Marya sterile prefilled syringe and pharmaceutical cartridge filling machine with CIP/SIP system
Overview
The performance and accuracy of Marya cartridge bottle filling and capping production line can be combined to meet the new GMP requirements, which can help you handle cartridge bottles under the best conditions. Our cartridge filling system reliably supports every step of your production cycle, from precise positioning under workstations to low particle capping using patented technology, from small-scale production of specialty drugs to large-scale distribution of products.
Aseptic pre-filling and sealing syringe lines are composed of four equipment: an ultrasonic bottle washing machine, an air-drying silicone oil injection integrated machine, a sterilization dryer, and a cartridge stoppering filling capping machine. It can complete complex functions such as spraying water, ultrasonic cleaning, air & water flushing of the inner and outer walls of cartridge bottles, air drying, silicone oil spraying, preheating, drying, and sterilization, heat source removing, cooling, stoppering, filling, capping, etc., achieving automation of the entire process. Each machine can be used alone or work in a linkage line, mainly used for the production of cartridge injections under sterile conditions in the pharmaceutical industry.
Technical Parameter
| Suitable Product Range |
0.1-20ml (change specification parts properly) |
| Power Supply |
380V 50Hz |
| Power |
4.4kw |
| Filling Error |
+/-1% |
| Compress Air Pressure |
0.6~0.8Mpa 20m3/h |
| Auto Stoppering Rate |
>=99.5% |
| Single Machine Noise |
<=70db |
| Weight |
750kg |
| Dimension |
1630x1320x1700(mm) |
Performance Features
- The design, materials, manufacturing, assembly and commissioning of the entire plastic pfs line are in accordance with the new GMP regulations.
- This 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 of plastic pfs machine: 0.1ml-20ml
- Capacity: 2000-30000 bph
- Filling head: 2-10 pcs, choose according to capacity;
- Various types of filling pump options: metal pump, peristaltic pump, ceramic pump;
- 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;
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- 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 machine are servo-driven and are located in the lower part of the machine frame, which allows precise positioning and avoids pollution of the environment;
- 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;
- 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
The production process steps of the Marya cartridge filling production line
1.Cleaning
Thorough cleaning of the inside and outside of the cartridge before filling and sealing is a crucial process step to remove residues and other pollutants from the inside and outside of the container. This step can prevent potential residual harmful substances from affecting the safety of the product and users. The Marya ultrasonic cleaning system has a wide range of applications, is an efficient, hygienic, and cost saving design solution that can assist customers in cleaning various types and specifications of containers, with simple operation and quick run.
Significant advantages:
Three water and three gas cleaning: ultrasonic cleaning, circulating water, injection water, compressed air injection etc. clean the inside and outside of the bottle multiple times to prevent cross contamination;
Cost saving: Independent recycling and filtration of circulating water, saving energy consumption costs;
Ergonomic design: Easy to adjust specifications and quick format changes improve operational flexibility;
2.Sterilization tunnel oven:
Whether you are filling liquid drugs into ampoules, vial bottles, injection and infusion bottles, cartridges, or syringes, the reliable pre-treatment of the container greatly contributes to product safety. Marya can provide various types of solutions, efficiently and continuously processing all different containers through preheating, high-temperature sterilization, and cooling stages to meet customer needs.
Significant advantages:
Fully automated: automatic bottle feeding,bottle delivering without the need for operator intervention, improving operational efficiency;
Tunnel type hot air circulation: The heat source is evenly distributed, and the effect of removing heat is good;
Customized: The drying sterilization and heat removal system can be customized according to customer needs;
3.Filling and sealing
Marya's filling system for pre-sterilization and bulk containers has both flexibility and accuracy: various filling technologies, including valve piston and peristaltic pump, material flow and time pressure filling, ensure that you can fill your products in a highly customized way. The tool format does not need to be changed. The filling station with a variable number of filling heads can improve the flexibility of the filling process. The subsequent sealing also comes in various ways, providing you with various methods, such as gas combustion or inserting vacuum plugs to seal the container. The Process Control (IPC) system further improves the filling quality by continuously checking the filling capacity and rubber plug position.
Significant advantages:
High accuracy filling process: use a positioning dial to deliver bottles (driven by a servo motor), and deliver 4 bottles at a time, ensuring accurate filling positioning
Adopting ceramic rotary valve pumps (8 sets) for 2-time filling, saving costs
Can provide a combination of filling and capping machine
Fully integrated barrier system (RABS, enclosed RABS, or isolator)
4.Barrier system:
Aseptic filling is related to product safety and requires the separation of operators and drug ingredients. Isolator technology helps establish this critical barrier. With years of experience in barrier system design and manufacturing, Marya has established a comprehensive product portfolio, including open RABS, closed RABS, closed systems, and isolation systems. We focus on the connection design of each functional section to ensure seamless interaction with other parts.
Significant advantages:
Safe filling of sterile and potent products
In-depth research on RABS, isolators, and related barrier technologies
Single source isolator, biological purification, and air treatment
5.Freeze-drying proces
For many years, freeze-drying has been successfully used to extend the shelf life of liquid drugs. The Marya freeze-drying process can be applied to the drying production of raw materials such as raw materials, traditional Chinese medicine slices, biological products, vaccines, blood products, active substances, antibiotic drugs, food, fruits, chemicals, pharmaceutical intermediates, etc., and to develop exclusive solutions for containers of different specifications for different products; The Marya freeze dryer allows products to be stored and transported for a long time after vacuum freeze-drying, maximizing the original activity of the product. Meanwhile, the Marya freeze dryer machine can be integrated into a complete set of washing, filling, and sealing machine systems, greatly saving costs and space.
Significant advantages:
Fully automated, reducing the tedious operation of the drying process;
Silicone oil freezing medium, error ≤ 1 ºC, uniform drying effect;
Our freeze dryer has a wide range of applications and can handle containers of different sizes and specifications;
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