1、 Equipment preparation and debugging
1. Check before startup
Confirm that the components of the filling machine are intact, the fasteners are not loose, the power/air supply connection is normal, and the pressure meets the standard (the working air pressure usually needs to be maintained at 0.6-0.8MPa).
Clean the parts of the equipment that come into contact with the liquid medicine (such as filling valves and buckets) to ensure that there are no residues; The material contact parts must comply with GMP standards, and 316L stainless steel material is preferred.
2. Parameter calibration
Adjust the mold according to the type of suppository (head shaped, duckbill shaped, etc.), and accurately set the filling amount (typical range is 2-5g/capsule), cooling temperature, and sealing pressure.
Before use, it is necessary to verify the accuracy of the filling amount and control the weight difference of the suppository within the industry standard range.
2、 Production process control
1. Filling and sealing operations
Maintain constant temperature and continuous stirring of the material barrel during filling to avoid liquid layering or viscosity changes; Using isobaric filling method to reduce bubble generation, seal immediately after filling.
During the sealing stage, it is necessary to monitor the temperature of the preheating and heat sealing molds to prevent overheating from causing deformation of the bolt shell or inadequate sealing.
2. Environmental and Health Management
The operating area needs to be kept clean and regularly cleaned of dust and debris; Parts that come into contact with the medication should be disinfected daily with neutral cleaning agents and 75% alcohol.
Operators should wear sterile protective equipment (masks, gloves, etc.), and unrelated personnel are prohibited from entering the filling area.
3、 Equipment maintenance and troubleshooting
1. Daily maintenance
Fill the transmission components (gears, chains) with food grade lubricating grease every week and regularly check the belt tension; The sealing ring should be replaced every quarter to prevent leakage of medication.
Monthly dust removal for the condenser of the refrigeration system to ensure cooling efficiency; Check the aging status of electrical circuits every month.
2. Fault handling
If abnormal vibration or response occurs during operation, immediately stop the machine and investigate issues such as mechanical jamming, sensor failure, or insufficient air source pressure.
When the filling accuracy deviation exceeds ± 1ml, the flowmeter needs to be calibrated; Regularly use laser aiming instruments to test the accuracy of equipment.
4、 Safety regulations
1. It is strictly prohibited to repair or adjust components while the equipment is in operation. Fault handling requires power-off and hanging warning signs.
2. The production line is equipped with an emergency stop button, and the operators need to be trained and familiar with the emergency response process.
Through standardized operation and meticulous maintenance, the failure rate can be significantly reduced, ensuring the finished product rate and quality stability of suppository filling.