prefilled syringe filling machine supplier
Shanghai ALWELL has a group of high-quality professional and technical personnel, focusing on the filling line research and development of pre-filled syringes.At present, our main products are: Automatic pre-filled syringe vacuum filling and plugging machine, high-speed pre-filled syringe filling production line, pre-filled flush syringe filling production line, syringe labeling machine, syringe light
inspection machine, syringe loading machine, vacuum mixing
tank, etc.Our products are in line with the requirements of the GMP specification, and have passed the European union's CE safety certification. Our products are sold all over the country and exported to Europe, America, the Middle East, Southeast Asia and other countries and regions, favoured and praised by domestic and foreign customers.
area
years experience
Intellectual property
professional techinicians
Patent certificate
prefilled syringe filling machine supplier
ALWELL has always upheld excellent quality and innovative concepts in the industry, and has obtained numerous authoritative certificates with its excellent strength. Among them, CE certification shows that the company's products comply with the relevant directives and harmonized standards of the European Union, and have the qualification of free circulation in the European market. At the same time, the company also has ISO 9001 quality management system certification, which indicates that in the whole process of product development, production, sales, etc., we strictly follow the quality management standards to ensure the stability and reliability of product quality. In addition, our products are in compliance with GMP specifications, laying a solid foundation for long-term cooperation with customers.
Products Description
prefilled syringe filling machine
suitable for a variety of hyaluronic acid, collagen, vegetable protein, the third generation of hyaluronic acid(including microspheres), chitosan, sodium hyaluronate, gel, crosslinked products, hyaluronic acid, water needleand other materials filling. Widely used in medical beauty, biopharmaceutical and other.
vacuum filling
Servo control of the whole machine, vacuum filling and vacuum plug are con.trolled separately, and the vacuum degree is adjustable
high-precision
Using high-precision ceramic plug pump, the filling accuracy can reach ±1%
High-Quality Customized Services
Can be customized according to customer requirements
Products parameter
| Applicable specification | Filling range | Number of filling pins | Productive capacity | Filling accuracy |
| 1ml long/1-3ml/5ml/10ml/20ml | 0.1-20ml | 1 | ≤700pcs/h | ±1% |
| 2 | ≤1400pcs/h | |||
| 5 | ≤4000pcs/h | |||
| 10 | ≤11000pcs/h | |||
| customized | According to customer requirements |
Products application
Application fields
PLLAmicrosphere filling/PLLAmicrosphere filling/ water needle filing/Recombinant collagen/Cotton sugar filling/High-viscosity vacuum filling
Residual air bubbles during the filling process of pre-filled syringes can lead to the following severe consequences, requiring serious attention:
1. Dose Inaccuracy
Key Impact: Air bubbles occupy the volume intended for the drug liquid, resulting in an actual delivered dose that is lower than the standard, compromising therapeutic efficacy (especially critical for drugs with a narrow therapeutic index, such as vaccines, insulin, or chemotherapeutic agents).
Risk Scenarios: In pediatric or high-precision medication, even minor dose deviations can lead to treatment failure or toxicity.
2. Drug Stability and Safety
Oxidation/Degradation: Contact with air bubbles can accelerate oxidation or aggregation for certain drugs (e.g., biologics, protein-based drugs), reducing potency or generating harmful substances.
Particulate Contamination: Bubble rupture can cause liquid surface turbulence, increasing the risk of glass fragment or stopper particle shedding.
3. Clinical Use Risks
Embolism Hazard: During intravenous injection, a significant volume of air (typically >0.5 mL) can cause air embolism, leading to vascular occlusion (potentially life-threatening in extreme cases). For subcutaneous or intramuscular injections, it may cause local tissue damage or pain.
Operational Hindrance: Healthcare professionals require additional steps to remove air, increasing procedural complexity and contamination risk, potentially delaying treatment in emergency situations.
4. Product Quality and Compliance Issues
Visual Defect: Air bubbles are considered visible particulates, which can lead to batch rejection or recall, violating GMP and pharmacopoeial standards (e.g., USP, EP).
Regulatory Penalties: Non-compliance with mandatory requirements for "freedom from visible bubbles" in injectables by agencies such as the FDA or EMA poses legal risks.
5. Additional Risks for Special Formulations
Viscous Drugs (e.g., monoclonal antibodies): Bubbles are difficult to expel and may interfere with the dose delivery mechanism of auto-injectors (e.g., pre-filled pens).
Lyophilized Products: Residual bubbles during reconstitution may affect dissolution efficiency.
Solutions and Preventive Measures
Process Optimization: Employ vacuum filling, pressure filling, or ultrasonic degassing technologies.
Equipment Calibration: Ensure proper fill needle insertion depth, speed, and angle to minimize turbulence.
Enhanced Quality Control: Implement 100% inline visual inspection (e.g., high-speed cameras combined with AI for micro-bubble detection).
Personnel Training: Standardize operating procedures to avoid bubble introduction during manual handling.
Shanghai ALWELL pre-filled syringe filling machine effectively addresses bubble-related issues during the filling process through multiple technological optimizations and process innovations. The following are its key solutions and advantages:
1. Core Technologies for Bubble Mitigation
(1) Vacuum Filling System
Technical Principle: Evacuates air from the syringe barrel cavity before filling, reducing residual air, followed by liquid injection.
Effect: Significantly reduces the probability of bubble formation (especially for high-viscosity liquids like biologics).
(2) Pressure Filling Control
Dynamic Pressure Regulation: Employs closed-loop pressure control during fill needle insertion into the liquid to avoid turbulence and gas entrapment.
Applicability: Suitable for oxidation-sensitive drugs (e.g., vaccines, monoclonal antibodies).
2. Key Optimizations in the Filling Process
Precise Fill Needle Positioning:
Utilizes servo motors to control insertion depth and angle, ensuring smooth liquid injection and preventing splashing and bubble entrainment.
Low-Speed Filling Mode:
For foam-prone liquids (e.g., formulations containing surfactants), reduces filling speed to minimize shear forces.
3. Capability to Handle Complex Formulations
High-Viscosity Liquids: Equipped with ceramic pumps or piston pumps to ensure uniform, bubble-free filling.
Lyophilized Products: Supports inert gas (e.g., nitrogen) protected filling for pre-filled syringes, avoiding reconstitution issues.
4. Industry Validation and Compliance
GMP Compliance: Equipment design meets GMP data integrity standards.
Case Studies: Successfully deployed in pre-filled syringe production for multiple domestic and international biopharmaceutical companies, with bubble defect rates controllable at <0.1%.
Contact us for details
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