Blogs

Ensuring the integrity of container closures is a critical aspect of pharmaceutical and biotechnology industries. Maintaining the integrity of containers, such as vials, syringes, and cartridges, is essential to preserve the quality, efficacy, and safety of products throughout their entire lifecycle. Traditionally, blue dye testing has been a widely used method to detect leaks and potential breaches in container closures. However, with the ever-evolving landscape of technology and scientific advancements, it is essential to explore and embrace alternative methods that offer higher sensitivity, reliability, and efficiency.

In this blog, we will explore cutting-edge container closure integrity testing methods that go beyond the limitations of blue dye testing. While blue dye testing has served as a valuable tool for detecting gross leaks, it may not be sufficient to detect micro-leaks or hairline cracks that could lead to potential risks during storage, distribution, and administration of pharmaceutical products.

High Voltage Leak Detection (HVLD) is a non-destructive and non-invasive container closure integrity test (CCIT) used to assess the closure integrity of parenteral product packaging, such as pre-filled syringes, vials, cartridges, ampoules, BFS, bottles, and pouches. By employing quantitative electrical conductivity measurements, this technique allows for non-destructive testing of packages.

The HVLD method involves passing micro-current signals through the sample packages. If there is a leak in the package, the electrical resistance of the sample decreases, leading to an increase in current flow. The newer MicroCurrent HVLD technology operates using approximately 50% less voltage and exposes the product and surrounding environment to less than 5% of the voltage compared to traditional HVLD solutions. This makes it a more efficient and safer option for evaluating packaging integrity in pharmaceutical and medical applications.

Vacuum Decay has proven to be an exceptionally effective technology for detecting leak paths and ensuring the integrity of packages. One of its key advantages is the ability to provide quantitative, deterministic, and reliable test results without causing any damage to the containers being tested. The process involves placing the packages in a meticulously fitted evacuation test chamber connected to an external vacuum source. Throughout the testing, the vacuum levels are constantly monitored to detect any deviations from the predetermined target vacuum level. If a package has defects, air will escape, leading to a noticeable change in the chamber vacuum level. Conversely, non-defective packages will retain the air, ensuring the chamber vacuum level remains constant. The versatility of this method is remarkable as it can accommodate a wide range of packaging formats, including filled and sealed rigid, semi-rigid, and flexible packages made from both non-porous and porous materials.

Helium leak testing is the method of locating leaks in various enclosed or sealed systems by using helium as a "tracer" gas and measuring the concentration of the gas as it escapes due to a leak. Helium is used as a tracer gas because it is non-toxic, non-flammable, and non-condensable, and its atmospheric concentration is less than 5 ppm. Helium, as the second-smallest molecule in the periodic table, can flow through practically any defect or openings. Furthermore, because it does not react with other compounds, helium is relatively safe to use. To find and measure the leak, a mass spectrometer leak detector (MSLD), also known as a helium leak detector, is used.

The OptiPac One-Touch Tool-less technology is intended for non-destructive leak detection of blister packages. To identify leaks, the OptiPac uses volumetric imaging technology to measure the motion of a blister package under vacuum. With new blister package formats, the interface is practical and straightforward to set up, requiring no tooling changeover or extensive parameter modifications as seen with previous non-destructive blister package integrity testing systems. The system collects volumetric data from each cavity, responding to variable cavity shapes, sizes, and configurations of various blister pack forms.

In conclusion, as the pharmaceutical and biotechnology industries strive to ensure the highest standards of container closure integrity, it is evident that traditional blue dye testing alone may not be sufficient to detect all potential risks. Fortunately, cutting-edge container closure integrity (CCI) methods offer superior sensitivity, reliability, and efficiency, surpassing the limitations of blue dye testing.

To ensure container closure integrity, PTI - Packaging Technologies & Inspection, with headquarters in Hawthorne, New York, has created and developed seven different inspection technology platforms. The technology solutions provided by PTI are centered on container closure integrity and give a deterministic measurement of package performance needed by critical applications.

• Vacuum Decay technology for pharmaceutical package inspection.
• Airborne Ultrasound technology for seal quality testing and analysis.
• MicroCurrent HVLD technology for high-risk parenteral applications.
• OptiPac volumetric imaging inspection technology for blister packaging.
• Automated container closure integrity testing CCIT solutions.

While operating under heightened legal and regulatory scrutiny, the pharmaceutical industry continues to be at the forefront of innovation in the domains of new drugs and drug delivery techniques. It is crucial that these products have extremely sterile packaging because they are used for life-saving purposes and must be completely free of contaminants for the duration of their shelf life until they reach the patient. PTI Inspection Systems' tools for testing pharmaceutical packaging are the most sensitive, dependable, and effective. PTI technologies produce quantitative test result information and are deterministic, non-destructive test methods.

The biotech sector encompasses a wide range of medical techniques, including tissue regeneration, genetic editing, and stem cell therapy. Parenteral packaging, such as pre-filled syringes, vials, IV bags, and other single-use bags, are generally used to package these medications. Testing the integrity of container closures is crucial for guaranteeing the quality of all biologics, especially parenterals. PTI's technologies are the most dependable and trustworthy options available for pharmaceutical and biotech packaging applications where the results have a significant impact on stability tests, clinical trials, production performance, and patient safety.

The medical device sector is critical to the health care system since it is involved in the delivery of numerous health care services. Over the last few decades, remarkable advances in medical technology have posed a challenge to the medical device packaging industr in terms of ensuring packaging quality and reliability. Although assessing package quality is crucial for all medical devices, it is especially critical for Class III medical device products. Therefore appropriate package integrity testing technologies are needed to ensure standardized packaging quality.

The nutritional market is progressive and dynamic and nutritional packages play a vital role in delivering the product safely. Most of the nutritional products are shelf-stable in nature and this is often the function of package performance. All nutritional products are subject to innate chemical reactions. Products deteriorate with the exposure to oxygen, moisture and bacteria. PTI has decades of experience designing technologies to inspect food and nutrition packages in the most efficient way possible while ensuring package and product quality. PTI is a pioneer in meeting the needs of infant nourishment packaging applications as well as the demanding specifications of this high-risk product.

PTI provides a comprehensive range of technologies for the industries indicated above. However, it is important to note that there are no one-size-fits-all solutions. Technologies that work in one field may not work in another. As a result, before finalizing any technology, manufacturers should assess industry requirements.

PTI - Packaging Technologies & Inspection - is a group of scientists, engineers, and packaging professionals who are working to improve the overall package quality experience throughout the packaging lifecycle.

To ensure container closure integrity, PTI has designed and developed seven different inspection technology platforms. Each technology is based on the idea that there cannot be a test method without a valid test method. The technology solutions provided by PTI are centred on container closure integrity testing and give a deterministic measurement of package performance needed by critical applications. By delivering package performance data from the development stage through to in-production online package inspection, the solutions are widely utilized to address a variety of packaging design and material difficulties. PTI offers services and consulting in package inspection technologies, container closure integrity and test methods for most of the package types.

List of Services Offered by PTI:

1. Feasibility Studies

The first step in assessing and choosing the optimal CCI technology and test technique for a particular application are feasibility studies. To examine and verify the performance and quality of a package, various test methods are available. The main goal of the feasibility study is to assess the client's application and identify the best inspection technology that will deliver the most precise, sensitive, and reliable data for conclusive package integrity verification.

Clients receive a clear report of a quantitative test technique from PTI's feasibility studies for container closure integrity testing (CCIT) and package quality inspection, which confirm the suggested strategy as it applies to a particular package format. Both positive control samples with certified defects and tested good test samples are used. The technology solution, a specific leak test technique, test settings, test result information, and acceptance criteria are all detailed in the report. The report on PTI's feasibility studies outlines a clear path from the client's problem description to the quantitative test methodologies and findings, as well as how to guarantee package integrity by validating a suggested strategy in relation to a particular package format.

2. Test Method Consulting

Engineers, scientists, and other specialists on PTI's staff are experts in developing test methods, consulting on them, and conducting feasibility studies for a range of applications. The report on PTI's feasibility studies outlines a clear path from the client's problem description to the quantitative test methodologies and findings, as well as how to guarantee package integrity by validating a suggested strategy in relation to a particular package format.

3. Technical Support

PTI service specialists offer remote help via a variety of virtual channels in addition to on-site service. Installation, calibration, training, and upgrades are among the remotely offered services of PTI. The GTS staff can adapt to your demands regarding service schedule. Installations, validation, and after-sale support and maintenance are all skills, our staff have received training in. This network provides services to a varied range of markets around the world.