Sterile API Isolation and Filling System
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.
Key Features:
- RABS (Restricted Access Barrier System) protection (ORABS, CRABS, ISOLATOR)
- Vacuum-sealed transfer & Sterile powder milling
- Automated lifting, mixing, filling, and capping
- System CIP/SIP station & Online particulate monitoring
- Effective reduction of contamination risks from particles and microorganisms
Performance Parameters
| No. |
Item |
Parameter |
| 1 | Chamber cleanliness | Grade A positive-pressure laminar airflow |
| 2 | Air volume | 85-500m3/h |
| 3 | HEPA filter type | H14 Grade |
| 4 | Air Velocity | 0.45m/s ±20% |
| 5 | VHP Concentration | 0-5000 ppm |
| 6 | Sterilization Time | 20-60min |
| 7 | Leakage Rate | 0.5 % vol/h @100 Pa |
| 8 | Noise Level | ≤65 dBA |
Technical Excellence
The facility currently boasts over 100 sets of state-of-the-art, automated production and processing equipment. Leveraging superior technical capabilities and professional manufacturing expertise, the mission is to "Simplify the Ordinary and Make Material Handling Easier." Support is provided throughout the powder handling lifecycle—helping solve complex challenges and build efficient, flexible, and sustainable production facilities.
Frequently Asked Questions
Do you provide customized solutions for specific production lines?
Yes. Our professional technical team interfaces directly with clients to provide optimized technical solutions. All equipment dimensions and interfaces can be adjusted to match your existing production requirements.
Which international standards does the equipment comply with?
Our equipment is designed to meet multiple global industry standards, including EU CE, US UL/OSHA, German TÜV, and Southeast Asian IEC certifications.
What is the expected production lead time for orders?
Standalone equipment is typically available from stock. For custom engineered systems, we offer industry-leading production cycles with guaranteed on-time delivery and optional free storage services.
What kind of after-sales support do you offer?
We provide a 24-hour response guarantee, remote technical support, and localized after-sales service. We also maintain a long-term stock of spare parts to ensure rapid supply at stable prices.
Are your payment terms flexible for international transactions?
Yes. We provide comprehensive quotation documents with clear breakdowns for equipment, testing, and transport. We offer flexible payment terms to suit different project needs.
Does the system support online monitoring for aseptic processes?
Absolutely. The system integrates advanced RABS isolation and includes online particulate monitoring to ensure full compliance with updated GMP requirements for sterile production.
CarniTe Machinery
