1、 Preparation before operation
1. Equipment inspection and parameter setting
Check whether the mechanical components (such as film feeding gripper, cooling system, tail sealing device) are firmly connected and whether the lubrication is sufficient.
Set parameters such as filling volume, speed, and air pressure to ensure compliance with production standards.
Confirm that the power supply, gas source, and vacuum system are operating normally.
2. Material and mold pretreatment
Select pre-treatment method based on drug properties:
Mix insoluble drugs with the matrix after grinding; Oil soluble drugs dissolve directly in the matrix; Water soluble drugs are absorbed by lanolin and then mixed together.
Apply lubricant (such as soap glycerol ethanol solution or liquid paraffin) on the inner wall of the suppository mold to facilitate demolding.
2、 Filling and sealing process
1. Film entry and filling
Manually clamp the shell roll film or send it into the track through an automatic film feeding mechanism, and start the film feeding gripper to complete continuous feeding.
The filling pump precisely fills the suppository shell through an embedded filling head (with an error of ± 2%), and the remaining liquid is circulated to the material barrel for repeated use.
The filling material bucket needs to be kept in a heated and insulated state, and the uniformity of the liquid medicine should be maintained through a stirring device.
2. Cooling and shaping
The filled suppository enters the cooling box and is quickly solidified by a chiller or cold air system.
Fully automatic equipment can adopt continuous cooling on the assembly line, and semi-automatic operation can temporarily store molds in the refrigerator to accelerate shaping.
3. Sealing and cutting
After cooling, the suppository is sequentially sealed, coded, dashed line cut, and roller trimmed to ensure the sealing and appearance of the seal are neat.
Adjust the gap between the tail sealing knife holder to about 0.2mm to avoid incomplete cutting or damage to the suppository.
3、 Closing and maintenance
1. Cleaning and resetting
After shutting down the equipment, clean up any residual medication and waste, and use specialized cleaning agents to disinfect the material barrels, pipelines, and filling heads.
Reset all mechanical components (such as film feeding mechanism, tail sealing tool), turn off the power and air source.
2. Quality inspection
Randomly inspect the weight, sealing integrity, and appearance of suppositories to ensure compliance with pharmacopoeia standards.