Natural Defects Positive Control
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Typical Applications
Worst-Case Method Validation
Demonstrates method capability against realistic defect types as part of a robust validation strategy.
New Packaging/Supplier Qualification
Systematically tests how different material combinations perform against relevant failure modes.
Process Optimization & Troubleshooting
Offers empirical evidence for fine-tuning equipment parameters like capping torque or filling alignment.
Training & Problem-Solving
Serves as hands-on tools for team training CCIT methods.
Core Value
Since real leaks are seldom perfect holes, regulators emphasize detecting "probable defects." Our positive controls address this need directly.
○ Real-World Relevance: Confirms your CCIT method can detect challenging, non-ideal defect types that pose actual risks, strengthening your validation package.
○ Process Risk Insight: Helps identify vulnerabilities in your packaging process. For example, simulators modeling "over-compressed stoppers" can verify the safety of capper settings.
○ Faster Root-Cause Analysis: Provides a comparative testing for investigating production leaks, accelerating troubleshooting and corrective actions.
Complete Solution
We support the custom development of defect simulators based on your specific failure history or concerns, helping you close the loop between testing data and production quality improvements.
More Information
Can one instrument test different package sizes?
Yes. Different package sizes and shapes can be tested by changing the test chamber, fixture or sample holder.
Can the system test pharmaceutical vials?
Yes. Vacuum decay testing can be configured for vials containing powder, lyophilized products or medicinal liquids. A package-specific chamber is normally required.
Which mode should be used for flexible packaging?
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?
Drive Process Efficiency
Use test data to optimize packaging operations, reducing waste and non-conformances.
Backed by Deep Expertise
Decades of specialization ensure we understand your integrity challenges and can provide practical solutions.
Designed for Compliance
Our products and guidance are aligned with regulatory expectations, helping you build a defensible quality system.
