BS EN ISO 8362-1:2019 - Injection Containers and Accessories: Injection Vials Made of Glass Tubing

Discover the essential standard for the production and quality assurance of injection vials made from glass tubing with the BS EN ISO 8362-1:2019. This comprehensive document is a must-have for professionals in the pharmaceutical and medical device industries, ensuring that your products meet the highest international standards for safety and efficacy.

Overview

The BS EN ISO 8362-1:2019 standard provides detailed specifications for injection vials made of glass tubing, which are crucial components in the packaging and delivery of injectable medications. This standard outlines the requirements for the design, material, and performance of these vials, ensuring they are suitable for their intended use in medical and pharmaceutical applications.

Key Features

• Standard Number: BS EN ISO 8362-1:2019
• Pages: 22
• Released: 2019-10-25
• ISBN: 978 0 580 51287 2
• Status: Standard

Why Choose BS EN ISO 8362-1:2019?

This standard is indispensable for manufacturers and quality assurance professionals who are involved in the production of glass vials for injections. By adhering to the guidelines set forth in this document, you can ensure that your products are compliant with international regulations, thereby enhancing their marketability and acceptance in global markets.

Benefits of Compliance

Compliance with the BS EN ISO 8362-1:2019 standard offers numerous benefits, including:

• Quality Assurance: Ensures that vials meet stringent quality and safety standards, reducing the risk of contamination and ensuring patient safety.
• Regulatory Compliance: Facilitates compliance with international regulatory requirements, simplifying the approval process for new products.
• Market Access: Enhances the credibility and acceptance of your products in international markets, opening up new business opportunities.
• Cost Efficiency: Reduces the likelihood of product recalls and associated costs by ensuring consistent quality and performance.

Detailed Specifications

The BS EN ISO 8362-1:2019 standard covers a range of specifications for glass tubing vials, including:

• Material Requirements: Specifications for the type and quality of glass used in vial production, ensuring durability and chemical resistance.
• Design Specifications: Guidelines for the dimensions and shape of vials to ensure compatibility with standard medical equipment and procedures.
• Performance Criteria: Testing methods and criteria for evaluating the performance of vials under various conditions, including pressure and temperature changes.

Who Should Use This Standard?

The BS EN ISO 8362-1:2019 standard is designed for a wide range of professionals, including:

• Pharmaceutical Manufacturers: Ensure that your injectable products are packaged in vials that meet international quality standards.
• Quality Assurance Professionals: Implement robust quality control processes to maintain compliance with industry standards.
• Regulatory Affairs Specialists: Navigate the complex landscape of international regulations with confidence.
• Medical Device Manufacturers: Develop and produce medical devices that incorporate glass vials, ensuring compatibility and safety.

Conclusion

In the fast-paced and highly regulated world of pharmaceuticals and medical devices, staying ahead of the curve is essential. The BS EN ISO 8362-1:2019 standard provides the guidance and assurance you need to produce high-quality, compliant injection vials made of glass tubing. By integrating this standard into your production and quality assurance processes, you can enhance the safety, efficacy, and marketability of your products.

Invest in the BS EN ISO 8362-1:2019 standard today and ensure that your products meet the highest standards of quality and safety, paving the way for success in the global marketplace.

BS EN ISO 8362-1:2019

This standard BS EN ISO 8362-1:2019 Injection containers and accessories is classified in these ICS categories:

• 11.040.20 Transfusion, infusion and injection equipment

This document specifies the form, dimensions and capacities of glass vials for injectable preparations. It also specifies the material from which such containers are made and the performance requirements of those containers.

This document is applicable to colourless or amber glass containers made from borosilicate or soda-lime glass, made from glass tubing, whether internally surface-treated or not, and intended to be used in the packaging, storage or transportation of products intended for injection.