Produces High-Purity Water for Injection

AUSTAR’s Full-Membrane WFI Generation System is engineered to meet the rigorous demands of pharmaceutical and biotechnology sectors. This system uniquely combines full-membrane technology with a multi-stage purification process to produce high-purity water for injection, crucial for sterile and non-sterile API production. The system’s automation and PLC integration facilitate seamless operation within complex production lines, while its high throughput capability ensures efficient water production suitable for scales from laboratory to industrial. Built with durable stainless steel, it resists corrosion and is compatible with harsh chemicals. It complies with GMP and FDA standards, with integrated CIP systems for streamlined maintenance, making it ideal for manufacturing monoclonal antibodies, vaccines, and various pharmaceutical formulations. Customization options are available, backed by comprehensive engineering support.

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Facilitates Fermentation and Filtration Operations

The Biopharmaceutical Fermentation and Filtration System is engineered to optimize your biopharmaceutical production line, integrating seamlessly into existing operations. This system uses cutting-edge ultrafiltration and bioreactor technology for efficient separation and purification, essential for producing high-purity monoclonal antibodies, insulin, and other biopharmaceuticals. With a robust design capable of continuous or batch operation, it supports diverse product types, including liquids and powders, while maximizing throughput. The system is PLC-controlled, allowing for high precision and remote monitoring to enhance process efficiency. Constructed with corrosion-resistant stainless steel, it meets stringent GMP and FDA standards, ensuring compliance and quality in your pharmaceutical manufacturing processes. Moreover, the system includes a CIP (Cleaning in Place) feature for straightforward maintenance and reliability over time. Customizable to your specific needs, it offers various material options and settings, backed by comprehensive engineering support.

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Cultivates and Manages Mammalian Cell Cultures

The bioreactor from AUSTAR is engineered for biopharmaceutical companies focusing on vaccines, monoclonal antibodies, and recombinant protein production. It features a modular design for scalability from lab to commercial-scale operations. The system employs temperature-controlled stirring and precise feeding mechanisms to cultivate mammalian cell cultures effectively. Its automation aligns with S88 standards and supports CFR 21 PART 11 compliance through comprehensive data recording and trend analysis functionalities. Designed in adherence to GMP and ASME-BPE guidelines, the bioreactor ensures high-quality cell culture batch processing. Integration with other units, such as biological fermentation tanks and chromatography equipment, is seamless, optimizing production flow and maintaining efficiency. With a focus on reducing maintenance time, this bioreactor includes features for easy cleaning. Optional customization allows tailoring to specific process requirements, supported by AUSTAR’s engineering and validation services.

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Cultivates and Ferments Microbial Cultures

AUSTAR’s Biological Fermentation Tank offers a robust solution for scaling biopharmaceutical production from research to commercial operations. This tank is engineered for precision microbial cultivation and fermentation, accommodating volumes from 5 to 30 kiloliters, and is ideal for producing biological drugs, including insulin, HPV vaccines, and pneumococcal vaccines.

The fermentation process is controlled with state-of-the-art automation technologies, ensuring optimal conditions for high oxygen-consuming bacteria such as E. coli and Pichia pastoris cultures. Built to comply with GMP regulations and ASME-BPE standards, the tank guarantees safety and reliability in demanding pharmaceutical environments.

The equipment’s modular design facilitates seamless integration into existing production lines, with configurable options available for tailoring to specific needs. AUSTAR provides comprehensive engineering support, ensuring each tank meets precise operational requirements. Constructed from materials adhering to ASME-U, GB150, and PED standards, the tank offers durable performance with excellent corrosion resistance, maintaining integrity over extensive use.

Cleaning is efficient and contamination-free, supporting compliance with stringent industry regulations. This versatility makes the AUSTAR Biological Fermentation Tank an indispensable asset for companies aiming to enhance their biomanufacturing processes.

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Prepares Buffers with Precise Dynamic Control

AUSTAR’s In-line Conditioning System is a versatile buffer management solution designed to streamline biopharmaceutical and nutraceutical production. The system operates on a precise in-line conditioning mechanism, utilizing limited stock solutions to ensure accurate buffer composition. It’s crucial for producing monoclonal antibodies, protein therapeutics, and various liquid formulations, including electrolyte beverages and nutrient-enriched drinks. Monitoring flow rate, pH, and conductivity through advanced sensors, this system employs AUSTAR’s proprietary technology for accurate feedback control. Suitable for continuous operations, it integrates seamlessly, offering substantial savings in space and resources. Constructed from corrosion-resistant materials, it aligns with stringent GMP and FDA compliance standards, ensuring reliability in pharmaceutical environments.

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Automates Biopharmaceutical Preparation and Sterilization

The Bioprocess Module from AUSTAR is engineered to streamline your biopharmaceutical production, featuring a compact 3D modular design. Specially crafted for the preparation of vaccines, monoclonal antibodies, and recombinant proteins, it automates steps like fermentation, harvesting, and buffer preparation. Leveraging components from leading international and domestic brands ensures superior system quality and reliability. The module incorporates a Siemens 300 series PLC and an MP277 touch screen for seamless control, while its design adheres to the GAMP5 v-model, ensuring robust compliance. The system is built for integration with existing lines, offering automatic control over production, cleaning, and sterilization processes, and is validated through extensive qualification documentation. Its modular framework supports continuous operation and easy maintenance, optimizing throughput and operational efficiency. Designed with GMP compliance, this equipment is a strategic choice for pharmaceutical manufacturers aiming for robust process management and high-quality end-product output.

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Integrates Upstream and Downstream Bioprocessing

The Hybrid Bioprocess System from AUSTAR seamlessly integrates stainless steel and single-use technologies to enhance both upstream and downstream bioprocessing. This flexible system is tailored for pharmaceutical, biopharmaceutical, and biotechnology firms, offering comprehensive solutions for processes such as media preparation, cell culture, and purification of biologics including monoclonal antibodies, vaccines, and insulin. With customizable configurations, this system supports automatic control and validation, ensuring optimized throughput and precision. Its hybrid design leverages the robustness of stainless steel and the adaptability of single-use components, providing cost-effective and scalable solutions. The system is compatible with cGMP standards and supports clean-in-place (CIP) protocols, minimizing maintenance downtime while maintaining strict sterility. Available engineering support and project management services ensure seamless integration into existing production lines, addressing diverse operational needs with precision and reliability.

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