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Ensuring product safety and integrity is crucial in the pharmaceutical and medical packaging sectors. With its advanced testing capabilities that ensure packaging reliability throughout its lifecycle, the PTI SIMS 1915+ system is transforming package design and quality assurance. This technology assists healthcare organizations in optimizing their package designs to secure delicate products and adhere to strict regulatory standards.

The SIMS 1915+'s accuracy and adaptability are essential in reducing the risks such as contamination or product deterioration. The SIMS 1915+ is establishing new benchmarks for packaging innovation and quality control as the industry continues to place a high priority on patient safety and operational effectiveness.

Helium Leak Testing using SIMS 1915+

The Seal Integrity Monitoring System (SIMS) 1915+ is a helium based leak detection method that has proven highly effective for various pharmaceutical and medical device packaging systems. By utilizing helium as the tracer gas, this method allows for precise quantitative testing, surpassing the capabilities of traditional vacuum bubble and dye penetration tests. It is suitable for a wide range of pharmaceutical and parenteral products, including vials, syringes, cartridges, and blister cards.

The SIMS 1915+ offers sensitivity as low as 1 x 10^-10 mbar/L/sec, providing detailed data sets rather than simple pass/fail results and enabling testing at both ambient and cryogenic temperatures. Each SIMS 1915+ unit is custom designed to meet specific client requirements and packaging configurations. PTI specializes in engineering custom test fixtures tailored to the exact component being tested, ensuring precision and accuracy to support your study objectives, package configurations, and quality monitoring needs. 

Benefits of SIMS 1915+

• The package to be tested, such as an IV bag, is placed in a sealed test chamber.
• Quantitative Leak Detection: Provides precise leak rate measurement for better quality control and analysis.
• Versatile and Comprehensive: Suitable for a wide range of packaging formats, including bottles, syringes, vials, and blister cards.
• Customization for Specific Needs: Tailored to customer specifications for packaging types and production environments. 
• Enhanced Regulatory Compliance: Provides verifiable evidence of packaging integrity, ensuring compliance with industry regulations. 
• Data integrity – ETHOS 21 CFR PART 11 compliant software.

SIMS 1915+ Options:

• Low-Temperature Add-on Systems LT80 and LT150 for ultra-cold CCI testing using helium leak detection methods. 
• A range of Vacuum Test Fixtures available to suit different package sizes and types.
• Helium leak testing for non-vacuum chamber applications, with custom test fixtures available.
• External helium leak standards offered in various leak rate ranges. 
• Helium Sniffer Probe to detect leak sites individually.
• Vacuum clamps, O-ring seals, chamber gaskets, and other essential components. 

The PTI SIMS 1915+ represents a significant advancement in packaging integrity testing, offering unparalleled sensitivity and precision for critical industries. Its adaptability and customizability ensure it can meet the diverse needs of modern packaging, ultimately enhancing product safety and reliability. Consequently, the SIMS 1915+ is instrumental in establishing new standards for packaging innovation and assurance, driving progress in maintaining the highest levels of product integrity.