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Package testing is a critical aspect of product quality assurance and safety across various industries, such as food and beverage, pharmaceuticals, industrial products and consumer goods. Ensuring the integrity of packaging materials and their ability to protect contents from environmental factors like moisture, oxygen, light, and physical damage is essential to maintaining product efficacy, safety, and shelf life. One of the key parameters evaluated in package testing is Container Closure Integrity (CCI), which refers to the ability of a package to maintain its integrity and prevent the ingress of harmful substances or the egress of beneficial ones. Establishing robust test methods for assessing CCI is vital to guarantee the reliability and effectiveness of packaging solutions.

In this blog, we will delve into the development of test methods for evaluating Container Closure Integrity (CCI) in package testing.

Overview of Test Method Development

Test method development in package quality testing serves as the cornerstone for assessing and guaranteeing the robustness of packaging materials and systems. The need for rigorous testing methodologies is paramount to meet regulatory requirements, industry standards, and consumer expectations. Package Testing Method Development at PTI’s CCIT Center of Excellence focuses on package/product characteristics and the extent to which the package characteristics need to be challenged to ensure closure integrity. Test method development includes the optimization of test parameter settings, including the level of vacuum or high voltage (depending on the technology), test cycle times, and pass/fail criteria for a particular test method. The detailed report will include test protocols and criteria, test results, and expected leak rates for the client with recommendations and conclusions. Before being included in the final report, each test method developed in Test Method Development is validated to make sure it is repeatable, accurate, precise and appropriate for the intended use. Developing the most accurate and appropriate test methods for package quality testing involves identifying the relevant data for testing.

Relevance of Test Method Development in Package Quality Testing

Test method development is essential for ensuring high-quality packaging. Here's a breakdown of why it's so crucial:

Reliable and Accurate Results:

• Standardized Approach: Testing can be subjective and inconsistent without a defined method, leading to unreliable data. Test method development creates a standardized process with clear procedures, equipment requirements, and data analysis methods. This consistency guarantees accurate and repeatable results that you can trust.

Optimizing Package Performance:

• Identifying Weaknesses: A well-designed test method can pinpoint weak spots in the packaging design or material selection. This valuable information allows manufacturers to identify areas for improvement and create a more robust and reliable package.
• Setting Benchmarks: Test method development establishes clear pass/fail criteria for package performance. This sets a benchmark for quality and helps manufacturers ensure their packaging consistently meets the required standards.

Cost Savings and Risk Reduction:

• Preventing Product Damage: By identifying potential package failures before products reach consumers, test methods help prevent costly product recalls and replacements. This creates significant cost savings for manufacturers.
• Optimizing Resource Allocation: A well-developed test method focuses resources on the most critical aspects of package performance, leading to a more efficient testing process. This saves time and money compared to generic or poorly designed testing procedures.

How can PTI's Consultative Services Help Accelerate the Process?

PTI's consultative services can expedite the package testing process through various means:

• Expertise in Testing Methods: PTI's team possesses in-depth knowledge of package testing methods, including advanced technologies and industry best practices. They can advise on the most appropriate testing methods for your specific packaging needs, ensuring efficient and accurate testing.
• Customized Testing Protocols: PTI can develop customized testing protocols tailored to your unique packaging requirements. By optimizing test parameters and procedures, PTI helps streamline and accellerate the testing process, saving time and resources.
• Equipment Selection and Optimization: PTI can assist in selecting the right testing equipment for your needs and optimizing its performance. This ensures that testing is conducted effectively and efficiently, without unnecessary delays or errors.
• Regulatory Compliance: PTI's experts are well-versed in regulatory requirements for package testing, including FDA and international standards organizations. They can ensure that your testing protocols meet regulatory standards, helping you navigate the regulatory process more smoothly.
• Troubleshooting and Problem-solving: If issues arise during the testing process, PTI can provide expert troubleshooting and problem-solving support. Their experienced team can quickly identify and address any issues, minimizing delays and ensuring testing progresses smoothly.

The development of robust test methods for assessing Container Closure Integrity (CCI) is essential for ensuring the safety, efficacy, and quality of packaged products across various industries. By employing appropriate methodologies and considering key factors in method development, manufacturers can uphold product integrity, comply with regulatory requirements, and safeguard consumer health and trust. Continuous innovation and refinement in CCI testing methodologies will contribute to advancements in packaging technology and product quality assurance in the future.

Nutraceuticals are products that are derived from food sources with extra health benefits, in addition to the basic nutritional value found in foods. They encompass a wide range of products including dietary supplements, functional foods, and beverages fortified with vitamins, minerals, herbs, or other bioactive compounds. The global nutraceutical market has been experiencing rapid growth, driven by factors such as increasing health consciousness among consumers, aging populations, and a growing emphasis on preventive healthcare.

Nutraceuticals are distinguished from traditional pharmaceuticals in that they are not strictly regulated as drugs but are instead classified as dietary supplements or functional foods. This classification allows nutraceutical manufacturers more flexibility in product development and marketing. However, it also places a greater responsibility on manufacturers to ensure the safety, efficacy, and quality of their products.

Package integrity testing plays a crucial role in ensuring the quality and safety of nutraceutical products. It involves the assessment of packaging materials and techniques to prevent contamination, spoilage, and degradation of the product during storage and transportation. The integrity of the packaging directly impacts the shelf-life, potency, and efficacy of the enclosed product.

Techniques to Evaluate Integrity of Nutraceuticals

1. VeriPac Series

The VeriPac series by PTI offers cutting-edge inspection systems designed for leak detection and package integrity testing. These systems employ a non-destructive and non-invasive approach, contributing to waste reduction while delivering real-time and quantitative results. The technology is based on the ASTM-approved Vacuum Decay leak test method F2338, a methodology recognized by the FDA for its reliability and accuracy.

The VeriPac testers seamlessly connect to specially designed test chambers, creating a controlled environment for the inspection process. During testing, a vacuum is applied to the package, and absolute transducer technology is employed to monitor changes in vacuum levels over a predefined test duration. This meticulous monitoring allows the system to swiftly identify leaks and defects within the package.

Given the adherence to the ASTM-approved Vacuum Decay leak test method F2338, these inspection systems not only meet industry standards but also comply with FDA regulations. This recognition further underscores the reliability and precision of the VeriPac series in ensuring the integrity of packages.

2. Seal-Sensor PQX Technology

The Seal-Sensor PQX is an advanced automated pouch seal quality inspection system designed for seamless integration into production lines. Leveraging Seal-Sensor Airborne Ultrasonic technology, this cutting-edge system conducts swift online scans of final pouch seals, aligning with ASTM Test Method F3004 and FDA consensus standards. Its deterministic and quantitative approach enables the rapid identification of defects, including incomplete seals, weak areas, and concealed issues that could compromise product quality.

The system operates with remarkable efficiency, delivering pass/fail results and generating traceable data in less than a second, even at speeds of up to 350 mm/sec. This ensures a quick and reliable assessment of seal quality, contributing to enhanced overall production efficiency.

The Seal-Sensor PQX is characterized by its user-friendly design and plug-and-play functionality, making it easy to integrate into existing manufacturing setups. Its modest footprint ensures that it can be seamlessly incorporated into various production environments without occupying excessive space. In the event of a defective pouch seal, the system features a built-in reject chute that promptly removes defective pouches from the production line. This not only prevents substandard products from progressing further in the manufacturing process but also helps maintain the integrity of the overall production flow.

Incorporating advanced technologies like the VeriPac series and Seal-Sensor PQX, package integrity testing revolutionizes nutraceutical quality control, ensuring products meet rigorous standards for safety and efficacy. By swiftly detecting defects and maintaining packaging integrity, these systems play a vital role in safeguarding the quality and reliability of nutraceuticals in an evolving market landscape.

The rise of flexible packaging has revolutionized various industries, offering lightweight, efficient, and versatile solutions. The global demand for flexible packaging is projected to continue its upward trajectory, driven by several factors. These include cost-effectiveness, sustainability, and versatility. Compared to rigid alternatives, flexible packaging offers significant cost advantages in terms of materials, transportation, and storage. Advancements in material science are leading to the development of eco-friendly flexible packaging solutions, catering to the growing demand for sustainable practices. Additionally, flexible packaging offers exceptional design flexibility, allowing for unique shapes, sizes, and printing options to enhance product branding and consumer appeal.

Despite these advantages, ensuring the integrity of these non-rigid packages presents certain challenges. The materials used in flexible packaging can be susceptible to puncture and tear, permeability, and microbial growth. Puncture and tear can occur during transportation, handling, or external pressure. Imperfections in seals or the material itself can allow the ingress of gases, moisture, and other contaminants, potentially impacting product quality and safety. If not properly protected, flexible packaging can create micro-environments conducive to microbial growth, posing a risk to perishable goods.

The pharmaceutical industry has increasingly embraced flexible packaging for various applications, including blister packs, pouches, and sachets. However, due to the critical nature of pharmaceutical products, ensuring package integrity is paramount to maintain sterility, efficacy, and safety.

To address the challenges and ensure the integrity of flexible packaging, various container closure integrity testing techniques are employed. These tests evaluate different aspects of the package, including seal strength, puncture resistance, permeability, and microbial barrier properties. Seal strength measures the ability of the seals to withstand pressure and prevent leaks. Puncture resistance assesses the package's ability to resist punctures from sharp objects. Permeability evaluates the rate at which gases, moisture, and other elements can permeate the packaging material. Microbial barrier properties test the package's resistance to microbial ingress.

VeriPac Flex Series for Flexible Package Integrity Testing

VeriPac Flex Systems offer flexible package testing using non-destructive methods based on ASTM standards. These systems, recognized by the FDA, are designed specifically for dry filled pouches and other flexible packaging. They provide high sensitivity and reliability without the need for settings or tooling changes, accommodating various package sizes and formats. Unlike methods like Water Bath and Dye Ingress, VeriPac systems offer objective results, reducing waste and providing quantitative data for leak detection. They give a clear PASS or FAIL result along with leak rate information, helping improve packaging processes.

Technology Overview

The VeriPac tester is connected to a FLEX chamber suitable for package size. Options like the integrated flexible test chamber (IFC) or drawer Style test chamber (D-Series) offer varied leak detection capabilities. The IFC suits sachets or stick packs with low headspace, while the D-Series is for large packages and bulk products. The VeriPac FLEX system uses a flexible membrane to test packages, preventing damage to the film. It's user-friendly, allowing multiple packages to be tested in one cycle.

Benefits of VeriPac Flex System

• Deterministic, non-destructive, non-invasive, non-subjective
• Vacuum Decay PERMA-Vac Technology
• ASTM Test Method F2338 and FDA Consensus Standard
• Non-destructive alternative to water bath leak test and other destructive test methods
• Testing is non-destructive allowing for increased sampling and testing frequency
• Capability to test different size pouches, stick packs or sachets without any changeover in parts or system settings.
• Deterministic, quantitative test method
• Non-destructive, non-subjective, no sample preparation
• Test multiple packages in a single test cycle
• Supports sustainable packaging and zero waste initiatives
• Simplifies the inspection and validation process
• Accurate and repeatable results