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Ensuring package integrity in pharmaceuticals and life sciences is crucial for maintaining the safety, efficacy, and sterility of products. Packaging must provide a secure barrier against contamination, environmental factors, and physical damage. Advanced testing methods, such as helium leak detection, is used to identify any defects or leaks in packaging that could compromise the product. Regulatory standards require stringent testing to ensure that pharmaceutical and life science products meet quality and safety guidelines. By maintaining package integrity, manufacturers can ensure that their products remain effective, safe, and compliant with industry regulations.

Package Integrity Testing with PTI's SIMS 1915+

The Seal Integrity Monitoring System (SIMS) 1915+ is an advanced helium-based leak detection solution designed to ensure the integrity of pharmaceutical and medical device packaging. By utilizing helium as a tracer gas, the system provides highly sensitive and quantitative leak detection, offering accuracy far beyond traditional methods like vacuum bubble and dye penetration testing. It is particularly effective for testing a wide range of pharmaceutical products, including vials, syringes, cartridges, and blister cards, ensuring the sterility and safety of these sensitive items.

The SIMS 1915+ offers a remarkable sensitivity of 1 x 10-10 mbar/L/sec, generating detailed data sets that provide a deeper understanding of the package’s integrity. Custom-built to meet specific client requirements, it ensures reliable performance under both ambient and cryogenic conditions, making it an ideal solution for life sciences packaging testing.

Advantages of using SIMS 1915+

• Cold Temp 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.
• 21 CFR Part 11 Data Integrity Software - ETHOS

SIMS 1915+ Options

• Low-Temperature Add-on Systems LT80, LT85 and LT150 for ultra-cold CCI testing utilizing helium leak detection methods.
• Various sizes of Vacuum Test Fixtures to accommodate all package types and sizes.
• Helium leak testing for non-vacuum chamber applications with custom test fixtures.
• External helium leak standards in a variety of leak rate ranges.
• Helium Sniffer Probe - for determining leak sites on a site-by-site basis.
• Vacuum clamps, O-ring seals, chamber gaskets, and other components.

In conclusion, the PTI SIMS 1915+ Helium Leak Detector is a crucial tool in ensuring the integrity and safety of pharmaceutical and life sciences packaging. Its ability to detect even the smallest leaks, including under cryogenic conditions, ensures that sensitive products remain sterile and effective. Ultimately, the SIMS 1915+ provides reliable performance, contributing to the overall safety and compliance of life sciences products

Helium leak detection is a highly reliable and sensitive method used across various industries, particularly in pharmaceutical, biologics and medical device applications. This technique is widely recognized for its ability to detect even the smallest leaks, ensuring the integrity of packaging systems. Helium, being an inert and non-toxic gas with a small atomic size, can easily penetrate micro-channels, making it ideal for leak testing. It is extensively used in quality control for glass vials, pre-filled syringes, bottles, blister packs, foil pouches, and combination products. The method provides precise and consistent results, enabling manufacturers to meet stringent regulatory requirements. By implementing helium leak detection, companies can ensure product safety, prevent contamination, and maintain high-quality standards.

Applications of Helium leak detection

• Pharmaceutical & Biologics: Ensures the packaging integrity of vials, syringes, bottles, blister packs, and foil pouches while detecting leaks in multi-chamber combination products and preventing contamination of sterile drugs and biopharmaceuticals.
• Medical Device Industry: Verifies the integrity of implantable devices, catheters, and diagnostic equipment while ensuring life-saving devices remain sealed and function properly.

Technology Overview

Helium leak testing is a method used to detect leaks in various enclosed or sealed systems by employing helium as a tracer gas. These systems can include a wide range of packaging formats, such as vials, syringes, cartridges, foil blister cards, bottles, tubes, and foil pouches or sachets, where helium can be introduced before or during the leak test cycle. This technique relies on a highly sensitive mass spectrometer detector to precisely assess the integrity of each sealed package or system.

Helium leak detection plays a vital role in ensuring the integrity and safety of sealed systems across multiple industries. Its exceptional sensitivity and accuracy make it indispensable for identifying even the smallest leaks in critical applications such as pharmaceuticals and medical device. By utilizing helium as a tracer gas, manufacturers can uphold strict quality control measures and comply with regulatory standards. This technology’s ability to deliver consistent and reliable results helps prevent contamination, enhance product safety, and optimize manufacturing efficiency. As industries continue to advance, helium leak detection will remain a trusted and essential solution for maintaining the highest standards of quality and safety.

The pharmaceutical industry depends on deep cold storage for delicate drug and biologic formulations, but traditional packaging may not withstand extreme temperatures, leading to potential leaks and degradation. PTI’s LT add-on units for SIMS helium leak detectors offer an innovative solution by evaluating package integrity at temperatures ranging from 0°C to -160°C. This advanced technology helps manufacturers identify defects and optimize packaging designs, ensuring superior performance under deep cold storage conditions.

LT Low Temperature Systems for SIMS Helium Leak Detectors

PTI’s SIMS 1915+ LT add-on units combine advanced helium leak detection with precise temperature conditioning to provide an effective solution for cold temperature leak detection. These systems are designed to test packages at ultra-low temperatures, ranging from 0°C to -160°C, ensuring package integrity is maintained in deep cold storage environments. Integrating a chiller allows the system to condition and monitor the package temperature while simultaneously conducting helium leak tests. 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.

This technology enables manufacturers to detect potential leaks in materials like elastomeric closures, which may become brittle or undergo physical changes at low temperatures. By evaluating package performance under cold conditions, manufacturers can optimize packaging designs to prevent leaks and maintain product quality. The LT systems improve product quality by identifying and addressing leaks early in the packaging process. Additionally, the system ensures compliance with regulatory standards such as USP 1207 and USP 382, ensuring product safety and reliability.

By combining precise temperature control with advanced helium leak testing, these systems help manufacturers identify and address potential leaks, particularly in critical areas like elastomeric seals. This technology not only enhances product quality but also improves packaging design and component evaluation to meet regulatory standards. Ultimately, the LT systems ensure the safety, reliability, and performance of delicate drug and biologic formulations in cold storage environments, ultimately protecting life-saving drugs and therapies.

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.

The integrity of packaging is crucial in maintaining the safety, sterility, and quality of pharmaceutical products. Ophthalmic bottles, such as those for eye drops and ocular medications, demand strict quality control to ensure reliability. The PTI SIMS 1915+ provides a precise solution for evaluating the package integrity of these bottles. By introducing helium into the packaging and detecting any leaks, even the most minute breaches can be identified. This advanced testing method ensures the medication's potency and sterility, ultimately safeguarding patient health.

SIMS 1915+ for Ophthalmic bottles

PTI Seal Integrity Monitoring System (SIMS) Model 1915+ is a helium-based leak detection system specifically designed for a broad range of pharmaceutical packaging applications, including ophthalmic bottles, pre-filled syringes, vials, cartridges, combination products, and blister cards. By using helium as a tracer gas, the system allows for precise quantitative evaluation of packaging integrity, offering enhanced accuracy over traditional vacuum bubble and dye penetration tests. This approach facilitates detailed comparisons across various packaging materials, formats, production line conditions, and storage stability, supporting the entire product lifecycle.

The SIMS 1915+ offers sensitivity levels as low as 1 x 10^-10 mbar/L/sec. The SIMS 1915+ is housed in a durable console frame with a stainless-steel working surface and an optional dual test port manifold. Designed as a freestanding unit, it includes locking wheels and an articulating arm system for easy operation and portability. Each SIMS 1915+ unit is tailored to meet the specific requirements and packaging configurations of the customer, including those for ophthalmic bottles.

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.
• Vacuum clamps, O-ring seals, chamber gaskets, and other essential components.

The SIMS 1915+ is an essential tool for ensuring the quality and safety of ophthalmic products. By detecting and addressing potential leak sources, manufacturers can prevent contamination, product degradation, and harm to patients. This highly sensitive and accurate system protects the integrity of ophthalmic packaging, maintaining the potency and sterility of the medication. Through thorough testing and analysis, manufacturers can optimize packaging design and production processes, ultimately improving patient safety and satisfaction.

Pharmaceuticals often require deep cold storage, but standard packaging may fail at such extreme temperatures, risking leaks and product damage. PTI's LT add-on units for their SIMS helium leak detectors address this by evaluating package integrity from 0°C down to -160°C, enabling manufacturers to identify packaging defects and optimize designs for these challenging conditions.

How does it transform the integrity of ultra-cold storage?

PTI's LT system, used with their SIMS helium leak detector, transforms ultra-cold storage integrity by enabling leak detection at temperatures as low as -160°C. This allows manufacturers to identify leaks that only occur at these extreme temperatures, specifically addressing the challenges posed by elastomeric component changes and primary seal failures, common in deep cold storage. By testing at actual storage temperatures, the LT helps optimize packaging design and assembly, minimizing leakage and ensuring product integrity in compliance with USP 1207 and USP 382, ultimately improving the safety and efficacy of temperature-sensitive pharmaceuticals.

Low-Temperature Helium Leak Testing

Integrating a chiller with a helium leak detector, such as the LT, enables precise package testing at temperatures as low as -160°C. This capability helps manufacturers detect potential leaks in packaging components, including elastomeric closures, that may arise under extreme cold conditions. Gaining insights into packaging performance at these temperatures allows manufacturers to enhance product integrity, minimize waste, and meet rigorous regulatory requirements.

The LT series offers several significant benefits for the pharmaceutical industry:

• Precision Leak Detection at Ultra-Low Temperatures – Effectively identifies leaks in packaging materials under extreme cold conditions.
• Improved Product Integrity – Protects sensitive pharmaceutical products from degradation, ensuring their stability and efficacy.
• Minimized Product Waste – Reduces losses caused by leaks and spoilage, leading to better inventory management and cost savings.
• Regulatory Adherence – Complies with stringent guidelines such as USP 1207, ensuring products meet the highest safety and quality standards.

With the pharmaceutical industry's increasing dependence on deep cold storage for temperature-sensitive products, reliable packaging is essential. Helium leak detection offers a precise and effective method for evaluating container closure integrity, ensuring that packaging remains intact in ultra-low temperature environments. By detecting and addressing potential leaks early, manufacturers can maintain product quality, reduce waste, and ultimately enhance patient safety.

Blister packs are widely used across various industries, including pharmaceuticals, to protect products from external contamination and environmental factors such as moisture, air, and light. Maintaining the integrity of these packages is paramount for ensuring product quality and adhering to regulatory standards. Among the available leak testing methods, helium leak testing has proven to be a highly reliable and precise technique for verifying the integrity of blister packs. This method not only ensures compliance with stringent industry regulations but also enhances product reliability by identifying potential packaging failures before they reach the end-user. Therefore, helium leak testing offers a significant advantage in maintaining the quality and safety of goods packaged in blister packs.

Key Standards for Blister Package Leak Detection 

• USP 1207: Guidance for container integrity testing principles and methods.
• ASTM Standards: Standards for packaging materials and testing methods.
• FDA Regulations: Regulations for packaging and labelling, including leak prevention.

Factors influencing the sensitivity and accuracy of helium leak detection 

• Exceptional Sensitivity: Detects even the smallest leaks that could compromise product quality.
• High Throughput: Ideal for high-volume production environments, ensuring efficient testing.
• Product Safety: Helium is non-reactive and inert, guaranteeing no product contamination.
• Precise Leak Identification: Accurately pinpoints the location and size of leaks
• Cost-Effective: Reduces product loss and enhances packaging integrity, resulting in long-term cost savings.
• Regulatory Compliance: Meets stringent industry standards for product safety and quality assurance.

Why is Helium Leak Detection Ideal for Blister Pack Testing? 

Helium is considered an ideal choice of tracer gas because of multiple reasons. Helium is non-toxic, non-flammable, non-condensable and its presence in the atmosphere is not more than 5ppm. The small atomic size of helium makes it easier to pass through leaks. Since helium does not react with other materials, it is relatively safe to use. Additionally, compared to other tracer gases helium is less expensive and is available in multiple cylinder sizes. Under this method, a helium leak detector otherwise known as Mass Spectrometer Leak Detector (MSLD) is used to identify and calculate size of the leak. The test part is first connected to a leak detector and then the tracer gas, helium is introduced. In the presence of a leak, helium escapes from the test parts and this partial pressure is measured and results are displayed on the meter.

In conclusion,helium leak detection is indispensable for ensuring the integrity of blister packs in the pharmaceutical and medical device industries. Its high sensitivity guarantees the detection of even minute leaks, safeguarding product safety and ensuring regulatory compliance. PTI's expertise and customized solutions empower manufacturers to seamlessly integrate this vital testing method into their quality assurance processes, thereby protecting both product integrity and patient health.

The integrity of packaging plays a critical role in ensuring the safety, sterility, and quality of pharmaceutical products. Ophthalmic bottles designed for eye drops and other ocular medications require stringent quality control to ensure product integrity. Helium leak detection offers a precise method to assess the package integrity of these bottles. By introducing helium gas into the bottle and monitoring for leakage, even the smallest breaches can be identified. This advanced technique safeguards the medication's potency and sterility, ultimately protecting patient health.

Ophthalmic Bottles - Applications

Eye Drops

• Single-use and multi-use bottles
• Dropper bottles
• Pump bottles

Contact Lens Solutions

• Bottles
• Pouches

Specialized Eye Care Products

• Diagnostic solutions
• Therapeutic eye drops

CCI testing of bottles using helium leak detection

To ensure the quality and safety of ophthalmic bottles, helium leak detection is employed as a sensitive and highly accurate method. This technique involves introducing helium gas into the bottle and then monitoring for any leakage. The bottles are subjected to a vacuum chamber, exposing the closure and neck to vacuum pressure. A small hole is created in the bottle base to allow helium gas to fill the interior. Helium gas is introduced into the bottle and sensitive detectors monitor for any leakage. By identifying and addressing potential leak sources, manufacturers can prevent contamination, product degradation, and patient harm. This method is particularly effective for detecting even the smallest leaks, ensuring the integrity of the packaging and safeguarding the quality of the ophthalmic product.

Technology Overview

• Helium gas, employed as a tracer, is utilized to detect and pinpoint leaks within ophthalmic packaging.
• Helium gas, escaping through any potential breach in the packaging, undergoes ionization when exposed to an electric beam.
• The ionized helium ions, generated from the leaked gas, are subjected to analysis based on their mass-to-charge ratio.
• By meticulously measuring the concentration of helium ions within the system, the leak rate can be precisely determined.
• The accurate determination of the leak rate enables a comprehensive assessment of the overall integrity of the ophthalmic packaging.

Helium leak detector is a critical tool for ensuring the quality and safety of ophthalmic products. By identifying and addressing potential leak sources, manufacturers can prevent contamination, product degradation, and patient harm. This sensitive and accurate method safeguards the integrity of ophthalmic packaging, protecting the potency and sterility of the medication. Through rigorous testing and analysis, manufacturers can optimize packaging design and production processes, ultimately enhancing patient safety and satisfaction.