Hard capsules are dosage forms made by filling a certain amount of drugs and excipients into empty capsules after the drugs have been processed into a uniform powder or granules. Capsules are one of the most widely used oral dosage forms and have the following characteristics: they can mask unpleasant odors of the drugs, disintegrate quickly, are well absorbed, have accurate dosages, good stability, and are easy to control in quality. With the continuous development of pharmaceutical equipment and the extensive use of fully automatic capsule filling machines, the production efficiency and quality of hard capsules have been greatly improved, while production costs have been reduced. The preparation of hard capsules generally involves the preparation of filling materials, capsule filling, capsule polishing, sub-packaging, and packaging, with capsule filling being the critical step.
According to the power, manual filling plate, semi-automatic capsule filling machine, and fully automatic capsule filling machine can be selected.
Semi-Automatic Capsule Filling Machine
A semi-automatic capsule filling machine primarily consists of the base and electrical control system, capsule feeder, filler, locking mechanism, and variable frequency speed controller.
1) Characteristics of Semi-Automatic Capsule Filling Machine
The semi-automatic capsule filling machine was an early pharmaceutical production device primarily used to fill drugs into empty capsules, equipped with different molds for various capsule sizes. It features an open design, making it economical and versatile. However, due to significant dust generation, contamination risks, and low efficiency, it is mainly used for laboratory or training purposes today.
2) Working Principle of Semi-Automatic Capsule Filling Machine
Empty capsules loaded in the capsule hopper are released in a row by the capsule feeder, falling onto the capsule comb. The capsules are pushed forward to the orientation position by the push plate. The capsule body faces downwards while the cap faces upwards, and under the action of the vacuum pump’s negative pressure airflow, the capsules enter the capsule mold. The capsule cap stays in the upper mold due to the mold hole flange, while the capsule body is sucked into the lower mold by the negative pressure. The operator manually separates the upper and lower molds. The lower mold stays on the rotating table ready for filling.
The hopper contains a screw drill that, driven by a variable frequency speed motor, forces the drug powder into the empty capsules. Similarly, the rotating table, driven by a variable frequency speed motor, rotates the mold. When the fill start button is pressed, the hopper, pushed by a cylinder, moves toward the mold. Once in place, the table motor and hopper motor automatically start, rotating the mold under the filling nozzle. The drug powder is filled into the empty capsules under the pressure of the screw drill. After one rotation of the lower mold plate, it automatically stops, and the cylinder pulls the hopper out of the mold, completing the filling process.
Fully Automatic Capsule Filling Machine
A fully automatic capsule filling machine mainly comprises the base and electrical control system, LCD interface, capsule hopper, capsule feeder, rotary table, drug hopper, filling device, capsule locking device, and capsule ejection device.
1) Characteristics of Fully Automatic Capsule Filling Machine
The fully automatic capsule filling machine is a newly developed piece of equipment. Its main function is to fill drugs into empty capsules, equipped with different molds to perform actions such as capsule feeding, separation, filling, waste ejection, locking, finished product discharge, and module cleaning simultaneously. The machine has a fully enclosed design that meets GMP requirements and features novel structure, accurate dosage, high production efficiency, safety, and environmental protection. It is widely used in pharmaceutical production.
2) Working Principle of Fully Automatic Capsule Filling Machine
Empty capsules in the hopper enter the sequencing device’s fork one by one as the machine operates. The capsules are oriented by the capsule guide slot and fork, with the capsule body facing downwards and the cap upwards. Each machine operation releases a row of capsules into the module holes, and the capsule body is separated from the cap by the vacuum separation system. The rotary table's intermittent motion moves the capsules to various stations. The lower module extends outward, separating from the upper module for filling.
The drug powder enters the dosing device’s powder ring from a stainless steel hopper, with the powder height in the ring controlled by a level sensor. The filling rod pushes the compacted powder column into the capsule body, and adjusting each group of filling rods' height changes the dosage. The lower module retracts, aligning with the upper module. The filled capsules are locked by the pushing rod and ejected for collection. The vacuum cleaner clears the module holes before the next cycle begins.
Operating Procedures for Different Types of Capsule Filling Machines
1. Semi-Automatic Capsule Filling Machine Operating Procedures
(1) Pre-Operation Inspection
1. Check if the equipment is tagged with "Intact" or "Cleaned" status signs.
2. Remove the "Cleaned" sign and prepare for production.
(2) Pre-Operation Equipment Check
1. Ensure the power connection is correct.
2. Verify that all parts of the equipment are functioning normally, the air compressor is operational, the accessories meet requirements, and the electrical circuits are safe.
3. Disinfect the equipment according to the cleaning procedure.
4. Select the appropriate mold, ensure it meets the requirements, and disinfect it.
(3) Installation
1. Install the hopper and fix it with screws, then choose and install the appropriate screw drill.
(4) Operation
1. Turn on the main power switch and run the machine empty to check for normal operation and display. Proceed to normal operation only if there are no abnormalities.
2. Turn on the vacuum pump and air compressor, and check the air pressure.
3. Load the qualified empty capsules into the capsule hopper, and test the capsule feeder. The capsules should feed smoothly with the capsule body facing down and the cap facing up. Adjust the capsule feeder or the vacuum pump's negative pressure as needed until normal operation is achieved. Be cautious when adjusting the capsule feeder to avoid finger injuries.
4. Add the drug powder or granules to the hopper, ensuring the amount covers the screw drill. Perform a test fill and adjust the speed and screw drill to stabilize the fill quantity to meet quality requirements.
5. Use the appropriate locking force for capsule capping, and check the capping for proper engagement. The locking should be tight and appropriate, with no open ends or dents. Adjust the locking force or check the capsule body, cap, or dome thickness if issues arise.
6. Begin formal filling, replenishing the drug and empty capsules as needed. Continuously monitor the capsule weight and appearance, making adjustments as necessary.
7. During operation, ensure the machine is functioning properly and do not leave the machine unattended while it is running.
8. After completion, turn off the main power, vacuum pump, air compressor, and the main power switch. Clean and maintain the equipment.
(5) Possible Malfunctions and Troubleshooting
Sudden Shutdown During Operation
Possible Causes:
1. Poor electrical contact or issues with the electrical control system.
2. Loose or damaged mechanical transmission parts, or motor overload.
Troubleshooting Methods:
1. Check the electrical control system and ensure the motor contactor is functioning properly.
2. Inspect the mechanical transmission parts for looseness or damage and check for motor overload, making necessary adjustments.
Capsule Feeding Not Smooth
Possible Causes:
1. Quality issues with empty capsules.
2. Loose capsule feeder.
3. Insufficient air pressure.
Troubleshooting Methods:
1. Inspect the capsules and use qualified ones.
2. Adjust the capsule feeder.
3. Adjust the vacuum air pressure.
Poor Separation of Capsule Body and Cap
Possible Causes:
1. Unqualified empty capsules, capsules locked too tightly, or capsules are damp.
2. Non-standard mold plate.
3. Insufficient vacuum air pressure, blocked or leaking vacuum pipeline.
Troubleshooting Methods:
1. Inspect the capsules and use qualified ones.
2. Replace the mold plate with a standard one and check the vacuum gauge pressure, also inspect and clean the vacuum pipeline and filter.
Poor Capsule Locking, Too Loose or Too Tight, or Open Ends or Dents
Possible Causes:
1. Insufficient compressed air pressure.
2. Inappropriate foot pedal pressure.
Troubleshooting Methods:
1. Adjust the air pressure.
2. Adjust the foot pedal pressure.
2. Automatic Capsule Filling Machine Operating Procedures
(1) Pre-Operation Inspection
1. Check if the equipment is tagged with "Intact" or "Cleaned" status signs.
2. Remove the "Cleaned" sign and prepare for production.
(2) Pre-Operation Equipment Check
1. Ensure the power connection is correct.
2. Check lubrication points and add lubricant (oil/grease).
3. Inspect all machine parts for looseness or misalignment, correct and tighten if necessary.
4. Insert the vacuum cleaner hose into the filling machine's vacuum pipe.
5. Open the vacuum pump water valve.
(3) Jog Operation Steps
1. Close the main power switch; the main power indicator light will turn on. Rotate the power switch to turn on the main power.
2. Start the vacuum pump switch; the vacuum pump indicator light will turn on, and the pump will start working.
3. Start the vacuum cleaner to begin dust collection.
4. Press the jog button to run in jog mode. After confirming normal operation, switch to normal operation.
5. Press the start button; the main motor indicator light will turn on, and the machine will start running. Adjust the frequency converter, with the frequency display set to zero.
(4) Automatic Filling Operation Steps
1. Load empty capsules into the capsule hopper.
2. Press the feed button; the feed motor will work. When the material level reaches a certain height, the feed motor will automatically stop.
3. Adjust the frequency converter to the desired operating speed.
4. To stop the machine, press the stop button, then turn off the vacuum pump and the main power.
5. In emergencies, press the emergency stop button to halt the machine.
(5) Replacing or Installing Molds
When changing capsule specifications, the metering disk, upper and lower modules, sequence forks, and guide slots must be replaced. After replacing parts, manually rotate the main motor handwheel for 1-2 cycles. If abnormal resistance is felt, stop and check the replaced parts to troubleshoot.
(6) Replacing and Installing Upper and Lower Modules
1. Loosen the fastening screws and remove the upper and lower modules.
2. The lower module is positioned by two cylindrical pins. After installing the lower module, tighten the screws.
3. When installing the lower module, insert the adjustment rods into the two outer capsule holes to align the upper and lower module holes, then tighten the screws. The adjustment rods should rotate smoothly.
4. When replacing modules, manually turn the main motor handwheel, ensuring to remove the adjustment rods during rotation.
(7) Replacing and Installing Capsule Dispensing Components
1. Unscrew the two fastening screws and remove the capsule hopper.
2. Manually turn the main motor handwheel to move the sequence fork to its highest position.
3. Unscrew the two screws securing the sequence fork assembly and detach it from the positioning pins.
4. Unscrew the two fastening screws securing the capsule guide slot and remove the guide slot assembly.
5. Unscrew the fastening screw on the sequence fork and remove the fork.
6. Install the replacement capsule dispensing components in reverse order.
(8) Replacing and Installing the Metering Disk and Filling Rods
1. Lift the powder hopper and turn it to the side.
2. Rotate the main motor handwheel to position the upper mold frame at its highest point.
3. Loosen the bolts and remove the clamping device from the mold frame.
4. Loosen the locking screw on the clamping device and pull out the lower pressing plate to install the filling rods.
5. Remove the mold frame and powder feeder.
6. Use a special wrench to unscrew the bolt securing the metering disk, then install the metering disk and powder ring.
7. Reinstall and tighten the powder feeder. Adjust the gap between the scraper bottom and the metering disk using the adjustment screw.
8. Reinstall and secure the mold frame, ensuring the metering disk can rotate smoothly. Insert the adjustment rods into each hole.
9. Install the filling rods and the clamping device.
(9) Possible Malfunctions and Troubleshooting
Capsule Cap-Body Separation Issues
Possible Causes
1. Non-compliant capsule size, too tight pre-locking.
2. Misalignment of upper and lower modules.
3. Foreign objects in mold holes.
4. Insufficient vacuum, blocked or leaking pipeline.
5. Vacuum suction plate not close to the template.
Troubleshooting Methods
1. Visually inspect the capsules.
2. Adjust the module position using the module adjustment rod, and check the alignment of the plate and positioning pin.
3. Check for foreign objects in the module; if present, use pliers or a brush to clean.
4. Check the vacuum gauge pressure, inspect the vacuum pipeline, and clean the filter.
5. Carefully adjust the position of the vacuum suction plate and inspect the vacuum pipeline and filter.
Sudden Shutdown During Operation
Possible Causes
1. Powder runs out.
2. Foreign objects mixed in the powder block the outlet.
3. Electrical control system components damaged.
4. Mechanical transmission parts loosen, damage or jam, causing motor overload.
Troubleshooting Methods
1. Add powder.
2. Check if foreign objects are mixed in the powder, and remove if found.
3. Check the hopper’s electrical control system and the motor contactor.
4. Inspect the mechanical transmission parts for loose or jammed components causing motor overload; carefully inspect, repair, and adjust the machine as necessary.
Automatic Feeding Failure
Possible Causes
1. Poor electrical contact.
2. Damaged material level sensor or feeding device.
3. Feeder switch tripped.
Troubleshooting Methods
1. Refer to the electrical schematic to check the corresponding circuit and have an electrician troubleshoot the fault.
2. Check the sensor sensitivity, clean the proximity sensor, and adjust the sensor sensitivity.
3. Check if the feeder switch protection is triggered and reset if necessary.
Poor Ejection of Finished Products
Possible Causes
1. Capsules have static electricity.
2. Blockage by foreign objects.
3. Excessive tilt angle of the discharge port.
4. Loose screws on the discharge port causing protrusion.
Troubleshooting Methods
1. Check if capsules are sticking in the discharge port; if so, use clean compressed air to blow out the products.
2. Check the position of the pusher and guide.
3. Clean the discharge port.
4. If the problem is due to excessive tilt angle, adjust the screws to reduce the tilt angle.
Contact Person: Ms. Wei
Tel: 86-15372434551
Fax: 86-571-88615836