Marya Aseptic Prefilled Syringe Filling Machine
As a portable packaging for various highly active injectable drugs such as innovative biological agents, syringes improve the accuracy of dosing and make expensive drugs easier to handle. From de-nesting to filling and sealing, efficiency and product and operator protection are crucial throughout the entire filling process. We will provide a diversified fully automatic syringe filling production line to meet the maximum product safety and process flexibility. The entire line design, materials, manufacturing, assembly, debugging, etc. all meet the requirements of the new GMP and FDA drug production specifications.
Production Introduction:
Aseptic prefilled syringe filling line is mainly used for the unpacking, tearing, filling, and stoppering of disposable syringes, cartridge bottles, and vial bottles in honeycomb trays of pharmaceutical factories, to achieve the filling and sealing of pharmaceutical solutions; Adopting a stable and speed-adjustable conveying system, it maintains A-level sterilization status after entering the filling system. Servo drive control ensures smooth transportation. High precision filling from water to high viscosity is achieved through servo control.
Applicable Industries:
This linkage production line is mainly used in the fields of biomedicine, antithrombotic drugs, aesthetic medicine industry, and is suitable for the production and packaging of sterile products such as vaccines, monoclonal antibodies, small molecule heparin, insulin, Hyaluronic acid, etc. The finished product can also be used in medical industries such as ophthalmology, dentistry, otology, orthopedics, and gynecology.
Production Advantage:
1. Improve the usage rate of liquid medicine and reduce costs: Using this production line for one-time filling and sealing of liquid medicine can reduce the additional filling volume of liquid medicine, and the residual volume of liquid medicine during use is small, which can improve the usage rate of liquid medicine and effectively reduce costs.
2. Low equipment cost and low pollution risk: The aseptic prefilled syringe filling line adopts box syringe bottles no washing no sterilizing, cartridge bottles, and vial bottles, without the need for bottle cleaning and sterilization. Therefore, there is no need to configure cleaning machines, drying machines, and other equipment, which can reduce equipment costs and also reduce pollution risks.
3. Integrating filling and stoppering to ensure the quality of the liquid medicine: filling is followed by stoppering, resulting in a short exposure time of liquid medicine and low risk of contamination.
4. Vacuum plugging can be used: after plugging, there is less residual air and the residual volume is less than 20μL, which can meet condition that Drugs meet extremely high requirements for oxygen residue.
This production line is used for commercial production of medium or high volume syringes, providing a low risk and flexible processing method for sterile syringes.
Production solution for Aseptic Prefilled Syringe Filling Line:
1. Formulation system
In terms of bioprocess, we provide flexible support the production of small and large volume parenterals (SVP/LVP) and infusions(IV). The process solution includes modular settings for temperature controlling stainless steel tanks, which can be assembled to meet customer specific settings.
2. Filling and sealing
The use of prefilled syringes to handle expensive injectable drugs requires extreme caution and accuracy. Our comprehensive filling and sealing system meets this requirement, while also having more advantages:
(1)The flexible processing system can gently remove the syringe from the tray, further improving the filling quality through basic filling weight and stopper position detection.
(2)Various filling systems, such as peristaltic pump, increase the sanitary level of the whole process.
(3)The exhaust pipe or vacuum plug ensures that the syringe is tightly sealed.
3. De-nesting
Our prefilled syringe production line has been gently treating syringes from the beginning. The dedicated processing device allows the syringe to be accurately removed from the nest box and tray without the need for operator intervention. Therefore, a single syringe can be more easily and pollution-free fed into the comprehensive examination station. As experts in the operation of nested syringes, we have developed exclusive solutions for highly automated nesting and safe positioning prefilled syringes prior to downstream processing. These devices can be effectively integrated with nesting and detection platforms.
4. Upstream treatment of ready-to-use containers
Whether you are running a low, medium, or high-speed production line, safety processes are crucial to maintaining product quality. We provide highly automated bag and box opening solutions for ready-to-use containers, helping you handle prefilled syringes safely and efficiently. Especially in the application environment of nested syringes, our automatic bag opening machine and automatic box opening machine reduce the risk of operator contact and contamination to a lower level through a fully automated sterile cleaning process.
5. Detection
Like all drug containers, prefilled syringes also need to be thoroughly inspected to ensure patient safety. We have variously manual, semi-automatic, and fully automatic detection machines that can detect particle and container defects in liquid and freeze-dried drugs. Based on our deep testing expertise, we provide leading technologies for visual inspection and container closure integrity testing(CCIT), including high voltage leak detection (HVLD), static division (SD), and headspace analysis (HSA). In addition, we provide a fully integrated online inspection solution for multiple detection tasks, such as container defect detection.
6. Rod insertion and labeling
The processing of syringes does not stop at filling. On the contrary, it requires further complex operational steps: from rod insertion to attaching visible and easily recognizable labels on the outside. We combine these two steps on one platform: using a rod insertion labeling machine, glass and plastic syringes of plunger rod insertion and label application can run at high speed, ensuring high-quality downstream aseptic treatment.
7. Sterilization
We provide diverse sterilization solutions for effectively handling porous loads and liquids in open, semi closed, or closed containers. Vacuum steam, steam/air mixtures, and hot water shower processes support you in achieving repeatable equipment and terminal sterilization processes while optimizing energy requirements.
At the same time, Maya can also provide you with RTU (ready to use) syringe filling and bulk syringe filling.
RTU (ready-to-use) syringe filling
With decades of experience, we provide you with a variety of flexible syringe, cartridge, and vial bottle platforms, covering both upstream and downstream processes. Our RTU syringe filling machine combination includes systems for low, medium, and high-speed liquid and freeze-drying drug production.
Bulk syringe filling
Bulk handling itself is a challenge: to achieve high-speed handling of containers, reliable and fast operations must be required. The bulk syringe equipment provides you with high precision and ease of use: precise feeding of the syringe barrel and variable filling and sealing stations, which can achieve soft processing of different sizes of bulk syringes.
Performance Features
1. Wide range of applicable specifications, high production capacity, and high filling accuracy:
| Applicable specifications |
1ml-20ml (according to user provided specifications) |
| Production capacity |
2000-30000 bottles/hour |
| Filling volume range |
0.1ml-20ml |
| Number of filling heads |
2-10 filling heads, selected according to production requirements |
| Filling accuracy |
≤±1% (determined based on drug characteristics) |
| Qualified rate |
≥99% |
2. Mature technology, adopting industry-leading high-end technology, stable performance, and cost savings:
(1)Flexible layout, suitable for specific room conditions;
(2)Suitable for toxic substances up to OEB5 in isolators;
(3)Automatic online filter sterilization;
(4)Automatic stacking of nest boxes and trays;
(5)Camera based nest tray status recognition;
(6)Precise placement of push rods for greater sterility;
(7)Flexible Recipe Editor for Customized Processes;
(8)Visual control push rod installation to improve accuracy;
(9)Gripper/pusher technology for careful syringe removal and placing on conveyor;
(10)Visual inspection based on camera and light transmission;
(11)A variety of filling pump forms: metal pump, peristaltic pump, ceramic pump;
(12)Online detection: Rapid response in case of particle or glass defects;
(13)Online detection: improves safety and quality during the filling process;
(14)Vacuum stoppage technology, suitable for viscous liquids and coated rubber stoppers, to avoid residual bubbles after stoppering;
Integrated hydrogen peroxide sterilization system;
(15)Modular settings for rapid delivery and customization;
(16)Prefilled and sealed bottles, cartridge bottles, and vial bottles can be freely interchanged with high efficiency;
(17)The ultra clean sterile robot is adopted, with more simple mechanism, less pollution risk and high factor of safety;
(18)High compatibility, suitable for all box prefilled bottles, cartridge bottles, and vial bottles currently on the market;
(19)After plugging, the residual air volume is small, and the residual volume is less than 20μL (vacuum plug);
(20)Adopting a one-time filling system;
(21)Adopting liquid level filling technology to prevent liquid medicine splashing;
(22)Adopting fully automatic production control and equipped with core workstation intelligent detection device;
(23)Upstream can be connected with automatic unpacking machines and automatic unpacking machines, while downstream can be connected with vial bottle capping machines, prefilled and sealing light inspection machines, and rotary rod labeling machines;
(24)Automatically remove the syringe from the honeycomb tray and place it back using a combination of servo system and cylinder;
(25)During the transmission process, the rubber stopper has no friction with the contact surface of liquid medicine and bottom rail, and is always protected by laminar flow to avoid the generation of particles and the risk of contamination;
(26)The main transmission components of the equipment are servo-driven and located in the lower part of the machine frame, with precise positioning and avoiding environmental pollution;
3. Multiple functions are optional, customized according to your needs:
(1)The servo motor can be configured to control the filling pump for filling, with high filling accuracy and convenient adjustment;
(2)Configurable filling system CIP/SIP system;
(3)Configurable vacuum filling system for filling high viscosity products;
(4)A nitrogen filling unit can be configured to isolate the liquid medicine from oxygen;
(5)Capable of configuring high-performance no bottle no filling, no bottle no capping, and linkage bottle squeezing shutdown functions;
(6)Configurable Open-RABS isolation protection system and 100 level air purification laminar flow system;
(7)According to whether the customer's product has toxicity or activity, a fully enclosed sterile isolation (Isolator) system and a bag in bag out (BIBO) system can be configured;
(8)Multiple robot collaborative control technologies can be configured to fully automate the process of prefilled syringe film tearing, lining removal, filling, stoppering, weighing, and other related processes;
(9)The filling volume autocorrection function can be configured, and the filling volume calibration of the filling pump can be fully automated;
(10)Adopting high-precision color touch screen operation monitoring, PLC automatic control, automatic protection, mainframe variable frequency speed regulation and other control technologies for fully automatic control and monitoring of the production process;
(11)We can customize relevant products according to the actual needs of customers.
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