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Flexible packaging has become widely used across pharmaceuticals, medical devices, and healthcare products due to its lightweight design, storage efficiency, and material versatility. Pouches, sachets, and multi-layer films support a wide range of product formats while helping manufacturers optimize space and logistics. At the same time, these materials behave differently from rigid containers during filling, sealing, storage, and distribution. This creates new inspection demands when confirming Container Closure Integrity (CCI). Reliable CCI verification for flexible materials depends on using test systems that match the physical behaviour of films and seals while delivering consistent and traceable results across production environments.

Understanding CCI Challenges with Flexible Packaging

Flexible packaging is designed to bend, compress, and expand, which creates added complexity during integrity testing. Unlike rigid containers, these materials respond dynamically to pressure and vacuum conditions. During testing, package deformation can hide small defects, making leak detection more difficult.

Seal construction adds another layer of challenge. Flexible pouches often use multi-layer films joined through heat sealing. Variations in sealing temperature, pressure, and dwell time can result in channel defects, weak seals, or micro voids that remain invisible during visual inspection. These hidden flaws may allow air or moisture to enter without obvious signs of failure.

Headspace variation further affects testing behaviour. Some packages contain minimal internal gas, while others rely on modified atmospheres. These differences influence how packages respond during testing and can lead to inconsistent measurements when non-adaptive systems are used.

Traditional inspection methods depend heavily on visual checks and destructive testing. Visual inspection is influenced by lighting, contrast, and operator experience, while destructive methods increase product waste and limit routine sampling.

Transport and handling also impact seal performance. Vibration, stacking pressure, and temperature changes during distribution can cause seal deformation after production. Together, these factors make flexible packaging one of the more challenging formats for maintaining reliable package integrity.

Choosing the Right Test Methods for Flexible Materials

Selecting a test method suited to flexible materials begins with choosing deterministic technologies that deliver data-driven outcomes rather than visual interpretation. Two widely adopted approaches include vacuum decay testing with VeriPac FLEX and Airborne Ultrasound testing.

1. VeriPac FLEX

VeriPac FLEX systems offer non-destructive inspection for pouches and flexible packaging, delivering clear PASS/FAIL results with quantitative leak-rate data. These systems support a wide range of package sizes and formats without requiring tooling changes, from small sachets and stick packs to large bulk pouches and bags. Based on ASTM F2338-24 vacuum decay leak testing and recognized by ISO 11607 and the FDA, VeriPac FLEX serves as an effective alternative to destructive methods by reducing subjectivity, waste, and testing costs. The technology also delivers fast return on investment while providing reliable detection of packaging defects and valuable process insights.

2. Airborne Ultrasound

Airborne Ultrasound is a non-destructive method used for seal quality testing and detect defects in packaging. It is defined under ASTM F3004 and recognized by the FDA as a standard for seal quality evaluation. This approach is widely applied for enhanced inspection of pouches and flexible packages. During testing, ultrasound waves pass through the package seal and reflect. The change in signal strength indicate the presence of leaks or defects, which are carefully analyzed for accurate detection. Airborne Ultrasound supports detailed seal assessment and is suitable for a wide range of materials, including Tyvek, paper, foil, film, aluminium, plastic, and poly.

Flexible packaging brings efficiency and adaptability, but it also introduces inspection demands that differ from rigid formats. Material movement, seal variation, and transport stress all influence how well a package performs beyond the production line. Visual and destructive checks alone often leave gaps in inspection coverage and repeatability. When manufacturers adopt objective, measurement-based verification aligned with packaging design and process conditions, they gain stronger visibility into seal performance. This approach supports consistent inspection practices from development through distribution. With dependable verification in place, manufacturers strengthen oversight, reduce uncertainty, and maintain steady package performance throughout the product lifecycle.

Ensuring the quality and safety of nutraceutical packaging depends on effective leak detection methods. Traditional techniques have been widely used but often lack efficiency, accuracy, and sustainability. These approaches can be time-consuming, inconsistent, and destructive, leading to material waste and higher costs. As packaging standards evolve, there is a growing need for solutions that deliver greater precision and repeatability without disrupting productivity. The VeriPac Series offers an alternative that overcomes these challenges while improving quality control. This blog examines the limitations of traditional leak testing and how VeriPac enhances package integrity testing to support product safety and compliance.

Limitations of Traditional Leak Testing Methods

Leak testing methods, such as dye ingress, bubble emission, and water bath testing, have been widely used across industries but come with several limitations.

• Destructive Testing – Requires sample destruction, leading to material waste and increased costs.
• Operator Dependence – Relies on human interpretation, making results inconsistent and subjective.
• Limited Sensitivity – Struggles to detect microleaks below 10 microns, which are critical in many applications.
• Contamination Risks – Exposure to water, dyes, or chemicals may introduce contamination risks.
• Slow and Labor-Intensive – Manual processes take time and are not suitable for high-volume testing.
• Lack of Quantifiable Data – Provides only a pass/fail result with no precise measurement or digital record.
• Inconsistent Repeatability – Results may vary between tests due to environmental factors and operator skill.
• Non-Compliance with Modern Standards – Many traditional methods do not meet evolving regulatory requirements for pharmaceuticals and medical devices.

The VeriPac Series: A Non-Destructive Alternative

The VeriPac Series provides an advanced, non-destructive approach to leak detection, offering superior accuracy and efficiency in nutraceutical package testing. This system utilizes Vacuum decay leak testing, a highly sensitive method for detecting leaks in flexible and rigid packaging. VeriPac Series minimize waste while providing operators clear insights into package quality. The VeriPac test system delivers real-time results through precise quantitative measurements, allowing early detection of packaging defects before process issues escalate. Tests can be conducted in any order and repeated on the same sample without damage. Good packages can be returned to the production line, making the process more reliable, sensitive, and efficient than destructive testing methods.

Technology Overview

VeriPac leak testers connect to a test chamber that is specially designed to contain the package to be tested. The package is placed inside the test chamber to which vacuum is applied. The absolute transducer technology is used to monitor the test chamber for both, the level of vacuum as well as the 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. The test cycle takes only a few seconds, results are non-subjective, and testing is non-destructive to both product and package.

VeriPac systems are capable of detecting microleaks as small as single-digit microns, making them ideal for applications where sterility, product stability, and moisture protection are critical. Designed to comply with ASTM and FDA standards, the VeriPac Series supports a wide range of packaging formats, including pouches, sachets, and blister packs.

By offering fast, and accurate package integrity testing, VeriPac helps manufacturers enhance quality control, reduce waste, and maintain regulatory compliance in industries such as pharmaceuticals, nutraceuticals, and medical devices.

Ensuring the reliability of Continuous Glucose Monitors (CGMs) begins with the integrity of their packaging. Packaging serves as a barrier, protecting the device from external factors that could compromise its performance. As the demand for CGMs grows, so does the need for advanced methods to uphold packaging quality and sterility. Vacuum decay technology has emerged as a trusted solution, offering a way to verify the integrity of CGM packaging with precision and consistency. By embracing innovative testing methods, manufacturers can confidently deliver products that meet the expectations of users relying on CGMs for effective diabetes management.

The Importance of Packaging Integrity in CGMs

Packaging integrity directly impacts the reliability and performance of Continuous Glucose Monitoring Devices (CGMs). These devices are trusted by individuals managing diabetes for accurate, real-time glucose readings. Packaging acts as a barrier, protecting the device components from external elements like moisture, contaminants, and physical damage that could interfere with sensor functionality.

To maintain the quality and reliability of CGMs, advanced testing methods such as vacuum decay are employed to ensure leak-free packaging. This non-destructive technology detects even the smallest compromises, helping manufacturers meet high-quality standards while preserving product sterility and performance.

Reliable packaging safeguards CGMs throughout their shelf life, ensuring they operate as intended when needed most. By adopting comprehensive package integrity testing, manufacturers enhance the trust and confidence of users, reinforcing the dependability of CGMs in supporting effective diabetes management.

Ensuring Sterility in CGM Packaging Using Vacuum Decay Technology

Sterility in Continuous Glucose Monitor (CGM) packaging safeguards the device's performance and reliability. Any breach in packaging can allow contaminants or moisture to enter, which may affect sensor functionality and overall usability. Vacuum decay technology is a non-destructive testing method designed to detect even the smallest leaks in CGM packaging. Unlike manual inspection and other non-deterministic methods, vacuum decay leak testing delivers precise, measurable, and consistent results to verify package integrity. This method is compatible with a variety of packaging types, including filled and sealed rigid, semi-rigid, and flexible packages made from porous or non-porous materials.

The vacuum decay process involves placing the test package in a tightly sealed chamber connected to an external vacuum source. The test chamber is monitored using single or dual vacuum transducer technology for both the level of vacuum and the change in a vacuum throughout a defined test duration. Variations in absolute or differential vacuum levels indicate the presence of leaks or defects within the package. This method is ideal for offline laboratory testing and can be configured for manual or fully automated operations. Non-destructive to both the product and packaging, it completes testing in just a few seconds. By minimizing product waste, vacuum decay testing reduces costs and often delivers ROI within six months.

Benefits of Vacuum Decay Technology

• Non-destructive technology, non-subjective, no sample preparation
• Defect detection down to 0.05 ccm
• Accurate, reliable, and repeatable results
• Pass/fail results backed by quantitative test data
• No tools are required to evaluate alternative package formats
• Identifies which cavity is defective
• Supports sustainable packaging and zero waste initiatives
• FDA recognized standard for package integrity testing

Maintaining the integrity of CGM packaging is central to delivering reliable devices that meet user expectations. By adopting innovative testing solutions, manufacturers can uphold the quality and sterility required for these life-enhancing tools. Consistent and precise packaging evaluation supports the performance of CGMs, ensuring they remain dependable throughout their shelf life. This commitment to quality not only enhances user trust but also reinforces the value of CGMs in diabetes management. With advancements in testing methods, the packaging process can continue to evolve, meeting the growing demand for high-performing medical devices with confidence and reliability.

Inhalers are widely used devices for delivering medication directly to the respiratory system, particularly for managing conditions like asthma and chronic obstructive pulmonary disease (COPD). The effectiveness of an inhaler depends significantly on its ability to maintain airtight integrity, ensuring proper dosage delivery and optimal performance. Leaks in inhalers can lead to medication loss, reduced efficacy, and inconsistent drug delivery, which may impact patient health.

Leak testing inhaler devices is a quality assurance process designed to identify and address potential weak points in the device. This process evaluates seals, valves, and other components to detect potential issues such as micro-leaks, improper assembly, or material degradation. Advanced leak detection methods, such as vacuum decay, are often employed for package integrity testing. By prioritizing robust leak testing protocols, manufacturers can improve inhaler quality, enhance patient trust, and meet regulatory requirements.

Common Leak Issues in Inhalers

Several factors can lead to leaks in inhaler systems, potentially compromising their functionality and the efficacy of the medication. Below are the most common leak issues encountered in inhalers:

• Valve Leaks: Caused by improper sealing or wear, leading to propellant loss and inconsistent medication delivery.
• Seal Failures: Occur between the canister and actuator due to material degradation or manufacturing defects, resulting in medication leakage.
• Physical Damage: Cracks or dents in the canister or actuator compromise pressure, reducing the effectiveness of drug delivery.
• O-Ring and Gasket Deterioration: Misaligned or degraded components increase the risk of leaks and contamination.
• Temperature Sensitivity: Extreme storage or transportation conditions weaken seals, compromising the device's integrity.
• Manufacturing Defects: Incorrect assembly or insufficient quality control can introduce flaws that lead to leaks.
• Aging Components: Over time, wear and tear on parts like valves and seals can result in diminished functionality and leakage.

How VeriPac Vacuum Decay Detects Microscopic Leaks in Inhalers?

The VeriPac vacuum decay leak testing method offers a precise and non-destructive solution for detecting microscopic leaks in inhalers. These systems deliver real-time results through accurate quantitative measurements, enabling the identification of packaging defects before significant process issues arise. VeriPac series employs the ASTM-approved, patented Vacuum Decay leak test method F2338, recognized by the FDA as a consensus standard for package integrity testing.

The process begins by placing the inhaler in a specialized test chamber connected to the VeriPac system. A vacuum is applied to the chamber, creating a pressure differential that highlights potential weak points in the packaging. The system continuously monitors the vacuum level and detects any pressure changes over a defined test period. Advanced vacuum transducer technology analyzes both absolute and differential pressure to identify even the smallest leaks with high accuracy. This method ensures the integrity of the inhaler packaging while preserving the product, eliminating waste associated with use of destructive testing methods.

Benefits of VeriPac Series

• Non-destructive, non-subjective, no sample preparation
• Deterministic, quantitative test method
• FDA recognized ASTM test method
• Referenced in USP 1207 guideline
• Cost-effective with rapid return on investment
• Simplifies inspection and validation process

Consistent leak detection helps identify any packaging flaws or imperfections that may compromise the inhaler’s performance. By using the VeriPac vacuum decay method, manufacturers can verify the integrity of inhaler packaging, ensuring that it functions as intended throughout its shelf life. This approach not only enhances patient trust but also contributes to the overall quality and reliability of inhaler products. Regular leak testing helps maintain the effectiveness of medications and ensures that patients receive the full therapeutic benefit of their prescribed treatments.

The biopharmaceutical industry is witnessing a paradigm shift in quality control practices, driven by the emergence of innovative technologies. As the demand for biological products continues to rise, ensuring their safety, efficacy, and consistency has become increasingly complex. Traditional quality control methods are often inadequate in addressing the unique challenges posed by biologics manufacturing.

However, advancements in technology offer promising solutions to these challenges, revolutionizing the way quality control is conducted in the biopharmaceutical sector. From novel analytical tools to sophisticated data analytics and automation, these innovative technologies are reshaping the landscape of quality assurance.

This blog delves into the transformative impact of these advanced, cutting-edge technologies on quality control in biological products. By enhancing detection sensitivity, accelerating testing processes, and enabling real-time monitoring, these innovations are poised to elevate the standards of quality assurance and ensure the delivery of safe and effective biopharmaceuticals to patients worldwide.

CCI Techniques for Biological Products Quality Control

1. Vacuum Decay Technology

Vacuum Decay technology, being recognized by the FDA, is a leak detection method ideal for Container Closure Integrity (CCI) testing in high-risk package applications. This non-destructive technique enhances package analysis and minimizes waste. It is highly sensitive in detecting leaks in sealed packaging, whether rigid, semi-rigid, flexible, or made from non-porous or porous materials. The technology consistently delivers repeatable, reliable, and quantitative test results. Vacuum Decay technology is widely recognized as a non-destructive alternative to the water bath leak test and dye ingress test.

In this method, packages are placed in a well-fitted evacuation test chamber connected to an external vacuum source. Utilizing single or dual vacuum transducer technology, the vacuum level and changes in the vacuum are monitored over a predetermined test period. Variations in absolute and differential vacuum indicate leaks and defects within the package. If a package is defective, air escapes through the leak into the test chamber. Non-defective packages retain the air, maintaining a constant chamber vacuum level.

2. MicroCurrent HVLD Technology

MicroCurrent HVLD technology is a non-destructive method that sends high-voltage current signals through packages. This method is recognized in USP 1207 as a deterministic test method. It is a practical solution for a wide range of liquid-filled parenteral products, including vials, ampoules, drug product cartridges, and pre-filled syringes. HVLD is unique among leak detection technologies as it does not require mass to pass through a defect site; it only requires electricity to pass through a crack. This feature makes HVLD highly sensitive to leaks that other test solutions cannot detect.

The technology relies on the basic principle of quantitative electrical conductivity measurements. In this method, the container is placed horizontally on a rotating stage. During rotation, high voltage and ground probes are applied to opposite sides of the container. If the package is defect-free, the container walls offer complete electrical resistance, and no current is detected passing through. If the package is defective, the resistance breaks down, allowing current to pass through.

Innovative technologies have ushered in a new era of quality control for biological products, significantly transforming the landscape of the biopharmaceutical industry. Through advancements in analytical techniques, automation, and data analytics, these technologies have revolutionized how quality assurance is conducted, ensuring the safety, efficacy, and consistency of biological products.

Overall, the integration of innovative technologies into quality control processes for biological products holds great promise for improving healthcare outcomes and driving the development of novel therapies to benefit patients worldwide.

In the early days, coffee was often packaged in simple sacks or bags made from natural materials, such as burlap or hemp. These materials were not very airtight, so they could not keep coffee fresh for long periods of time. Vacuum sealed packaging was invented during the 1900s. This packaging removes all of the air from the packaging, which helps to keep coffee fresh for an extended period of time. Vacuum sealed packaging is also lightweight and relatively inexpensive, so it quickly became the most popular type of coffee packaging.

In recent years, there has been a growing trend towards more sustainable coffee packaging. This trend is driven by concerns about the environmental impact of traditional coffee packaging materials, such as plastic and tin.

Overview of Coffee Packaging

Coffee packaging refers to the process of packaging and presenting coffee beans or ground coffee for distribution, sale, and consumption. Coffee packaging serves several important purposes, including preserving the freshness and flavor of the coffee, protecting it from external elements such as light, moisture, and oxygen, and providing information to consumers.

Coffee packaging plays a crucial role in ensuring that coffee reaches consumers in optimal condition, with its flavor and aroma preserved. It also serves as a means of communication between coffee producers and consumers, conveying information about the coffee's characteristics and the values of the company that produces it.

Integrity testing of coffee packaging ensures that the packaging is free of leaks and defects that could compromise the quality of the coffee. This is important to do, as leaks can allow oxygen, moisture, and light to enter the packaging, which can all degrade the flavor of the coffee.

Here are some of the benefits of integrity testing for coffee packaging:

• It can help prevent coffee from going stale or developing off-flavors.
• It can help protect coffee from contamination.
• It can help ensure that coffee meets quality standards.
• It can help reduce product recalls.
• It can help improve customer satisfaction.

Quality Testing Using Vacuum Decay Technology

Vacuum decay technology is a non-destructive method for testing the integrity of coffee packaging. It is a Container Closure Integrity Test (CCIT) method with a proven capability of non-destructively testing packaging at the production line with unmatched reliability and sensitivity. Non-destructive testing not only allows a greater understanding of package quality, but also reduces waste as compared to destructive test methods. Waste reduction, in turn, results in a higher return on investment and brings operations closer to green initiatives.

Vacuum decay technology operates by placing sample packages in a closely fitting evacuation test chamber, which is equipped with an external vacuum source. Single or dual vacuum transducer technology is used to monitor the test chamber for both the level of vacuum as well as the 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. VeriPac series is a practical alternative to destructive test methods and can precisely detect leaks as small as 5 microns, identifying process issues before they become critical, avoiding catastrophic quality deviations.

Benefits of Vacuum Decay Test System

• Non-destructive technology.
• ASTM Test Method F2338, FDA Consensus Standard and referenced in USP 1207 Guidelines.
• Accurate, repeatable results.
• Pass/fail results backed by quantitative test data.
• Completely tool-less with no changeover to test different packaging formats.
• Identifies which cavity is defective.
• Eliminates destructive, subjective testing methods.

Vacuum decay technology is a valuable tool for ensuring the quality of coffee packaging. It can help prevent coffee from going stale or developing off-flavors. It can also help protect coffee from contamination. If you are a coffee roaster or retailer, integrity testing of coffee packaging is an important quality control measure that you should implement.

Vacuum Decay is a non-destructive method for testing the integrity of container closures for package integrity and leak path detection. The technology provides quantitative, deterministic, and reliable test results to assure package integrity in comparison to manual inspection and other non-deterministic test techniques. The vast range of package types that may be accommodated by Vacuum Decay technology includes filled and sealed rigid, semi-rigid, and flexible packaging consisting of non-porous or porous materials.

Vacuum Decay Technology

Vacuum Decay is one of the most efficient and accurate vacuum-based leak detection methods. The method operates by placing the package within a properly outfitted evacuation test chamber that contains an external vacuum source. To detect any deviations from a predetermined targeted vacuum level, the vacuum levels are continually monitored. If there is a defect in the packaging, air or liquid will leak into the chamber from the package and cause a change in pressure. On the other hand, non-defective packages do not leak any pressure into the chamber, maintaining the chamber vacuum level constant. The test cycle is quick, non-invasive, and non-destructive to both the product and the container. The Vacuum decay system can detect both major and minor defects, regardless of where they are located. The system has various applications in the field of pharmaceuticals and medical devices.

Applications of Vacuum Decay Technology in Various Industries

• Pharmaceutical

Pharmaceutical products are a range of substances used for treating, diagnosing, or changing organic processes to help the management of public health. Pharmaceutical products are tested to make sure they adhere to strict safety and quality requirements. Previously, pharmaceutical packaging was only subjected to sterility testing. However, the United States has recognized that sterility testing alone is not sufficient to maintain the integrity of pharma products. FDA (Food and Drug Administration) has published guidance related to pharma industry on submission of documentation for sterilization process evaluation in human and veterinary drug products.

Container closure integrity (CCI) testing is a non-destructive package inspection technology for finding leaks and avoiding potential contamination. A test like this is necessary since any defect in the container might allow foreign particles to enter the product and thereby reduce its shelf life. Since it impacts both the product and the patient, a manufacturer places high priority on implementing the proper container closure system. Thus, the relevance of container closure integrity testing in the pharmaceutical industry has increased substantially over time. Vacuum Decay and MicroCurrent HVLD are the most chosen technologies for testing pharmaceuticals.

• Medical Device

Maintaining medical device package integrity is essential to make sure the product is delivered to the end user unharmed. Medical device packaging and delivery options range from rigid non-porous containers to flexible porous packaging. Every packaging format has a different set of characteristics and requirements, so choosing the right inspection technique requires a thorough approach. Package challenges have risen along with packaging format and material innovations. Among all medical equipment, Class III devices produce the greatest risk to maintaining package integrity. These implanted devices preserve or maintain life. Pacemakers, cardiovascular stents, respiratory ventilators, and breast implants are a few examples of Class III medical devices. Since these devices are inserted into human bodies directly, even a small packaging defect puts patient’s safety at risk. Therefore, it is essential to evaluate the container closure integrity of medical devices.

Vacuum Decay Technology Benefits

• Non-destructive, non-subjective and does not require sample preparation.
• Detection of defects down to 0.01 cc/min.
• Results show that they are more accurate than dye ingress.
• Quantitative, deterministic testing technique.
• Supports initiatives for waste reduction and sustainable packaging.
• ASTM test method and FDA recognized standard.

When determining the integrity of pharmaceutical and medical devices, Vacuum decay leak testing is the best non-destructive option. The test measurement generates a reliable and accurate quantitative result, as well as a pass or fail decision. The FDA recognizes the standard Vacuum Decay leak test technique (ASTM F2338) as a consensus standard for evaluating container closure integrity (CCI). The test technique is referenced in the United States Pharmacopeia Chapter on CCI (USP Chapter 1207) and listed in ISO 11607.

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.

Ophthalmic products are sterile preparations that include contact lenses, specific surgical implants, eye gels, lotions, powders, parenteral medications, ophthalmic inserts, prefilled syringes, etc. These products are applied onto the exterior surface of the eye. Ophthalmic products are packaged by various pharmaceutical firms in various ways and in various materials. According to pharmaceutical production and packaging requirements, all ophthalmic products must pass a strict sterility test.

Plastic containers are used to package almost all commercially accessible ophthalmic products. Plastic bottles, which are mainly made of Low-Density Polyethylene (LDP), Polypropylene (PP), High-Density Polyethylene (HDPE), and other materials depending on the specific product demand, are the most widely used materials for packaging of ophthalmic products. These plastic packaging components, which include bottles, fittings, and closures, enjoy universal acceptability due to obvious advantages such as ease of use, reduced spillage, and little breakage. In the late 1940s, Alcon was the first business to produce these packaging components, known as "Drop-Trainers" for ophthalmic medications, and they quickly became the industry standard for packaging topical ophthalmic products.

VeriPac Vacuum Decay Technology

Vacuum decay is a testing process that has been validated over many years and has been improved by new technological advancements. The test method is straightforward in concept, and it tests container integrity using basic physical attributes. It includes drawing vacuum on a package inside a test chamber and checking for any degradation in the vacuum level, which would indicate a leak. It saves money by avoiding wasting product during a leak test, and many products provide a quick return on investment.

Leak testers from VeriPac attach to a test chamber that is specifically constructed to hold the package being evaluated. The package is then placed inside the vacuum-sealed test chamber. The test chamber is monitored for both the level of vacuum and the change in vacuum over a defined test time using single or dual vacuum transducer technology. The presence of leaks and faults within the package is indicated by variations in absolute and differential vacuum. A test's sensitivity is determined by the package design, the package test fixture, and crucial time and pressure test parameters. Manual or fully automated testing systems are available. For QA/QC statistical process control, this inspection method is appropriate for laboratory offline testing and production applications. The test cycle is quick, non-invasive, and non-destructive to both the product and the packaging.

The VeriPac 455 is a non-destructing and quantitative inspection device that enables the very sensitive identification of empty and pre-filtered syringes, liquid filled and freezed vials, as well as other forms of liquid filled packaging, without any preparation of the sample. The VeriPac 455 is adequate to the challenge of testing these types of products, which necessitates the highest level of sensitivity, reproducibility, and accuracy.

Benefits of VeriPac 455

• No sample preparation, non-destructive, and non-subjective
• Highest level of sensitivity, repeatability and accuracy
• Results have been shown to be superior to dye intrusion
• Deterministic, quantitative test method
• Supports zero-waste and sustainable packaging
• ASTM test method and FDA standard
• Capable of detecting leak rates as low as 0.01 cc/min

Over the last two decades, pharmaceutical industry has seen tremendous growth in the form of technological advancements and drug delivery system innovations. However, such innovations have increased quality assurance challenges for drug manufactures. For this reason, drug product manufacturers give at most importance to their quality control procedures as well as package integrity tests. All packaging forms, whether pouches constructed of porous or nonporous material, rigid thermoformed trays with Tyvek or film lids, bottles with induction-welded seals, or blister packs, need verification that their sterile-barrier characteristics are not compromised. Previously, only sterility testing was conducted on pharmaceutical packaging. However, when it was realized that sterility testing alone is not sufficient to hold the integrity of the medical products, the US FDA published Guidance for Industry for Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products. This emphasized the importance of verification of microbial barrier properties of a pharmaceutical product package (i.e., CCI).

Relevance of CCIT in pharmaceutical package testing

Container Closure Integrity Testing is an assay to evaluate whether container closure systems can maintain sterile barriers against potential damage. Even a minute defect in the container can cause external elements to enter the product, thereby reducing its shelf life. Common threats that can pass through a defected container closure system include microorganisms, reactive gases, and other substances. Considering the ability of such threat to deteriorate product quality, undertaking appropriate CCI tests are beyond crucial. However, it should be noted that CCI is not a one-time process, rather an integral and comprehensive approach. It is evaluated throughout the manufacturing lifecycle of a sterile drug product -from primary package development until the products are dispatched.

Container closure systems are made up of primary packaging components and secondary packaging components. Components like vials or syringes that are in direct contact with the product are called primary packaging components. Although there are multiple CCI techniques available in the market today, regulatory guidelines have broadly classified methods into probabilistic and deterministic test methods. Under a probabilistic test method, results are generated through a series of events, each with a respective probability distribution. Thus, the accuracy of the results cannot be assured. In contrast to a probabilistic method, deterministic test methods assure quantitative results with higher level of accuracy and reliability. The United States Pharmacopeia in 2016 issued new guidelines stating that deterministic methods are preferred over probabilistic test methods. Container closure integrity testing can be performed in many different ways. All the testing methods have pros and cons. Given below is a list of non-destructive Container Closure Integrity test methods:

• Airborne Ultrasound technology
• Vacuum Decay technology
• Microcurrent HVLD technology
• Helium Leak Detection
• Pressure Decay leak testing
• Force Decay leak testing

Right from clinical trials to drug packaging, all aspects for pharmaceutical industry are subject to strict quality control regulations. The process of selecting and validating appropriate packaging for pharmaceutical products takes a significant effort. Pharmaceutical package testing is conducted to ensure the suitability of drug packaging for its intended use. It included all components containing the product, even if they are in direct contact with the drug or not. As such, containers should be capable of retaining the healing properties of the drug product throughout its shelf life or until it is administered. Even a minute breach in container closure integrity can compromise the safety and effectiveness of the drug product. This realization has prompted pharmaceutical product manufacturers to conduct appropriate container closure integrity tests to ensure product sterility throughout its lifecycle.

Why use Vacuum Decay technology for pharmaceutical package testing?

PTI’s Vacuum Decay technology is a non-destructive container closure integrity testing method, capable of evaluating both liquid and air-filled containers and detecting defects as small as below 1 micron. Non-destructive testing provides a greater understanding of package quality while also reducing waste. Waste reduction delivers a fast return on investment and brings operations closer to green initiatives. Proven to be the most practical and sensitive vacuum-based leak test method, Vacuum Decay technology is an ASTM test method, FDA consensus standard, eliminating false positives and subjective results associated with manual visual inspection. Vacuum Decay technology can identify leaks in sealed rigid, semi-rigid and flexible packaging made of non-porous or porous materials. It provides reliable, accurate and repeatable test results that ensure deterministic package testing and leak detection.

Vacuum Decay technology operates by placing sample packages in a closely fitting evacuation test chamber, which is equipped with an external vacuum source. Single or dual vacuum transducer technology is used to monitor the test chamber for both the level of vacuum as well as the 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. Vacuum Decay technology is a practical alternative and significant improvement to destructive test methods and can precisely detect leaks as small as 5 microns, identifying process issues before they become critical, avoiding catastrophic quality deviations.

Benefits of PTI’s Vacuum Decay Test System

• Better process control - reliable and sensitive leak detection of quality critical defects.
• The advantage of test results that are both qualitative (pass/fail) and quantitative (Statistical data with each test result).
• Repeatable test results demonstrate the reliability of the instrument and test data.
• Cost savings - Eliminates product loss, waste and mess of both packaging and coffee that results from using destructive testing methods
• Using a non-destructive leak test method allows an increase in the number of products samples tested.
• Rapid test cycle and minimal training required to operate tester.
• Rapid ROI due to substantial cost savings and elimination of product loss.

What is Container Closure Integrity Testing?

Container Closure Integrity Testing can be understood as a leak detection test conducted using non-destructive package inspection systems to ensure product stability throughout its shelf life. CCIT plays a major part in ensuring that the products are free from possible contamination. While there are multiple ways to conduct a CCI test, it can be broadly classified into probabilistic and deterministic test methods. Traditional test methods like bubble test, dye ingress and microbial challenge by immersion come under probabilistic test methods. However, upon realizing that such tests lacked accuracy and reliability, The United States Pharmacopeia released guidelines in 2016 stating that deterministic methods ae preferred over probabilistic test methods. Vacuum Decay technology and Airborne Ultrasound technology are among the most preferred deterministic test methods.

VeriPac Test Systems for Effective CCI Testing

The VeriPac test methods are non-destructive, non-invasive inspection system for CCI and package integrity testing. They utilize the ASTM approved patented vacuum decay leak test method recognized by the FDA as a consensus standard for package integrity testing.

This ASTM method was developed using VeriPac leak test instruments and has proven its capabilities under GMP regulatory guidelines. Applications for VeriPac technology include stability studies, clinical trials, quality assurance testing and statistical process control (SPC). VeriPac testers feature the patented PERMA-Vac manifold system and dynamic test modes that provide the ability to test a wide range of package formats. Leak detection of high-risk applications requires the highest level of test measurement reliability. The VeriPac series have redefined the reliability and accuracy of test measurement systems.

How do Veripac Test systems Operate?

VeriPac leak testers connect to a test chamber that is specially designed to contain the package to be tested. The package is placed inside the test chamber to which vacuum is applied. The single or dual vacuum transducer technology is used to monitor the test chamber for both the level of vacuum as well as the 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. Test systems can be designed for manual or automatic operation. This inspection method is suitable for laboratory offline testing and production applications for QA/QC statistical process control. The test cycle takes only a few seconds, is non-invasive and non-destructive to both product and package, making it an ideal choice for CCI inspection across industries.

Inspection Criteria

• Seal quality testing 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)

Blister packs are popular packaging options for pharmaceuticals and consumer goods. A wide range of pharmaceutical products are packed in blister packs, ranging from capsules and tablets to high-risk hormone-based drugs and steroidal treatments. Commonly made of thermoformed plastic, these are quite useful in guarding products against external factors like heat, moisture and humidity.

However, concerns over integrity of blister packaging have increased over the years. Even a minute breach in the packaging can result in compromised package integrity. Hence, pharmaceutical manufacturers concerned about quality and shelf life of their products make Container Closure Integrity testing a crucial part of their manufacturing process. There are several methods available to test blister packs, and each has its own merits and demerits. For instance, the most common method to test blister packs remain dye ingress. However, this method is subjective, probabilistic and lacked accuracy in test results. This encouraged manufacturers to use non-destructive CCI test methods, that were accurate and produced quantitative results with measurable result data.

Blister Package Inspection with VeriPac UBV Technology

The VeriPac UBV Leak Detection System is a deterministic, non-destructive technology designed specifically for multi-cavity blister packs. The VeriPac UBV utilizes volumetric imaging under vacuum to detect the presence and location of leaks. It is a rapid test requiring no changeover or sample preparation. Operators simply input the number of blister cavities, place the blister pack on the inspection plate and press the START button. Within seconds, the operator sees a definitive pass/fail result, along with a volumetric measurement reading. The location of the defective cavity is presented to the operator with an image of the tested package. The intuitive and simple method makes it a practical solution giving rapid feedback to production line operators.

The UBV technology can provide rapid detection of defects as small as 10 microns with a fast test time, averaging 10-30 seconds depending on blister cavity volume. Test system requires no tools or test parameter changes for different blister formats. This technology is particularly advantageous for small to tiny blister cavities that are notoriously difficult to detect with a standard Vacuum Decay technology due to the very low headspace.

Technology Overview

Under this method, the sample is first placed inside the hinged test chamber. After pressing the start button, vacuum is pulled to a defined level. The blisters expand under vacuum, driving air out of the blister through any leaks present. If there is a leak in the blister, the air escapes into the chamber leaving a collapsed blister package. During the dynamic vacuum test sequence, a volumetric measurement reading is taken which determines which blister cavities are defective.

Benefits of VeriPac UBV Technology

• Non-destructive technology
• Accurate and repeatable results
• Pass/fail results backed by quantitative test data
• Completely tool-less
• No changeover to test different blister formats
• Identifies which cavity is defective
• Eliminates destructive, subjective testing methods

We all know that the primary function of any package is storing, handling & protecting the product. So, what is package integrity? Package integrity is defined as a package’s ability to protect its contents from potential hazards that include various physical, microbial & chemical factors. Its usefulness may have many nuances depending on the products & content. But industries like pharmaceutical, nutrition & medical device, deal with lifesaving & sustaining products that are shipped across the globe. Any discontinuity in the package can result in the contamination of the product making a life-saving product into a life-threatening one. Therefore, package integrity is imperative to ensure the safety of the products at the time of use.

The selection of the appropriate package inspection method is essential to maintain the quality standards that the regulatory bodies stand by today. Since 2016, the United States Pharmacopeia (USP) released guidance encouraging the use of deterministic, reliable test methods. Package leak test methods offered by CCIT s.a. are all deterministic, non-destructive, quantitative test methods with a specific on the reliability of the test result to assure integrity at the highest level.

VeriPac Vacuum Decay Technology

Vacuum decay is validated as one of the most reliable & sensitive vacuum-based leak detection methods that give quantitative & reproducible results with a pass or fail determination. PTI’s VeriPac inspection method is based on vacuum decay technology. It is one of the most ideal non-destructive container closure integrity testing solutions for different types of package formats that include parenteral packaging and other types of flexible and semi-flexible package formats. This method is non-invasive, non-subjective & requires no sample preparation. VeriPac 400 series can be used in various applications like stability studies, clinical trials, quality assurance testing and production statistical process control.

With PERMA-VAC, PTI redefined the vacuum-based leak detection method and addresses vacuum decay leak detection at the very core of physical test measurement & maximizing the SNR between good and defective samples.

Microcurrent HVLD

PTI has revolutionized the conventional HVLD method with the new HVLDmc – MicroCurrent HVLD, a highly sensitive leak detection method for all Parenteral and Biologic Products. The new E-scan 655 Microcurrent HVLD system exposes the product and environment to less than 5% of the voltage than conventional HVLD solutions. Referenced in USP <1207>, PTI’s HVLDmc has proven to be a highly sensitive leak detection method for applications like pre-filled syringes, vials, cartridges, ampoules, BFS, bottles, pouches.

Airborne Ultrasound

PTI’s proprietary Airborne Ultrasound technology is one of the most reliable seal quality inspection methods that characterize the overall quality and uniformity of the seal. This technology can be integrated for 100% online leak detection of pouch seals. Airborne ultrasound can be used for many material types such as Tyvek ®, paper, foil, film, aluminum, plastic & poly. This technology is referenced in the new USP <1207> Chapter guidance as a deterministic test method for seal quality testing. It is also an ASTM Test Method and FDA-recognized standard for seal quality testing.

Automated Inline Solutions

CCIT provides automated package inspection solutions across all PTI technology platforms – Vacuum Decay, Airborne Ultrasound and MicroCurrent HVLD. The Automated Systems are designed using PTI’s VeriPac, MicroCurrent HVLD and Airborne Ultrasound technologies for applications that include automated statistical process control (SPC) testing and 100% inline testing. The configurations are equipped with the capability of fully automated inspection with robotic pick and place. HVLDmc and Vacuum Decay overlap in capabilities, but more importantly encompass the full parenteral market range. The Airborne Ultrasound Technology for the 100% inline inspection of pouch seals has been an efficacious solution to verify final pouch seal quality.

Helium Leak Testing

Helium leak testing can be used for packaging tests quantitatively using helium as a tracer gas. Helium-based leak testing systems allow comparison between multiple packaging materials and forms production line settings and stability storage conditions, supporting the entire lifecycle. This method is also effective for various package types including cold form blister cards, foil pouches, parenteral vials, syringes, pre-filled syringes and unique medical devices.

The package systems of complex drug and biologic required to be stored at below -20°C, and needs storage and distribution environment that include dry ice (~-78.5°C), or even liquid nitrogen (~-200°C) can be quantitively and accurately tested using helium leak detection technology. This one technology has many applications for container closure integrity testing of pharmaceutical and medical device products.

In today's world, with the popularity of health products continuing to rise, manufacturers must ensure products are packed properly. Because of this reason, the universal health-wise regulation has set a fixed standard for nutritional products packaging process. This is for the elimination of defects happening due to innate chemical reactions within the nutritional products. Such defects can expose products to oxygen, moisture or bacteria- compromising its quality and reducing shelf life.

Nutritional products including dairy products and protein powders are mostly shelf stable in nature. The high fat content in dairy products including cream, butter and ghee is prone to deterioration in its storage process, causing auto-oxidative reactions. The defects in the dairy products can be eliminated through proper nutritional packaging inspection only. Similarly, protein-based powders including soy and casein are extensively used as energy sources. Inefficiencies in packaging of such products can have an adverse effect on consumer’s health. Therefore, conducting package integrity testing of nutritional products are vital to eliminate defects in packaging as well as possibility of product contamination.

Vacuum Decay Technology – The Ideal Nutritional Packaging Inspection Solution

Vacuum Decay technology is a deterministic Container Closure Integrity test method for evaluating quality of nutritional product packaging. The non-destructive testing method improves quality of packaging and reduces wastage compared to destructive test methods. Cost-effective non-destructive testing results in higher return on investments and ensures quality of products.

Vacuum Decay technology operates by placing sample packages in a closely fitting evacuation test chamber, with an external vacuum source. A single or dual vacuum transducer technology monitors the test chamber over a predetermined test period. The changes occurring in vacuum levels are analyzed to identify leaks and defects within the package. CCIT’s VeriPac series helps in detecting small leaks before it becomes critical in quality abbreviations.

Benefits of Vacuum Decay technology

• Non-destructive package inspection technology
• ASTM Test Method F2338, FDA Consensus Standard and referenced in USP 1207 Guidelines
• Accurate, reliable and repeatable test results.
• Pass/fail results backed by quantitative test data.
• Completely tool-less with no changeover to test different packaging formats.
• Eliminates the need for destructive, subjective testing methods.