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In the pharmaceutical industry, the safety and efficacy of products are of utmost importance, and maintaining these qualities throughout the distribution and storage chain is a critical aspect of ensuring public health. One key element in achieving this goal is the rigorous implementation of Container Closure Integrity (CCI) testing.

CCIT refers to the evaluation of the ability of a pharmaceutical package to prevent the ingress of contaminants, as well as the escape of the product, ensuring that the package maintains its integrity over time. This process is essential in safeguarding the quality and safety of pharmaceutical products, as any compromise in the packaging can lead to contamination, degradation, or other adverse effects on the medication.

Traditional Container Closure Integrity (CCI) assessment has heavily relied on destructive testing methods, such as water bath and dye tests. These approaches involve immersing packaging materials in water or applying dyes to identify potential leaks. However, these methods present significant drawbacks. They are time-consuming, requiring substantial resources for testing and result analysis, which is highly subjective and varies from operator to operator. This prolonged process can hamper production efficiency and delay product release.

Moreover, the accuracy of these methods is questionable, as they may not reliably detect all types of leaks. The subjective nature of human interpretation in analyzing results leads to potential inconsistencies and misinterpretations. Additionally, the destructive nature of these tests contributes to product loss and waste, escalating production costs and raising environmental concerns.

In the context of a growing emphasis on sustainable practices, there is a rising demand for alternative, non-destructive, and objective CCI testing approaches that can address these limitations and align with contemporary production and sustainability standards.

CCI Testing using Vacuum decay technology

To guarantee integrity and consistency of packages, the ability to precisely detect leaks and defects is necessary. Over the years industry has seen an increasing demand for non-destructive package integrity testing methods. One such method is Vacuum Decay technology.

Vacuum Decay is a test method that has been proven over decades as the most practical and sensitive vacuum-based leak test method. It is a simple test method that challenges container integrity based on fundamental physical properties. Vacuum Decay technology creates reliable and accurate quantitative results with a pass or fail determination and has been established as a non-destructive deterministic alternative method to the blue dye test. The standard vacuum decay leak test method (ASTM F2338), developed using PTI's VeriPac instruments, is recognized by the FDA as a consensus standard for container closure integrity testing. The test method is listed in ISO 11607 and referenced in the United States Pharmacopeia Chapter on CCI (USP Chapter 1207)

How does Vacuum Decay Technology work?

Under this method, the leak testers are first connected to a test chamber that is specifically designed to hold the package to be tested. Vacuum is applied to the package placed inside the test chamber. Using single or dual vacuum transducer technology test chamber and level of vacuum are monitored along with a change in vacuum over a predetermined test time. The changes in absolute and differential vacuum indicate the presence of leaks and defects within the package. This inspection method is suitable for laboratory offline testing and can be designed for manual or fully automated operation. The test cycle is non-destructive to both product and package and takes only a few seconds. It provides significant savings by not wasting products for a leak test and generates a return on investment in under six months for many products.

Key Benefits of Vacuum Decay Technology

• Non-destructive and non-invasive
• No sample preparation
• ASTM approved test method
• FDA Recognized Consensus Standard
• Allows for increased sampling
• Quantitative results
• Eliminates cost and waste of destructive testing
• Test results can be easily validated
• SPC laboratory testing or online applications

In today's fast-paced world, businesses across various industries are constantly seeking ways to streamline their operations, enhance productivity, and deliver innovative solutions to their customers. To meet these demands, many companies turn to Comprehensive Integrator and Original Equipment Manufacturer (OEM) solutions. These versatile services offer a range of benefits, from reducing development time to ensuring product quality and scalability.

PTI's Integrator and OEM Solutions are designed to help manufacturers automate their package integrity testing processes. PTI offers a variety of sensory technologies, including Airborne Ultrasound, Vacuum Decay, Microcurrent HVLD, and Force Decay, that can be integrated into existing packaging lines or used to create new PIT systems. PTI also works closely with OEMs to integrate its technologies into their equipment.

PTI's Integrator and OEM Solutions offer a number of benefits, including:

• Increased productivity: By automating package integrity testing, manufacturers can free up operators to focus on other tasks, such as production or quality control.
• Improved product quality: Automated package integrity testing can help to identify and remove defective products from the production line, preventing them from reaching customers.
• Reduced costs: It can help to reduce the cost of labor and materials, as well as the risk of recalls.
• Compliance with regulations: PTI's solutions can help to ensure that products meet regulatory requirements for package integrity.

If you are a manufacturer who is looking to automate your package integrity testing process, PTI's Integrator and OEM Solutions can help. PTI has a team of experienced engineers who can help you to select the right sensory technology and integrate them into your production line. PTI also offers a variety of services, such as training and support, to help you get the most out of your PIT system.

Here are some of the specific solutions that PTI offers:

• Airborne ultrasound technology is used to inspect and analyze seals non-destructively. PTI's Seal-Scan® and Seal-Sensor products use airborne ultrasound to provide real-time seal quality inspection on the production line.
• Vacuum decay technology is used to leak test packages and containers. PTI's VeriPac platform uses vacuum decay to provide a deterministic method for leak testing that is repeatable and reliable.
• MicroCurrent HVLD technology is a CCIT test used to inspect packages for defects such as pinholes and cracks. PTI's MicroCurrent HVLD technology is non-destructive and can be used to inspect a variety of package materials.
• Force decay technology is used to measure the force required to open a package. PTI's Force Decay technology can be used to detect counterfeit products or to verify the integrity of packages.

If you are interested in learning more about PTI's Integrator and OEM Solutions, please visit our website or contact us for a consultation.

The ability of container closure systems to maintain a sterile barrier against potential contaminants that could lower the quality of the finished product can be understood as container closure integrity. External contaminants may enter the product through even the smallest leak or breach of the sterile barrier, impairing its capacity to perform as expected. Despite being popular leak testing techniques, dye ingress and microbial ingress have been shown to produce results that are often inaccurate and subjective. Deterministic test methodologies that can be controlled, calibrated, and provide a firm determination of CCI have therefore been encouraged by regulatory bodies.

Vacuum Decay is a non-destructive container closure integrity testing (CCIT) method for detecting leak paths and package integrity. The test method is simple in principle and challenges container integrity based on fundamental physical properties. This test provides a quantitative result that is accurate, repeatable, reproducible, and reliable with a pass/fail determination.

Our line of non-destructive VeriPac package testing equipment is backed by the tradition of excellence and performance reliability that PTI brings. The FDA acknowledges the standard Vacuum Decay leak test method (ASTM F2338), which was created using PTI's VeriPac instruments, as a consensus standard for testing container closure integrity (CCI). The test method is referenced in the United States Pharmacopeia Chapter on CCI and listed in ISO 11607 (USP Chapter 1207). The test is conducted by drawing vacuum on a package inside of a test chamber, and the vacuum level is checked for any decay that might signify a leak. The technique has established itself as a non-destructive substitute for the water bath leak test. By avoiding product waste for a leak test, it offers significant savings and, for many products, achieves return on investment in less than six months.

Industry Applications:

1. Pharmaceutical Industry

Pharmaceutical manufacturers prioritize quality control and package integrity because defects in pharmaceutical product manufacturing can directly affect drug quality. Even minor defects in the packaging or container may allow outside elements or contaminants to enter the drug. A manufacturer prioritizes implementing the proper container closure system because it affects both the product and the patient. CCI testing is a non-destructive package inspection technology for detecting leaks and avoiding potential contamination. The regulatory bodies take CCI's negligence very seriously. The guidelines support deterministic, dependable test methods for measuring industry-wide quality standards.

2. Food and Nutrition Industry

Packaging is crucial to today's food and nutrition industry. Packaging serves a variety of purposes, including product safety, brand awareness, product promotion, product protection and product delivery. Food and nutrition products are packaged so that they stay fresh for the entire shelf life. However, the challenges associated with packaging food and nutrition products have increased due to frequent innovations in packaging formats and the move towards sustainable packaging materials.

In order to ensure that the products are free from any type of contamination or defect, manufacturers are encouraged to perform appropriate package integrity tests. Various Container Closure Integrity Testing techniques are now available on the market to guarantee the quality and sterility of packages for the duration of their shelf life or until they are delivered to the consumer. Vacuum Decay technology and Airborne Ultrasound technology, among other methods, are very useful in food and nutrition package inspection.

Benefits of Vacuum Decay Technology

• Non-destructive, non-invasive, no sample preparation
• Accurate, reliable, repeatable results
• Supports sustainable packaging and zero waste initiatives
• FDA recognized standard for package integrity testing
• ASTM test method F2338

There are certain aspects that need to be maintained regardless of whether you operate in the food packaging sector or the pharmaceutical products manufacturing industry to ensure that a quality product will be provided to the clients. Package integrity testing is required for items that must be packaged so that they can be sterilized and maintained sterile for a defined amount of time, throughout the product lifecycle.

Package Integrity Testing Using VeriPac 455

The VeriPac 455 is a non-destructive, non-invasive, and highly sensitive Container Closure Integrity Testing (CCIT) method that may be implemented into protocols at any stage of the handling process. Stability research, clinical trial investigations, quality assurance testing, and production statistical process control are examples of applications for this technology (SPC). Leak rates as low as 0.05 cc/min can be found with the VeriPac 455. Results have consistently outperformed and outperformed the dye ingress test in terms of accuracy.

The VeriPac 455 core technology is based on the ASTM vacuum decay leak test method (F2338-09) recognized by the FDA as a consensus standard for package integrity testing. This test method was developed using VeriPac leak test instruments. The VeriPac 455 is equipped with the patented PERMA-Vac dual vacuum transducer technology, which increases test sensitivity and yields reproducible, dependable results.

Additionally, the VeriPac 455 contains major improvements in networking and internet access that enable remote operation, system monitoring, and MES integration. Test systems can be built to operate automatically or manually. This inspection method is appropriate for QA/QC statistical process control and laboratory offline testing. The test cycle only lasts a few seconds, the results are objective, and the testing is non-destructive to the product and the package.

Inspection Criteria

• Measures seal integrity of entire container or package
• Measures and verifies container closure system integrity
• Tests for gas leaks for dry products (lyophilized vials, powder filled)
• Tests for liquid leaks (liquid filled vials, pre-filled syringes)

Benefits

• Non-destructive, non-subjective, no sample preparation
• Defect detection down to 0.01 cc/min
• Highest level of sensitivity, repeatability and accuracy
• Results proven superior to dye ingress
• Deterministic, quantitative test method
• Supports sustainable packaging and zero waste initiatives
• ASTM test method F2338 and FDA standard for package integrity testing
• Vacuum Decay technology referenced in USP 1207 guidelines

Medical devices play a key role in the diagnosis and treatment of many conditions and life saving treatments. To insure patient safety, the effectiveness of such medical devices should be carefully evaluated. Package integrity testing of medical devices is a crucial part of the manufacturing process.

Medical device package testing methods offered by PTI

PTI’s Airborne Ultrasound technology (ABUS) is a seal quality inspection test method, capable of non-destructively examining packaging seal quality for defects, primarily flexible packaging seals. Under this method, ultrasound waves are passed through the pouch seal, creating a reflection of sound waves. The signal strength variations are analyzed to identify the presence of seal defects. Airborne Ultrasound technology creates a quick analysis of the seal area without tampering with the packaging to identify many common seal defects, such as incomplete or missing seals, wrinkles, and channel defects. The technology is in high demand due to its applicability across several industries, specifically the medical device industry. “Ultrasound is the only technology capable of identifying what the quality of that physical bonded nature of the seal materials are,” comments Tyler Harris, applications engineer at PTI- Packaging Technologies & Inspection. Medical device packaging including TYVEK® pouches is a very common application for ABUS technology.

PTI's Seal Scan (Offline) and Seal-Sensor (Inline) technology have further redefined pouch seal integrity testing. Both these technologies utilize non-contact airborne ultrasonic testing technology. With these advancements, Airborne Ultrasound technology has positioned itself to be the most sensitive method for non-destructive seal quality testing, in both the laboratory and in automated 100% inline testing production lines. ABUS is an ASTM Test Method F3004, recognized by the FDA as a standard for seal quality inspection and also referenced in the USP 1207 chapter guidelines.

For several decades, Vacuum Decay has been proven to be the most practical and sensitive leak detection method for medical device and pharmaceutical packaging. It is a Container Closure Integrity Test (CCIT) capable of evaluating a wide range of packaging formats including filled and sealed rigid, semi-rigid and flexible packaging made of non-porous or porous materials. Vacuum Decay, being a non-destructive test method, does not cause any damage to the package being tested. This reduces significant waste and allows operators to have a thorough understanding of package integrity and package quality.

PTI’s VeriPac inspection technique is an ASTM approved (F2338), FDA recognized testing method capable of evaluating a wide range of high-risk package applications. To conduct this test, packages are first placed in a well-fitted evacuation test chamber, which has an internal or external vacuum source. The test operator continuously monitors the vacuum levels to identify variations from a pre-determined targeted vacuum level. In the presence of a defect, air escapes from the package into the test chamber. Packages without any defect retain the air, maintaining a constant chamber vacuum level. It is an ideal solution for medical device manufacturers to assure that the product meets regulatory standards. Based on the packaging materials used and the level of test sensitivity required, manufacturers can select the appropriate VeriPac model.