Life-saving drugs—including vaccines, monoclonal antibodies, oncology drugs, and parenteral formulations—require packaging systems that maintain sterility and protect the product throughout its shelf life. Traditional destructive test methods once served as the standard approach for checking package integrity, but these methods do not offer the sensitivity, repeatability, or scientific defensibility needed for today’s high-risk drug categories.
With increasing regulatory pressure from USP <1207>, the FDA, EMA, and other global agencies, manufacturers must now adopt deterministic, non-destructive, and validated CCI testing methods. These methods not only enhance detection accuracy but also preserve valuable product, support strong quality systems, and ensure patient safety.
Non-destructive Container Closure Integrity testing (CCIT) has emerged as the most reliable and scientifically sound approach to safeguarding high-value, life-saving drug products. PTI has led this shift by developing deterministic technologies that ensure accurate, repeatable, and regulatory-compliant inspection across all packaging formats.
Limitations of Destructive Tests
Destructive methods such as dye ingress testing have long been used in the industry, but their deficiencies are widely known. They rely heavily on operator interpretation, have limited sensitivity, and cannot generate quantitative data. Dye ingress is particularly inconsistent because its results depend on factors such as dye concentration, immersion conditions, and subjective visual inspection.
Destructive CCI tests also lead to product loss. In many cases—especially with high-value biologics, limited-volume batches, or clinical supplies—sacrificing samples is costly and impractical. Additionally, destructive methods cannot be performed at the frequency or consistency needed to establish statistical confidence in batch integrity.
Ultimately, destructive tests do not align with modern regulatory standards or the safety expectations surrounding life-saving drugs.
Benefits of Non-Destructive Testing
Non-destructive CCI methods eliminate the drawbacks of destructive testing and provide significant advantages for protecting high-value drugs:
- Complete product retention: Packages remain intact, ensuring no loss of valuable or limited drug product.
- Supports higher testing frequency: Enables increased sampling or even 100% testing without affecting batch volume.
- Quantitative and deterministic results: Provides measurable, traceable data for trend analysis and quality improvement.
- Enhanced leak detection sensitivity: Identifies micro-leaks that destructive methods commonly miss.
- Ideal for biologics and advanced therapies: Particularly important for products with high manufacturing costs and strict sterility requirements.
- Regulatory compliance: Meets USP <1207> expectations for deterministic, instrument-based CCI testing.
PTI’s Approach to Life-Saving Drug Package Integrity
PTI has become a global leader in deterministic, non-destructive CCI technologies specifically developed for pharmaceutical and biologic products. With solutions implemented across major drug categories, PTI systems deliver unmatched sensitivity, repeatability, and compliance with regulatory expectations.
PTI’s vacuum decay technology, delivered through the VeriPac series, is widely adopted for vials, syringes, cartridges, flexible packaging, and combination devices. Vacuum decay offers exceptionally high sensitivity to micro-leaks, producing quantitative results unattainable through destructive methods.
PTI also emphasizes comprehensive method development, validation support, and data integrity across all inspection workflows, ensuring that life-saving drugs remain protected from packaging to patient use.
Conclusion
The integrity of pharmaceutical packaging plays a critical role in protecting life-saving drugs. Destructive and probabilistic methods like dye ingress testing no longer meet the sensitivity, reliability, or regulatory expectations required for modern therapies. Their inability to detect micro-leaks, along with significant product wastage, makes them unsuitable for high-value drug products.
Non-destructive CCI testing provides the accuracy, repeatability, and scientific foundation necessary to ensure sterility and stability. PTI’s deterministic technologies—including vacuum decay and HVLD—empower manufacturers to retain product, increase testing frequency, and maintain strong regulatory compliance.
By adopting non-destructive CCI methods, pharmaceutical companies strengthen their ability to deliver safe, effective, and uncompromised therapies to patients who depend on them.