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Foil pouches packaging solution for various industries, including pharmaceuticals and medical devices. Ensuring the integrity of these pouches is crucial to maintain product quality and safety. Helium leak detection systems such as SIMS 1915+ helium-based technology play a vital role in this process. By identifying potential leaks early on these systems help prevent product contamination, extend shelf life, and safeguard customer health.

Foil pouches offer a straightforward and effective solution for sterile barrier packaging, particularly well-suited for medical equipment and pharmaceuticals. Ensuring the integrity of these pouches is crucial to maintain product quality and safety. SIMS 1915+ helps in safeguarding product integrity. The integrity of foil pouches is crucial to maintain product quality and safety. Pouch defects can compromise product quality and introduce contamination risks, potentially leading to product degradation and health hazards for patients. Consequently, rigorous testing of foil pouches is essential to ensure package quality and reliability.

Why are foil pouches used in pharmaceutical industry

Foil pouches are lightweight, flexible, and cost-effective, making them easy to store and transport. Foil pouches can be resealed, extending product shelf life and preventing contamination. Package property of foil pouches help protect sensitive medications from moisture, oxygen, and light, ensuring product integrity. Foil pouches are also compatible with various sterilization methods, making them suitable for sterile product. It can be customized to accommodate different product sizes and shapes, offering versatility in packaging design. By using leak detection systems like SIMS 1915+, manufacturers can further enhance the quality and safety of foil pouch packaging, ensuring medications reach consumers in pristine condition.

Foil pouches package integrity testing using SIMS 1915+

The SIMS 1915+ is a helium leak detection system specifically designed for the pharmaceutical and medical device industries. It utilizes helium as a tracer gas to accurately detect leaks in a variety of packaging formats, including foil pouches, bottles, vials, blister cards, syringes, and cartridges. Unlike traditional methods like vacuum bubble and dye penetration tests, SIMS 1915+ provides quantitative measurements, ensuring a higher level of precision. This advanced system offers numerous applications, including package design validation, tooling certification, manufacturing line setup, and ongoing quality control. Its oil-free pump, detector, and integrated power system are tailored to the specific needs of the industry, enabling the detection of leaks as small as 1 x 10-10 mbar L/s at room temperature. Each SIMS 1915+ device can be customized to meet the unique requirements of individual clients, providing a flexible and reliable solution for maintaining product integrity.

Applications of SIMS 1915+ include:

• Pre-filled syringes
• Bottles
• Blister packs
• Foil pouches
• Vials
• Combination products (cartridges)

Benefits of SIMS 1915+ in foil pouches

• Detects microscopic defects invisible to the eye, ensuring product integrity.
• Provides precise leak rate measurements for rigorous quality control.
• Offers rapid testing cycles for efficient production.
• Adapts to diverse foil pouch configurations.
• Ensures adherence to regulatory standards and industry best practices.

Pharmaceutical products are often stored and transported in vials, particularly high-potency medications that need strict protection. Vials—both glass and, increasingly, polymeric vials represent one of the most frequently examined package systems in the field of helium leak detection. The elastomeric closure and land seal of a vial, which are physically forced together by a folded aluminium seal, form the main sealing interface of a conventional vial system.

Package integrity testing of vials using SIMS 1915+

The Seal Integrity Monitoring System (SIMS) 1915+, a helium-based leak detection system, is a most effective option. Using helium as the tracer gas, packages can be quantitatively assessed to levels significantly higher than the vacuum bubble and dye penetration test procedures. By enabling direct comparison across various packing materials and forms, production line settings, and stable storage conditions, this quantitative approach enables the whole lifespan. SIMS 1915+ can be used for manufacturing line setup, tooling qualification, package design, and continuous product quality monitoring.

Every SIMS 1915+ helium leak testing equipment is tailored to the client's requirements. The medical device and pharmaceutical sectors are the target market for the Seal Integrity Monitoring equipment (SIMS) Model 1915+ helium-based leak testing equipment. Its integrated system and detector enable quantitative examination of package systems at ambient temperature with sensitivity levels as low as 1 x 10 -10 mbar L/s. The simplest part is the Helium Leak Detector Module (HLDM), which is contained in a Console Frame Assembly with an optional Dual Test Port Manifold and a stainless steel worktable. Convenient features of the standalone consoles include an articulating arm system and a locking wheel for connecting the computer and peripherals.

Advantages of using SIMS 1915+

• Cryogenic Testing: Accurate leak detection down to -150°C.
• Enhanced Integrity: Identifies leaks not visible at room temperature.
• Improved Quality & Safety: Ensures product integrity at storage temperatures.
• Versatility: Customizable to meet specific needs.
• High Sensitivity: Detects even the smallest leaks./li>

SIMS 1915+ helium leak detection system emerges as the preferred choice for assessing the package integrity of vials, particularly in the context of the growing cell and gene therapy market. Its ability to perform sensitive leak detection at cryogenic temperatures, coupled with its versatility and data integrity features, makes it an invaluable tool for ensuring the quality, safety, and efficacy of these critical therapies.