Wenzhou Zungwan - Packaging Machinery Equipment Manufacturers
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APFS3500
ZUNGWAN
The APFS3500 represents a significant advancement in pharmaceutical packaging, originally developed as a pioneering solution for pre-sterilized syringe processing. This sophisticated equipment integrates automatic syringe nest-tubing-feeding, precise vacuum filling, and secure vacuum plugging into a cohesive, fully monitored operational workflow. Engineered to handle a diverse range of fluid viscosities, the system excels not only with standard aqueous solutions but also demonstrates exceptional capability when processing transparent, highly viscous fluids such as ester acid. By maintaining a continuous, automated cycle from feeding to final plugging, facilities can achieve consistent output while minimizing the risk of human error or contamination in sensitive environments.
Versatility in consumable adaptation is a cornerstone of the APFS3500's design architecture. The system is meticulously calibrated to process pre-sterilized syringes (SCF type) manufactured by industry-leading providers including BD, BG, and SCHOTT, alongside major domestic suppliers. This broad compatibility ensures that production facilities can source containers flexibly without facing hardware bottlenecks. For specialized applications or unique container geometries, comprehensive custom-designed OEM solutions are available. This adaptability allows the equipment to be tailored to specific production lines, ensuring that even non-standard syringe types are handled with the same rigorous precision and care as conventional formats.
At the core of the machine's fluid delivery system are five synchronized filling nozzles, designed to maximize throughput without compromising individual dose accuracy. To drive this intricate mechanical sequence, the equipment utilizes four sets of premium servo motors sourced from YASUKAWA, Japan. These advanced motors govern the precise row-by-row movement during the filling operation, ensuring that each syringe is positioned with absolute exactness. The integration of these top-tier Japanese servo systems guarantees not only the volumetric accuracy of the fill but also the mechanical reliability of the plugging phase, translating to a smooth, vibration-free operation that protects delicate glass or polymer containers from mechanical stress.
Fluid transfer is managed by robust stainless steel (SS) rotating pumps, which provide a consistent, pulsation-free flow essential for maintaining strict dosing tolerances. Recognizing the need for rapid changeovers in dynamic production environments, the APFS3500 eliminates the need for mechanical tooling during batch adjustments. Operators can execute filling volume set-ups and fine-tune accuracy directly through the digital interface. This tool-free calibration drastically reduces downtime between different product runs, allowing production managers to optimize scheduling and maintain high overall equipment effectiveness. The tactile response of the digital controls ensures that even micro-adjustments are applied instantly and accurately.
The operational nerve center of the machine is a sophisticated Siemens color touch screen, providing an intuitive, multi-language interface for global usability. This intelligent control panel offers comprehensive real-time monitoring and display of every critical operating status. Operators have immediate visual access to essential environmental metrics, including vacuum pressure, nitrogen pressure, and compressed air (C/A) pressure. In the event of an operational anomaly, the system features an advanced fault alarm with precise position indication, alongside detailed fault recording for subsequent analysis. This level of diagnostic transparency empowers maintenance teams to identify and resolve issues swiftly, ensuring continuous, safe operation.
To achieve the zero-defect manufacturing standards required in the pharmaceutical sector, the APFS3500 offers an optional, highly advanced Machine Vision System (MVS). This integrated optical inspection technology rigorously monitors the plugging quality of every single unit passing through the line. By analyzing the exact depth, angle, and seating of the stopper, the MVS ensures that only syringes meeting the strictest acceptability criteria proceed to the next stage. This automated visual quality control acts as a relentless safeguard against compromised seals, protecting product efficacy and ultimately ensuring patient safety while maintaining an exceptionally high yield of acceptable finished products.
In strict adherence to industry documentation requirements, the system is equipped with robust data management capabilities. All critical process parameters can be timely printed, securely stored, and easily retrieved on demand. This functionality is vital for facilities that must maintain rigorous batch records and audit trails. By automating the logging of operational data, the machine removes the variability of manual record-keeping, providing a verifiable history of the production environment for every single batch. This seamless data traceability supports compliance with international regulatory standards and facilitates continuous process improvement through detailed historical data analysis.
The physical construction of the APFS3500 is uncompromisingly focused on hygiene and durability, strictly adhering to Good Manufacturing Practice (GMP) standards. All components that come into direct contact with the pharmaceutical product are meticulously crafted from SUS 316L stainless steel and medical-grade silicon rubber. These core materials are selected for their superior corrosion resistance and non-reactive properties, ensuring absolute purity of the filled liquid. Furthermore, the exterior of the machine is heavily coated with SUS 304 stainless steel and 6061 oxidated aluminum alloy. This smooth, non-porous exterior finish not only provides exceptional structural integrity but also facilitates rigorous cleaning and sterilization protocols, maintaining a pristine sterile production environment.
Filling volume : 0.1-0.5ml,0.5-3ml,10-30ml
Filling nozzle : 5sets
X travel distance: 900mm
Printer: Hot-sensible printing paper,width 56mm,max.20alphabets per line
Machine vision system resolution(Option):752x480dpi
Vacuum : 0-98Kpa(0-750mmHg)
Nitrogen: 1kg/cm2,0.1m3/min
Power supply:3P 380V/220V,50-60Hz,5.5Kw
Dimension: 3050x1600x1900mm
Net weight: 950Kg
Investing in advanced pharmaceutical machinery requires the assurance of long-term operational stability. We provide a comprehensive global after-sales service system designed to minimize disruption and maximize your return on investment:
1-Year Comprehensive Warranty: Covers free replacement of essential spare parts to protect your initial equipment investment.
24-Hour Rapid Response: Our dedicated technical support team is available around the clock for operational queries, remote diagnostics, and troubleshooting.
On-Site Commissioning: Professional installation and setup services empower your personnel with the practical knowledge required to maintain peak production efficiency.
The ZUNGWAN APFS3500 is designed for the automatic filling and stoppering of pre-sterilized syringes supplied in tub-and-nest formats. It integrates syringe nest handling, synchronized filling, vacuum-assisted processing, stopper insertion and process monitoring within one controlled system.
Five synchronized filling nozzles and four servo motors coordinate the row-by-row movement of the syringe nest. Filling parameters, pressure conditions, alarms and operating status can be viewed through the touchscreen interface.
The machine can be configured for specified SCF syringe formats and liquid characteristics. Syringe dimensions, nest layout, stopper design, fill volume, viscosity and production requirements should be reviewed before the final machine configuration is approved.
Pre-sterilized syringes are commonly delivered in a nest placed inside a tub. The APFS3500 receives the syringe nest and positions each row for filling and stoppering without requiring the syringes to be individually fed through a conventional bottle conveyor.
The published process includes:
Loading the pre-sterilized syringe tub and nest
Positioning the syringe rows
Moving the nest through the filling sequence
Vacuum-assisted filling
Vacuum-assisted stopper insertion
Monitoring the operating status and process conditions
The exact loading, lid-removal and discharge arrangement should be confirmed for the ordered configuration. It is also necessary to determine whether tub handling is manual, assisted or fully automatic at each upstream and downstream interface.
Handling syringes inside the nest reduces unnecessary contact between individual containers. However, correct nest positioning remains important because variations in the tub, nest or syringe flange may affect nozzle alignment and stopper insertion.
The APFS3500 uses five synchronized filling nozzles to process a row of syringes during each filling cycle. The movement and filling sequence are coordinated through servo control.
Published filling-volume configurations include:
0.1–0.5 ml
0.5–3 ml
10–30 ml
The original specification does not list a 3–10 ml configuration. If the required dose falls within this range, pump and format compatibility should be confirmed before ordering.
The filling system uses stainless steel rotary pumps. Filling volume and fine adjustments are entered through the touchscreen without mechanical tools.
The final dosing arrangement should be selected according to:
Target fill volume
Acceptable fill tolerance
Liquid viscosity
Product sensitivity
Required product-contact materials
Cleaning and sterilization method
Batch size
Frequency of product changeovers
Actual filling performance should be verified with the intended product or a technically representative placebo medium. Results obtained with water may not represent the performance of a viscous, foaming or shear-sensitive formulation.
Four YASKAWA servo motors coordinate filling, stopper insertion and row movement. Servo-controlled positioning helps align each syringe row with the filling and stoppering stations.
The syringe nest, barrel dimensions and flange position must remain within the approved tolerances. Engineering trials are recommended when using a new syringe supplier or a customized nest format.
The APFS3500 incorporates vacuum-assisted filling for suitable liquid products. Vacuum processing can help control trapped air when filling transparent or higher-viscosity formulations.
The required vacuum level depends on the product, fill volume, syringe geometry and cycle. Excessive vacuum may affect foaming, evaporation or product behaviour, while insufficient vacuum may leave unwanted air in the syringe.
Product testing is therefore necessary before production parameters are finalized.
After filling, the stopper is inserted under controlled vacuum conditions. This method is intended to position the stopper without pushing a large volume of air into the filled syringe.
Vacuum stoppering can help:
Control the air space between the product and stopper
Reduce bubble formation during stopper insertion
Support more consistent stopper placement
Limit unnecessary mechanical compression of the stopper
Improve repeatability across the syringe nest
Stoppering performance depends on the syringe barrel, stopper material, stopper coating, dimensional tolerances and specified final stopper position.
The equipment page lists an adjustable vacuum range of 0–98 kPa. The operating setpoint must be established through product and container-closure testing rather than automatically using the maximum value.
The published nitrogen requirement is 1 kg/cm² at 0.1 m³/min. Nitrogen may be used when the approved process requires controlled gas conditions.
Nitrogen supply does not by itself establish product stability or an oxygen-free package. Residual oxygen, headspace and product compatibility must be evaluated as part of the formulation and packaging process.
The APFS3500 is designed for pre-sterilized SCF-type syringes. The original product information identifies compatibility with formats supplied by:
BD
BG
SCHOTT
Major Chinese syringe manufacturers
Other syringe formats may be evaluated through a customized design.
Brand identification alone is not sufficient for final compatibility. The engineering review should include the exact syringe drawing, tub and nest dimensions, syringe quantity per nest, stopper drawing and manufacturing tolerances.
The following components should be tested together:
Syringe barrel
Syringe flange
Tub
Nest
Rubber stopper or plunger stopper
Tip closure
Product-contact tubing
Filling nozzle
Pump components
Small dimensional differences can influence nozzle entry, stopper placement and row positioning. Representative production components should therefore be supplied for machine trials and Factory Acceptance Testing.
The machine is intended for normal liquid products and may also be configured for certain transparent, higher-viscosity liquids.
Before confirming the filling system, provide information about:
Viscosity at the filling temperature
Density
Surface tension
Tendency to foam
Sensitivity to air or oxygen
Presence of particles or suspended solids
Required filling temperature
Compatibility with 316L stainless steel and silicone
Required cleaning or sterilization method
Allowable product loss
Do not assume that every pharmaceutical liquid can use the same pump, tubing, nozzle or vacuum setting.
Four YASKAWA servo motors are used to coordinate critical machine movements. Servo control supports repeatable positioning during row indexing, filling and stoppering.
The control system should be commissioned using the actual nest and syringe format. Mechanical positioning, servo parameters and recipe data must be verified after a format change.
The Siemens color touchscreen displays machine and process information, including:
Current operating status
Vacuum pressure
Nitrogen pressure
Compressed-air pressure
Fault location
Fault description
Alarm records
Process settings
The interface supports multiple languages. The required language package should be specified before the control program is finalized.
Filling-volume settings and accuracy adjustments are entered through the touchscreen without mechanical tools. Access levels should be configured so that operators, maintenance personnel and administrators have permissions appropriate to their responsibilities.
A documented parameter-management procedure is recommended for pharmaceutical production.
The APFS3500 monitors operating conditions throughout the automatic process. Fault alarms include position information to help operators identify where an interruption occurred.
Published data-management functions include:
Real-time operating-status display
Pressure monitoring
Fault indication
Alarm recording
Process-parameter storage
Parameter retrieval
Process-data printing
The integrated printer uses 56 mm thermal paper and supports up to 20 characters per line according to the published specification.
These functions support routine process review, but they should not automatically be described as 21 CFR Part 11 compliant or as a complete electronic batch-record system. Audit trails, electronic signatures, user management, data security and system integration must be evaluated separately when required.
A machine vision system is available as an option. The published camera resolution is 752 × 480 pixels.
The vision system is intended to monitor stoppering quality and improve the detection of incorrectly processed syringes. The inspection scope must be defined before ordering.
Possible inspection requirements include:
Stopper presence
Stopper position
Incorrect stopper depth
Missing component detection
Row-position verification
Rejection or alarm logic
The standard product information does not state that the vision system performs particle inspection, cosmetic-defect inspection or 100% fill-volume verification. These functions should not be claimed unless a separate inspection system is specified and validated.
The published construction materials include:
SUS 316L stainless steel for product-contact metal parts
Medical-grade silicone rubber for applicable product-contact components
SUS 304 stainless steel for the machine structure and exterior
Oxidized 6061 aluminum alloy for designated machine components
Product compatibility should be assessed for every formulation. If the process requires alternative elastomers, single-use assemblies or specific surface-finish documentation, these requirements must be included in the technical agreement.
Cleaning procedures should cover the pump, filling nozzles, tubing and all other product-contact components.
Before machine approval, determine:
Which parts can be removed
Which parts can be cleaned in place
Whether components require autoclaving
Whether single-use product paths are needed
Required cleaning agents
Acceptable product carryover
Maximum changeover time
Cleaning verification or validation requirements
The cleaning method should be agreed upon before the product-contact system is finalized.
The APFS3500 processes syringes that have already been sterilized by the syringe supplier. The machine itself does not wash or sterilize the syringes.
The complete production process may require integration with:
Laminar airflow protection
Open or closed RABS
An isolator
Tub and bag transfer equipment
Environmental monitoring
Particle monitoring
Approved cleaning and decontamination procedures
Sterile product-transfer systems
The equipment should not be described as delivering an aseptic product by itself. Aseptic assurance depends on the cleanroom, barrier system, operators, materials, transfer method, environmental controls and validated manufacturing process.
Parameter | Published specification |
|---|---|
Machine model | APFS3500 |
Applicable container | Pre-sterilized SCF syringe in tub-and-nest format |
Published syringe suppliers | BD, BG, SCHOTT and major Chinese suppliers |
Filling-volume configurations | 0.1–0.5 ml, 0.5–3 ml and 10–30 ml |
Number of filling nozzles | 5 sets |
Filling system | Stainless steel rotary pumps |
Filling method | Vacuum-assisted filling |
Closing method | Vacuum stoppering |
Motion control | Four YASKAWA servo motors |
X-axis travel distance | 900 mm |
Control interface | Siemens color touchscreen |
Optional vision resolution | 752 × 480 pixels |
Vacuum range | 0–98 kPa |
Nitrogen requirement | 1 kg/cm², 0.1 m³/min |
Process records | Printing, storage and retrieval |
Printer | 56 mm thermal paper, maximum 20 characters per line |
Parameter | Published specification |
|---|---|
Power supply | Three-phase 380V or 220V, 50–60Hz |
Installed power | 5.5 kW |
Machine dimensions | 3050 × 1600 × 1900 mm |
Net weight | 950 kg |
Product-contact metal | SUS 316L |
Product-contact elastomer | Medical-grade silicone rubber |
Machine construction | SUS 304 and oxidized 6061 aluminum alloy |
The required production speed, compressed-air consumption, operating temperature, filling tolerance and compatible nest formats are not clearly stated on the current product page. These parameters should be included in the final technical agreement and order confirmation.
Provide the following information for technical review:
Syringe manufacturer and product code
Syringe material and nominal volume
Syringe dimensional drawing
Tub and nest drawings
Number of syringes in each nest
Stopper manufacturer and drawing
Target filling volume
Required filling tolerance
Product viscosity and density
Foaming and air-sensitivity information
Required batch size and production output
Nitrogen-flushing requirements
Required vacuum conditions
Cleaning and sterilization method
Barrier-system or laminar-flow requirements
Vision-inspection requirements
Data-recording and user-access requirements
Upstream and downstream line equipment
Factory Acceptance Test protocol
Qualification and documentation requirements
Representative syringes, nests, tubs and stoppers should be supplied before FAT. For pharmaceutical product trials, use an approved representative or placebo medium unless the handling of the actual formulation has been formally arranged.
ZUNGWAN manufactures filling, capping, labeling and cartoning equipment for pharmaceutical, cosmetic, food and daily chemical applications.
The company states that it has:
ISO 9001 quality-management certification
More than 20 invention and utility-model patents
More than 100 domestic customers
More than 400 international customers
Experience with standalone machines and integrated packaging lines
Remote installation guidance and after-sales technical support
Some ZUNGWAN equipment has obtained CE certification, but CE status should be confirmed for the exact APFS3500 configuration rather than assumed from the company’s general certification information.
For pharmaceutical projects, documentation requirements, material certificates, electrical standards, FAT procedures, spare parts and installation support should be agreed upon in the purchase contract.
No. It is designed to handle syringes that have already been washed, assembled and sterilized by the syringe manufacturer. The machine does not replace upstream syringe sterilization or the facility’s aseptic-processing controls.
SCF generally refers to pre-sterilized, ready-to-fill syringe systems supplied in a nest and tub. Exact terminology varies among syringe manufacturers, so the syringe product code and technical drawing should be provided.
Potentially. The original product information states that customized designs are available for other syringe types. Compatibility must be confirmed using the syringe, nest, tub and stopper drawings and physical samples.
Vacuum-assisted filling can help control trapped air when filling certain clear or higher-viscosity products. The required vacuum level depends on the formulation, syringe geometry and fill volume.
Stoppering inserts the rubber stopper or plunger stopper into the syringe barrel. Capping normally refers to applying an external cap or tip closure. The APFS3500 page specifically describes vacuum stopper insertion.
No. Actual output depends on the fill volume, viscosity, vacuum cycle, stopper behaviour, nest configuration and inspection requirements. Production speed should be confirmed through application testing.
The current product page does not list this range. It lists 0.1–0.5 ml, 0.5–3 ml and 10–30 ml. A 3–10 ml configuration should be confirmed directly before it is included in the specification.
No. The stoppering-quality vision system is listed as an option. Its inspection criteria, camera arrangement, rejection logic and validation requirements must be defined for the project.
The page lists parameter printing, storage and retrieval, but does not provide enough information to claim 21 CFR Part 11 compliance. Electronic signatures, audit trails, user access and data integrity functions require separate confirmation.
Barrier-system integration should be evaluated as a project configuration. Machine dimensions, access, airflow, material transfer, maintenance access and decontamination requirements must be reviewed with the cleanroom and isolator supplier.
Provide representative syringes, tubs, nests, stoppers and tip closures. Product data or an approved placebo medium should also be supplied for filling and vacuum trials.
The FAT protocol can cover format handling, row positioning, filling repeatability, stopper placement, alarm functions, pressure monitoring, recipe operation, data printing, vision inspection when fitted, cleaning access and safety functions.
Configure Your Syringe Filling Process
Send us your syringe, tub, nest and stopper specifications, target fill volume, liquid characteristics, required output and controlled-environment requirements. Our team will review the complete filling and stoppering process.
Representative syringes, nests and stoppers are recommended for configuration review and FAT planning.
