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The pharmaceutical industry requires deep cold storage for complex drug and biologic formulations, but traditional packaging may not endure these extreme temperatures, risking leaks and product degradation. The PTI LT add-on units for SIMS helium leak detectors provide advanced solutions, assessing package integrity at 0°C to -160°C. This allows manufacturers to identify defects and enhance their packaging to ensure reliability in deep cold storage conditions.

Key Challenges in Container Closure Integrity Testing

• Material Challenges: Elastomers and plastics may become brittle at low temperatures, compromising seals and the overall integrity of containers.
• Leakage Risks: Both primary and secondary seals are at risk of failure under extreme cold conditions.
• Testing Limitations: Conventional leak testing methods may not provide reliable results at low temperatures.
• Regulatory Compliance: It's critical to comply with USP 1207 and international standards to ensure packaging meets required quality benchmarks.
• Logistics and Transportation: Effective temperature control and maintaining packaging durability during transit are key to ensuring product integrity.

Ensuring Container Closure Integrity in Cold Storage

As the pharmaceutical industry continues to develop complex drug and biologic formulations, there is an increasing demand for deeper cold storage to maintain product quality attributes. Products such as cell and gene therapies or protein-based treatments often require storage at ultra-low temperatures, below -20°C, and may involve dry ice (-78.5°C) or liquid nitrogen (-200°C). Despite the sophistication of these products, their packaging systems, such as screw or crimp top vials, are traditionally designed and may not be adequately tested for such extreme cold storage conditions. At these low temperatures, materials like elastomers can become brittle, leading to potential leaks, especially at primary seal areas, such as between the elastomeric closure and the vial. These leaks are not typically detectable at room temperature, making it crucial to test container closure integrity (CCI) under cold conditions.

To address this challenge, PTI developed the LT Low Temperature Add -On Solutions, designed for use with PTI’s SIMS helium leak detectors. Various models are available depending on application and low temperature needs. This system integrates a temperature conditioning chiller, allowing for temperature monitoring and helium leak testing of packages down to -160°C. By providing a method for testing CCI at low temperatures, the LT enables manufacturers to make informed decisions on packaging design, assembly parameters, and performance at cold storage temperatures. This solution helps ensure that products remain sealed, stable, and effective during storage and distribution in cold chain environments.

Ensuring container closure integrity (CCI) for sterile products in cold storage is essential to maintaining product quality and safety. The increasing use of ultra-low temperatures in storage, particularly for biologics and gene therapies, requires advanced testing methods to detect potential leaks and material failures. PTI’s LT Test System provides a reliable solution for testing CCI at temperatures as low as -160°C, helping manufacturers optimize packaging design and performance. By adopting these technologies, companies can ensure product stability and integrity throughout the cold chain, from storage to transportation.