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The pharmaceutical industry needs deep cold storage for complex drug and biologic formulations. Traditional packaging may not withstand these extreme temperatures, leading to potential leaks and product degradation. The PTI LT add-on units for SIMS helium leak detectors offer advanced solutions that evaluates package integrity at temps ranging from 0°C to -160°C, helping manufacturers identify defects and optimize their packaging for deep cold storage.

Low Temperature Packaging - Overview and Applications

The pharmaceutical industry's increasing focus on complex drug and biologic formulations necessitates stringent temperature control to maintain product quality and efficacy. These sensitive products, often requiring storage at ultra-low temperatures, present unique challenges for packaging integrity.

Low-temperature packaging is critical for a diverse range of products, including:

• Vials
• Biologics and Gene Therapies: These complex biological products often require ultra-low temperature storage to maintain their potency and efficacy.
• Vaccines: Many vaccines, especially those derived from live viruses or fragile proteins, necessitate storage at low temperatures to prevent degradation.
• Pharmaceutical Ingredients: Certain pharmaceutical ingredients, particularly those derived from natural sources or with complex molecular structures, may require low-temperature storage to prevent degradation.

The Challenge of Low-Temperature Package

• Material Issues: Elastomers and plastics can become brittle, affecting seals and container integrity.
• Leakage Risks: Primary and secondary seals may fail at low temperatures.
• Testing Limitations: Traditional leak testing methods may be ineffective.
• Regulatory Compliance: Adherence to USP 1207 and international standards is crucial.
• Logistics and Transportation: Maintaining temperature control and ensuring package durability are essential.

Low Temperature Package Leak Detection using Helium Leak Testing

SIMS Low Temp Add-On units include models LT 80, LT 85 and LT 150, are designed to address the critical challenge of ensuring package integrity at extremely low temperatures. By combining a chiller with a helium leak detector, the LT80, for example, allows for accurate testing of packages down to -80°C. This enables manufacturers to identify potential leaks in packaging materials, such as elastomeric closures, that may occur at these low temperatures. By understanding the performance of packaging systems under extreme conditions, manufacturers can improve product quality, reduce waste, and comply with stringent regulatory standards.

The LT systems offer several key advantages for the pharmaceutical industry:

• Accurate Low-Temperature Leak Detection: Precisely identifies leaks in packaging materials at ultra-low temperatures
• Enhanced Product Quality: Ensures the integrity of sensitive products, preventing degradation and maintaining potency.
• Reduced Product Loss: Minimizes waste due to leakage and spoilage, optimizing inventory and reducing costs.
• Regulatory Compliance: Adheres to strict regulatory standards like USP 1207, ensuring product safety and quality.

The pharmaceutical industry's growing reliance on deep cold storage for sensitive products demand robust and reliable packaging solutions. Helium leak detection provides a powerful tool for assessing container closure integrity, ensuring that packages can withstand the rigors of ultra-low temperature environments. By proactively identifying and addressing potential leaks, manufacturers can safeguard product quality, reduce waste, and ultimately improve patient outcomes.