Product Details
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 Profile
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 & packaging machines, also
include medical blister packagings and injection madical devices.
With a team of experienced engineers and technicians, Suzhou
Lingyao Intelligent Equipment Co., Ltd. provides customized
solutions to meet the specific requirements of its customers. The
company also offers excellent after-sales service and technical
support to ensure customer satisfaction.
Overall, Suzhou Lingyao Intelligent Equipment Co., Ltd. is known
for its commitment to quality, innovation, and customer service in
the intelligent equipment industry.