Sterile auxiliary system for pharmaceutical formulation
Ensure a sterile environment in your production line with fully integrated auxiliary systems designed for precise mixing, screening, and sterilization, optimizing your biopharmaceutical and pharmaceutical processes.
Integrates and Automates Sterile Production Processes
The Auxiliary System for Sterile Formulation Production Lines by AUSTAR seamlessly integrates a suite of high-efficiency components tailored for pharmaceutical and biotech applications. This system excels in automating critical processes like mixing, screening, and sterilization of powders and liquids. It’s engineered for large-scale production, handling high volumes of sterile preparations, and crafted from materials that resist corrosion under rigorous production environments. The system ensures compliance with cGMP requirements, supporting robust regulatory adherence. Featuring integrated VHP space sterilization, it delivers precise environmental control, while its sterile isolation systems maintain product integrity throughout each stage of production. Reduced energy consumption is achieved via optimized component operations, while advanced automation allows for minimal manual intervention, boosting throughput and reducing downtime. With customization options available, AUSTAR’s engineering support ensures the system is tailored to meet specific operational needs, all while simplifying maintenance with integrated cleaning features.
Benefits
- Enhances production efficiency with integrated, continuous operation.
- Ensures compliance and product quality with cGMP-approved processes.
- Lowers operational costs by automating key processes, reducing manual intervention.
- Maintains sterile conditions with advanced isolation and space sterilization systems.
- Provides robust scalability, adapting to varying production demands and sizes.
- Applications
- Sterile api production,Large volume infusion production,Fine chemicals,Pharmaceutical powder,Biopharmaceuticals,Sterile preparations,Non-sterile api production
- End products
- Solid oral doses of pharmaceutical powders,Oral solid dosage non-sterile apis,Lyophilized biopharmaceutical vials,Large volume iv bags,Sterile active pharmaceutical ingredients (apis),Sterilized chemical reagents,Sterile injectable antibiotics
- Steps before
- Material Mixing,Screening,Sampling,Bottle and Plug Cleaning
- Steps after
- Sterilization,Freeze-drying,Filling,Visual Inspection
- Input ingredients
- sterile ingredients,raw materials,bottles and plugs for cleaning
- Output ingredients
- freeze-dried products,filled vials,sterile finished products
- Market info
- Austar is known for specializing in the design and manufacture of engineered-to-order industrial equipment, particularly in the pharmaceutical and biotechnology sectors, offering solutions that focus on quality, innovation, and meeting specific customer requirements.
- Automation
- Highly automated production line
- Compliance
- cGMP requirements
- Environment Control
- Sterile environment for sterile preparations
- Integration
- Integrated Steris Sterilization system
- Solution Type
- Freeze-dryer loading,unloading,Material transfer
- Compliance with regulatory requirements
- cGMP
- Integrated process equipment
- Freeze-dryer,filling machine,sterilization system
- Automation level
- Highly automated
- Sterile environment maintenance
- Sterile isolation,VHP space sterilization
- Sterile and closed material transfer
- Optimized solution
- Batch vs. continuous operation
- Batch
- Material mixing and screening
- Included
- Process control system
- Fully integrated
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- CGMP compliance
- Yes
- Sterility Assurance Level (SAL)
- 10^-6
- VHP sterilization compliance
- Yes
- CE marking
- Yes
- FDA compliance
- Yes
- ISO 14644 for cleanrooms
- Yes
- Control panel type
- PLC/SCADA interface
- Integration possibilities
- Sterile mixing system integration
- Integration possibilities
- Sterile isolation system integration
- Integration possibilities
- VHP space sterilization system integration
- Footprint
- Compact for facility optimization
- Sterilization integration
- Integrated Steris Sterilization system
- Automation level
- Highly automated production line
- Compliance
- cGMP Compliance