Final filtration & PUPSIT

Final filtration & PUPSIT

Automation of Single-Use Systems

Sterilizing filtration of vaccines and parenteral drugs before filling is a crucial step in pharmaceutical good manufacturing practices. To ensure this step is carried out under the safest conditions, the automated final filtration system offers advanced features: filter integrity testing before and after production (PUPSIT – Pre-Use, Post-Sterilization Integrity Testing), sterility assurance, and data integrity.

Automated Filtration and Adaptability

Our automated filtration system (AFS) simplifies the transfer and final filtration of your products by seamlessly integrating with your single-use systems, linking the finished product tank and the filler. Thanks to its high flexibility, the AFS is compatible with most common filter integrity testing equipment and a wide range of market sterilizing filters, such as Pall, Sartorius, and other brands.

Data Integrity and Reporting

The automated filtration system meets the rigorous requirements of the pharmaceutical industry: it ensures the transfer of production data (batch reports and audit trails) to the plant’s SCADA/MES system.

Compactness and Flexibility

The AFS is distinguished by its compactness, allowing smooth integration into often restricted production spaces. Its compact design optimizes space utilization while maintaining high operational efficiency. This compactness is paired with flexibility, facilitating the configuration of single-use assemblies to meet specific production needs.

Compliance and Certification

Certified CE, the AFS fully adheres to cGMP and GAMP5 good manufacturing practices, ensuring complete compliance with industry quality and safety standards.

Advantages

  • Compliance with GMP Annex 1 – Ensures full adherence to good manufacturing practices specific to sterilizing filtration, guaranteeing the quality and safety of pharmaceutical products.
  • Adapted to Different Filter Sizes – Designed to accommodate various filter formats, providing flexibility to meet specific filtration requirements for different types of products.
  • Compatibility with Multiple Brands – Operates with a wide range of sterilizing filter brands, such as Pall and Sartorius, allowing for easy integration with existing equipment.
  • Flow Regulation and Monitoring – Incorporates advanced flow regulation and monitoring systems, ensuring precise control and optimal management of the filtration process.
  • Requires Minimal Floor Space – Its compact design allows for installation in restricted production areas, optimizing space utilization and facilitating integration into existing production lines.
  • Complete Automation – Offers a fully automated process for product transfer and filtration, reducing the need for manual intervention and minimizing the risk of human error.
  • Assured Data Integrity – Provides detailed production reports and audit trails, ensuring the integrity and traceability of data throughout the filtration process.
  • Minimal Maintenance – Designed for reliable operation with minimal maintenance, reducing downtime and improving overall operational efficiency.

Ask for an Analysis of your Needs

Discover how our solutions can be tailored to transform your production processes. Contact us today for a personalized analysis of your specific situation and explore the benefits of automation!

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