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Aseptic pre-filled syringe filling and sealing line
1. Introduction
Aseptic pre-filled syringe filling and sealing line is mainly used for the unpacking, tearing, filling and plugging of disposable syringes in nest boxes in pharmaceutical plants. It’s mainly for the production and packaging of various aseptic products such as vaccines, monoclonal antibodies, small molecule heparin, insulin and hyaluronic acid.
2. Performance
- The design, materials, manufacturing, assembly and commissioning of the whole prefilled syringe filling line manufacturing process are in accordance with the new GMP regulations;
- These syringe liquid filling machine adopts servo control system to automatically complete the processes of honeycomb tray unpacking, tearing film, conveying, filling, plug feeding, plug filling and tray output. It’s with electromechanical integration control, stable operation and high degree of automation;
- Applications: 1ml - 20ml (according to user specifications);
- Filling range: 0.1ml-20ml;
- Capacity: 2000-30000 bph;
- Filling head: 2-10 pcs, choose according to capacity;
- Various types of syringe filling pump options: metal pump, peristaltic pump, ceramic pump;
- PFS machine filling accuracy: ≤ ± 1% (depending on the characteristics of the medicine);
- Pass rate ≥99.9% ;
- Automatic removal and return of the syringe from the honeycomb tray by means of a servo system combined with a cylinder;
- Fully automatic production control with intelligent testing devices at the core stations;
- No friction between the contact surface of the pluger and the drug solution and the bottom rail during transport. The stopper is always protected by laminar flow, avoiding the risk of particles and contamination;
- The main drive components of the syringe filling line are servo-driven and are located in the lower part of the machine frame, which allows precise positioning and avoids pollution of the environment.
- The plastic syringe filling machine can be equipped with a servo motor controlled filling pump for filling, which is highly accurate and easy to adjust;
- Configurable filling system CIP/SIP system;
- A nitrogen filling unit can be configured to isolate the medicinal solution from oxygen;
- Can be equipped with a vacuum filling system for filling the high viscous products;
- Configurable with Open-RABS isolation protection system and Class 100 air purification laminar flow system;
- The high-performance no bottle no filling, no bottle no capping and linked bottle squeeze stop function can be configured;
- Pharmaceutical syringe filling machine can be equipped with multiple robots for collaborative control technology to fully automate the process of tearing film, de-lining, filling, pluging and weighing of pre-filled syringes;
- The automatic calibration of the filling volume can be configured to calibrate the filling volume fully automated;
- Can be equipped with fully closed aseptic isolation (Isolator) systems and bag-in-bag-out (BIBO) systems if needed;
- Fully automatic control and monitoring of the production process using control technologies such as high-precision colour touch screen operation and monitoring, PLC automatic control, automatic protection and mainframe variable frequency speed regulation;
- Can customized relevant products according to the actual needs of the customer.
3. Successful Prefilled Syringe Filling Line Case
We did a successful prefilled syringe filling line in Malaysia, click on the following link to learn more details: Malaysia-Prefilled-Syringe-Filling-Production-Line-Project
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