BS EN ISO 22413:2021 - Transfer Sets for Pharmaceutical Preparations

Standard Number: BS EN ISO 22413:2021

Pages: 24

Released: 2021-06-29

ISBN: 978 0 539 13492 6

Status: Standard

Overview

The BS EN ISO 22413:2021 is a comprehensive standard that outlines the requirements and test methods for transfer sets used in pharmaceutical preparations. This standard is essential for ensuring the safety, efficacy, and quality of pharmaceutical products during the transfer process. Released on June 29, 2021, this document is a critical resource for professionals in the pharmaceutical industry, providing guidelines that help maintain the integrity of pharmaceutical preparations.

Key Features

• Comprehensive Guidelines: The standard provides detailed requirements and test methods to ensure that transfer sets meet the necessary safety and quality standards.
• Industry Relevance: Applicable to a wide range of pharmaceutical preparations, making it a versatile resource for various applications within the industry.
• Up-to-Date Information: As a 2021 release, it includes the latest advancements and considerations in the field of pharmaceutical transfer technology.

Importance of Compliance

Compliance with the BS EN ISO 22413:2021 standard is crucial for pharmaceutical companies aiming to maintain high standards of product safety and quality. By adhering to these guidelines, companies can ensure that their transfer sets are reliable and effective, minimizing the risk of contamination or degradation of pharmaceutical products during transfer.

Who Should Use This Standard?

This standard is designed for use by a variety of professionals within the pharmaceutical industry, including:

• Quality Assurance Managers: To ensure that all transfer sets meet the required standards and specifications.
• Regulatory Affairs Specialists: To assist in the preparation of documentation for regulatory submissions.
• Product Development Teams: To guide the design and testing of new transfer set products.

Detailed Content

Spanning 24 pages, the BS EN ISO 22413:2021 standard provides a thorough exploration of the requirements and test methods for transfer sets. It covers various aspects, including material specifications, design criteria, and performance testing, ensuring that all potential variables are addressed.

Benefits of Using BS EN ISO 22413:2021

Adopting the BS EN ISO 22413:2021 standard offers numerous benefits, including:

• Enhanced Product Safety: By following the standard, companies can significantly reduce the risk of contamination and ensure the safety of their pharmaceutical products.
• Improved Quality Control: The standard provides a framework for rigorous testing and quality assurance, leading to higher quality products.
• Regulatory Compliance: Meeting the requirements of this standard can facilitate smoother regulatory approvals and market access.

Conclusion

The BS EN ISO 22413:2021 standard is an indispensable tool for professionals in the pharmaceutical industry. By providing clear and detailed guidelines for the design, testing, and use of transfer sets, it helps ensure that pharmaceutical preparations are handled safely and effectively. Whether you are involved in quality assurance, regulatory affairs, or product development, this standard is a valuable resource that can enhance your operations and contribute to the overall success of your pharmaceutical products.

BS EN ISO 22413:2021

This standard BS EN ISO 22413:2021 Transfer sets for pharmaceutical preparations. Requirements and test methods is classified in these ICS categories:

• 11.040.20 Transfusion, infusion and injection equipment

This document specifies requirements and test methods for sterilized single-use transfer sets that are used for pharmaceutical preparations.