Precision in Every Drop: AUSTAR's End-to-End PFS Solution from Filling to Inspection and Packaging

From individual machine excellence to integrated line synergy, we provide a full-chain guarantee for biopharmaceuticals.

In the biopharmaceutical industry, the quality of every injectable impacts patient safety and corporate reputation. As prefilled syringes (PFS) become the preferred packaging for vaccines, monoclonal antibodies, biosimilars, and other high-end formulations—thanks to their precision dosing, contamination reduction, and ease of use—demands for accuracy, efficiency, and compliance in filling, inspection, and packaging have never been higher.

AUSTAR Group has been deeply engaged in the field of pharmaceutical equipment, now introduces an integrated PFS solution covering filling, visual inspection, and blister packaging. Through robust technological innovation, we ensure every drop of biopharmaceutical value is safeguarded.

Precision Filling: AUSTAR Intelligent PFS Filling Machine

Addressing Industry Pain Points: High drug costs (some exceeding $150 per milliliter), inaccurate filling in traditional equipment, time-consuming format changeovers, cumbersome compliance documentation, and costly unplanned downtime.

AUSTAR's Solutions:

1. Precision Filling, Minimized Waste
     ✓  Dynamic calibration technology with proprietary servo control to minimize filling deviations.
     ✓  Anti-drip design and specialized back-suction program ensure 99.9% filling consistency.
     ✓  Standardized molds and smart parameter memory enable changeovers in just 20 minutes.

2. Stable Operation, Smart Monitoring
     ✓  15-inch touchscreen displays 20+ core parameters in real time.
     ✓  Compliant with 21 CFR Part 11, enabling electronic signatures and audit trails; data stored locally or integrated with MES.
     ✓ In-house core components prolong wear parts' lifespan by 30%; IoT modules enable predictive maintenance, reducing unplanned downtime by over 50%.

3. Durability and Compliance
     ✓ 316L stainless steel product contact parts, Ra ≤0.4μm surface finish, CIP residues ≤0.5ppm, meeting cGMP standards.
     ✓ SIP integrates steam barriers and 0.22μm sterilizing-grade filters, validated per EN 285.
     ✓ 7 regional service centers across China, 24/7 engineer support, critical spare parts delivered within 48 hours.

Intelligent Inspection: C-True Automatic PFS Visual Inspection Machine

With the rapid growth of the global PFS market, demand for automated, intelligent inspection systems is surging. The C-True Automatic PFS Visual Inspection Machine rises to the challenge.

Key Features:
✓ AI + Traditional Algorithm Dual Engine: Combines deep learning with rule-based algorithms for high detection accuracy and low false rejection rates.
✓ Visual Tracking Technology: Ensures precise multi-angle imaging during high-speed inspection.
✓ Full Specification Compatibility: Covers 0.5ml–20ml glass or plastic PFS, supports Luer Lock, Luer Slip, and fixed-needle types.
✓ Cosmetics Industry-Friendly: Optimized for both low-viscosity (water-like) and high-viscosity (gel-type) products like hyaluronic acid and collagen.
✓ Compliance & Traceability: Meets NMPA, EU GMP Annex 1, and FDA 21 CFR Part 11 requirements; supports electronic signatures, batch tracing, and MES/ERP integration.

Precision Packaging: PFS Blister Packaging & Cartoning Integrated Solution

The final packaging stage for PFS presents challenges in efficiency, cost, and compliance. AUSTAR's integrated packaging line delivers a seamless, smart, and efficient closed-loop production system.

Core Value:

✓ End-to-End Integration: Uninterrupted workflow from PFS loading and blister forming to inspection and cartoning.

✓ Ultimate Safety: Fully enclosed, low-oxygen, or dust-free environments combined with multi-level defect      detection.

✓ Flexible Production: Modular design supports quick changeovers for small-batch, multi-variety production.

✓ Smart Operation: AI-powered vision analysis and predictive maintenance maximize overall equipment      effectiveness (OEE).

Line-Wide Synergy: 1+1+1 > 3

AUSTAR's integrated PFS solution delivers value through deep collaboration across filling, inspection, and packaging:

• Seamless Data Flow: From filling parameters to inspection results and packaging details, enabling a      complete digital twin.

• Optimized Efficiency: Balanced line design eliminates bottlenecks and maximizes OEE.

• Unified Compliance: A single compliance strategy covering the entire process from filling to packaging.

• Rapid Response: Single-supplier accountability simplifies coordination and enhances service efficiency.

Conclusion

The rise of PFS marks a shift toward precision, efficiency, and safety in biopharmaceuticals. Rather than pursuing “disruptive innovation,” AUSTAR focuses on solving each practical challenge in production—from precise filling and intelligent inspection to secure packaging.

By integrating standalone advantages into a comprehensive solution, we deliver synergistic processes, complete data management, and worry-free operation—making AUSTAR a trusted partner on your production line.

If you face challenges in PFS line efficiency, quality control, or compliance, give AUSTAR a chance. Let us solve your problems with one integrated solution.