CarniTe Machinery
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Features: Batch Coding, Print Registration Control, Sterilization Capability, Tamper-Evident Packaging, Temperature Control, Vacuum Packaging
System Overview:
This system is a fully integrated solution developed in strict compliance with the new 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 system's key operational areas employ ISPE-recommended RABS (Restricted Access Barrier System) protection, which maximally reduces personnel and material contact probability, effectively lowering the risk of product contamination in compliance with updated GMP requirements. Available systems include ORABS, CRABS, and ISOLATOR.
Application Scenarios:
| No. | Item | Parameter |
|---|---|---|
| 1 | Chamber cleanliness | Grade A positive-pressure laminar airflow |
| 2 | Air volume | 85-500m3/h |
| 3 | HEPA filter type–inlet | HEPA High-Efficiency Particulate Air Filter, H14 Grade |
| 4 | Air Velocity | 0.45m/s ±20% |
| 5 | Number of Gloves and Chambers | As Required |
| 6 | VHP Concentration | 0-5000 ppm |
| 7 | Biological Indicator | 6 log Including VHP Sterilization |
| 8 | Sterilization Time | 20-60min |
| 9 | Airflow Configuration | Grade A positive-pressure laminar airflow |
| 10 | Leakage Rate | 0.5 % vol/h @100 Pa |
| 11 | Pressure Differential | 0-85pa ±5pa |
| 12 | Illumination | ≥500 Lux |
| 13 | Noise | ≤65 dBA |
| 14 | Power Supply | 220V, 50HZ 3P |
The factory boasts over 100 sets of state-of-the-art, automated production and processing equipment. With experienced engineers and highly skilled technicians, the manufacturing team provides professional support throughout the powder handling lifecycle—helping customers solve complex challenges and build efficient, flexible, and sustainable production facilities.
Our ETO (Engineered-to-Order) powder and solids systems are designed to provide comprehensive, enclosed, automated, and intelligent solutions for global pharmaceutical and chemical industries.
