The pharmaceutical industry requires deep cold storage for intricate drug and biologic formulations. Traditional packaging may not endure these extreme temperatures, resulting in leaks and product degradation. PTI's LT add-on units for SIMS helium leak detectors provide advanced solutions that assess package integrity at temperatures ranging from 0°C to -160°C. This helps manufacturers detect defects and optimize packaging for reliable performance in deep cold storage.
How does Cold Temperature Leak Detection with PTI's SIMS 1915+ LT add-on units work?
Cold temperature leak detection with PTI's SIMS 1915+ LT add-on units work by combining advanced helium leak detection technology with a cooling system that allows for accurate testing of packages at ultra-low temperatures, down to -1600°C. The system incorporates a Chiller that conditions and monitors the temperature of the package while simultaneously performing helium leak testing. Helium is introduced into the package, and any leaks, particularly in critical areas like elastomeric seals, are detected by the SIMS 1915+ helium leak detector. The add-on units enable manufacturers to evaluate package integrity under cold storage conditions, ensuring materials like elastomeric closures, which may experience physical changes at low temperatures, are tested for potential leaks. This process helps manufacturers optimize packaging designs, improve product quality, and ensure compliance with regulations like USP 1207 and USP 382. The SIMS 1915+ LT system offers a comprehensive solution for assessing package integrity in deep cold storage environments.
The LT systems provide several important benefits for the pharmaceutical industry:
- Precise Low-Temperature Leak Detection: Effectively detects leaks in packaging materials at extremely low temperatures.
- Improved Product Quality: Maintains the integrity of sensitive products, preventing degradation and preserving potency.
- Minimized Product Loss: Reduces waste caused by leakage and spoilage, optimizing inventory and lowering costs.
- Regulatory Compliance: Meets stringent regulatory requirements, such as USP 1207 and USP 382 ensuring the safety and quality of products.
By combining helium leak detection with precise temperature conditioning, these systems help manufacturers detect leaks, particularly in vulnerable areas like elastomeric seals, and optimize packaging designs to maintain product quality. With the ability to test packages at temperatures ranging from 0°C to -160°C, the LT systems offer significant advantages, including improved product quality, reduced waste, and regulatory compliance with standards like USP 1207. This comprehensive approach to cold temperature leak detection ensures the safety, reliability, and efficacy of sensitive pharmaceutical products, safeguarding both product integrity and patient outcomes.
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