Fully automated WFI-based sodium chloride solution preparation system. Stainless steel jacketed compounding vessel (200–2,000 L, configurable) with continuous stirring and 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.

In-house tooling division develops all injection molds for 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 produced in ISO Class 7 cleanrooms from USP Class VI / ISO 10993-compliant medical-grade PP resin with 100% CMM dimensional inspection.

Core filling station operates under ISO 5 (Class 100) unidirectional laminar airflow within an ISO 7 background cleanroom. Servo-driven ceramic pump filling system achieves ±0.5% fill accuracy at 220 syringes per minute. Integrated 100% in-process weight check (IPC) rejects any unit outside tolerance. Automated stoppering with force-feedback verification ensures complete stopper seating on every unit.

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 uses polarized LED illumination at multiple wavelengths, high-speed cameras (≥2,000 fps), and a deep-learning engine trained on 500,000+ PP syringe images. Detection accuracy reaches 99.5% for particles ≥50 µm with false rejection rates reduced by 40% versus rule-based systems.

Servo-electric actuators with force-displacement monitoring insert and verify every plunger rod assembly (5–20 N, ±0.5 N accuracy). Inline thermal transfer printer applies variable data at 200 labels per minute. 100% vision system 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.

Final station packages each labeled syringe into individual pillow packs at 220 packs per minute. Continuous film forming, optional nitrogen flushing (headspace O₂ <1%), and precision heat sealing (±1°C temperature control) ensure hermetic, shelf-stable packaging. 100% seal integrity verification and barcode scan with automatic reject diverter for any failed pack.

Single-Source Turnkey

All 6 production stations from a single supplier. Zero inter-vendor coordination overhead, one project manager, one timeline, one accountability.

Industry-Leading Technology

Deep-learning vision system specifically optimized for polypropylene - solving the industry's most challenging inspection problem with 99.5% accuracy and 40% fewer false rejects.

Rapid Deployment

Proven platform with standardized station interfaces enables fast installation and qualification. From contract signing to first validated batch in as little as 12 weeks.

Contractual Performance

OEE >85% is not a target - it is a contractual commitment backed by our engineering team's on-site support during ramp-up and beyond.

Global Regulatory Ready

Equipment and documentation designed for simultaneous compliance with EU GMP, WHO GMP, FDA 21 CFR Part 11, USP <790>, and EU GMP Annex 1 (2022).

Total Cost of Ownership

European-level quality and compliance at a highly competitive total cost of ownership. 10-year spare parts availability guarantee included.

Mechanism design, DFM analysis, human factors, and material selection for PP syringe components. Complete design documentation ready for regulatory submission.

PP barrel, tip cap & stopper molds in S136 steel. USP Class VI, ISO 10993 compliant materials. Full material traceability with CoA, CoC, and DSC documentation.

Full 6-station line engineering, integration, and factory acceptance test (FAT) at DROFEN facility. Client witnesses FAT execution before equipment shipment.

On-site installation, IQ/OQ execution (4–6 weeks), followed by PQ with production batches (8–12 weeks). Complete DQ/IQ/OQ/PQ documentation package delivered.

Technical dossier preparation, DMF support, and submission assistance for CDSCO (India), SFDA (Saudi Arabia), FDA (US), and EMA (EU) regulatory pathways.

Ongoing spare parts supply (10-year guarantee), process optimization, remote monitoring, and on-site service within 48 hours for critical issues. Dedicated account manager for the life of the equipment.

India (CDSCO)

Supporting Indian pharmaceutical manufacturers with complete PFS production lines meeting CDSCO registration requirements and WHO prequalification standards.

Middle East (SFDA)

Turnkey solutions for Saudi Arabia's growing pharmaceutical manufacturing sector with full SFDA compliance and track-and-trace serialization built in.

Southeast Asia & LATAM

Established presence in emerging pharmaceutical markets with installed base across 12+ countries. GMP audit support and local distributor network introductions included.