10mL Insulin Vial Filling and Capping Machine: High-Speed, GMP Compliant, Temperature-Controlled

Transform your insulin production with our state-of-the-art vial filling and capping machine, engineered for precision and efficiency in diabetes care. This fully automated system is tailored for 10mL insulin vials, ensuring compliance with global Sterile standards and optimal handling of temperature-sensitive formulations.

Key Features and Specifications

• Model Options: LYQCL80+LYASMR620/48+LYKGF8, LYQCL1000+LYASMR620/48+LYKGF10, LYQCL120+LYASMR620/55+LYKGF12.
• Vial Size Compatibility: 2-30ml national standard vials.
• Capacity: Ranges from 6000 to 26000 pcs/hr depending on the model.
• Dosing Accuracy: Ceramic piston pump with ±0.5% accuracy.
• Temperature Control: Dynamic cooling system maintains 2-8°C to prevent protein denaturation.
• Material and Compliance: Constructed with 316L stainless steel, meeting GMP and FDA standards.
• Clarity: Greater than 99%.
• Breakage Rate: Less than 0.5%.
• Filling Tolerance: 1.5%.
• Water and Air Consumption: Fresh water at 0.2-0.4Mpa/0.6-1.0 m³/hr; compressed air at 0.3-0.6Mpa/35-80 m³/hr.
• Capping and Sealing: Handles 13mm rubber stoppers and aluminum seals with >99% pass rate.
• Vacuum & Exhaust: Vacuum pumping speed of 60m³/h and exhaust volume of 3500-4800m³/h.
• Power and Dimensions: Power ranges from 90kW to 110kW; dimensions approximately 12600 X 2260 X 2445mm.

Innovative Features

• Smart HMI-PLC Interface: Monitors fill volume, capping torque, and environmental conditions in real-time.
• Anti-Drip & Self-Cleaning Nozzles: Reduces product waste and contamination risks.
• Modular Design: Allows quick changes between vial formats, minimizing downtime.

Ideal Applications

1. Insulin Analogs: Products like glargine and aspart requiring strict temperature control.
2. Combination Therapies: Multi-dose vials for insulin and GLP-1 agonists.
3. Emerging Markets: High diabetes prevalence regions, such as the Middle East.

Certifications and Support

• Certifications: CE-marked, ISO 15378:2021 compliant.
• Support: 24/7 remote technical support available.

This machine is a game-changer for insulin production, combining innovative technology with robust compliance to meet the evolving demands of the Sterile industry.

Application Scenarios

• High-Volume Insulin Production: Seamlessly integrates into existing production lines, achieving up to 8,000 vials/hour.
• Temperature-Sensitive Formulations: Ensures the integrity of biologics with built-in temperature control.

Selection Guide

• Production Scale: Choose based on desired output capacity and vial size adaptability.
• Regulatory Compliance: Ensure alignment with GMP and FDA standards for sterile production.
• Customization Needs: Consider modularity for quick format changes and anti-drip features for precision.

FAQ

Q: How does the temperature control system benefit insulin production?
A: It maintains a consistent 2-8°C environment during filling, crucial for preventing protein denaturation and ensuring the efficacy of insulin products.

Q: What makes the machine suitable for high-speed production?
A: Its high-speed output capability of up to 8,000 vials/hour and seamless integration into existing lines make it ideal for large-scale manufacturing.