PD ISO/TS 23565:2021 Biotechnology. Bioprocessing. General requirements and considerations for equipment systems used in the manufacturing of cells for therapeutic use

Standard Number: PD ISO/TS 23565:2021

Pages: 26

Released: 2021-12-13

ISBN: 978 0 539 02414 2

Name: Biotechnology. Bioprocessing. General requirements and considerations for equipment systems used in the manufacturing of cells for therapeutic use

Status: Standard

Overview

In the rapidly evolving field of biotechnology, ensuring the highest standards in bioprocessing is crucial. The PD ISO/TS 23565:2021 standard provides comprehensive guidelines and considerations for equipment systems used in the manufacturing of cells for therapeutic use. This standard is an essential resource for professionals involved in the bioprocessing industry, offering a detailed framework to ensure the quality, safety, and efficacy of therapeutic cell manufacturing processes.

Key Features

• Comprehensive Guidelines: The standard offers detailed requirements and considerations for equipment systems, ensuring that all aspects of the bioprocessing workflow are covered.
• Quality Assurance: By adhering to this standard, organizations can ensure that their bioprocessing equipment meets the highest quality standards, thereby enhancing the reliability and safety of therapeutic cell products.
• Industry Relevance: Released on December 13, 2021, this standard reflects the latest advancements and best practices in the field of biotechnology and bioprocessing.
• Global Recognition: As an ISO/TS standard, it is recognized and respected worldwide, making it a valuable asset for organizations operating on a global scale.

Detailed Content

The PD ISO/TS 23565:2021 standard spans 26 pages, meticulously detailing the general requirements and considerations for equipment systems used in the manufacturing of cells for therapeutic use. Key areas covered include:

• Design and Construction: Guidelines on the design and construction of bioprocessing equipment to ensure optimal performance and compliance with regulatory standards.
• Installation and Commissioning: Best practices for the installation and commissioning of equipment systems to ensure they are fit for purpose and operate efficiently.
• Operation and Maintenance: Recommendations for the operation and maintenance of bioprocessing equipment to ensure longevity and consistent performance.
• Validation and Qualification: Procedures for the validation and qualification of equipment systems to ensure they meet the required specifications and regulatory requirements.
• Documentation and Records: Requirements for documentation and record-keeping to ensure traceability and compliance with regulatory standards.

Benefits of Compliance

Adhering to the PD ISO/TS 23565:2021 standard offers numerous benefits, including:

• Enhanced Product Quality: Ensuring that bioprocessing equipment meets the highest standards can significantly enhance the quality of therapeutic cell products.
• Regulatory Compliance: Compliance with this standard helps organizations meet regulatory requirements, reducing the risk of non-compliance and associated penalties.
• Operational Efficiency: Implementing the guidelines and best practices outlined in the standard can improve the efficiency and reliability of bioprocessing operations.
• Market Competitiveness: Organizations that adhere to recognized standards are often viewed more favorably by stakeholders, enhancing their competitiveness in the market.

Who Should Use This Standard?

The PD ISO/TS 23565:2021 standard is designed for a wide range of professionals and organizations involved in the bioprocessing industry, including:

• Biotechnology companies
• Pharmaceutical manufacturers
• Research and development organizations
• Quality assurance and regulatory compliance professionals
• Equipment manufacturers and suppliers

Conclusion

In the dynamic and highly regulated field of biotechnology, maintaining the highest standards in bioprocessing is essential. The PD ISO/TS 23565:2021 standard provides a comprehensive framework for ensuring the quality, safety, and efficacy of equipment systems used in the manufacturing of cells for therapeutic use. By adhering to this standard, organizations can enhance their product quality, ensure regulatory compliance, and improve operational efficiency, ultimately contributing to the advancement of therapeutic cell manufacturing and the broader biotechnology industry.

PD ISO/TS 23565:2021

This standard PD ISO/TS 23565:2021 Biotechnology. Bioprocessing. General requirements and considerations for equipment systems used in the manufacturing of cells for therapeutic use is classified in these ICS categories:

• 07.080 Biology. Botany. Zoology

This document specifies minimum requirements and general considerations for equipment, consisting of hardware, software and consumables, used in the manufacturing of cells for therapeutic use. This includes equipment for processing cells for therapeutic use starting from cell isolation/selection, expansion, washing and volume reduction, from cell finish through to cryopreservation for the storage of cells for therapeutic use.

This document gives guidance on the design, use and maintenance of equipment and equipment systems to both suppliers and users from aspects including the target parties, i.e. supplier or user, and phase of involved task, i.e. design, use or maintenance.

This document is applicable to any unit operation system that is used, alone or in combination, for the manufacturing of cells for therapeutic use, meeting user requirements. It is applicable to devices used for the purpose of monitoring equipment status.

It does not apply to:

• processing equipment for cells for therapeutic use used at the point of care;

• devices used for analytical purposes;

• biosafety cabinets, general cell culture equipment (such as CO ₂ incubators, etc.), and software to control multiple equipment systems or multiple unit operations.