Product Specification

Integrated Aseptic Vial Washing and Filling Line (2-30ml)

Continuous 12-Meter Monoblock for Insulin, Vaccines, and Advanced Biologics

Product Overview

In the commercial manufacturing of highly potent liquid biologics—such as insulin formulations and specialized vaccines—maintaining an unbroken sterility chain is a critical regulatory mandate. The Lingyao LYQCL + LYASMR Series Integrated Aseptic Vial Processing Line is a heavy-duty, continuous-motion automation platform engineered to flawlessly execute ultrasonic washing, thermal depyrogenation, micro-dosing, and stoppering for 2ml to 30ml tubular and molded glass vials.

Stretching up to 13.2 meters and achieving sustained outputs ranging from 6,000 to 26,000 Vials Per Hour (VPH), this formidable production architecture unifies primary packaging. Fully compatible with O-RABS (Open Restricted Access Barrier Systems) and Closed Isolator technologies, it guarantees strict Zone A (ISO Class 5) aseptic conditions and delivers an elite dosing precision of ≤ ±0.5%, securing your facility's compliance with FDA and WHO cGMP standards.

The Cause: Fragmented Lines and Volumetric Giveaway in Biologics

Scaling up the production of sensitive biologic liquids using disconnected standalone machines introduces severe compliance and financial risks:

1. Airborne Contamination Risks: Transferring sterilized vials between a depyrogenation oven and a separate filling station exposes open containers to ambient cleanroom particulates. For sensitive drugs like insulin, even microscopic contamination causes catastrophic batch rejection.

2. Lethal Volumetric Drift: High-potency biological preparations demand exact dosage. Outdated pneumatic pumps experience volumetric drift. A 1.5% filling variance on a 10ml insulin vial not only wastes tens of thousands of dollars in raw API per shift but also creates severe clinical risks for patients.

3. Synchronization Failures: Disparate control systems between washers, ovens, and fillers lead to line accumulation, frequent glass breakage, and disastrous production downtime.

The Solution: Unified Mechanical Linkage and Servo-Peristaltic Dosing

The Lingyao engineering team resolved these aseptic vulnerabilities by unifying the entire primary packaging process into a single, closed-loop PLC network.

To eliminate contamination risks, the process initiates with an Ultrasonic Washing Station, feeding seamlessly into a Hot Air Circulation Depyrogenation Oven. Vials transition immediately from the cooling zone into the highly protected Zone A filling environment. This unbroken physical linkage completely prevents ambient air exposure.

To conquer micro-dosing drift, the fluid pathway utilizes highly advanced, servo-driven Peristaltic Pumps or 316L Ceramic Plungers. This guarantees low-shear fluid handling for sensitive proteins and locks volumetric tolerance to a strict ≤ ±0.5%. The system features a synchronized post-fill Nitrogen Flushing Station prior to stoppering, effectively displacing oxygen to protect the integrity of oxidation-sensitive biologics.

Technical Specifications

Targeted Advanced Healthcare Applications

• Insulin & Liquid Biologics: Uncompromised, low-shear aseptic processing for temperature and shear-sensitive protein formulations.

• Sterile Liquid Vaccines: High-capacity, continuous operations designed specifically for rapid scale-up during critical immunization demands.

• Specialized Aqueous Solutions: Highly accurate micro-dosing for high-value APIs requiring strict isolation barrier technology integration.

Turnkey Global Deployment and Validation Execution

Deploying a heavy-duty, 13-meter aseptic filling line requires rigorous engineering execution. Supported by the international capabilities of our TachoCraft Thailand manufacturing base, Lingyao delivers a true Turnkey Solution.

Governed by an advanced Schneider Electric PLC & HMI Architecture (IEC60204-1 Compliant), this machine is ready for strict electronic batch recording. We accompany your capital investment with comprehensive IQ/OQ/PQ validation dossiers, FAT/SAT execution, and full material traceability. Our global engineering team provides complete site installation, validation support, and operator training, drastically expediting strict regulatory compliance audits across expanding markets worldwide.