How to Improve SBS Integrity with Labthink C660 and C690 Leak Testers

Sterile Barrier System (SBS) is the minimum package that prevents the ingress of microorganisms and allows aseptic presentation of the product at the point of use. To maintain the highest levels of safety, manufacturers are increasingly turning to advanced instrumentation like the Labthink C660B and C660M to validate and monitor their packaging performance.

This article explores how a dual-testing approach, combining qualitative leak detection with quantitative seal strength analysis, provides the rigorous data required for ISO 11607 compliance.

The Integrity Challenge: Why Leak and Seal Strength Tests Matter？

A Sterile Barrier System must remain intact from the point of sterilization until it is opened by a healthcare professional. However, flexible medical packaging faces numerous risks during its lifecycle, including pressure changes during air transport, mechanical shocks during shipping, and compression in storage.

Relying on visual inspection alone is insufficient since micro-leaks or "weak spots" in a seal are often invisible to the naked eye but can compromise the entire sterile field.

ISO 11607-1/2 standards mandate that manufacturers provide documented, quantitative evidence that the SBS maintains its integrity. Therefore, verifying seal performance after simulated environmental stresses (such as drop or compression tests) is a critical component of any medical device packaging validation program.

Rapid Screening with the Labthink C660B Vacuum Leak Tester

The Labthink C660B is a reliable, water-bath vacuum leak tester. It is primarily utilized to screen packaged SBS products for gross leaks, identifying breaches that could lead to immediate contamination.

Application and Methodology

The C660B is particularly effective for testing packs after they have undergone line trials or physical stress simulations. By placing the package in the water-filled vacuum chamber, operators can observe the formation of bubbles, which clearly indicates the location of a leak.

Key Capabilities:

l  Multiple Test Modes: It supports various vacuum levels and hold times to match specific pouch or blister requirements.

l  Standardized Testing: The instrument aligns with standards such as ASTM D3078, providing a repeatable method to screen for seal failures and material punctures across different production batches.

Quantitative Validation with the C660M Leak and Seal Strength Tester

While the C660B identifies if a package leaks, the Labthink C660M explains how much pressure that package can withstand before it fails.

As a comprehensive platform for leak and seal strength testers, the C660M provides the numeric data necessary for rigorous validation and routine quality monitoring.

Performance and Precision

The C660M is designed for flexible SBS packs, closures, and tubes. It allows engineers to pinpoint exactly where a seal might be weakening under internal pressure.

Strategic Use of C660M:

l  Burst Testing: Measures the maximum pressure the SBS can handle before a catastrophic failure occurs.

l  Creep and Creep-to-Failure: Evaluates the seal’s ability to hold a specific pressure over time, simulating long-term storage or high-altitude transport.

l  Numeric Data for Validation: Unlike qualitative "pass/fail" tests, the C660M generates precise pressure and time data, which is essential for establishing "worst-case" limits in a sterile barrier system validation study.

Setting Acceptance Criteria and Supporting ISO Validation

C660M helps to establish a numeric baseline for burst strength, allowing manufacturers to set scientific acceptance criteria for their production lines. Meanwhile, the C660B serves as an efficient, daily tool for routine monitoring and post-distribution simulation checks.

Trending this data over time allows for proactive quality control.

For example, if burst strength data from the C660M begin to trend downward, even if the packs still "pass" a gross leak test, engineers can intervene to adjust sealing parameters on the production line before a failure occurs. This data-driven approach is the cornerstone of ISO-driven sterile barrier validation and ongoing requalification.

Deterministic & Nondestructive CCIT

High-Sensitivity Integrity Testing with the C690M

In the pharmaceutical industry, the packaging of high-stakes biologics requires more sensitive formulations, manufacturers utilize deterministic, nondestructive Container Closure Integrity Testing (CCIT). By employing advanced vacuum decay technology, the Labthink C690M provides a rigorous framework designed specifically for the stringent precision demands of sterile barrier systems.

Performance and Precision

The C690M is engineered for complex pharmaceutical formats that require ultra-fine detection limits. By replacing visual assessments with controlled physical measurements, it offers the technical precision necessary to meet the industry’s strict Maximum Allowable Leakage Limit for biological products.

Strategic Advantages of C690M:

• Micro-Leak Sensitivity: Capable of identifying defects as small as 2 μm. This ensures that even the most minute pathways for oxygen-driven degradation or microbial ingress are captured, preserving the efficacy of the drug.
• Exceptional Repeatability: The system relies on quantifiable physical data, delivering high repeatability across multiple test cycles. This level of consistency is essential for maintaining the narrow quality tolerances required in pharmaceutical manufacturing.
• Nondestructive Analysis: Because the test does not damage the packaging or the contents, the C690M allows for the integrity of the actual market-bound product to be verified, providing a higher level of assurance for every batch.

Regulatory and Standard Compliance

The C690M provides the objective data required for modern regulatory submissions. The system’s vacuum decay methodology conforms to ASTM F2338 (Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method), ensuring the testing protocol is globally recognized and aligns with the deterministic principles outlined in USP <1207>.

Let’s Build A Multi-Layered Defense for Patient Safety

Improving the integrity of a sterile barrier system requires the right combination of technology and methodology.

Labthink remains at the forefront of packaging technology, providing the high-end instruments and services required to protect patient health. To learn more about optimizing your SBS integrity testing, visit the Labthink website or contact their technical support team for a consultation on ISO 11607 compliance.