About the company

Refined Sciences is part of the Rotating Seals Group, an independent enterprise with in-depth-knowledge of the biopharmaceutical industry. We aim to meet or exceed your expectations with regards of conformance, quality and reliability, utilizing innovating technologies to our Single-Use and Multi-Use components and assemblies.

We know how important risk mitigation is to your process. We strive to minimize your risk by using best practices in design, qualification and validation of our products and the processes to manufacture them.

Our markets

We come from bioprocessing. Our roots go back to over 25 years of designing and providing components and equipment to critical biopharmaceutical applications, such as:

  • Vaccine production
  • Monoclonal antibodies (mAbs) production
  • Cell and Gene Therapies

Our solutions are used in upstream and downstream processes.

Products & Services

Our customer-centric approach is core to our business model. Our solutions are flexible, made with components that are brand neutral and customized to your preferences. Our Single-Use solutions aim to increase ease of use to mitigate risk, while maintaining the highest levels of conformance and quality. This is paired with an unparallel level of customer service.

  • single-use assembly

    Single-Use Assemblies

    Our SIMPLE-USE line provides solutions to Single-Use Components and Assemblies for bioprocessing. Done better, done right.

    • Fluid transfer assemblies: tubing, manifolds, pump assemblies
    • Sampling assemblies: bottles, bag assemblies
    • Other custom assemblies
  • Conformance

    Conformance

    Our long experience with Industry Standards development committees provides us an in-depth understanding of the conformance requirements and best practices for the manufacturing of Single-Use components and assemblies, ensuring conformance to the required levels of:

    • Biocompatibility
    • ADIF
    • Bioburden/Sterility
    • Endotoxins
    • Particulates
    • Integrity
    • Shelf-life qualification
    • Packaging qualification
  • ISO 13485

    Quality

    Quality is at the center of our design and manufacturing processes:

    • Cleanroom certified as ISO 8, meeting ISO 7 levels per ISO 14644
    • Manufacturing in certified ISO 9001, ISO 13485 facility
    • Use of current Good Manufacturing Practices (cGMP)
    • Strict Change Management and Change Notification processes
    • Quarterly qualification of manufacturing processes

News

ISPE Boston
8 September 2023

Join us at the ISPE Boston Product Show

Join us at the ISPE Boston Product Show on September 20th!

News Archive

Contact us

Please contact us for a consultation, and we promise that you will not be disappointed.

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