Pre-Filled Syringe (PFS) Filling-Capping Monobloc Systems
Iso class 5 syringe filling monobloc.
Veterinary syringe tip filling monobloc.
For vaccines, biologics & injectables requiring precision.
Integrated Processes:
1. Aseptic Barrel Handling — Nest loading with ISO Class 5 compatibility
2. Precision Volumetric Filling — Peristaltic/piston pumps (±0.3% accuracy)
3. Plunger Stopper Insertion — Controlled insertion depth (±0.1mm)
4. Tip Cap Orientation & Sealing — Tamper-evident flip-off caps
5. 100% In-Process Control — Vision inspection optional
Critical Compliance Features: — FDA 21 CFR Part 211 / EU Annex 1 ready — Material traceability (SAT/OQ documentation) — Cleanroom-compatible (ISO 14644 Class 5-8)
| Parameter | Specification | Competitive Advantage |
|---|---|---|
| Capacity Range | 0.1ml — 50ml | Handles micro-dosing to large-volume |
| Accuracy | ±0.5% of setpoint | Exceeds ISO 7886-1 requirements |
| Speed | 120-400 syringes/min | 30% faster than rotary indexers |
| Change Parts | Tool-free <15 min | REDUCES downtime 65% vs competitors |
| Environment | ISO Class 5 laminar flow | Eliminates separate cleanroom enclosure |
Dual-Mode Syringe Processing Technology
For complete syringe manufacturing or drug filling operations
1️⃣ Assembly-Only Monoblocs
For syringe manufacturers
mermaid
graph LR
A[Barrel] —> E[Assembly Turntable]
B[Plunger] —> E
C[Rod] —> E
D[Tip] —> E
E —> F[Finished Syringe]
4-Station Vibe Bowls: Orient complex components
Servo-Assembly: Precision mating of glass/plastic parts
Output: 200-500 syringes/hour
For pharmaceutical fill-finish
Closed System: Zero human contact with product/syringes
Flexible Filling:
Top-fill: Standard barrel loading
Bottom-fill: Through-tip filling (veterinary applications)
Dosing Options:
+ High-Viscosity: Piston/Ceramic/Gear pumps (hyaluronic acid, botox)
+ Low-Viscosity: Peristaltic pumps (vaccines, <1µl precision)
| Feature | LOCUS ROBOTICS | Industry Standard |
|---|---|---|
| Occlusion Detection | Real-time pressure monitoring | Manual sampling |
| Stopper Placement | Servo-controlled insertion | Pneumatic impact |
| Particulate Control | Integrated 0.22μm filtration | External systems |
| Data Integrity | 21 CFR Part 11 compliant software | Basic PLC |
Our closed RABS design maintains Grade A conditions without isolator costs. Features:
Laminar flow HEPA filtration
VHP-compatible surfaces
Automatic SIP/CIP cycles
In-Weight Checks: Reject under/over-filled units
Cap Torque Monitoring: 0.5-6 Nm range
Optional Vision Inspection:
Plunger position (±0.2mm)
Barrel defects (cracks, particulates)
Cap orientation
FAT/SAT protocols included
IQ/OQ documentation package
Performance Qualification templates
3rd-party audit assistance
Precision Dosing Comparison
| Dosing Method | Viscosity Range | Accuracy | Ideal Applications |
| Piston Filler | 1,000-50,000 cP | ±0.5% | Dermal fillers, biogels |
| Ceramic Pump | 500-20,000 cP | ±0.3% | Botox, peptide serums |
| Peristaltic | 1-1,000 cP | ±1% | Vaccines, insulin |
| Gear Pump | 2,000-100,000 cP | ±0.5% | Silicone-based implants |
Sterile Processing Capabilities
GMP-Grade Configurations:
— ISO Class A Environment:
— Laminar flow hoods with H14 HEPA
— Particle counters (0.5-5.0 µm monitoring)
— VHP-compatible surfaces
— Critical Components:
— 316L electropolished stainless steel
— USP Class VI tubing/contact parts
— Documentation:
— DQ/IQ/OQ validation packages
— 21 CFR Part 11 compliant data logging
Technical Specifications
| Parameter | Standard | GMP Upgrade |
| Capacity | 0.1ml-50ml | 0.05ml-100ml |
| Accuracy | ±1% | ±0.5% |
| Speed | 150 syringes/hr | 80 syringes/hr (Class A) |
| Changeover | 30 min | 45 min (sterile protocol) |
| Air Quality | ISO Class 8 | ISO Class 5 |
Industry-Specific Solutions
Cosmetic Applications
— Botox/hyaluronic acid filling
— Silicone implant loading
— Sterile assembly of mesotherapy syringes
Pharmaceutical
— Vaccine filling (0.5ml PFS)
— Auto-injector assembly (2.0ml)
— Veterinary dose packaging
Biotechnology
— Micro-dosing (<10µl) for clinical trials
— ADC (Antibody-Drug Conjugate) handling
Modular Expansion Options
diff
+ Integrated Subsystems:
— Vision Inspection: Plunger depth/particulate check
— Labeling: Tamper-evident labeling station
— Track & Trace: 2D barcode printing/verification
— Packaging: Blistering/case packing systems
Unique through-tip filling capability for veterinary syringes — eliminates contamination risk during plunger insertion. Achieves 99.98% fill accuracy for viscous suspensions.
Delta robots for delicate glass syringe transfer
Vision-guided part orientation
Collision detection sensors
Pre-written FAT/SAT protocols
Material certificates (3.1/3.2)
Particulate validation reports
Tamper evident flip off cap torque control.
Syringe nest transfer system 316L stainless.
Iso class 5 syringe assembly laminar flow.
4 station syringe part orientation system.
Pharmaceutical-Grade Syringe Packaging.
🌐 Request Compliance Audit: Free gap analysis with throughput simulation.
Ready to optimize your dosing process?
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Free line configuration for your products, throughput validation testing!
Contact Specialists for Packaging Equipment:
Compliance Roadmap:
