Basic Specifications
Model NO.:
FDNPI02
Machine Material:
Stainless Steel
Packaging Material:
Aluminum, Glass, PVC
Warranty:
24 Months
Package Size:
500cm * 200cm * 300cm
Gross Weight:
3000.00kg
Core Features: Batch Coding, Print Registration Control, Sterilization Capability, Tamper-Evident Packaging, Temperature Control, Vacuum Packaging.
Sterile API Isolation and Filling System
This system is a fully integrated solution developed in strict compliance with GMP requirements, applicable to sterile powder production processes such as sterile lyophilization, crystalline drying, spray drying, and sterile powder injections. It utilizes automation and containment measures to minimize and isolate manual interventions, thereby ensuring aseptic process integrity.
The key operational areas employ ISPE-recommended RABS (Restricted Access Barrier System) protection, which effectively lowers the risk of product contamination by particles and microorganisms. Available configurations include ORABS, CRABS, and ISOLATOR.
Application Scenarios:
- Sterile post-processing integrated three-in-one system
- Lyophilization and spray drying post-processing
- Sterile powder injection batching, mixing, and filling isolation
- Sterile raw material sampling isolation operation
- Vacuum-sealed transfer & sterile powder milling
- Automated lifting, mixing, and nitrogen purging
Performance Parameters
| Item |
Technical Parameter |
| Chamber Cleanliness | Grade A positive-pressure laminar airflow |
| Air Volume | 85-500m³/h |
| HEPA Filter Type | H14 Grade High-Efficiency Filter |
| Air Velocity | 0.45m/s ±20% |
| VHP Concentration | 0-5000 ppm |
| Biological Indicator | 6 log Including VHP Sterilization |
| Sterilization Time | 20-60 min |
| Leakage Rate | 0.5 % vol/h @100 Pa |
| Illumination / Noise | ≥500 Lux / ≤65 dBA |
Manufacturing Excellence
The facility boasts over 100 sets of state-of-the-art, automated production equipment. With experienced engineers and highly skilled technicians, the manufacturing process is integrated and validated to meet international standards.
Global Standards & Presence
Frequently Asked Questions
Can the equipment be customized for existing production lines?
Yes. Our technical team provides comprehensive solutions to ensure all equipment dimensions and interfaces align perfectly with your current infrastructure.
What international standards does the equipment comply with?
The equipment complies with multiple global standards, including EU CE, US UL/OSHA, German TÜV, and Southeast Asian IEC requirements.
What is the typical production lead time?
Standalone units are often available from stock. For custom engineering projects, we offer competitive lead times with guaranteed on-time delivery.
How is after-sales technical support handled?
We provide 24-hour response times, remote technical assistance, and localized service. Spare parts are maintained in stock for long-term availability.
What are the available payment and transaction terms?
We offer transparent quotations with detailed breakdowns for equipment, testing, and transport. Flexible payment terms are available to suit project needs.
How is the equipment protected during international shipping?
All systems are packed in professional-grade wooden packages specifically designed for secure maritime or land transport to prevent damage.
CarniTe Machinery
