ISO 11607-4 Sterile Barrier Packaging Evaluation

The ISO 11607 series provides a comprehensive framework for evaluating sterile barrier packaging, ensuring that the materials and design of medical device packages meet stringent requirements to prevent contamination during transport and use. The fourth part of this standard focuses specifically on permeability testing, which is critical in determining whether the package can maintain sterility throughout its lifecycle.

The process involves assessing the integrity of the packaging against various environmental factors such as moisture vapor transmission rate (MVTR), oxygen permeability (O2P), and microbial ingress. This evaluation ensures that the packaging not only protects the product but also complies with regulatory standards, thereby safeguarding patient safety.

For quality managers and compliance officers, understanding these tests is crucial for ensuring that products meet international standards. R&D engineers benefit from this service by validating their design choices through rigorous testing protocols. Additionally, procurement teams can leverage this expertise to source materials that align with the stringent requirements of the standard.

The application of ISO 11607-4 permeability tests is particularly important in industries where sterility is paramount, such as medical device manufacturing and pharmaceutical packaging. By ensuring that the packaging maintains its integrity under various conditions, manufacturers can reduce risks associated with contamination and extend shelf life effectively.

Applied Standards

**Applied Standards for ISO 11607-4 Sterile Barrier Packaging Evaluation**
Standard Number	Title
ISO 11607-4:2015	Sterilization of medical devices—Packaging and labelling—Part 4: Permeability testing for barrier packaging intended to maintain sterility up to the time of use

**Additional Supporting Standards**
Standard Number	Title
ASTM D3985-14	Permeability of plastic films and sheets to water vapor: cup method
EN ISO 12276:2018	Vacuum packaging—Determination of permeability to oxygen, carbon dioxide, nitrogen, hydrogen chloride and ammonia

Why Choose This Test

Ensures compliance with international standards.
Reduces risks associated with product contamination.
Validates the integrity of packaging materials under various conditions.
Extends shelf life and maintains sterility up to the time of use.
Provides detailed data on permeability, aiding in informed decision-making.

Frequently Asked Questions

What is the ISO 11607-4 standard?

ISO 11607-4 is part of a series that provides guidelines for evaluating sterile barrier packaging, specifically focusing on permeability testing to ensure the integrity and sterility of medical device packages.

Why is permeability testing important in flexible packaging?

Permeability testing ensures that the packaging maintains its barrier properties against moisture, oxygen, and microorganisms, preventing contamination and ensuring product sterility.

What equipment is used for this test?

The test typically uses specialized permeability testers that can measure the vapor transmission rate (VTR) of films or sheets, including moisture vapor and oxygen.

How long does it take to perform this test?

The duration varies depending on the complexity of the packaging and the specific parameters being tested. Typically, results are available within a few working days.

What kind of data is generated from this test?

The test generates detailed data on MVTR, O2P, and microbial ingress resistance, providing valuable insights into the packaging's performance under various environmental conditions.

Is this test applicable to all types of flexible packaging?

Yes, it is applicable to a wide range of materials used in flexible packaging, including films, sheets, and pouches intended for maintaining sterility.

How does this test benefit the healthcare industry?

By ensuring that packaging maintains its integrity, it reduces risks of contamination during transport and use, thereby enhancing patient safety in the healthcare sector.

What is the role of compliance officers in this process?

Compliance officers ensure that the packaging meets all relevant standards and regulations, including ISO 11607-4, to prevent any potential issues with product safety.