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Low head space packages are a common type of packaging used for a variety of products, including pharmaceuticals, medical devices, and food. These packages are designed to have a minimal amount of space between the product and the packaging material, which can help extend the shelf life of the product and protect it from contamination. Low head space packages are typically made of a flexible material, such as film or foil. The material is then sealed to the product, creating a tight seal that helps to preserve the product's integrity.

However, low head space packages can also be more susceptible to leaks, which can lead to sterility breaches, product spoilage and contamination. Therefore, it is important to ensure that these packages are properly sealed to prevent leaks and contamination. VeriPac 410 is a non-destructive seal and leak detection system that can help ensure the integrity of low head space packages.

Applications of low head space packages

Low head space packages are used in a variety of industries, including:

• Pharmaceutical industry: Low head space packages are used to package pharmaceuticals, such as tablets, capsules, and transdermal patches.
• Medical device industry: Low head space packages are used to package medical devices, such as, suture packaging.
• Personal care industry: Low head space packages are used to package personal care products, such as serums, lotions and creams packaged in sachets and pouches.

Low Head Space Package Inspection Using Force Decay Technology

Force Decay serves as a quantitative method for detecting leaks, especially in packaging with low headspace. The applicable packaging formats encompass non-porous materials, such as films, laminates, or foils. This method, being non-destructive, leaves the sample packages undamaged and unaltered. Following the completion of the test, the packages can seamlessly return to the batch without the need for disposal.

The testing system employs nested tooling to position the package consistently and restrict the unmeasured expansion of the package under examination. Initiating the test involves creating a vacuum in the test chamber, prompting the package to expand within it. Vacuum levels are continuously monitored throughout the test cycle, evaluating the package using the ASTM F2338 vacuum decay leak test method.

Multiple packages can undergo testing in a single test cycle, with the force decay measurement system discerning any defective packages. Defective packages exhibit a decay in the expansion force or vacuum level during the test cycle. The location of the defective package or cavity is then pinpointed. Force decay proves most effective when assessing multi-cavity package formats.

PTI’s VeriPac 410 inspection technique leverages force decay technology for non-destructive seal and leak detection in blister packs, sachets, and pouches with low headspace. VeriPac 410 functions as a vacuum based Container Closure Integrity test (CCIT) method, capable of testing multiple packages in a single test cycle. The force decay measurement system identifies any defective packages. This technology accurately measures force by observing the surface deflection of a package during a typical vacuum-based test cycle. The force measurement capability enables the VeriPac 410 series to pinpoint which package is defective while also conducting leak tests on packages with minimal headspace. Force decay remains the most effective technology, particularly in the assessment of multi-cavity package formats. This technology is scalable from the laboratory to automated inline inspection platforms.

Benefits of Force Decay leak testing

• Non-destructive and non-invasive
• Non-destructive, non-subjective, no sample preparation
• The test protocol is programmed into the testing unit with high degree of repeatability.
• Multiple packages can be tested in a single test cycle
• The test is operator independent and can be performed with minimal training
• Supports sustainable packaging initiatives
• Optimal solution for in-process testing
• Cost effective with rapid return on investment

The pharmaceutical packaging industry is constantly developing as pharmaceutical manufacturers require reliable and efficient packaging solutions that meet a variety of requirements. Packaging is essential for the safe storage and administration of pharmaceutical products. Packaging pharmaceuticals is important not only for storing and protecting products but is also helpful in identifying, marketing, and promoting different brands, and making pharmaceutical products easier to use. Vials, blister packs, bottles, syringes, ampoules, etc are the most common pharmaceutical packages. The packages must perform correctly to ensure that the drug product remains uncompromised throughout the distribution cycle and shelf life. These packages are later tested to guarantee their quality and integrity.

Testing Package Integrity Using VeriPac 355 Series

VeriPac 355 is a non-destructive micro leak detection device for testing container closure integrity and package integrity on a variety of products and packaging types. This system is specially designed to test containers for dry product gas leaks as well as liquid leaks. Since it is non-destructive and does not need sample preparation, the VeriPac 355 can be integrated into protocols at any step in the handling process. The VeriPac 355 is the ideal non-destructive quantitative test technique for various pharmaceutical and food applications, with the capacity to detect leak rates as low as 0.2 cc/min depending on package parameters. The VeriPac 355 core technology is based on the ASTM vacuum decay leak testing method (F2338-09), which is recognized by the FDA as a consensus standard for package integrity testing. VeriPac leak test instruments were used to develop this test method.

Technology Overview

The VeriPac 355 leak tester is connected to a test chamber intended to hold the package to be tested. The package is placed inside the vacuum-sealed test chamber. High-resolution absolute transducer technology is utilized to monitor the test chamber for, both the level of vacuum and the change in vacuum during a pre-defined test duration. This is capable of detecting both gross and micro leaks. The test cycle is only a few seconds long and the results are objective. The testing is non-destructive to both the product and the package.

The sensitivity of a test is determined by the sensitivity of the transducer, the package design, the package test fixture, and the crucial test parameters of time and pressure. Test systems can be configured to operate manually or semi-automatically. This method is suitable for offline laboratory testing and QA/QC statistical process control.

Advantages of VeriPac 355

• Non-destructive, non-subjective, and no sample preparation is required
• Deterministic, quantitative test method
• Detection of defects down to 0.2 ccm (5 microns)
• High sensitivity, repeatability, and accuracy
• Operator receives a PASS/FAIL result within a short cycle time
• Portable modular design with a small footprint
• FDA standard and ASTM F2338 test method

VeriPac technology is the optimal non-destructive solution for determining container closure integrity in a variety of package configurations. The strategy for choosing the right VeriPac model is based on the package type and the required leak test sensitivity. Configurations can be optimized and customized to the needs of each application. The VeriPac Series will analyze a wide range of high-risk package applications and ensure that the product fulfills regulatory standards and customer requirements for integrity.

Pre-filled syringes have a significant role in the injectable drugs market. Because of its convenience, efficiency, and patient safety, pre-filled syringes are now widely utilized in a variety of medical areas. Pre-filled syringes, which are rapidly replacing traditional syringes are frequently used to deliver vaccinations. Defects in pre-filled syringes are mostly determined by pharmaceutical product design and syringe process design. Patient-related concerns are also a regulatory concern. As a result, it is critical for manufacturers to have a thorough understanding of the various tests involved in order to assure patient safety.

Evaluating leak test using Vacuum Decay Vs MicroCurrent HVLD Test Methods

Manufacturers perform Container Closure Integrity testing to ensure that the product maintains sterility and microbiological quality until the point of use. Container closure integrity testing evaluates a container closure system's capacity to maintain a sterile barrier against contaminants that might affect the quality of the resulting pharmaceutical and biological products. Various test techniques may be used to challenge Container Closure Integrity (CCI), however, not all of them are equally capable of finding package leaks. Vacuum Decay and High Voltage Leak Detection (HVLD) are the two deterministic test techniques for CCI mentioned in USP 1207, that are frequently used for parenteral products.

Technologies Overview

Vacuum decay leak testing is a CCI test method that has been proven over decades and improved with new technology innovations. When compared to destructive testing techniques, non-destructive testing not only provides for a better knowledge of package quality but also minimizes waste. As a result of the waste reduction, the return on investment will be higher.

Vacuum Decay method operates by enclosing sample packages in a tight-fitting evacuation test chamber with an external vacuum source. The test chamber is monitored for both the level of vacuum and the change in vacuum during a set test duration using either single or dual vacuum transducer technology. The existence of leaks or flaws within the package is indicated by variations in an absolute and differential vacuum. The Vacuum Decay method for leak detection of pre-filled syringes have proven to be an effective method of testing.

Benefits of Vacuum Decay

• ASTM Test Method F2338 and referenced in USP 1207 Guidelines
• Deterministic, quantitative test method
• Repeatable, rapid, and reliable testing
• Non-destructive technology
• Completely tool-less with no changeover to test different packaging formats

High Voltage Leak Detection (HVLD) is a deterministic CCI test method for package inspection of non-porous pharmaceutical and parenteral goods. This technique is based on the fundamental characteristic of electricity. MicroCurrent HVLD technique, the latest evolution of HVLD developed by PTI, promises to provide a high degree of CCI assurance throughout the whole range of parenteral goods.

This method operates by scanning the container which can be done offline in the laboratory or online in an automated robotic platform. On one side of the container, a high voltage is supplied, while the other side has a ground probe. If there is no leak in the package, the two container walls (high voltage and ground) offer complete electrical resistance, and no substantial current is measured passing through the vial. The break-down resistance is achieved when there is a micro-leak or fracture in one of the container walls, and the current passes through. HVLD is the only leak detection technique that does not require mass to flow through a defect location, instead of relying on electricity to pass through a crack.

Benefits of MicroCurrent HVLD

• Non-destructive technology
• Non-invasive, no sample preparation
• High level of repeatability and accuracy
• Offline and 100% online inspection at high production speeds
• Low voltage exposure to product and environment

Pre-filled syringes have emerged as a practical and dependable source for unit dosage medication as the pharmaceutical industry continues to seek possibilities to create convenient drug delivery techniques. We, at CCIT put a lot of effort into developing customized handling solutions that guarantee that syringes are moved without touching their piston to minimize product loss.

A significant challenge faced by the pharmaceutical industry is insuring the container closure integrity of parenteral products. Therefore, maintaining the quality of parenteral products is critical in order to make sure they are actually sterile and safe for delivery to patients. Parenteral products are often packaged in a variety of formats. Liquid-filled containers, such as ampoules, syringes, and vials are the most prevalent forms. Microbial infection, exposure to gases, and water vapor can all lead to product degradation if the packaging is breached. Pharmaceutical products that save lives might lose their effectiveness or even cause adverse effects. As a result, container closure integrity is an important factor of the lifetime of a sterile pharmaceutical product.

Ensuring quality control with Vacuum decay technology

Vacuum decay is a test technique for determining closed container integrity (CCI) for high-risk packaging applications that provides quantitative and deterministic quality assurance with rapid, consistent, and reliable test results. The Vacuum decay method provides non-destructive and non-invasive leak detection in hermetically sealed containers. This is actually a simple test method and it tests container integrity using basic physical characteristics. It entails drawing vacuum on a package inside a test chamber and checking for any deterioration in the vacuum level, which would indicate a leak. As a non-destructive alternative to the water bath leak test, the approach has gained popularity. It saves money by not wasting items during the leak test.

This technique is applicable to a wide range of packaging formats. The Food and Drug Administration (FDA) has designated the standard vacuum decay leak test technique (ASTM F2338) as a consensus standard for container closure integrity testing. The test technique is mentioned in the United States Pharmacopeia Chapter on CCI (USP Chapter 1207) and is listed in ISO 11607.  It may be used to evaluate rigid or flexible packaging, as well as plastic, glass, or metal containers, making it useful in the pharmaceutical and food and beverage sectors.

Benefits of using Vacuum decay technology

• Non-destructive, non-invasive, no sample preparation
• Cost effective with rapid return on investment
• ASTM test method and FDA standard
• Pass/fail results backed by quantitative test data
• Capability to test multiple packages in a single test cycle
• Non-subjective, accurate and repeatable results

CCIT.s.a are leading providers of various CCI test methods including Vacuum Decay, MicroCurrent HVLD, and Helium Leak Detection, manufactured by our affiliate PTI Inspection Systems in the United States. We specialize in test method development for all container closure integrity of pharmaceuticals, medical device and nutritional products and package quality testing projects. Our aim is to provide customers with deterministic non-destructive technologies for container closure integrity and then provide full support in the complete implementation of CCI systems.