BS EN ISO 8362-6:2011

BS EN ISO 8362-6:2011 - Specifications for Injection Moulded Ampoules

The BS EN ISO 8362-6:2011 standard is a crucial reference for organizations involved in the healthcare technology sector, specifically concerning the design and manufacture of injection-moulded ampoules. This standard offers guidelines for ampoules intended for the packing of sterile medicinal products. It is essential for ensuring safety, quality, and compliance in manufacturing practices.

This standard aligns with the ISO 8362-6:2010 framework, providing identical specifications to foster international compatibility and adherence to established best practices. Designed to enhance the consistency and reliability of ampoules, BS EN ISO 8362-6:2011 addresses various aspects of production, including materials selection, product design, performance requirements, and testing methodologies. The document encapsulates comprehensive guidelines that aid manufacturers in developing ampoules that meet the rigorous demands of modern healthcare applications.

Key Highlights:

• Applicability: The standard applies to the specifications of glass ampoules.
• Materials: The standard covers criteria for materials that ensure the integrity and sterility of pharmaceutical products.
• Design and Construction: It prescribes design features that facilitate safe opening and optimal dispensing of the contents.
• Testing Requirements: Includes protocols for performance testing to verify compliance with safety and quality benchmarks.

Compliance with BS EN ISO 8362-6:2011 is not only beneficial for manufacturers but also critical for healthcare providers, as it directly impacts patient safety and treatment efficacy. By establishing standardized requirements for the design and production of ampoules, this standard plays a pivotal role in the pharmaceutical packaging sector.

As the healthcare landscape continually evolves, certainty surrounding the materials and processes used in pharmaceutical packaging is essential. BS EN ISO 8362-6:2011 provides that certainty, enabling stakeholders to meet both regulatory demands and customer expectations.

For entities operating in the pharmaceutical and healthcare sectors, this standard represents an invaluable resource. Purchase your copy today to ensure that your organization adheres to the highest standards of quality and safety in the production of injection-moulded ampoules.

Ordering Information

This product is available in both PDF and hardcopy formats at a price of £134.00. The ISBN for this standard is 978 0 580 64643 0. Secure your organization's compliance and quality assurance today!