
   • Observe powder flow, die filling, ejection.
3. Check trial tablets
   • Collect few tablets and test:
     • Average weight & individual weights
     • Thickness
     • Hardness
     • Friability (if needed at start)
     • Appearance (capping, lamination, picking, sticking, chipping)
   • Adjust:
     • Fill cam for weight
     • Compression force for hardness/thickness
     • Speed if defects appear
4. Lock parameters
   • Once within target specs, document:
     • Machine speed (rpm)
     • Main & pre-compression force (or scale settings)
     • Target average weight and limits
     • Target hardness/thickness range

5. Routine Operation of Compression Machine

1. Start batch run
   • Gradually increase speed to planned rpm.
   • Maintain continuous powder level in hopper.
   • Avoid big changes in feed level (affects weight).
2. In-process checks (typical)
   • At defined frequency (e.g. every 15–30 min or X tablets):
     • Average weight & individual weight variation
     • Thickness
     • Hardness
     • Appearance (visual)
     • Friability at defined intervals
   • Record results in BMR with time and machine parameters.
   • If out of limits:
     • Stop machine or divert tablets
     • Investigate (blend flow, cam drift, tooling issues)
     • Correct setting, segregate affected tablets, document.
3. Watch for defects
   • Capping / lamination → adjust compression profile, speed, dwell time, blend moisture.
   • Sticking / picking → polish punches, improve lubrication, adjust dwell time.
   • Weight not uniform → check feeder speed, blend uniformity, granule flow, level.
4. Housekeeping during run
   • Wipe spillage frequently, keep area tidy.
   • Don’t use oil/grease near die table.
   • No unnecessary items on compression platform.

6. Safety & GMP Behaviour

• Never run with guards open; interlocks must be functional.
• Keep hands and tools away from moving turret/punches.
• Use tools only as per SOP (no makeshift tools).
• No eating/drinking, no jewellery, no loose clothing.
• All adjustments and stoppages must be recorded (time + reason).

7. Completion of Batch

1. Run down
   • Stop feed, allow machine to compress remaining powder.
   • Stop machine as per SOP.
2. Reconciliation
   • Count/computer count vs. theoretical yield:
     • Good tablets
     • Rejected tablets
     • In-process samples
   • Explain any yield loss beyond limits.
3. Cleaning & status
   • Remove tooling as per cleaning SOP.
   • Clean machine and area (dry/wet as specified).
   • Affix appropriate status label: “CLEANED / READY FOR USE” or “UNDER CLEANING”.
   • QA visual check/clearance if required.
4. Documentation
   • Complete all BMR entries:
     • Start/stop times
     • In-process results and adjustments
     • Yield and reconciliation
     • Deviations, if any
   • Get signatures (operator, supervisor, QA).