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Oral Liquid Filling Line

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Oral Liquid Filling Line

BRIEF INTRODUCTION

Oral liquid production line is a GMP-compliant automated manufacturing solution designed for oral liquids, biological products, and other aseptic formulations, meeting high standards for the entire process including bottle washing, sterilization, filling, capping, and labeling. The line is composed of key equipment including the JKQXL Vertical Ultrasonic Bottle Washer, JKRX Series Hot Air Circulation Depyrogenation Tunnel, and JKKF-24 Oral Liquid Filling and Capping Machine, offering compact layout, smooth integration, and stable, reliable operation. The line is suitable for 10 mL glass oral liquid bottles (rubber stopper with aluminum cap) and is also compatible with bottles ranging from 2–50 mL. Quick format changeover allows flexible adaptation for multiple product specifications. Under 10 mL glass bottle water-based conditions, the line can achieve a maximum output of 12,000 bottles per hour.

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Product Positioning

Designed to meet GMP-compliant production requirements for pharmaceuticals such as oral liquid preparations and biological products, covering the entire process of vial washing / sterilization / filling / stoppering / labeling.

Applicable Packaging Type & Specifications

Container type: 10 mL glass vials with rubber stopper and aluminum cap
Filling volume range: 2 – 50 mL (standard: 10 mL)
Maximum output: 12,000 vials/hour
(Measured under operating conditions of 10 mL glass oral liquid vials filled with aqueous solution)

Process Flow

Vial infeed → Washing: ultrasonic + three-water / three-air process, high-temperature WFI at 60–65 °C → Sterilization: dry heat depyrogenation, 250 °C × 15 min, air velocity 0.7–0.8 m/s → Filling: servo-driven piston pump, accuracy ≤ ±1% → Stoppering / Capping: stopper & cap placement accuracy ≥ 99% → Capping: qualified rate ≥ 99%, with door interlock protection → Labeling: labeling rate ≥ 99%, labeling accuracy ±0.5 mm

Core Modules

Control System & Data Integrity

Siemens / Mitsubishi PLC with HMI, supporting emergency stop, safety door interlock, and audible & visual alarms; one-button CIP start.
Full-line sensor monitoring (missing vial, full vial, no vial–no fill, no vial–no cap).
Compliant with 21 CFR Part 11, including audit trail, automatic batch record generation, and one-key recipe changeover (≥ 100 recipes).

Cleaning & Sterilization Strategy

Filling system supports automatic CIP/SIP, ensuring high online cleaning efficiency.
Dry heat depyrogenation tunnel: 250 °C × 15 min, optional high-efficiency mode: 300 °C × 5 min.
Online filter integrity testing; positive-pressure standby mode for energy-saving operation during night shifts.