Standard Operating Procedure for the Fully Automatic Waxing Machine for Large Pills (Universal for Disc / Linear Type, GMP Version)
1. Preparations before startup (Pre-production inspection)
On-site and personnel preparations
The workshop environment is clean and dry, with a humidity of no more than 60%. There are no powder residues, old wax scraps or accumulated water inside or outside the equipment. The entire machine is wiped and disinfected with 75% alcohol.
The operators wear clean work clothes, heat-resistant gloves, goggles and masks. Wet hands are prohibited when operating the equipment.
Check the equipment grounding, three-phase power supply, air compressor pressure (standard 0.4–0.6 MPa), and ensure that the emergency stop button is in the reset position.
Ensure that the wax pool and cooling water pool are free of water accumulation and impurities; strictly prohibit water from entering the high-temperature wax pool to prevent the wax liquid from splashing and causing burns.
2. Preparation of materials and molds
Place the corresponding size molds (3g/6g/9g), lock and position them, and check that the suction cups and grippers are free from wear and air leakage.
Add food-grade paraffin wax to the wax tank, ensuring the liquid level is no lower than the minimum mark and no higher than the overflow outlet; add normal temperature fresh water (18–25℃) to the cooling water tank.
The assembled plastic shell to be dipped in wax must be dry on the surface, free of powder and moisture, and have a tight and seamless fit. Otherwise, there will be wax bubbles, poor sealing, and the shell will be damaged.
II. Startup Heating and Parameter Settings
Turn off the main power switch, then open the equipment control panel and touch screen, and start the air source switch.
In the process of setting process parameters on the touch screen (for reference):
Wax liquid temperature: 70 - 75℃ (If the temperature is too high, it will melt the plastic shell; if it is too low, the wax layer will be thick and prone to cracking and air leakage.)
Cooling water temperature: 18 - 25℃
Wax dipping depth, immersion time 1-2 seconds, dwell time for dripping wax after lifting, equipment operating speed
Start the heating system for the wax pool and the water circulation cooling system. Wait for the wax liquid to heat up and melt. After the wax melts, keep it at a constant temperature for 10 to 15 minutes to allow the bubbles to fully rise and dissipate, avoiding the formation of defective products with air holes on the wax surface.
After the temperature reaches the set value, first activate the point operation mode and conduct a 3 to 5 cycle no-load trial run: check whether the rotation disk / mechanical arm, suction cups, cylinders, and sensors operate smoothly, and whether there is any jamming, air leakage, or abnormal noise.
III. Formal Automatic Production Operating Procedure
1. The upper shell processing station
The plastic ball shells containing the prepared pills and securely fastened are manually poured into the feeding hopper. The conveyor belt automatically feeds the materials, and the equipment automatically sorts, aligns and precisely positions them, inserting each one into the positioning holes of the workpiece fixtures.
2. Retrieve the transfer workstation
The suction cup / mechanical gripper precisely adheres to the plastic shell, fixes it vertically, ensures that the combined seam of the two hemispheres is facing downwards, and smoothly transports it to the top of the wax pool.
3. Constant-temperature wax application station (core process)
The work clothes descend vertically at a slow pace. The plastic shell joint area is immersed in the molten paraffin for 1 to 2 seconds. It is slowly immersed and then quickly lifted to reduce the entrainment of air bubbles by the wax liquid.
After the lifting process, pause briefly above the wax pool to allow the excess wax to drip back into the pool naturally, to prevent the wax layer from being too thick or the surface from bulging.
High-end medicines can adopt a secondary wax coating process (three up and three down technique), with thin layers of wax for multi-layer sealing. This results in better sealing performance and a more attractive appearance.
4. Water-cooled Stabilization Station
After the wax dipping process is completed, it is immediately transferred to the top of the cooling water tank. The plastic shell falls into the circulating cold water for rapid cooling. The wax layer instantly solidifies and takes on its final shape, preventing the uneven thickness and sealing failure caused by the flow of the hot wax layer.
5. Automatic Discharge and Collection Station
The cooled wax-coated honey pills are transported along with the water flow to the discharge port, and then automatically roll down into the clean receiving basket. The operators collect and inspect them at regular intervals.
Key points for on-site inspection during operation
Real-time monitoring of wax temperature, water temperature and air pressure is carried out. In case of over-temperature, material shortage or jamming of equipment, an automatic alarm will be triggered and the machine will stop running.
Inspect the quality of the wax seal: no bubbles, no leakage, the wax layer is uniform and shiny, and the plastic shell does not deform.
The hopper should be refilled in time. It is not allowed to run with an empty hopper for a long time. Do not reach out to touch the moving parts or the hot wax pool.
IV. Shutdown procedures upon production completion
First, stop the automatic operation. After all the plastic shells in the hopper have completed the wax dipping and discharging process, switch to the manual mode.
Stop the conveying, grasping and wax dipping mechanisms, and shut down the water circulation system; the wax liquid can be kept warm without turning on the heating (for continuous production the next day), and it should be shut down again if there is a long-term shutdown.
When the wax liquid temperature drops below 60℃, clean the remaining wax stains and powder on the equipment surface; disassemble the work fixtures and hoppers for cleaning and disinfection, and dry and store the 304 stainless steel components.
Empty the wastewater in the cooling water tank, clean the workshop workstations, and complete the records of equipment operation, process parameters, and cleaning.
Turn off the touch screen, the air supply, and the main power supply. Confirm that the emergency stop has been pressed and locked.
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V. Common Process禁忌 and Safety Precautions
It is strictly prohibited to dip the plastic shell in the wax bath with water, and it is also forbidden to add water to the high-temperature wax tank. This is to prevent the wax liquid from splashing and causing burns or fires.
The wax temperature must not exceed 85℃ to prevent the wax from smoking and catching fire, as well as to avoid the plastic ball shell from deforming and melting.
During equipment operation, the safety guard cover must not be opened. In case of any malfunction, the emergency stop button should be pressed immediately.
Regularly clean the impurities at the bottom of the wax pool to prevent carbonized impurities from causing black spots in the wax seal and resulting in substandard appearance.
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