Sterile Barrier System (SBS) Testing

What Is Sterile Barrier System (SBS) Testing?

Sterile Barrier System (SBS) Testing is a critical evaluation process designed to ensure the integrity of primary packaging for medical devices. The fundamental purpose of this testing is to verify that the Sterile Barrier System (SBS) can prevent microbial contamination and maintain the sterility of the product from the point of sterilisation until its use.

For medical device manufacturers, robust sterile barrier testing is not just a quality measure but a regulatory necessity, crucial for patient safety and ensuring that devices perform as intended without risk of infection. This validation is predominantly governed by the international standard ISO 11607-1, which outlines the requirements for materials, sterile barrier systems, and packaging systems that are intended to maintain sterility of terminally sterilised medical devices.

SBS testing is typically performed after transportation simulation (distribution) testing and real-time and accelerated aging to show that the SBS integrity is still intact after being subjected to the hazards of transportation and storage.

What Sterile Barrier System (SBS) Testing Do We Perform?

At Applus+ Laboratories, we provide comprehensive Sterile Barrier Testing services to validate the integrity and performance of your medical device packaging. Our expert team understands the nuances of ISO 11607 and associated standards, ensuring your SBS meets the stringent requirements for market approval, including FDA 510k submissions and CE marking under MDR 2017/745.

Our suite of sterile barrier integrity tests includes, but is not limited to:

• Visual Inspection (ASTM F1886): A meticulous examination using the naked eye to identify any defects, tears, or imperfections in the sterile barrier that could compromise sterility.
• Dye Penetration Testing (ASTM F1929, ASTM F3039): This test uses a coloured liquid to detect leaks in package seals by observing for any dye penetration, indicating a breach in the seal integrity.
• Bubble Emission Test / Gross Leak Detection (ASTM F2096, ASTM D3078): This method involves submerging the package and applying internal pressure to identify leaks by the presence of a stream of bubbles, effectively determining the overpressure tightness of the entire packaging.
• Seal Strength Testing (ASTM F88/F88M, NF EN 868-5): Measures the force required to separate a test strip containing the seal, ensuring the seal is strong enough to maintain integrity but can be opened by the end-user without excessive force. This is critical for peelability and assessing the homogeneity of packaging seals.
• Burst Testing (ASTM F1140): Evaluates the strength of package seals by inflating the package until it bursts, determining the pressure at which failure occurs.

We pride ourselves on an optimised distribution of samples across the different required tests to minimise your sampling needs. Furthermore, Applus+ Laboratories offers all available tests to provide a complete validation solution.

What Are The Benefits Of Sterile Barrier System (SBS) Testing?

Engaging in thorough Sterile Barrier Testing offers numerous crucial benefits for medical device manufacturers:

• Ensuring Patient Safety: The foremost benefit is safeguarding patients by ensuring medical devices remain sterile until the point of use, preventing healthcare-associated infections.
• Regulatory Compliance: Essential for meeting global regulatory requirements, including ISO 11607, FDA 510k premarket notification, and CE marking (MDR 2017/745), facilitating market access in key regions.
• Market Access and Speed: Successful validation expedites the process of bringing new or modified medical devices to market.
• Risk Mitigation: Proactively identifies potential packaging failures, reducing the risk of costly product recalls, regulatory actions, and damage to brand reputation.
• Product Quality Assurance: Provides documented evidence that the sterile barrier system effectively protects the device throughout its intended shelf life and the rigours of distribution and handling.
• Cost-Effectiveness: Identifying and rectifying packaging issues early in the development cycle can prevent more significant expenses later.
• Supporting Design Changes: Validates that any changes to packaging materials or design do not adversely affect the sterility or integrity of the SBS.

Why Choose Applus+ Laboratories For Sterile Barrier System (SBS) Testing?

Choosing Applus+ Laboratories for your Sterile Barrier Testing needs ensures you partner with a laboratory renowned for its expertise, precision, and commitment to client success in the medical device packaging sector.

• Accredited Expertise: Our laboratories operate under COFRAC accreditation (scope available upon request), signifying adherence to the highest international quality and competency standards, providing results you can trust for your ISO 11607 validation.
• Comprehensive Regulatory Knowledge: We possess extensive experience with global regulatory landscapes, including FDA requirements and European MDR (Medical Device Regulation), guiding you through complex validation processes.
• Full Range of Testing Capabilities: We offer all available tests for sterile barrier systems, providing a one-stop solution for your validation needs, from seal strength to leak detection.
• Optimised and Efficient Processes: We propose an optimised distribution of samples to minimise your material requirements and offer short test lead times. For urgent needs, our SPEED ACCESS options can deliver results in less than a week.
• State-of-the-Art Facilities: Our testing is conducted using calibrated equipment in controlled environments, ensuring accurate and repeatable results for your packaging validation.

Partner with Applus+ Laboratories to ensure your sterile medical device packaging meets the highest standards of safety, integrity, and regulatory compliance.