Views: 65 Author: Site Editor Publish Time: 2026-03-22 Origin: Site
The fully automatic hard capsule filling machine consists of the following main systems (see Figures 8-1 and 8-2):
(1) Empty Capsule Feeding Device: Composed of a hopper and conveying pipeline. It stores empty capsules and feeds them vertically one by one into the capsule orienting device.
(2) Capsule Orienting and Separation Device: Empty capsules enter the selector fork; each downward stroke delivers six capsules (caps upward). The vacuum separation system then precisely inserts and separates the cap and body into the mold segments.
(3) Powder Feeding Device: Consists of powder hopper, screw feeder, and delivery tube. Under screw rotation and stirring, powder is controllably delivered to the dosing disc.
(4) Dosing Disc Mechanism: Matched to capsule size and fill weight. Powder undergoes five intermittent compression cycles in the rotating dosing disc to form a compact slug, which is then pushed into the capsule body in the lower mold.
(5) Capsule Filling and Closing Mechanism: After the powder slug is inserted into the body, the upper mold cap is aligned and locked onto the body.
(6) Main Drive System (Inside Cabinet): Powered by a motor, Ferguson-type intermittent indexing box, gear pairs, reducers, cam assemblies, and chain drives. A variable-frequency motor enables stepless speed control.
(7) Electrical Control System: PLC-based, with touchscreen display of all process parameters.
During operation, empty capsules from the hopper are vertically oriented and drop cap-up into the capsule plate holes. The vacuum system separates the cap and body. The separated body moves under the dosing disc, where the tamping pins push the pre-compressed powder slug into the body. Unseparated capsules are automatically rejected. Filled bodies and caps are then aligned and locked at the closing station before ejection through the discharge chute.
(1) Inspect all components for damage and lubricate every grease point.
(2) Switch on the main power and set the air circuit breaker to “ON”. The control panel display will illuminate.
(3) Press the vacuum pump “ON” touchscreen button and verify correct rotation direction.
(4) Operating air pressure must be maintained between 0.4–0.7 MPa.
(1) Confirm vacuum pump rotation matches the arrow direction, then turn the speed knob “R” to the lowest setting.
(2) Start the capsule feeding motor. Press “ON”, gradually increase speed to maximum, and confirm smooth operation with no jamming or abnormal noise.
(3) Load empty capsules into the hopper. Run at low speed first, then gradually increase to the optimal speed (speed depends on capsule quality).
(4) Install the lower mold on the rotary table, add powder to the hopper, press the filling “ON” button, and begin capsule filling.
(5) Place the upper mold over the filled lower mold, move both to the locking station, insert the pins into the holes, turn the locking plate downward, and gently press the foot pedal valve to complete locking and discharge into the collection bin.
(1) Reduce speed knob “R” to minimum, press vacuum pump “OFF”, then press capsule feeding “OFF” to stop filling.
(2) Turn off the main power switch; all indicator lights will extinguish.
(3) Perform full machine cleaning according to post-operation SOP requirements.
(1) Monitor the oil-mist lubrication system every 2 hours. Add oil to the cup when low (1–3 min per drop) and record on the maintenance card. (2) Before each production run or after idle periods, perform a complete inspection of the pneumatic system, electrical system, drive system, and oil-mist system. Record results in the equipment maintenance log.
(1) Operators must follow personnel hygiene and gowning procedures. Wear latex gloves, 3M mask, safety goggles, etc. as required.
(2) Collect batch production records and status labels from the supervisor; verify consistency with actual production.
(3) Select and inspect molds from the mold room, complete handover and signing of mold borrowing records.
(4) Retrieve sieves, dust collector bags, containers, etc. Confirm they are intact, clean, and within validity period (or re-clean and obtain supervisor approval). Disinfect with 75% alcohol before use.
(5) Verify environmental conditions: 18–26 °C, 45–65% RH. Confirm machine and tools are clean with no residue from previous batches. Install molds per capsule filling machine SOP and change status label to “In Operation”.
(6) Install the capsule sorting/polishing machine per its SOP.
(7) Manually rotate the machine (filling rods in/out of dosing disc ≥2 times) to verify dosing disc accuracy, then jog at low speed for one full cycle. Confirm mold alignment. Wipe all powder-contact surfaces with 75% alcohol and allow to evaporate completely.
(8) Collect final-blended granules and empty capsules from intermediate stations. Double-check batch details, re-weigh, and record.
(9) After installation verification by supervisor and QA, begin production.
(1) Supervisor and QA calculate and approve target fill weight and range. Record empty capsule weight (average of 3 × 30 capsules), target filled weight, and locking tightness. Locking must be secure but allow slight play to avoid crushed heads.
(2) Add a small amount of powder, adjust fill weight per SOP, obtain QA first-article approval, then start normal production. Monitor: machine speed, filled capsule weight, appearance (locking, crushing, peeling, detached caps).
(3) Connect the sorting/polishing machine at the discharge. Use clean compressed air to remove light-weight, empty, fragmented, or separated-cap defects. Perform pre-production test to ensure empty shells are blown out.
(4) Continuously monitor capsule flow to prevent jamming in the polisher.
(5) Replace polishing brushes when surface powder buildup affects finish.
(6) Every 30 minutes, sample specified quantity, check weight and variation. Record on the capsule filling log sheet. If deviation exceeds limits, stop immediately, readjust, and re-verify. Samples are treated as waste powder.
(7) Store qualified product in double-lined stainless-steel drums, weigh, calculate yield, and attach labels.
(1) Collect and weigh all waste powder from dust collector, vacuum pump, dosing disc, test capsules, and filter bags. Hand over to supervisor and update waste log. Balance material inventory.
(2) Replace status label to “Ready for Cleaning”. Clean machine and area per SOP. After cleaning and QA approval, change label to “Cleaned” and attach green clearance certificate.
(3) Complete all batch records, equipment usage logs, cleaning records, and station logs. Submit to supervisor.
(4) Operators may leave the production site only after turning off the water, electricity and gas switches or valves and confirming again.
Table 8-1 shows the forms or records required during production.
Table 8-1 Forms or records to be filled during the production process | ||
Form or record name | Filler | Fill-in time |
Production Status Identification Card | Manufacturing Team Leader | Before feeding production |
Temperature and Humidity Record Sheet | Workstation Operator | Fill in every 2 hours |
Batch Production Record | Workstation Operator/Team Leader | Fill in promptly according to production process |
Deviation Record Sheet | Workstation Operator/Team Leader | Record when production deviation occurs |
Capsule Filling Record Sheet | Workstation Operator | Fill in every half hour during filling process |
Instrument Calibration Record | Workstation Operator | Fill in promptly after instrument calibration |
Instrument Usage Record | Workstation Operator | After instrument use |
Instrument Cleaning Record | Workstation Operator | After instrument cleaning |
Equipment Usage Record | Workstation Operator | After equipment use |
Equipment Cleaning Record | Workstation Operator | After equipment cleaning |
Workstation Cleaning Record | Workstation Operator | After job site cleaning |
Solid Dosage Production Area Cleaning and Clearance Record Sheet | Workstation Operator/Team Leader | After cleaning at the end of production |
Intermediate and Semi-finished Product Label Card | Workstation Operator | Label semi-finished product barrel weight |
Intermediate Station Label Card | Workstation Operator | Label semi-finished product |
Cleaning Verification Certificate | Workstation Operator/QA Personnel | After cleaning at the end of production |
Table 8-2 shows the common problems and solutions during capsule filling.
Table 8-2 Common problems and solutions in the capsule filling process | |||
Abnormal | Number | Cause Analysis | Solution |
Unsatisfactory filling difference | 1 | Particle size/granule bulk density is not ideal | Replace the appropriate measuring plate, re-granulate or granulate, increase the amount of lubricant |
2 | Filling rod position is not suitable | Adjust the filling rod position to the appropriate height | |
3 | Filling part spring breakage | Replace the spring | |
4 | Filling rod sticking | Clean the filling rod, lower the filling rod pressure | |
Capsules not separating | 1 | Vacuum pump pressure is insufficient | Increase the vacuum pump vacuum |
2 | Vacuum tube blockage or rupture脱落 | Check and clear the vacuum pipe | |
3 | Upper and lower mold misalignment | Re-calibrate the upper and lower mold positions | |
4 | Dust collector bag clogging | Clean the powder in the collection powder bucket bag or replace the bag regularly | |
5 | Dust collector leakage | Re-seal the collection powder bucket or use another collection powder bucket with good sealing | |
Capsule dosing port not dispensing | 1 | Material inlet blockage | Clear the debris at the discharge port |
2 | Empty capsules have peeling phenomenon | Check and clear | |
3 | Empty capsule body cap has detachment phenomenon | Check and clear | |
Capsule cap throwing | 1 | Vacuum pump pressure is too high | Reduce the vacuum pump vacuum |
2 | Machine speed is too high | Reduce the machine speed | |
Capsule crushed head | 1 | Filling machine lock port station needle position adjustment is too high or tilted, capsules are crushed | Lower or correct the position of the top needle (pay attention to the tightness of the capsule lock) |
2 | The length of the medicinal powder column in the capsule is too long, exceeding the length of the capsule body, resulting in overlong capsules | Use a thinner measuring plate, increase the filling rod pressure, compress the length of the powder column (only effective for powders with good compressibility). If this phenomenon occurs in multiple batches of powder, it is recommended to use a larger capsule | |
Capsule peeling | 1 | Filling machine needle position is tilted | Adjust the position of the top needle |
2 | Empty capsules themselves are not round enough | Use other capsules | |
Automatic shutdown | 1 | Machine load is too large | Reduce machine load |
2 | Powder surface detector fails to detect medicinal powder | Manual feeding; adjust the detector position or sensitivity | |
3 | Material hopper agitator reverses, material feeding speed is slow | Reconnect the mixer wires | |
4 | Insufficient empty capsules | Add empty capsules | |
Table 8-3 shows the common problems and solutions during capsule polishing.
Table 8-3 Common Issues and Solutions During Capsule Polishing Process | |||
abnormal | Number | Cause Analysis | Solution |
Capsules with minor filling defects, empty shells, fragments, or separated caps cannot be eliminated as defective products. | 1 | Compressed air pressure is too low | Increase the compressed air pressure |
2 | Capsules are added too quickly | Slow down the addition speed | |
Qualified semi-finished products are rejected | 1 | Compressed air pressure is too high | Reduce the compressed air pressure |
2 | Capsules are added too quickly | Slow down the addition speed | |
The surface of semi-finished products is covered with dust, not polished clean | 1 | Too much dust on the brush | Clean or replace the brush |
2 | Polishing machine motor rotates too fast | Lower the motor rotation speed | |