In regulated industries such as pharmaceuticals, biologics, and medical devices, packaging integrity is inseparable from product quality and patient safety. Regulatory authorities expect manufacturers to verify container closure integrity (CCI) using scientifically validated, deterministic, and globally accepted test methods. PTI has built its entire technology portfolio around these expectations, ensuring full alignment with ASTM standards, USP <1207>, and international regulatory frameworks. PTI’s commitment to deterministic and data-driven testing makes its platforms the preferred choice for manufacturers looking to strengthen compliance and quality assurance.
Overview of ASTM Methods Relevant to Packaging Integrity
ASTM International provides a set of rigorous methods that define how packaging integrity should be evaluated. PTI’s technologies are engineered to operate precisely within the parameters established by these standards, ensuring that results are meaningful, and repeatable.
1. ASTM F2338 – Vacuum Decay Testing
ASTM F2338 is one of the most widely recognized deterministic standards for non-destructive leak detection, especially for rigid and semi-rigid containers. This test method originally established in 2003 was developed using PTI VeriPac instruments. The method uses pressure differentials to quantify even very small leak pathways, making it suitable for sterile products, stability studies, and routine quality control. Vacuum Decay is valued in the industry because it provides objective, numerical data and eliminates the subjectivity of traditional probabilistic tests.
2. ASTM F2391 – Helium Leak Detection
ASTM F2391provides guidance for using helium mass spectrometry as an ultra-sensitive CCI technique. This method is typically used during development, validation, and feasibility studies when extremely tight sensitivity—down to 10?¹° mbar·L/s—is required. Helium-based methods are especially relevant for complex drug–device platforms, high-value biologics, and packaging systems that require the highest level of integrity assurance.
3. ASTM F3004 – Airborne Ultrasound Seal Integrity Evaluation
ASTM F3004 defines a non-destructive approach for evaluating the seal integrity of flexible packages. Ultrasonic inspection technology, which this standard is based on, generates high-resolution images of the seal area and can detect defects such as channels, inclusions, wrinkles, or weak seals. These are issues that often remain undetected through visual inspection or conventional destructive tests, making ASTM F3004 important for flexible packaging used across pharmaceutical and medical device applications.
Role of PTI Technologies in Supporting Compliance
PTI’s CCI solutions are designed to fit within the compliance expectations set by global regulatory authorities. By offering deterministic methods aligned with ASTM and USP standards, PTI helps manufacturers establish a robust, defensible quality framework.
PTI technologies integrate seamlessly into compliance structures defined by:
- USP <1207>, which prioritizes deterministic test methods over probabilistic approaches
- FDA guidance on CCI testing and sterility assurance
- EU Annex 1, particularly the 2023 revision emphasizing improved control over container integrity
- ISO 11607 for medical device packaging integrity
- ICH Q9 and Q10, which frame risk-based quality management
Beyond method alignment, PTI systems incorporate advanced data integrity controls—secure audit trails, encrypted electronic records, and role-based access—supporting 21 CFR Part 11 requirements. These capabilities ensure that packaging integrity results are reliable, traceable, and fully compliant during regulatory inspections.
PTI also plays a crucial role in method lifecycle support. Its application engineers assist manufacturers in method development, feasibility studies, and validation activities (IQ/OQ/PQ), ensuring that each method meets the sensitivity and repeatability expectations laid out in global guidelines. This partnership-oriented approach is particularly valuable for companies dealing with new and complex container systems, or high-value biologics.
The Importance of Standardization in CCI Testing
Standardization forms the backbone of modern quality systems. Without standardized, deterministic methods, manufacturers risk variability, inconsistent results, and regulatory observations. ASTM standards provide a common scientific foundation, enabling manufacturers around the world to evaluate packaging using uniform criteria.
Standardization strengthens:
- Test reproducibility across sites
- Regulatory acceptance of data
- Risk mitigation for sterility failures
- Packaging development and optimization
- Overall product safety and lifecycle quality
PTI contributes to this ecosystem by designing technologies that comply with the most trusted global standards while actively participating in the evolution of CCI science. PTI’s research, industry collaborations, and continuous technological innovation help shape best practices that are now widely adopted across the pharmaceutical packaging industry.
Conclusion
PTI’s technologies are engineered to meet the highest expectations of global regulatory authorities by aligning directly with ASTM methods, USP <1207> principles, and the requirements outlined in FDA and EU guidelines. By offering deterministic and quantitative solutions—including Vacuum Decay, Helium Leak Detection, HVLD, and Ultrasonic Seal Testing—PTI empowers manufacturers to ensure that their packaging systems maintain integrity throughout the product lifecycle. The combination of scientific rigor, regulatory alignment, and robust method development support makes PTI a trusted leader in the global package integrity testing space.