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Blister packaging is a popular form of packaging used in the pharmaceutical, medical device, and consumer goods industries. It consists of a cavity or pocket made from a formable web of plastic or aluminum, which securely holds the product (such as tablets, capsules, or small devices) and is sealed with a lidding material.

Ensuring the integrity of blister packages is of utmost importance, especially for products that are sensitive to moisture, air, or contaminants. A leak in the blister package can compromise the quality, efficacy, and shelf life of the enclosed product, leading to potential safety risks for consumers and financial losses for manufacturers.

Leak testing is a critical quality control process that assesses the seal integrity of blister packages to identify potential leaks or weak seals. By performing leak testing, manufacturers can identify defective packages and take corrective action before products reach the market.

OptiPac Technology for Blister Package Leak Detection

The OptiPac One-Touch Tool-less system is designed for non-destructive Container Closure Integrity Testing (CCIT) of blister packages. It is a deterministic technique that utilizes volumetric imaging in vacuum together with topographic imaging to identify leaks and where they are located. The OptiPac employs controlled inputs and measured outputs using concepts similar to those used in a vacuum-based dye ingress test, but without the inconvenience and reliability difficulties of the dye ingress approach. By utilizing One-Touch Technology, OptiPac provides a quick test cycle without the need for complicated parameter modifications or changeovers, as seen with other non-destructive blister package inspection systems.

OptiPac Blister Package Inspection System which makes use of volumetric imaging technology provides high levels of sensitivity and reliability. The volumetric imaging method uses many imaging techniques with a complex deep algorithm. The test operator selects a recipe for the blister package using the HMI touch screen, then arranges it in any direction on the test plate. Vacuum is drawn to a predetermined vacuum as soon as he presses the start button. Under vacuum, the blisters enlarge, and any air leaks cause the air to be forced out of the blister. If the blister has a leak, air enters the chamber and collapses the blister cavity. To identify which blister cavities are defective, volumetric images and measurements can be acquired during the test technique. Additionally, the system shows the quantitative measurement for each product tested along with a clear pass/fail result.

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.
• No changeover to test different blister formats.
• Pre-loaded recipe library with easy recipe setup and validation of new blister formats.
• Completely tool-less.
• Identifies defective cavity.

Proper leak testing can improve production efficiency and reduce waste by identifying and resolving issues in the packaging process promptly. It enhances overall product quality and increases consumer confidence, which are essential factors for maintaining a competitive edge in the market.

As technology advances, we can expect further developments in leak testing methods, leading to even more accurate, efficient, and cost-effective solutions. Manufacturers should stay updated on these advancements and continuously improve their testing procedures to stay at the forefront of quality assurance.

Automated pouch seal inspection is a technology-driven quality control process used to evaluate the integrity of seals on pouch packaging. It employs advanced machinery, sensors, and algorithms to detect and analyze seal defects, ensuring the quality, safety, and reliability of packaged products.

The purpose of automated pouch seal inspection is to identify and address any issues that may compromise the integrity of the seals. By automating the inspection process, manufacturers can achieve higher inspection speeds, greater accuracy, and improved overall efficiency compared to manual inspection methods. By implementing automated pouch seal inspection, manufacturers can improve their quality control processes, minimize the risk of product defects, and enhance customer satisfaction. The technology allows for increased inspection throughput, reduced labor costs, and the ability to detect even subtle seal defects that may be missed by manual inspection methods. Read on to learn more about the automated pouch seal inspection techniques offered by PTI.

Seal-Sensor Technology

Seal-Sensor™ is an airborne ultrasonic technique that inspects the final pouch seal 100% online non-destructively. The Seal-Sensor is an accurate, quantitative, fast and reliable method of testing pouch seals for defects. The Seal-Sensor detects incomplete seals, partial or weak areas of seals, and many other common defects in seals that appear visually acceptable but affect product quality, value and shelf life. In less than a second, a single linear scan (L-scan) of the pouch seal provides a pass/fail result and quantitative, traceable data.

Benefits of Seal-Sensor Technology

• Deterministic inspection method producing quantitative results.
• Non-destructive, non-invasive, no sample preparation.
• Works for any material and combinations, regardless of color, transparency, print, surface finish and porosity.
• Can be integrated for 100% online defect detection of the final pouch seal.
• Repeatable and reliable results.
• Eliminates subjective, manual vision inspection methods.
• Economical, cost-effective solution for seal integrity testing of the final pouch seal.

VeriPac LPX Technology

Based on decades of consistent performance in the pharmaceutical, biologics, and medical device sectors, VeriPac vacuum decay technology has been proven to be the most sensitive and reliable vacuum-based leak testing method available. It is a fully automated package quality inspection system for 100% inline testing. The LPX enables enhanced automated testing that offers a high degree of confidence in the efficiency of the packaging procedure. The LPX is an effective and reliable solution that enables process-related quality issues to be identified and resolved as soon as possible.

The VeriPac LPX has a dynamic robotic design that is adjusted to your production needs. To fulfill the demands of a manufacturing line, the LPX Series offers modular, scalable solutions. With the help of this flexible platform, a range of package forms may be reliably tested. Flexible packaging, rigid containers, and parenteral pharmaceuticals are some of the applications of LPX automation.

Benefits of VeriPac LPX Technology

• Automated testing enables the highest level of container quality assurance.
• Deterministic, quantitative test method.
• ASTM Test Method F2338 and FDA standard, ISO 11607.
• Highly accurate test results - low false positives and false negatives.
• Non-destructive, non-subjective, no sample preparation.
• Pick-and-Place option back into the production line.
• Auto reject option of defects removed from the production line.
• USP <1207> compliant.

Automated pouch seal inspection relies on various technologies to ensure the quality and integrity of pouch seals. Manufacturers can achieve comprehensive and reliable pouch seal inspection, ensuring product quality and customer safety. The specific technologies employed may vary depending on the industry, application, and quality standards. Automated pouch seal inspection plays a crucial role in maintaining the integrity of packaged products and preventing issues such as leaks, contamination, or compromised freshness.

Since many years ago, manufacturers have tested the quality of container closures, and their perceived value has constantly grown. Companies that once relied on probabilistic techniques like the blue dye test are now aiming to use a more reliable and predictable procedure for integrity testing of various package formats. The pharmaceutical industry is getting ready to adapt to the deterministic testing world in order to enhance quality, increase efficiency, and comply with changing regulatory standards.

Overview of Airborne Ultrasound Technology

Airborne ultrasound technology is a seal quality inspection technique. It is an ASTM test method F3004, the FDA approved standard for seal quality testing. Such tests are mainly performed to provide enhanced seal quality testing of pouches, flexible packages and tray seals. Airborne ultrasound technology ensures in-depth seal quality analysis and applies to multiple packaging materials including Tyvek, paper, foil, film, aluminum, plastic and poly.

In this technique, sound waves are reflected when ultrasound waves pass through the package seal. Signal strength is reduced or eliminated in the presence of leakage / fault. Such deviations are closely monitored to detect leakage. The inability to detect non-leak defects is a common challenge faced by most leak test methods. However, with Airborne ultrasound technology, users can identify various types of seal defects; visible and invisible, leaky and non-leaky, process-related and random.

Seal-Scan and Seal-Sensor Technology

Seal-Scan and Seal-Sensor are the two variants of Airborne ultrasound technology that utilizes non-contact airborne ultrasonic testing technology. With advancements in the form of seal-scans and seal-sensors, Airborne ultrasound technology has proven to be the most effective method for non-destructive seal integrity testing in both offline laboratory testing for seal quality analysis and 100% inline testing on the production line.

Seal-Scan® is a non-destructive offline technology that is highly effective in inspecting and analyzing pouch seal defects. It is a deterministic, quantitative, high-resolution package integrity testing method for identifying defects and sealing integrity for consistency. What makes this technique unique is that it is a non-invasive technique and requires no sample preparation. Seal-Scan® provides advanced digital imaging software tools for process control, offering in-depth seal quality analysis. This technology is capable of producing opto-acoustic images and detailed statistical analysis using L-scan and C-scan modes. An L-scan is a single linear scan along the x-axis of the seal that provides a line graph of seal integrity and simulates an online inspection. A C-scan produces multiple scans (in the X and Y-axis of the seal area) that provide a high-resolution ultrasonic image of the seal structure.

Seal-Sensor™ is an Airborne ultrasonic technology (ABUS) that non-destructively inspects the final pouch seal 100% online. The seal sensor detects incomplete seals, partial or weak areas of the seal, and many other common defects in a seal that are visually acceptable, but have that affect product quality, value, and shelf life. A pass/fail result and quantitative, traceable data are produced in less than a second by a single linear scan (L-scan) of the pouch seal. The Seal-Sensor is a definitive, quantitative, rapid and reliable approach to inspecting pouch seals for defects.

Benefits of Airborne Ultrasound Technology

• Non-destructive, non-subjective, no sample preparation.
• Accurate and reliable results.
• Can accommodate a number of packaging formats and materials.
• Eliminates subjective manual inspection methods.
• Deterministic inspection method producing quantitative results.
• ASTM Test Method F3004 and FDA Standard for seal quality inspection.

Today, package integrity test solutions continue to evolve, driven by industry demands, regulatory requirements, and advancements in technology. The focus remains on improving sensitivity, accuracy, and efficiency to ensure the integrity and safety of packaged products.