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When selecting a testing method for sterile medical devices, manufacturers need a solution that ensures packaging integrity and product safety. By considering factors such as regulatory requirements, operational efficiency, and the specific needs of the device, manufacturers can make informed decisions that enhance their quality control processes. The right testing method helps ensure that medical devices remain sterile and effective throughout their lifecycle. Adopting the right testing technology not only improves product reliability but also supports compliance, ultimately fostering trust with consumers and meeting industry standards for safe medical products.

Unique Challenges of Sterile Medical Devices

Sterile medical devices face a range of unique challenges that demand strict attention to detail in their design, packaging, and quality control. One of the primary concerns is maintaining sterility throughout the device's lifecycle, from production to end-use. This requires secure packaging that protects against contamination from environmental factors like moisture, temperature fluctuations, and physical damage. The packaging materials must be carefully selected to maintain sterile barrier integrity while ensuring compatibility with the sterilization process, whether through steam, radiation, or gas. Additionally, regulatory requirements for sterile devices are stringent, necessitating ongoing testing for packaging integrity, sterility, and functionality. Methods like Container Closure Integrity Testing (CCIT) are used to ensure that packaging is airtight and secure. Manufacturers must also consider the impact of storage, transportation, and handling, which can introduce risks of contamination or damage. These challenges require a careful balance of innovation, compliance, and rigorous testing to ensure safety and effectiveness.

Why Vacuum Decay Technology for Sterile Medical Devices?

Vacuum Decay leak testing Technology offers a reliable and non-destructive method for testing the integrity of sterile medical device packaging. Vacuum Decay Technology detects even the smallest leaks in packaging by monitoring vacuum levels during testing. This method is highly sensitive and effective for detecting micro-leaks in a wide range of packaging formats, including rigid, semi-rigid, and flexible materials. It also supports sustainability efforts, as it reduces the need for destructive testing and minimizes waste. Vacuum Decay Technology helps manufacturers ensure packaging integrity, meet regulatory requirements, and safeguard the sterility of medical devices throughout their lifecycle.

In this method, the leak testers are connected to a test chamber designed to hold the package being tested. A vacuum is applied to the package inside the chamber, and the test chamber's vacuum level is monitored using single or dual vacuum transducer technology. During a predetermined test period, any changes in the vacuum level, both absolute and differential, are observed. These variations indicate the presence of leaks or defects in the package. This testing approach is ideal for laboratory offline testing and can be configured for either manual or fully automated operation.

Key Benefits of Vacuum Decay Technology

• Non-destructive and non-invasive
• No sample preparation
• ASTM approved test method F2338
• FDA Recognized Consensus Standard
• ISO 11607 Standard
• Allows for increased sampling
• Quantitative results
• Eliminates cost and waste of destructive testing

Vacuum decay technology is capable of detecting leaks and defects in packaging, preserving sterility throughout the product's lifecycle. By providing accurate results, this method helps meet industry standards and regulatory requirements. As the demand for high-quality, safe medical products grows, vacuum decay technology offers a streamlined approach to evaluating packaging performance. Understanding how this technology works can assist manufacturers in making informed decisions when choosing the most suitable testing method for their sterile medical devices.

The integrity of pre-filled syringes is a major concern in pharmaceutical manufacturing, as these products must remain sterile and secure throughout their entire lifecycle. As the demand for injectable medications and therapies grow, so does the need for reliable methods to confirm the integrity of syringe containers. Container closure integrity (CCI) testing is an integral process in verifying that pre-filled syringes maintain sterility and secure their contents throughout their lifecycle. With ongoing advancements in testing technology, pharmaceutical manufacturers now have access to more precise and efficient solutions to evaluate syringe integrity. These innovations help streamline the testing process, reduce operational costs, and maintain high-quality standards, supporting compliance with industry regulations and ensuring the safety of patients who rely on injectable therapies.

Why Pre-Filled Syringe Integrity Matters?

Pre-filled syringes (PFS) have become a widely preferred choice in pharmaceutical packaging due to their convenience, accurate dosing, and enhanced safety. As a critical component of modern drug delivery systems, maintaining their integrity impacts both patient health and pharmaceutical quality. Here’s why it matters:

• Preserving Sterility: Pre-filled syringes are often used for injectable medications, which must remain sterile to avoid contamination. A breach in integrity can lead to microbial ingress, risking patient health and compromising the medication's safety.
• Ensuring Dosage Accuracy: Damage or leaks in the syringe can lead to product loss, affecting the precision of the delivered dose. For drugs with critical dosing requirements, such as biologics or vaccines, this could significantly impact treatment outcomes.
• Protecting Drug Stability: Many medications in pre-filled syringes are sensitive to environmental factors like oxygen, moisture, or light. A loss of container closure integrity (CCI) could expose the drug to these elements, reducing its potency or rendering it ineffective.
• Mitigating Contamination Risks: Leaks in the syringe body or seal can allow external contaminants to enter, which may degrade the medication or pose direct health risks to patients.
• Enhancing Patient Trust and Brand Reputation: Patients and healthcare professionals rely on pre-filled syringes for their convenience and reliability. Compromised integrity not only risks patient health.

CCI Testing of Pre-filled Syringes Using E-Scan MicroCurrent HVLD

Container Closure Integrity (CCI) testing ensures pre-filled syringes maintain sterility and protect the quality of their contents. The E-Scan MicroCurrent High Voltage Leak Detection (HVLD) system provides an advanced, non-invasive method for detecting leaks in pre-filled syringes. E-Scan 605, 615 and 655 models employs MicroCurrent conductivity technology (HVLDmc) for non-destructive container and product testing, utilizing lower voltage levels compared to other conductivity-based methods. This non-contact test requires no sample preparation. It is compatible with a wide range of liquid-based products, including low-conductivity sterile water for injection (WFI) and protein-based products with suspensions. Its features include rapid test cycles, simple operation, quick changeovers, and easy recipe configuration, enabling flexibility across diverse applications.

The testing process uses electrode probes to scan sealed, non-conductive containers made of materials such as glass, plastic, or poly-laminate. The container must be liquid filled. If a defect like a pinhole or crack exists, the system detects changes in resistance and current flow, indicating a breach. The approximate location of the defect can also be identified on the advanced lab R&D models. E-Scan MicroCurrent technology is scalable and adaptable, offering configurations for both laboratory testing and fully automated production lines, making it a versatile solution for CCI testing in pharmaceutical packaging.

Benefits of MicroCurrent HVLD Technology

• Non-destructive, non-invasive, no sample preparation
• Highly effective across all parenteral products, including extremely low conductivity liquids (WFI)
• Ensure higher levels of accuracy and reliability in results
• Characterizes overall quality and uniformity of the seal
• Offline and 100% online inspection at high production speeds
• Simplifies the inspection and validation process
• Referenced in USP 1207 Guideline

E-Scan MicroCurrent HVLD Technology brings a modern approach to pre-filled syringe testing, focusing on precision, efficiency, and non-destructive methods. It supports the pharmaceutical industry’s pursuit of reliable quality assurance while preserving product integrity and reducing waste. By embracing this advanced solution, manufacturers enhance their ability to meet stringent standards, ensuring safe and effective delivery of medications. This technology embodies innovation in packaging integrity, meeting the demands of both healthcare providers and patients.

Chevron seals are a type of sealing mechanism used in various packaging applications, known for their distinctive V-shaped or chevron pattern. These seals are often employed in flexible packaging materials like pouches, bags, and sachets. The design of chevron seals allows them to maintain strength and flexibility, even when subjected to stress, and they are widely used in applications that require reliable containment of the product. Traditional testing methods often involve destructive processes or are limited in their ability to detect certain seal defects. However, the move toward non-destructive testing techniques, such as Seal-Scan® airborne ultrasound technology, is transforming the way manufacturers approach seal inspection.

The Need for Precision in Chevron Seal Inspections

Chevron seals are widely used in applications where maintaining airtightness, sterile barrier protection and preventing contamination are priorities, such as in medical devices and pharmaceuticals. Precision in inspecting these seals ensures they function as intended, avoiding issues like leaks or compromised integrity that can lead to product failures or safety concerns. Advanced inspection techniques, such as non-destructive testing and high-resolution imaging, are effective for identifying even the smallest imperfections that might otherwise go unnoticed. Automated systems enhance accuracy and consistency, reducing the likelihood of human error and improving efficiency in quality assurance processes. Ensuring that chevron seals meet stringent standards also supports compliance with industry regulations, safeguarding consumer trust and preventing costly recalls. As packaging and sealing technologies evolve, maintaining precise inspection practices ensures reliable performance, upholds product quality, and aligns with the growing demands for safety and accountability in regulated industries.

Seal Integrity Testing Using Seal Scan® Technology

Ensuring the quality of chevron seals is critical to maintaining the performance and reliability of sealed products. Seal-Scan® systems offer a non-destructive and highly precise solution for assessing seal quality. By leveraging Airborne Ultrasound Technology, these systems detect and analyze defects in pouch seals with exceptional accuracy. This deterministic, quantitative, and high-resolution approach to package integrity testing ensures consistent seal quality by identifying defects and verifying seal integrity.

The technology operates by scanning pouch seals or packaging materials using two focused ultrasonic sensors. As ultrasonic waves pass through single or multi-layered bonded materials, variations in the medium reflect the sound waves, reducing signal strength. The amount of signal transmitted through the seal correlates directly to its quality. Seal-Scan® detects a wide range of defects, including both leaking and non-leaking issues, as well as process-related and random defects. It generates Opto-Acoustic images and detailed statistical analysis using L-Scan and C-Scan modes. L-Scan generates a line graph of seal integrity along the X-axis, simulating online inspection, while C-Scan creates high-resolution ultrasonic images by scanning along both the X and Y axes of the seal area. The technology can be seamlessly integrated into production lines using the Seal-Sensor for 100% on-line defect detection.

Seal Scan Technology Benefits

• Deterministic inspection method producing quantitative results.
• Works for any material and combinations, regardless of color, transparency, print, surface finish and porosity.
• Produces high resolution Opto-Acoustic image of seal.
• Characterizes overall quality and uniformity of the seal.
• ASTM Test Method F3004 and FDA standard for seal quality inspection.

The shift toward non-destructive testing techniques in chevron seal quality control marks a significant advancement in packaging inspection. By adopting methods like Seal-Scan® technology, manufacturers can ensure more accurate and reliable assessments of seal integrity without compromising the packaging. This approach helps streamline production processes, reduce waste, and maintain high-quality standards across industries. As the demand for efficient and precise quality control grows, non-destructive testing will continue to play an increasing role in improving packaging reliability and product safety. By embracing these innovative solutions, manufacturers are better equipped to meet the challenges of modern packaging requirements.

Pharmaceutical products are designed to enhance health and support effective treatment. Ensuring the quality and safety of these products relies on maintaining intact packaging that protects against contamination, moisture, and other external factors. Integrity testing methods, such as Vacuum Decay, helium leak detection, and high voltage leak detection, verify that packaging meets regulatory standards like USP <1207>. These methods identify even the smallest leaks, confirming that containers perform their intended function. Comprehensive integrity testing helps manufacturers achieve compliance, mitigate risks, and ensure product safety and reliability.

VeriPac Delta for Package Integrity Testing

VeriPac Delta is a dual technology non-destructive quantitative test system for pharmaceutical CCI applications. Capable of detecting leak rates as small as 5 microns, depending on package specifications, it provides a non-destructive, quantitative testing solution for pharmaceutical and food applications. It is specifically designed for testing gas leaks in dry product containers, such as lyophilized and powder-filled vials, as well as liquid leaks in liquid-filled vials and prefilled syringes.

The VeriPac Delta employs two primary technologies: Vacuum Decay and Pressure Decay. Vacuum Decay leak testing, based on ASTM F2338-09 and recognized by the FDA as a consensus method, delivers sensitivity down to 5 microns. Pressure Decay testing, compliant with ASTM F2095, achieves similar sensitivity with rapid test cycles of just 10 seconds. Together, these technologies provide precise, efficient, and reliable solutions for comprehensive package integrity assessments.

Technology Overview

The VeriPac Delta connects to a specially engineered test chamber. During testing, vacuum or pressure is applied to the package within the chamber. Using high-resolution absolute transducer technology, the system monitors the applied vacuum or pressure levels and detects changes over a specified test duration. This enables accurate detection of gross and micro leaks. The test cycle completes in a few seconds, delivering objective, non-destructive results that preserve both the product and its packaging.

The sensitivity of the test depends on factors such as transducer capability, package design, test fixture, and key parameters like time and pressure. The VeriPac Delta system can be configured for manual or semi-automatic operation, making it suitable for laboratory offline testing and QA/QC statistical process control.

Benefits of VeriPac Delta Technology

• Non-destructive, non-subjective, no sample preparation
• Deterministic, quantitative test method
• Small footprint and modular portable design
• Defect detection down to 0.2 ccm (5 micron)
• ASTM test method and FDA standard
• High level of sensitivity, repeatability and accuracy

The integrity of pharmaceutical products relies on robust packaging that preserves quality and prevents contamination. The VeriPac Delta is an effective and versatile solution for pharmaceutical package integrity testing. By combining non-destructive methodologies, rapid testing cycles, and exceptional sensitivity, it offers more than just leak detection—it provides a comprehensive approach to safeguarding product integrity. Its adaptability across diverse packaging formats ensures its value in advancing quality assurance processes within the pharmaceutical industry.