Products Description
This equipment is a vacuum filling and capping machine specifically developed by our company for various RTU pre-filled packaging materials. It is also compatible with pre-filled syringes, cartridges, vials, and other RTU packaging materials. Utilizing full servo control and vacuum filling and capping, it boasts advantages such as small footprint, wide adaptability, high filling accuracy, and no air bubble generation. Furthermore, it is easy to clean, operate, and maintain. The entire machine design fully complies with GMP specifications and is suitable for filling various materials such as hyaluronic acid, collagen, plant proteins, third-generation hyaluronic acid (including microspheres), chitosan, sodium hyaluronate, gels, cross-linked products, hyaluronic acid, mesotherapy injections, and insulin. It is widely used in the medical aesthetics and biopharmaceutical industries.
Product Advantages
The machine is equipped with hundreds of laminar flow, with aseptic operationglove box, the whole process of aseptic environment operation
Vacuum gas pipeline is equipped with Burst filter and sanitary diaphragmvalve, and equipped with high-precision vacuum sensor, effectively monitor
Using high-precision ceramic plug pump, the filling accuracy can reach ±1%
The whole machine SUS304, the parts in contact with the material are made of316L and medical silicone, which fully meets the requirements of GMP
Servo control of the whole machine, vacuum filling and vacuum plug are con.trolled separately, and the vacuum degree is adjustable
Intelligent software operation, accurate setting of each step
Parameter
|
Machine name |
Cartridge Capping & Vial Filling Sealing Machine |
|
Applicable materials |
liquid and paste |
|
Applicable specifications |
1mllong/1-3ml/5ml/10ml/20ml/30ml plastic pre-filled needle syringe (need to replace the specifications) |
|
Filling range |
0.1-30ml(need to replace the plunger pump) |
|
Number of filling needles |
1/2/5/10 |
|
Filling accuracy |
±1% |
|
Production capacity |
700-11000 PCS/hour |
|
Cap pass rate |
≥99.9% |
|
Equipment noise |
≤70 dB |
|
Total power |
about 5KW |
|
Voltage |
380V 50Hz |
|
Compressed air |
0.6-0.7Mpa |
|
Dimensions |
1800*900*2400(mm) (including laminar flow) |
|
Weight |
800KG |
* Note, The above parameters are reference values. Actual parameters vary according to packing materials, filling amount, material characteristics and vacuum degree.
Multiple optional functions are available for customization to meet your specific needs:
(1) Filling driven by servo motor-controlled pump, delivering high precision and easy parameter adjustment.
(2) CIP/SIP system available as an add-on feature.
(3) Integrated online sterilization for the cooling zone of the hot air circulation tunnel oven.
(4) Compact equipment layout with glass-door protective enclosure; compatible with Open-RABS/Closed-RABS isolation systems and Class 100 laminar airflow purification.
(5) Vacuum-assisted filling system configurable for handling high-viscosity products.
(6) Fully enclosed aseptic isolator system optionally available for processing toxic or potent active products.
To meet the growing production demands of the pharmaceutical industry for pre-filled syringes, ALWELL has integrated the R&D and manufacturing resources across its product lines to launch a comprehensive pre-filled liquid preparation solution.
This solution fully meets the production process requirements of ready-to-use pre-filled syringes, cartridges, and vials. It not only includes basic processes such as unpacking, filling, and sealing, but also connects the entire production process from upstream pharmaceutical water preparation and liquid preparation systems to downstream testing, sterilization, and packaging.
For products with high sterility requirements, it enables fully automated unpacking and allows the use of isolators instead of open-type access barriers, significantly reducing manual intervention and providing a higher level of sterility assurance in the production process.
This system has been widely applied in the pharmaceutical and cosmetic industries and is suitable for the automated and intelligent production of high-end products such as anesthetics, dental materials, adrenaline, vaccines, oncology and anticancer drugs, and hyaluronic acid.
Container & Application Compatibility Matrix
| Container Format | Specification Range | Primary Application |
|---|---|---|
| Glass Cartridges | 1.5 ml, 1.8 ml, 3.0 ml (Dental & Pen Refills) | Insulin, GLP-1 agonists, Growth Hormones, Dental Anesthetics |
| Injection Vials | 2R, 6R, 10R, 20R, 50R (Glass & COP/COC) | Vaccines, Biologics, Monoclonal Antibodies, Lyophilized Powders |
Particle-Free Crimping & Micro-Particle Control
To meet EU-GMP Annex 1 Class A cleanroom requirements, the sealing station employs specialized continuous rotary knife crimping heads rather than traditional press jaws. This mechanism eliminates metal friction and aluminum dust generation during capping, ensuring zero particulate contamination and superior Container Closure Integrity (CCI).
cGMP & 21 CFR Part 11 Data Integrity
- Control Platform: Industrial Siemens S7-1500 PLC with touch-screen HMI.
- Data Integrity: Multi-tier user access control, electronic signature support, and immutable electronic batch audit logging compliant with FDA 21 CFR Part 11.
- Validation Package: Full documentation suite provided including DQ, IQ, OQ, PQ execution templates, material 3.1 certificates, and FAT/SAT scripts.
Procurement & Process FAQs
Q: How does the line switch between cartridge bottom-stoppering and vial top-stoppering?
A: The machine features dual dedicated stoppering stations along its indexing starwheel. Operators can select the appropriate station via pre-saved PLC recipes. Combined with tool-less starwheel mounts, format switching can be completed within 30 to 45 minutes.
Q: What is the footprint of this dual-use machine compared to buying two separate lines for cartridges and vials?
A: Integrating cartridge and vial packaging into one combi chassis reduces total cleanroom footprint by 40% to 50% compared to installing two separate lines. This significantly lowers HVAC airflow requirements, cleanroom construction costs, and operator staffing demands for small-to-medium pharmaceutical plants and CDMOs.
Q: How does the dosing system ensure zero liquid tailing when handling sensitive or high-value biopharmaceuticals?
A: The machine features servo-driven diving nozzles paired with a programmable liquid-suction (suck-back) function. When dosing liquid into narrow-neck glass cartridges or vials, the nozzle lowers near the container bottom and lifts continuously with the liquid level, eliminating neck splash, micro-bubble formation, and fluid tailing on sealing areas.
Q: What specific changeover parts are required when switching between 3.0ml cartridges and 10R vials?
A: Changeover kit includes container-specific starwheels, neck-guiding tracks, bottom plunger/top stopper positioning nests, and capping head dies. All changeover components feature color-coded, tool-less quick-release mounts, enabling rapid batch transitions in under 45 minutes by a single trained operator.
Q: Does the equipment support CIP/SIP (Clean-in-Place / Sterilize-in-Place) or single-use disposable fluid paths?
A: Yes. For traditional high-purity ceramic pumps, automated CIP/SIP manifolds can be integrated. Alternatively, for CDMOs requiring quick product turnarounds without cleaning validation overhead, the system supports fully pre-sterilized single-use peristaltic tubing and nozzle assemblies.
For more information please contact us
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