BS ISO 11040-7:2024 Prefilled Syringes Packaging Systems for Sterilized Subassembled Syringes Ready for Filling

Standard Number: BS ISO 11040-7:2024

Pages: 34

Released: 2024-06-04

ISBN: 978 0 539 17730 5

Status: Standard

Overview

The BS ISO 11040-7:2024 standard is an essential document for professionals in the pharmaceutical and medical device industries. This comprehensive standard provides detailed guidelines and specifications for the packaging systems of prefilled syringes, specifically focusing on sterilized subassembled syringes that are ready for filling. With 34 pages of in-depth information, this standard ensures that your packaging processes meet the highest levels of safety, efficiency, and compliance.

Key Features

• Comprehensive Guidelines: The standard offers a thorough set of guidelines that cover every aspect of packaging systems for prefilled syringes, ensuring that all critical factors are addressed.
• Focus on Sterilization: Emphasizes the importance of sterilization in the packaging process, providing detailed instructions to maintain sterility and prevent contamination.
• Ready for Filling: Specifically designed for subassembled syringes that are ready for filling, making it highly relevant for modern pharmaceutical manufacturing processes.
• Global Compliance: Adheres to international standards, ensuring that your packaging systems are compliant with global regulations and best practices.

Benefits

Implementing the BS ISO 11040-7:2024 standard in your packaging processes offers numerous benefits:

• Enhanced Safety: By following the guidelines, you can significantly reduce the risk of contamination and ensure the safety of the end-users.
• Improved Efficiency: Streamlined packaging processes lead to increased efficiency, reducing downtime and operational costs.
• Regulatory Compliance: Stay ahead of regulatory requirements and avoid potential legal issues by adhering to internationally recognized standards.
• Quality Assurance: Ensure consistent quality in your packaging systems, enhancing the overall reliability and performance of your products.

Who Should Use This Standard?

The BS ISO 11040-7:2024 standard is ideal for a wide range of professionals and organizations, including:

• Pharmaceutical Manufacturers
• Medical Device Companies
• Quality Assurance Teams
• Regulatory Affairs Specialists
• Packaging Engineers

Detailed Content

The standard is divided into several sections, each addressing a specific aspect of the packaging systems for prefilled syringes. Key sections include:

• Introduction: An overview of the standard's scope and objectives.
• Definitions: Clear definitions of key terms and concepts used throughout the document.
• Packaging Materials: Specifications for materials used in the packaging process, ensuring they meet the required standards for safety and sterility.
• Sterilization Processes: Detailed guidelines on the sterilization methods and procedures to be followed.
• Quality Control: Instructions for implementing quality control measures to maintain the integrity of the packaging systems.
• Testing and Validation: Procedures for testing and validating the packaging systems to ensure they meet the required standards.

Why Choose BS ISO 11040-7:2024?

Choosing the BS ISO 11040-7:2024 standard for your packaging systems offers several advantages:

• Expertly Crafted: Developed by industry experts with extensive knowledge and experience in pharmaceutical packaging.
• Up-to-Date: Reflects the latest advancements and best practices in the field, ensuring your processes are current and effective.
• International Recognition: Recognized and respected globally, providing a mark of quality and reliability for your products.
• Comprehensive Coverage: Covers all critical aspects of packaging systems, leaving no stone unturned.

Conclusion

The BS ISO 11040-7:2024 standard is an invaluable resource for anyone involved in the packaging of prefilled syringes. By adhering to this standard, you can ensure that your packaging systems are safe, efficient, and compliant with international regulations. With its comprehensive guidelines and detailed instructions, this standard is a must-have for pharmaceutical manufacturers, medical device companies, and quality assurance teams.

BS ISO 11040-7:2024

• 11.040.25 Syringes, needles and catheters
• 11.040.25 Syringes, needles and catheters