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Life science companies are facing growing challenges in storing complex drug formulations, especially as advanced biologics and cell and gene therapies become more common. These innovative treatments often require ultra-low temperature storage conditions to maintain stability, potency, and safety.

Traditional cold chain solutions are no longer sufficient to meet the stringent demands of modern pharmaceuticals. Companies must now invest in specialized equipment, real-time monitoring, and rigorous quality control systems. Regulatory expectations have also intensified, pushing organizations to adopt robust validation and documentation practices.

To support these efforts, PTI’s advanced helium leak detection technology plays a vital role in ensuring packaging integrity under ultra-low temperature conditions.

Challenges Faced in Storing Complex Drug Formulations at Ultra-Low Temperatures

Storing advanced drug formulations at ultra-low temperatures isn’t as simple as just putting them in a freezer. These extreme conditions can create several serious challenges. Here's a look at what makes it so tough:

• Packaging Materials Can Become Brittle: Not all materials are built to handle the deep freeze. Rubber stoppers, plastic parts, and even some glass vials can become brittle and crack when exposed to ultra-low temperatures. This can break the protective seal around the medicine, risking contamination.
• Shrinkage Can Break the Seal: Different packaging components shrink at different rates in the cold. For example, the glass vial, the rubber stopper, and the metal cap all contract differently. Even tiny changes in size can break the seal and let in unwanted air or moisture, things that can damage the drug or reduce its effectiveness.
• Pressure Changes During Shipping: Drugs that are stored in dry ice or liquid nitrogen often travel by air. During flights, changes in air pressure and temperature can cause stress on the packaging. This makes it easier for small leaks to form—leaks that may go unnoticed but can be harmful.
• Old Leak Detection Methods Aren’t Good Enough: Traditional ways of checking for leak, like using dyes or microbial tests, don’t work well for these ultra-cold products. They’re not sensitive enough, and they can even damage the product during testing. Plus, they can’t really mimic the freezing and thawing that happens in real storage and shipping.

How does Helium Leak Detection Work with Ultra-low Temperatures?

Helium leak testing with ultra-low temperatures identifies microscopic leaks in packaging that may occur under extreme cold, especially with biologics stored below -20°C. At these temperatures, elastomeric components like rubber stoppers can undergo physical changes, leading to leaks at primary seal areas, which aren't detectable at room temperature. The process involves conditioning the sealed package to ultra-low temperatures, often as low as -80°C, and introducing helium tracer gas to detect any leaks.

Helium, being small and inert, passes through even the tiniest leaks, enabling precise detection. Specialized systems like PTI’s LT80 allow simultaneous temperature conditioning and leak testing, providing real-time data and ensuring package integrity. The LT80 system is compatible with existing PTI SIMS units and helps meet regulatory standards like USP 1207. By using helium leak detection, manufacturers gain insights into the best materials and designs for packaging under extreme cold, ensuring product quality and safety.

To meet the demands of ultra-sensitive drug formulations, life science companies are adopting advanced testing technologies like helium leak detection. This ensures packaging integrity under extreme cold conditions, safeguarding product stability and efficacy. As therapies become more complex, maintaining control over storage environments is essential for quality and compliance. These innovations ultimately enhance patient safety and strengthen supply chain reliability.

Accurate leak detection is crucial in pharmaceutical packaging to ensure the integrity and safety of the product. Leaks can lead to contamination, reduced efficacy, or compromised shelf life, posing risks to both patients and manufacturers. Different packaging types, such as blister packs, vials, and syringes, require tailored detection methods to address their unique characteristics. Implementing reliable and sensitive leak detection systems helps maintain compliance with industry standards and ensures the highest quality and safety for pharmaceutical products. Let's understand how SIMS 1915+ helium leak detection ensures package integrity across diverse packaging types.

Helium Leak Detection using SIMS 1915+

The Seal Integrity Monitoring System (SIMS) 1915+ utilizes a helium-based leak detection method, proven effective for a wide range of pharmaceutical and medical device packaging systems. By using helium as a tracer gas, the system allows for highly sensitive, quantitative testing that surpasses traditional vacuum bubble and dye penetration methods. This approach is ideal for testing various pharmaceutical and parenteral products such as vials, syringes, cartridges, and blister cards.

SIMS 1915+ offers quantitative analysis with a sensitivity as low as 1 x 10-10 mbar/L/sec, providing detailed data sets instead of basic pass/fail results. It supports testing under both ambient and cryogenic storage conditions. Each SIMS 1915+ Helium Leak Testing system is custom-built to meet client-specific standards and packaging configurations.

Advantages of using SIMS 1915+

• Cryogenic Testing: Accurate leak detection down to -160°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.
• Rapid test cycle
• 21 CFR Part 11 Data Integrity Software

In conclusion, the PTI SIMS 1915+ provides advanced, highly sensitive leak detection for a wide range of pharmaceutical and medical device packaging, ensuring product integrity even in extreme conditions. With custom-built fixtures and helium-based testing, it delivers precise, quantitative results that surpass traditional methods. The system's versatility allows it to meet the unique needs of various packaging configurations, offering reliable and accurate data. Its ability to detect even the smallest leaks ensures enhanced quality, safety, and compliance in the pharmaceutical and biotechnology industries.