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Capillary Positive Control

These standards incorporate ultra-fine, elongated quartz capillaries with sub-micron internal diameters to simulate molecular-flow-level leakage. They are designed to challenge the detection limits of CCIT systems, serving as the benchmark for ultimate sensitivity validation.

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Pore Size

Position

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Typical Applications

Core Value

Built on over twenty years of specialization in package integrity, our capillary standards translate deep research into reliable, practical laboratory tools.

 

○ Proven Reliability: Our design is informed by extensive research into package behavior and leak physics, ensuring a representative and stable leakage model.

 

○ Precision Compliance Support: Aligned with global regulatory expectations for "challenge samples," our graduated series enable systematic validation of method detection limits.

 

○ Cost-Effective Performance: Through optimized manufacturing, we deliver better performance at a practical cost, making advanced sensitivity validation an accessible part of your quality system.

 

 

Complete Capillary Positive Control Solution

 

Zhonglin combine decades of research insight with a clear understanding of international regulations to provide practical, end-to-end validation support.

 

You can choose what you need from the normal standards, or let us know what else you want. We will contact as soon as possible.

 

Customization Options
Pore Size 0.1/0.2/0.4/0.5/0.7/0.9/1/2/3/4/5/8/10/15/20/50μm
Implantation Position Up/Middle/Bottom/Neck
Qty 1-100/101-400/>400

 

Why Choose Zholion Capillary Positive Control Samples?

 

  • Ultra-fine capillary leak simulation: Uses quartz capillaries to create stable and defined micro-leak channels.
  • High-sensitivity validation support: Suitable for challenging the detection limits of advanced CCIT systems.
  • Repeatable leakage performance: Helps compare test responses under controlled and consistent conditions.
  • Traceable calibration certificates: Available to support validation records, audits, and quality documentation.
  • Comply with USP <1207>: Designed to support container closure integrity testing method validation and lifecycle control.
  • Standard and custom ranges: Available for different pore sizes, implantation positions, container types, and quantities.
  • Useful for method comparison: Helps compare different instruments, parameters, and CCIT technologies using the same micro-leak standard.

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More Information

  • Related articles
  • Frequently Asked Questions
  • Q:

    Can one instrument test different package sizes?

    A:

    Yes. Different package sizes and shapes can be tested by changing the test chamber, fixture or sample holder.

  • Q:

    Can the system test pharmaceutical vials?

    A:

    Yes. Vacuum decay testing can be configured for vials containing powder, lyophilized products or medicinal liquids. A package-specific chamber is normally required.

  • Q:

    Which mode should be used for flexible packaging?

    A:

    Pressure decay is generally more suitable for flexible packages that may deform significantly when exposed to vacuum. The final method should be confirmed through package evaluation and feasibility testing.

Why Choose Zholion?

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