In the field of ophthalmic preparation production, the sterile eye drops linkage production line developed by Shanghai Bolaida Intelligent Technology Co., Ltd. has achieved closed-loop operation from empty bottle processing to finished product packaging through process integration and technical optimization, providing a stable and reliable solution for sterile preparation production.
1、 Core production process
The production line is centered around "aseptic control" and is progressing in an orderly manner in four key stages:
1Bottle sorting and pretreatmentAdopting a rotary table bottle sorting equipment, it automatically sorts out messy empty bottles and arranges them in a directional manner. Some models are equipped with mechanical arms to assist in positioning, ensuring a uniform posture of the bottle body; Accurately transport empty bottles to the cleaning station through a conveyor belt to avoid the risk of contamination caused by manual contact.
2Cleaning and sterilizationCombining physical cleaning and chemical sterilization technology - first remove particles and surface pollutants inside the bottle by high-pressure air washing or ultrasonic water washing, and then perform vacuum vaporization sterilization through a tunnel type hydrogen peroxide sterilization box; RABS (Restricted Access Barrier System) is set up in the front and rear buffer zones to maintain a completely sealed and sterile environment throughout the process, and to simultaneously complete bottle drying.
3Filling and sealingCeramic plunger pump paired with weighing feedback system, achieving precise filling of trace amounts of medicine solution. The chuck positioning device below the filling head ensures alignment of the bottle mouth; Subsequently, the piston pressing mechanism is driven by a cylinder to accurately press the inner stopper arranged by the oscillator into the bottle mouth. Finally, the motor drives the capping head, which, together with the anti rotation silicone block and the three jaw clamping mechanism, completes the tightening of the outer cap. The spring buffering design prevents damage to the bottle cap.
4quality controlSet up online detection modules at key nodes to monitor real-time filling accuracy and sealing integrity, ensuring that each batch of products meets quality standards.
2、 Key technological highlights
•High precision control technology: Servo motor and mass flowmeter are used to work together, the filling accuracy can reach ± 0.5%, and it is suitable for low viscosity liquid medicine within the range of 1-5000cP to viscous cream; Dynamic compensation technology can detect changes in liquid density and temperature in real time, automatically adjust filling parameters, and ensure consistency in batch production.
•Aseptic assurance systemIntegrated laminar flow purification system and hydrogen peroxide steam sterilization module, in compliance with pharmaceutical industry GMP standards and food HAACP standards; The fully enclosed pipeline design is combined with CIP (In Place Cleaning) system to achieve "zero contact" filling, greatly reducing the risk of contamination.
•Flexible designThe quick change chuck structure supports switching between circular, square, and irregular bottle bodies, as well as adjusting the specifications from 50ml to 5L, reducing the changeover time to 10-15 minutes; Multi station parallel processing technology can achieve synchronous filling of liquids and powders, meeting personalized production needs.
•Intelligent operation and maintenanceBy using digital twin technology to construct a 3D simulation model of the equipment, mechanical failures can be predicted in advance and maintenance can be carried out, reducing unplanned downtime by more than 40%; The OPC UA protocol enables device interconnection, real-time uploading of production data to the MES system, and supports dynamic optimization of process parameters.
3、 Application value and advantages
This production line demonstrates multiple values in practical applications:
•cost optimizationCompared to non continuous sterilization production methods, it reduces a large number of operational positions and lowers labor costs; Automated processes reduce material loss and improve resource utilization.
•Environmental SafetyThe decomposition products of vaporized hydrogen peroxide are only water and oxygen, with no chemical residues, which meets the requirements of green production; Fully sterile control is applied to the production of new eye drops without preservatives, meeting the market's demand for high safety preparations.
•Easy to operateSimply manually pour the bag wrapped plastic bottle into the bottle sorting machine, and the subsequent process will be fully automated, reducing labor intensity; The sterilization effect can be verified through both chemical and biological indicators to ensure production stability.
At present, this production line has been widely used in the production of sterile preparations such as eye drops and nose drops, providing practical support for the safe and intelligent development of the ophthalmic pharmaceutical industry.