Basic Specifications
Machine Material
Stainless Steel
Packaging Material
Aluminum, Glass, PVC
Transport Package
Wooden Package
Key Features: Batch Coding, Print Registration Control, Sterilization Capability, Tamper-Evident Packaging, Temperature Control, Vacuum Packaging.
Product Description
Sterile API Isolation and Filling System
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.
System Overview
It overcomes limitations of traditional production, including discontinuous operation and low automation levels, and reduces the risks of cross-contamination and secondary contamination associated with the inability to perform CIP/SIP. The key operational areas employ ISPE-recommended RABS (Restricted Access Barrier System) protection, effectively lowering the risk of product contamination by particles and microorganisms.
Application Scenarios
- Sterile post-processing integrated three-in-one system
- Lyophilization and spray drying post-processing system
- Sterile powder injection batching, mixing, and filling isolation system
- Sterile raw material sampling isolation operation system
- Vacuum-sealed transfer & Sterile powder milling/granulation
- Automatic filling & capping
- System CIP/SIP station & Online particulate monitoring
Manufacturing Capabilities
Our factory currently boasts over 100 sets of state-of-the-art, automated production and processing equipment. Our experienced engineers and highly skilled technicians serve over a thousand pharmaceutical companies globally, providing professional support throughout the powder handling lifecycle. We provide comprehensive, enclosed, automated, and intelligent solutions for powders and solids handling.
Frequently Asked Questions
Can the equipment be customized for specific production lines?
Yes. Our professional technical team interfaces directly with you to provide optimized technical solutions. All equipment dimensions and interfaces can be adjusted to match your existing production setup.
What international standards does the equipment comply with?
Our systems comply with multiple global industry standards, including EU CE, US UL/OSHA, German TÜV, and Southeast Asian IEC.
What is the typical production lead time?
Standalone equipment is often available from stock. For custom engineering projects, our lead times are highly competitive 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 maintain long-term stock of spare parts at stable prices.
How are transactions and payments handled?
We provide detailed, transparent quotation documents covering equipment, packaging, testing, and transport. We also offer flexible payment terms to suit our clients' needs.
Is the system suitable for highly sensitive sterile powders?
Absolutely. The system uses RABS (ORABS, CRABS, ISLATOR) protection to ensure Grade A cleanliness, making it ideal for sterile lyophilization, spray drying, and powder injections.
CarniTe Machinery
