6-Station Integrated Production Line
Station 01
NaCl Solution Preparation
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Station 02
Syringe Mold Development & Component Supply
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Station 03
Saline Filling & Stoppering
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Station 04
Automated Light Inspection Machine
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Station 05
Plunger Rod Insertion & Labeling
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Station 06
Pillow Packaging Machine
Station 01
NaCl Solution Preparation
Pharmaceutical-Grade Saline Compounding System
The production line begins with a fully automated WFI-based sodium chloride solution preparation system. A stainless steel jacketed compounding vessel (200–2,000 L, configurable) dissolves pharmaceutical-grade NaCl (0.9% w/v) under continuous stirring with temperature control (±0.5°C). Inline conductivity monitoring, pH adjustment, and 0.22 µm sterilizing-grade filtration ensure every batch meets USP <1>, EP 0193, and WHO TRS 961 specifications before transfer to the filling suite.
Key Features
| WFI-Based | USP <1> | EP 0193 | 0.22 µm Filtration | CIP/SIP |
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Station 02
Syringe Mold Development & Component Supply
PP Barrel, Tip Cap & Plunger Stopper Tooling
DROFEN's in-house tooling division develops and manufactures all injection molds for the PP syringe components - barrel (3 ml / 5 ml / 10 ml), Luer-Lock tip cap, and plunger stopper. S136 stainless steel molds with 16–32 cavity configurations guarantee ≥1,000,000 shot service life. All components are produced in ISO Class 7 cleanrooms from USP Class VI / ISO 10993-compliant medical-grade PP resin, with 100% dimensional inspection by CMM and vision systems.
Key Features
| S136 Steel | ISO Class 7 | USP Class VI | ISO 10993 | CMM Inspection |
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Station 03
Saline Filling & Stoppering
Aseptic Fill-Finish Under ISO 5 Laminar Air Flow
The core filling station operates under ISO 5 (Class 100) unidirectional laminar airflow within an ISO 7 background cleanroom. A servo-driven ceramic pump filling system achieves ±0.5% fill accuracy at speeds up to 220 syringes per minute. Integrated 100% in-process weight check (IPC) rejects any unit outside ±1.5% tolerance. Automated stoppering with force-feedback verification ensures complete stopper seating on every unit. CIP/SIP of all product-contact surfaces is fully automated with cycle documentation.
Key Features
| ISO 5 Cleanroom | Ceramic Pump | ±0.5% Accuracy | CIP/SIP | SAL 10⁻⁶ |
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Station 04
Automated Light Inspection Machine
AI-Powered Vision Inspection for PP Syringes
Polypropylene syringes present the most challenging inspection scenario in the industry - low optical clarity, conical shadow zones, and silicone oil droplets that mimic particulate matter. DROFEN's multi-spectral AI vision inspection system overcomes these obstacles with polarized LED illumination at multiple wavelengths, high-speed cameras (≥2,000 fps), and a deep-learning classification engine trained on 500,000+ PP syringe images. Detection accuracy reaches 99.5% for particles ≥50 µm, with false rejection rates reduced by 40% compared to rule-based systems. Full compliance with USP <790>, EU GMP Annex 1 (2022), and 21 CFR Part 11.
Key Features
| AI Vision | Multi-Spectral LED | USP <790> | EU GMP Annex 1 | PP-Optimized |
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Station 05
Plunger Rod Insertion & Labeling
Servo Insertion with GS1 Serialization & Track-and-Trace
The plunger rod insertion station uses servo-electric actuators with force-displacement monitoring to insert and verify every plunger rod assembly. Insertion force (5–20 N, ±0.5 N accuracy) and backstop engagement are confirmed on each unit - any out-of-spec assembly is automatically rejected before labeling. An inline thermal transfer printer applies variable data (batch number, manufacturing date, expiry date, serial number) at 200 labels per minute. A 100% vision system immediately verifies label presence, print quality, and barcode readability. GS1 DataMatrix and GS1-128 serialization supports EU FMD, India CDSCO, Saudi SFDA, and FDA DSCSA track-and-trace requirements.
Key Features
| Servo Insertion | GS1 DataMatrix | EU FMD | SFDA Track & Trace | CDSCO |
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Station 06
Pillow Packaging Machine
220 Packs/Min High-Speed Automated Packaging
The final station packages each labeled syringe into an individual pillow pack at 220 packs per minute - the headline throughput of the entire production line. Continuous film forming, nitrogen flushing (optional, headspace O₂ <1%), and precision heat sealing (±1°C temperature control) ensure hermetic, shelf-stable packaging. An integrated thermal transfer printer applies batch and expiry data to each pack, followed by 100% barcode verification. Automatic reject diverter removes any pack with failed seal integrity, missing label, or unreadable barcode. Compatible with PE/PP laminate and foil laminate film materials for standard and moisture-barrier applications.
Key Features
| 220 packs/min | Nitrogen Flush | Heat Seal ±1°C | GS1 Barcode | Auto Reject |
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Technical Specifications at a Glance
Overall Line
| Maximum Throughput | 220 syringes/min |
| Compatible Formats | 3ml.5 ml.10 ml PP |
| OEE Target | >85% |
| Format Changeover | < 30 min (SMED) |
| Footprint | ~120 m2(configurable) |
Filling Station
| Fill Volume Accuracy | ±0.5%(CV) |
| Cleanroom Class | ISO 5 LAF/ISO7 Background |
| Bioburden Control | <10 CFU/m3 |
| Stopper Seating | Force-feedback verified |
| CIP/SIP | Fully automated, documented |
Inspection Station
| Detection Accuracy (PP) | 99.50% |
| Min. Detectable Particle | ≥ 50 µm |
| False Rejection Reduction | −40% vs. rule-based |
| Camera Speed | ≥ 2,000 fps |
| Compliance | USP <790>, EU GMP Annex 1 |
Labeling Station
| Labeling Speed | 200 syringes/min |
| Insertion Force Accuracy | ±0.5 N |
| Label Verification | 100% vision inspection |
| Serialization | GS1DataMatrix.GS1-128 |
| Compliance | EUFMD.SFDA·CDSCO.DSCSA |
Packaging Station
| Packaging Speed | 220 packs/min |
| Seal Temp Control | ±1℃ |
| Nitrogen Flush | Headspace O2 < 1%(optional) |
| Film Changeover | <15 min |
| Barcode Verification | 100% GS1scan |
Regulatory Compliance
| GMP | EU GMP.WHO GMP |
| Electronic Records | FDA 21CFR Part 11 |
| Sterile Mfg | EUGMPAnnex1(2022) |
| Particulate | USP<790>.EP2.9.20 |
| Device Standard | ISO 11040·ISO 13485 |
One-Stop CDMO Service - From Concept to Commercial Launch
DROFEN provides end-to-end project management across all 6 phases - a single contract, a single team, zero inter-vendor coordination overhead.
Phase 01
Device Design & Engineering
Mechanism design, DFM analysis, human factors, material selection for PP syringe components
Phase 02
Mold Development & Component Supply
PP barrel, tip cap & stopper molds; USP Class VI, ISO 10993 compliant; full material traceability
Phase 03
Line Design, Build & FAT
Full 6-station line engineering; factory acceptance test at DROFEN facility before shipment
Phase 04
Installation & Validation (IQ/OQ/PQ)
IQ/OQ: 4–6 weeks · PQ: 8–12 weeks · Complete DQ/IQ/OQ/PQ documentation package
Phase 05
Regulatory Filing Support
CDSCO · SFDA · FDA · EMA - technical dossier, DMF preparation, and submission assistance
Phase 06
Commercial Production Support
Spare parts, process optimization, 24/7 remote monitoring, on-site service within 48 hours
To First Batch
Contractual Guarantee
Spare Parts Availability
FDA · EU · CDSCO · SFDA
Priority Market Focus - India & Saudi Arabia
India
World's 2nd Largest Diabetic Population
India's Production Linked Incentive (PLI) scheme for medical devices provides significant capital support for domestic PFS manufacturing. DROFEN's CDSCO regulatory expertise and local service engineers (48-hour on-site response) make India a priority deployment market.
| Diabetic Patients | 101 million |
| Annual Saline Flush Demand | >2 billion units |
| PLI Scheme Incentive | Up to 20% production-linked subsidy |
| DROFEN Service | CDSCO documentation + local engineers |
Saudi Arabia
Vision 2030 - 40% Domestic Manufacturing Target
Saudi Arabia's Vision 2030 healthcare localization strategy mandates 40% domestic pharmaceutical manufacturing by 2030. DROFEN's SFDA registration support and Arabic-language technical documentation accelerate market entry for PFS production lines.
| Addressable Population | 55+ million (GCC) |
| Domestic Mfg Target | 40% by 2030 (Vision 2030) |
| Government Programs | SPIMACO · NIC · NIDLP |
| DROFEN Service | SFDA registration + Arabic documentation |
Ready to Build Your PFS Production Line?
Contact DROFEN MACHINERY for a free technical proposal, equipment quotation, and regulatory roadmap tailored to your target market. Our engineering team responds within 5 business days.