BS ISO 11040-4:2024 Prefilled Syringes Glass Barrels for Injectables and Sterilized Subassembled Syringes Ready for Filling

Standard Number: BS ISO 11040-4:2024

Pages: 64

Released: 2024-06-04

ISBN: 978 0 539 16328 5

Name: Prefilled Syringes Glass Barrels for Injectables and Sterilized Subassembled Syringes Ready for Filling

Status: Standard

Overview

The BS ISO 11040-4:2024 standard is an essential document for professionals in the pharmaceutical and medical device industries. This comprehensive standard provides detailed guidelines and specifications for prefilled syringes, specifically focusing on glass barrels for injectables and sterilized subassembled syringes that are ready for filling. With 64 pages of in-depth information, this standard is a crucial resource for ensuring the safety, quality, and efficiency of injectable products.

Key Features

• Comprehensive Guidelines: The standard offers extensive guidelines on the design, manufacturing, and testing of glass barrels for prefilled syringes, ensuring they meet the highest quality and safety standards.
• Focus on Sterilization: Detailed instructions on the sterilization process for subassembled syringes, ensuring they are ready for filling and use in medical settings.
• Quality Assurance: Emphasizes the importance of quality control and assurance throughout the manufacturing process, helping to maintain the integrity and reliability of injectable products.
• Global Relevance: As an ISO standard, it is recognized and respected worldwide, making it a valuable resource for international companies and organizations.

Benefits

Adhering to the BS ISO 11040-4:2024 standard offers numerous benefits for manufacturers, healthcare providers, and patients alike:

• Enhanced Safety: By following the guidelines, manufacturers can ensure that their products are safe for use, reducing the risk of contamination and other safety issues.
• Improved Quality: The standard's focus on quality control helps to ensure that each syringe meets stringent quality requirements, leading to more reliable and effective medical treatments.
• Regulatory Compliance: Compliance with this ISO standard can help manufacturers meet regulatory requirements in various markets, facilitating smoother market entry and acceptance.
• Increased Efficiency: The detailed guidelines on sterilization and subassembly processes can help streamline manufacturing operations, reducing production time and costs.

Who Should Use This Standard?

The BS ISO 11040-4:2024 standard is designed for a wide range of professionals and organizations involved in the production and use of prefilled syringes, including:

• Pharmaceutical Manufacturers: Companies producing injectable medications can benefit from the detailed guidelines on syringe design and manufacturing.
• Medical Device Manufacturers: Organizations involved in the production of medical devices, including syringes, can use this standard to ensure their products meet high-quality standards.
• Quality Assurance Professionals: Individuals responsible for quality control and assurance can use the standard to develop and implement effective quality management systems.
• Regulatory Authorities: Regulatory bodies can reference this standard when evaluating the safety and quality of prefilled syringes and related products.

Detailed Content

The BS ISO 11040-4:2024 standard covers a wide range of topics related to prefilled syringes and glass barrels for injectables, including:

• Design Specifications: Detailed design requirements for glass barrels, including dimensions, materials, and performance criteria.
• Manufacturing Processes: Guidelines for the manufacturing of glass barrels and subassembled syringes, including best practices for ensuring quality and consistency.
• Sterilization Procedures: Comprehensive instructions on the sterilization of subassembled syringes, ensuring they are ready for filling and use.
• Testing and Validation: Requirements for testing and validating the performance and safety of prefilled syringes, including methods for assessing sterility, integrity, and functionality.
• Quality Control: Emphasis on quality control measures throughout the manufacturing process, helping to ensure the reliability and safety of the final product.

Why Choose BS ISO 11040-4:2024?

Choosing the BS ISO 11040-4:2024 standard means opting for a document that is:

• Authoritative: Developed by experts in the field, this standard is based on the latest research and industry best practices.
• Comprehensive: With 64 pages of detailed information, it covers all aspects of prefilled syringe production, from design to quality control.
• Globally Recognized: As an ISO standard, it is respected and accepted worldwide, making it a valuable resource for international operations.
• Up-to-Date: Released in 2024, it reflects the most current knowledge and technological advancements in the field.

Conclusion

The BS ISO 11040-4:2024 standard is an indispensable resource for anyone involved in the production, regulation, or use of prefilled syringes. Its comprehensive guidelines and focus on quality and safety make it a valuable tool for ensuring the reliability and effectiveness of injectable products. By adhering to this standard, manufacturers can enhance their product quality, ensure regulatory compliance, and ultimately contribute to better patient outcomes.

BS ISO 11040-4:2024

This standard BS ISO 11040-4:2024 Prefilled syringes is classified in these ICS categories:

• 11.040.25 Syringes, needles and catheters