When the market demand for oral liquids extends from "efficacy" to "safety, stability, and traceability", a truly automated turnkey production line becomes the core competitiveness of pharmaceutical companies. Taking a typical oral liquid workshop with a production capacity of 60-120 bottles/minute as an example, this article systematically reviews its equipment composition, technical highlights, and verification logic to help decision-makers understand the complete value behind the "turnkey" approach in one go.
Turnkey does not mean equipment stacking, but rather a three-layer logic of "pre-processing filling post-processing", with automation, digitization, and compliance as the axes, to achieve "zero manual intervention" from raw material storage to finished product stacking.
1. Pre treatment layer: Purified water, injection water, CIP/SIP station, distribution tank, sterilization and filtration unit are centrally arranged through modular pry, and the pipeline is made of 316L electrolytic polishing, Ra≤0.4 μm， Avoid blind spots.
2. Filling layer: The washing, drying, filling and sealing integrated machine (BFS or traditional washing, drying, filling and rolling) is the core, combined with online weighing, visual inspection, and residual oxygen detection, to achieve ± 0.5% filling accuracy and 100% appearance inspection.
3. Rear layer: seamless connection between labeling, boxing, wrapping, and palletizing robots, automatic palletizing, real-time inventory updates, truly achieving "no one touches the bottle after light inspection".
1. Intelligent liquid dispensing system
-Adopting magnetic levitation stirring+weighing module closed-loop control, concentration deviation ≤ 0.3%.
-Equipped with automatic feeding (vacuum suction/dust-free feeding station), online pH/conductivity/temperature monitoring, and automatic data archiving to MES.
-The tank is integrated with a "one click CIP/SIP" program, and the cleaning verification meets the requirements of sterile drugs.
2. Washing, drying, filling and sealing integrated machine
-Bottle washing: Four stage cleaning with ultrasound, purified water, injection water, and compressed air, reducing water consumption by 30%.
-Drying: Class 100 laminar flow tunnel oven.
-Filling: Ceramic piston pump, servo drive, single bottle weighing feedback, supports multi specification switching.
-Sealing/capping: vacuum suction+servo torque capping, with a pass rate of ≥ 99.8%.
3. Online detection and traceability
-Visual system: camera+AI algorithm, capable of identifying black spots, cracked bottles, liquid level differences, and aluminum cap misalignment.
-Weighing unit: dynamic scale, with an accuracy of ± 10 mg, NG bottles are automatically removed to the isolation box.
-Third level traceability: laser coding of bottle body (third level code) → box printing → tray RFID, achieving full traceability of raw materials, personnel, environment, equipment, and inspection data.
4. Rear packaging
-Spider hand boxing machine: servo multi axis linkage, adaptable to different box types, with a speed of up to 150 boxes/minute.
-Stacking robot: with visual guidance, zero pallet positioning error.
-The OEE of the entire line is ≥ 85%, and the batch change time is shortened to within 30 minutes.
-Real time collection of 3000+I/O points, key data synchronized to the cloud, supporting remote monitoring on mobile phones and tablets.
-Electronic Batch Records (EBR) are automatically generated and audit trails comply with 21 CFR Part 11.
-Reserved digital twin interface, which can be connected to AI predictive maintenance system in the later stage to reduce downtime risk.
4、 Verification and delivery
-Special sterilization validation, simulated filling of culture medium three times qualified;
-At the final delivery, customers only need to provide raw materials and labels to produce commercial batches.
A fully automated turnkey production line for oral liquids is not only a combination of equipment, but also a deep integration of process, regulations, digitization, and engineering management. It allows pharmaceutical companies to invest more energy into research and development and marketing, while entrusting "stable and compliant production" to this smart production line with confidence.
