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Biologics, a class of pharmaceutical products derived from living organisms, have revolutionized the field of medicine by offering targeted and highly effective treatments for various diseases. Biologics, including vaccines, monoclonal antibodies, and gene therapies, being highly sensitive and complex products, require meticulous handling and storage.

As the demand for these innovative therapies continues to rise, the importance of robust biologics packaging becomes paramount. In this blog post, we will delve into the significance of biologics packaging inspection, specifically container closure integrity, and explore how helium leak detection plays a crucial role in ensuring the quality and safety of these life-changing medications.

Biologics are inherently vulnerable. Their intricate structures and potent nature necessitate a delicate balance between protection and functionality. Packaging plays a pivotal role in this, acting as a shield against environmental threats like moisture, oxygen, and microbial contamination.

Failing to meet stringent packaging requirements can have dire consequences. Leaky packages could lead to microbial contamination, compromising patient safety. Uncontrolled temperature exposure can render the drug ineffective. Even minor packaging flaws can impact dosage accuracy, potentially jeopardizing treatment efficacy. Therefore, thorough and reliable packaging inspection is not just a quality control measure; it's a critical safeguard for patient well-being. This is where helium leak detection emerges as a powerful tool.

Helium leak detection (HLD) is a precise and reliable technique designed to identify even the smallest leaks in sealed systems. This method utilizes helium as a tracer gas, leveraging its inert, non-condensable, non-flammable, and safe properties. The small atomic size of helium allows it to easily penetrate leaks, facilitating the detection of minute imperfections. The variation in helium concentration is measured and expressed as a leakage rate.

The benefits of using helium include its lower weight compared to other inert gases like neon, its cost-effectiveness, and its availability in various cylinder sizes and pure forms. Unlike hydrogen, which is smaller than helium but not inert, helium provides a dependable and efficient solution for leak detection in diverse applications.

The functionality of a helium leak detector is based on the principles of a field mass spectrometer. An electric beam emitted from the filament ionizes the leaked helium gas, and the resulting ions are accelerated by increased voltage. These ions escape through a split and enter the magnetic field of the analyzer. Due to the mass-dependent circular paths of the ions, only helium ions reach the collector. A specialized detector converts the ion current into an electrical current, which is then amplified by leak detection devices and displayed on a screen. The measured current corresponds to the helium concentration, indicating the presence and magnitude of a leak.

Compared to conventional vacuum bubble and dye penetration test methods, packages can be quantitatively tested using helium as the tracer gas that ensures higher levels of accuracy. Such an approach allows a comparison between multiple packaging materials and forms production line settings and stability storage conditions, supporting the entire lifecycle.

• Helium is a highly sensitive leak test technology, equipped with the detection of extremely small leaks which is not possible with other leak testing methods.
• Using a high vacuum technique, the leak test thresholds to be set down as low as 1×10-12l.sec-1, a sensitivity level allowing unique comparisons between package components, for example.

In today's health-conscious world, the popularity of nutraceuticals – those magical molecules promising a healthier you – is exploding. From vitamin gummies to herbal concoctions, these nutritional powerhouses line our shelves, offering a convenient path to wellness. But what about the very container that holds these life-changing potions? Nutraceutical packaging comes with unique challenges and navigating them requires innovative solutions and cutting-edge testing methods.

While nutraceuticals offer a plethora of health benefits, their packaging comes with inherent risks that can compromise product quality and safety. The nutraceutical industry faces unique challenges related to packaging, including ingredient stability, contamination, and regulatory compliance. Exposure to light, moisture, and oxygen can degrade the potency of bioactive compounds, rendering the product less effective. Contamination during the manufacturing and packaging process poses a risk to consumer safety. Additionally, regulatory bodies impose stringent standards to ensure the quality and authenticity of nutraceutical products.

Methods to Ensure Integrity of Nutraceutical Packaging

To address these challenges, manufacturers are turning to advanced testing methods for package integrity. Package integrity testing involves assessing the strength and robustness of the packaging to prevent leaks, breakages, or other vulnerabilities.

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.

One of the key advantages of the VeriPac series lies in its efficiency and objectivity. The entire process is quick, eliminating the need for subjective assessments and ensuring a non-destructive testing approach. This makes the VeriPac series suitable for various testing scenarios, ranging from laboratory offline testing to the rigorous demands of 100% inline testing in production environments.

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-SensorTM 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.

As the nutraceutical boom continues, innovative packaging and rigorous testing methods like VeriPac and Seal-Sensor PQX are crucial to ensure the safety, efficacy, and trust in these life-changing supplements. By prioritizing package integrity, we unlock the true potential of these wellness wonders.

Tablets and capsules, the backbone of oral medication, are commonly encapsulated in blister packs. These packs, crafted from thermoformed plastic and sealed with aluminum foil or film, offer a trifecta of advantages: protection, tamper evidence, and convenience. Shielding pharmaceuticals from physical damage, moisture, and light, blister packs ensure dosing accuracy and provide tamper evidence, instilling confidence in consumers. Furthermore, their user-friendly design facilitates easy dispensing and portability of individual doses.

Package integrity testing emerges as a critical component in pharmaceutical quality control. Compromised packaging poses multifaceted risks, including product loss, contamination, and degradation. Leaking or damaged packages can lead to economic setbacks for manufacturers and jeopardize consumer safety. Exposure to external elements such as moisture, light, or oxygen can degrade the quality of medication, compromising its therapeutic efficacy.

OptiPac Technology: Pioneering Non-Destructive Integrity Testing

The OptiPac Leak Detection System is a non-destructive container closure integrity testing method specifically designed for blister packs. Employing One-Touch Technology, OptiPac ensures a swift test cycle without the need for changeovers or sample preparation. This innovative technology enables rapid detection of sub-5-micron defects, contingent on blister cavity volume. Unlike the vacuum-based blue dye test, OptiPac applies controlled inputs and measured outputs, eliminating the complications and reliability issues associated with dye ingress methods.

Technology Overview

OptiPac employs volumetric imaging technology under vacuum, coupled with topographic imaging, to identify the presence and location of leaks. The testing process involves placing the sample on the testing area, initiating a vacuum-based measurement upon pressing the start button. As the blisters expand under vacuum, air is drawn out through any leaks present. In the case of a leak, the air escapes into the chamber, causing a collapsed blister cavity. The dynamic vacuum test sequence captures volumetric images and measurement readings, pinpointing defective blister cavities. The system delivers a clear pass/fail result, along with quantitative measurements for each package test. OptiPac systems by PTI yield definitive results based on accurate and measurable quantitative data, reliably detecting leaks down to 5 microns. The interface is user-friendly, requiring no intricate parameter adjustments for new blister packaging formats, setting it apart from other non-destructive blister package inspection systems.

OptiPac’s insightful technology offers a suite of advanced functions:

• Auto configuration for easy recipe setup and validation of new blister formats
• Auto orientation of blister packs (test blister packs in any position –no specific orientation)
• Auto calibration is an integrated one-touch function
• Advanced batch reporting with audit trail including image of blister pack and defect results

OptiPac Benefits

• Non-destructive technology - Pass/Fail results backed by quantitative test data
• Completely tool-less
• No changeover to test different blister formats
• Identifies defective cavity
• Pre-loaded recipe library with easy recipe setup and validation of new blister formats