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In sectors where maintaining product integrity is critical, such as pharmaceuticals, medical devices, and biotechnology, ensuring secure, leak-proof packaging is essential. Even the slightest defect in the seal can compromise sterility, reduce efficacy, and pose serious safety risks. Packaging failures can lead not only to product recalls and regulatory penalties but also to damage to brand reputation and patient trust.

To prevent such outcomes, manufacturers are increasingly adopting advanced leak detection technologies that offer both precision and reliability. PTI’s advanced helium leak testing solutions provide exceptional sensitivity and can identify micro leaks that conventional methods often miss. Designed to meet strict industry regulations, these systems support a wide range of packaging types and help companies maintain quality assurance across diverse applications.

Why Helium? The Ideal Tracer Gas

• Non-toxic and Inert: Helium is chemically inert and non-reactive, ensuring no interaction with the product or packaging materials.
• Small Atomic Size: Its minute atomic size allows it to permeate even the tiniest leaks, making detection highly sensitive.
• Low Atmospheric Concentration: With minimal natural presence, helium provides a clear signal against background noise.
• Non-condensable and Non-flammable: Helium's properties ensure safety during testing procedures.

Ensuring Integrity with PTI Helium Testing

PTI’s helium leak detection method offers high-precision leak detection for critical packaging applications. Using helium as a tracer gas enables the identification of extremely small leaks with exceptional sensitivity. The SIMS 1915+ system developed by PTI can detect leak rates as low as 1 x 10?¹° mbar·L/sec, ensuring thorough evaluation of package integrity. This method is highly effective for a range of packaging types, including vials, syringes, blister packs, and combination products.

PTI’s solutions are aligned with regulatory requirements such as USP <1207> and 21 CFR Part 11, supporting compliance and audit readiness. The system also allows for reliable, repeatable results through calibrated standards and advanced data acquisition. Its flexibility across multiple industries, including pharmaceuticals, biotechnology, and medical devices, makes it a trusted choice for quality assurance. With PTI’s helium leak testing, manufacturers can confidently ensure product safety, integrity, and regulatory compliance. The technology also supports cold temperature testing, making it ideal for products that require storage and handling under controlled conditions. By integrating helium leak testing into their quality control programs, companies gain actionable insights and strengthen risk mitigation efforts.

Applications Across Industries

PTI's helium leak testing methods are employed across various sectors to ensure product integrity:

• Pharmaceuticals: Verifying the sterility and efficacy of drug packaging.
• Medical Devices: Ensuring the functionality and safety of medical equipment.

In conclusion, precision leak detection is vital for maintaining product quality and safety in highly regulated industries. PTI’s helium leak testing technology provides the advanced sensitivity needed to detect even the smallest packaging breaches. By enabling manufacturers to meet strict compliance standards, PTI helps protect brand reputation and ensure customer trust.