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Helium leak testing services are precision methods used in the pharmaceutical and medical device industries to detect even the smallest leaks in packaging. Using helium as a tracer gas, this technique ensures sterile barriers remain intact, which is critical for patient safety and product efficacy. It is especially valuable for testing sealed containers like vials, blister packs, and pre-filled syringes. By verifying seal integrity, helium leak testing supports regulatory compliance with strict industry standards. This process helps manufacturers reduce the risk of contamination, product recalls, and compromised shelf life.

What Helium Leak Testing Services Include?

PTI's Helium Leak Testing Services offer comprehensive solutions for ensuring the integrity of pharmaceutical and medical device packaging. Our services encompass a range of offerings to support clients in maintaining high-quality standards and regulatory compliance.

• System Installation & Qualification: This includes installation, operational, and performance qualification (IQ/OQ/PQ) to meet strict regulatory standards.
• Method Development & Feasibility Testing: Offers lab-scale studies or on-site validation to develop compliant and effective test methods before full implementation.
• Onsite or In-House Testing: Flexible testing options at client facilities or PTI’s Centres of Excellence, including capabilities for cold storage testing.
• Training & Support Services: Comprehensive on-site training and service contracts for ongoing maintenance, calibration, and repairs.
• Regulatory Compliance & Accuracy: Deterministic testing method aligned with USP <1207>, delivering precise, reliable results that eliminate subjectivity and support compliance.

Benefits of Helium Leak Testing in Packaging

Helium-based testing is an advanced solution for ensuring container closure integrity (CCI) in pharmaceutical packaging. By using helium, a small, inert, and non-toxic gas, as a tracer, this method delivers unmatched sensitivity and precision in leak detection.

Key Benefits:

• Unmatched Sensitivity: Helium leak detection can detect extremely small leaks (down to 1×10¹° mbar·L/sec), far beyond the capabilities of traditional methods. This makes it ideal for critical pharmaceutical applications where even microscopic breaches matter.
• Quantitative, Reliable Data: The method provides measurable leak rates, enabling not just pass/fail results but also in-depth comparisons across package types, materials, production lines, and storage conditions.
• Fast and Efficient Testing: Most helium test cycles are under 1 minute, with some as short as 30 seconds, supporting rapid testing, even on 100% of production units.
• Supports Regulatory Compliance: With growing regulatory emphasis on deterministic CCI testing, helium leak detection aligns perfectly with modern standards, helping eliminate reliance on traditional sterility tests and ensuring robust contamination prevention.

Helium leak testing services play a vital role in modernizing pharmaceutical and medical device packaging processes. They provide manufacturers with advanced tools to proactively ensure product safety and quality. With its precision and adaptability, helium testing supports both innovation and risk mitigation across packaging lines. As the industry moves toward more deterministic and data-driven quality control, helium leak detection stands out as a trusted and future-ready solution.