1
Product behavior
Define viscosity or rheology at filling temperature, foaming tendency, air sensitivity, particulates, shear concerns and cleanability.
HIJ-GZB100 · vacuum fill and plug platform
Prefilled Syringe Vacuum Filling Machine
Configure vacuum-assisted filling and stopper placement around the real syringe, product, fill volume, cleanroom interface and FAT acceptance criteria.
01Use representative product and the nominated SCF syringe/stopper set.
02Define acceptable fill accuracy, visible air, stopper position and reject handling.
03Confirm utilities, laminar-flow boundary and validation-document scope before quotation.
0.5–20 mlPublished size list; dedicated parts and confirmation required
600–800 p/hPublished single-needle reference capacity
≤±1–2%Published accuracy; verify with the actual product at FAT
Application fit
Use vacuum filling when the product and stopper process justify it
The machine document identifies liquids, ointment-like products and viscous materials as the application range. Selection should be based on a product trial and agreed syringe acceptance—not broad therapeutic claims.
2
Syringe and stopper
Provide the exact SCF syringe, nest/tub presentation, stopper, target fill volume and acceptable stopper position. Sizes are not universal without format parts.
3
Acceptance criteria
Agree fill accuracy, visible-air limit, stopper-height window, cosmetic defects, reject rules and sample quantity before FAT.
Send these samples before engineering
- Representative product in sufficient quantity for setup and repeat runs
- Nominated syringe tubs/nests and supplier drawings
- Production stoppers and any required transfer components
- Cleaning agents and product-contact compatibility requirements
- Approved quality methods for fill mass, visible air and stopper position
Machine process
Four coordinated stages from loading to vacuum plugging
The source document describes manual grouped syringe loading, automatic feeding, vacuum-assisted filling, automatic stopper feeding and vacuum plugging. The actual configuration must be proven with the nominated components.
1
Load and feed
The standard document describes manual loading in groups of ten followed by automatic machine feeding.
2
Vacuum-assisted fill
A ceramic plunger pump meters product while the filling needle rises with the liquid level to reduce splashing.
3
Feed the stopper
The stopper-feeding system orients and presents the nominated rubber stopper for placement.
4
Vacuum plug and discharge
The vacuum stopper system is designed to place the stopper close to the liquid surface before automatic discharge.
FAT rule: demonstrate the complete cycle with the actual formulation, syringe and stopper. A water-only demonstration cannot establish performance for a viscous production material.
Verified technical data
HIJ-GZB100 published reference specifications
These values come from the available HIJ-GZB100 technical document. The final quotation must identify the exact syringe, stopper, fill system, format parts and optional modules.
| Parameter | Published value | Buyer confirmation needed |
|---|---|---|
| Applicable material | Liquid and ointment | Representative product, filling temperature and cleaning method |
| Published syringe sizes | 0.5, 1, 2.25, 3, 5, 10 and 20 ml; not universal | Exact supplier, barrel drawing, nest/tub and dedicated format parts |
| Injection needles | 1 | Product path, needle design and target accepted output |
| Production capacity | 600–800 syringes/hour | Verify with actual product, fill volume, vacuum cycle and acceptance criteria |
| Filling accuracy | ≤±1–2% | Define the calculation method, samples, product conditions and acceptance window |
| Total power | 2.5 kW | 380 V or 220 V, 50–60 Hz configuration |
| Compressed air | 0.6–0.7 MPa; 15 L/s | Required air quality, connection and site capacity |
| Dimensions | 808 × 758 × 1760 mm | Confirm guarding, optional hood, service access and transfer space |
| Equipment weight | 380 kg | Floor, installation and moving route |
| Materials | AISI 304 exterior; AISI 316L and medical silicone product-contact parts | Material certificates, elastomer compatibility and surface requirements |
PLC/HMI monitoring
The document lists Siemens HMI, PLC and servo motor as the standard configuration, with real-time station status and fault display.
Ceramic plunger pump
The published design uses a ceramic plunger pump for quantitative filling. Confirm the valve/pump range against the required dose.
Compact standalone module
The document supports standalone operation or line connection. Confirm the upstream loading and downstream handling boundary.
SCF format and automation boundary
Define what arrives at the filler and what leaves it
The GZB100 document identifies SCF syringes from BD, BG, SCHOTT and major domestic manufacturers, with customization for other types. Compatibility still depends on the exact component drawing and tooling.
1
Standard loading scope
The published base process uses manual grouped syringe loading, followed by automatic machine feeding, filling, plugging and discharge.
2
Optional denesting
An automatic nest-removal module is listed as an option. Define tub opening, liner removal, denesting and transfer responsibilities separately.
3
Format change
Syringe sizes are not universal. List every barrel and stopper combination and identify the included mold, guide and product-path change parts.
Quotation boundary checklist
- Tub, nest, syringe and stopper supplier drawings
- Manual or automatic denesting scope
- Number of formats and change-part list
- Product supply tank, tubing and connection boundary
- Discharge handling and downstream accumulation
- Optional laminar-flow cover dimensions and interface
Aseptic integration boundary
The machine supports your process; your facility owns the validated state
The GZB100 document lists an optional laminar-flow hood and modular line connection. Final aseptic performance depends on the installed environment, airflow, cleaning, sterilization, interventions, components and approved procedures.
Verified construction and options
- AISI 304 stainless-steel exterior
- AISI 316L and medical silicone product-contact parts
- Optional laminar-flow hood
- Modular standalone or connected-line arrangement
- Real-time status, alarm and fault-location display
Customer-defined qualification scope
- Cleanroom classification and environmental monitoring
- Airflow study and critical-zone protection
- Cleaning/sterilization method and residue limits
- Intervention and changeover procedures
- DQ/IQ/OQ/PQ protocols and release criteria
Compliance wording: HIJ can engineer the equipment and documentation to support the customer’s validation process. The machine is not itself FDA approved or independently “GMP certified.”
URS and FAT evidence
Make vacuum-fill performance measurable before purchase
Use one approved input pack and one FAT protocol so the proposal, machine build and acceptance test describe the same process.
Required RFQ inputs
- Product composition, viscosity/rheology and filling temperature
- Target dose and permitted accuracy method
- Exact syringe, nest/tub and stopper drawings plus samples
- Visible-air and stopper-position acceptance limits
- Required accepted output and batch pattern
- Cleanroom/LAF interface and utility conditions
- Documentation, language and downstream scope
Minimum FAT evidence
- Nominated product, syringe, stopper and format parts
- Repeat fill-weight or volume study using the agreed method
- Visible-air inspection against the agreed limit
- Stopper placement and rebound challenge
- Start, stop, alarm, fault and recovery records
- Cleaning/changeover demonstration within the agreed scope
- Retained samples and signed open-item list
Do not accept a water demo as final evidence when the production formulation has materially different viscosity, foaming or air-release behavior.
Frequently asked questions
Prefilled syringe vacuum filling machine FAQ
Answers based on the published HIJ-GZB100 document and the project inputs that must still be confirmed.
What syringe sizes does the HIJ-GZB100 support?
The published size list is 0.5, 1, 2.25, 3, 5, 10 and 20 ml. These formats are not universal: confirm the exact syringe supplier, barrel, nest/tub, stopper and required mold or guide parts in the quotation.
What is the published output of the HIJ-GZB100?
The source document lists 600–800 syringes per hour with one filling needle. Actual accepted output depends on product behavior, dose, vacuum cycle, syringe/stopper format, loading method and agreed inspection criteria.
Does vacuum filling guarantee zero bubbles?
No universal zero-bubble guarantee should be made without a defined inspection method and product trial. The vacuum filling system is designed for viscous materials and to reduce incomplete filling or visible air; acceptance must be demonstrated with the actual formulation during FAT.
Can the machine be installed under laminar flow?
An optional laminar-flow hood is listed in the HIJ-GZB100 document. The final arrangement must be coordinated with the facility’s cleanroom, airflow, environmental-monitoring and qualification strategy.
What materials contact the product?
The published document states AISI 316L stainless steel and medical silicone for product-contact parts, with an AISI 304 stainless-steel exterior. Confirm certificates, surface requirements and chemical compatibility for the ordered configuration.
What should be tested during FAT?
Use the nominated product, syringe and stopper. Test the agreed fill-accuracy method, visible-air limit, stopper position, vacuum cycle, accepted output, alarms, recovery, changeover and cleaning scope; retain samples and record open items.
Project inquiry
Configure the GZB100 around your product and syringe
Send the formulation, target dose, syringe and stopper drawings, samples, accepted output, visible-air limit, cleanroom interface and required documentation. HIJ can return a project-specific equipment and FAT scope.