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{"title":"Automated Vial Filling Capping Line with Sterile Integrity Assurance Precision","imgUrl":"https:\/\/img.ismap.com\/nimg\/4f\/01\/eeb42c53b9e5c564d31950ca4508-200x200-1\/automated_vial_filling_capping_line_with_sterile_integrity_assurance_precision_solution_for_vaccine_and_biologics_production.jpg","attrs":{"Brand Name":"","Model Number":"LYFCM","Place of Origin":"China(Thailand available)","Certification":"CE, ISO, GMP"}}
Injection Vial Filling Machine for 2-30ml Glass Vials with Nitrogen Purging Support for Antibody and Vaccine Production
The injection vial filling machine is designed for filling 2-30ml glass vials and incorporates nitrogen purging support, making it ideal for applications involving monoclonal antibodies and viral vector solutions. Key features include:
Pharmaceutical-Grade Aseptic Assurance
Class 100 Cleanroom Standards: Equipped with a triple air filtration system that maintains microbial load control achieving SAL≤10⁻⁶ (viral inactivation level).
Comprehensive Contamination Prevention: Utilizes ultrasonic deep cleaning, 300℃ dry heat sterilization, and nitrogen protection during filling to meet EMA/FDA aseptic requirements.
International Value: Suitable for manufacturing regimens adhering to European and American standards, such as those for regenerative medicine.
High-Precision Filling and Flexible Production
±0.5% Dosage Error Control: Features a servo-driven piston pump with a touchscreen interface for real-time adjustment, ensuring product consistency.
Modular Quick Changeover: Capable of switching between different vial sizes and formulations in just 30 minutes to accommodate small batch and multi-product needs.
Specifications
Weight
9000KG
Dimensions
12600mm L x 2260mm W x 2445mm H
Total Power
95KW
Voltage/Frequency
380V/50Hz
Filling Method
Stainless Steel Pump or Peristaltic Pump (customizable)
Global Compliance Certification Coverage
Triple Certification Assurance: Compliant with GMP, ISO 13485, and FDA 21 CFR Part 11, supporting electronic batch records for audit-ready documentation.
EMA Virus Inactivation Validation: Process documentation is available for SAL≤10⁻⁶ verification, facilitating expeditious overseas registration of biological products.
Smart Technology and Traceability Systems
End-to-End Traceability: PLC-controlled integration with QR code tracking ensures full traceability of raw materials through to finished products.
Remote Operational Support: Multi-language interface (English/German/Spanish) along with IoT diagnostics mitigate the risk of downtime for international clients.
Lifecycle Cost Efficiency
Energy-Efficient Design: Nitrogen consumption reduced by 40% compared to traditional systems, and energy optimization in dry heat sterilization lowers operational costs by 30%.
Company Details
Bronze Gleitlager
,
Bronze Sleeve Bushings
and
Graphite Plugged Bushings
from Quality China Factory
Business Type:
Manufacturer
Year Established:
2013
Total Annual:
5,000,000-10,000,000
Employee Number:
50~200
Ecer Certification:
Verified Supplier
Established in 2013, Suzhou Lingyao Intelligent Equipment Co., Ltd. has a strong reputation for providing innovative and reliable solutions to meet the diverse needs of companies. The company's product range includes a wide variety of equipment such as intelligent filling machines, labeling... Established in 2013, Suzhou Lingyao Intelligent Equipment Co., Ltd. has a strong reputation for providing innovative and reliable solutions to meet the diverse needs of companies. The company's product range includes a wide variety of equipment such as intelligent filling machines, labeling...