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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.

The physical ability of a package to protect its contents with the necessary level of protection during a specific time is referred to as package integrity. Package integrity tests are performed to detect packaging issues that might affect the sterility of a medical device. Previously, microbial challenge or dye penetration testing was used to determine whether the product packaging has maintained its microbial barrier qualities. Due to technological advancements, VeriPac FLEX systems are currently being used for testing the package integrity of flexible packages.

VeriPac FLEX Systems to Ensure the Integrity of Flexible Packages

CCIT’s VeriPac FLEX systems are versatile non-destructive package inspection systems that are intended particularly for evaluating dry-filled pouches and flexible packaging. VeriPac FLEX systems are available in several configurations for both the leak test instrument and the test chamber capacity to accommodate various package specifications and test sensitivity requirements. VeriPac inspection systems provide a simple PASS or FAIL result, as well as quantitative test data. They offer unparalleled sensitivity, reliability, and practicality in testing a wide variety of flexible package formats and sizes, without changing settings or tools.

The ASTM technique for vacuum decay leak testing (F2338), which is specified in ISO 11607 and recognized by the FDA as a consensus standard for package integrity test solutions, is used by VeriPac FLEX Systems. As an alternative to destructive testing, they eliminate subjectivity while also reducing waste and cost. When compared to destructive techniques like water bath or blue dye leak test, vacuum decay leak testing technology has proven to provide a quick return on investment. The VeriPac test devices consistently detect significant packaging errors and provide useful packaging process information.

Technology Overview

On the basis of the package size, the VeriPac tester is initially attached to the appropriate FLEX chamber. The Integrated Flexible test Chamber (IFC) and Drawer Style test chamber (D-Series) are the two test chamber configurations available to connect with the VeriPac instrument depending on package specification and test sensitivity requirements. The Integrated Flexible test Chamber (IFC) is designed for low-headspace sachets or stick packs. Depending on the package size and requirements, the Drawer Style test chamber (D-Series) is available in 2 basic sizes: Small (D) and Large (DXL). Custom designs are possible for large packaging types and bulk products. The way the package is tested is what sets VeriPac FLEX systems apart. CCIT makes use of a flexible membrane that fits the shape and size of the package, preventing stress and damage to the film materials. In a single test cycle, several packages can be tested.

VeriPac FLEX System Advantages

• Non-destructive, non-subjective, no sample preparation
• Cost-effective with rapid return on investment
• Accurate and repeatable results
• USP< 1207> compliant
• Supports sustainable packaging and zero waste initiatives
• ASTM test method and FDA standard
• Deterministic, quantitative test method
• Simplifies the inspection and validation process

Manufacturers are still struggling with quality standards for flexible packaging. CCIT’s VeriPac FLEX has proven to minimize manufacturing waste and costs while boosting package quality assurance and brand value. It has high test sensitivity and is capable of identifying micro leaks down to the single digit micron range.

Pharmaceutical package integrity testing has always been an important aspect of the quality control and manufacturing process. Container Closure Integrity is critical for protecting the product throughout its lifespan until it is delivered to the patient. CCIT uses non-destructive inspection technologies for ensuring container closure integrity of vials, ampoules, syringes, cartridges, and auto-injectors.

Ampoules must be properly sealed since any crack or defect might contaminate the sterile substance inside. Microbial contamination, exposure to gases, water vapor, and solvent loss can all cause product degradation if there is any breach in the package. Hence, container closure integrity is an essential stage in the lifecycle of a sterile pharmaceutical product. Patients may be at risk if the container closure integrity is compromised. Drugs that are meant to save lives might lose their effectiveness or cause fatal side effects. CCI defects can cause oxidation, which can reduce a drug's potency and shelf life.

Integrity Testing of Ampoules using MicroCurrent HVLD

MicroCurrent HVLD technology detects leaks in nonporous, rigid, or flexible packaging such as ampoules that contains liquid products. This is a non-destructive High Voltage Leak Detection Technology that is highly effective across all parenteral products (vials, syringes, ampoules and BFS). The test technique detects pinholes, microcracks, stopper/plunger leaks, non-visible leaks under crimping, and many other defects by scanning a non-conductive container sealed with electrode probes. Any crack or other defect in the container can cause a resistance difference and a change in the current flow, which would indicate a breach. It is also possible to determine the approximate position of the defect.

When compared to conventional HVLD technologies, MicroCurrent HVLD uses around 50% less voltage and exposes the product and environment to less than 5% of the voltage. At high production speeds, this HVLD method may be simply transitioned from offline to 100 percent inline testing applications. It is a cost-effective online container closure testing solution that requires only minor infrastructure changes. This method is non-invasive and does not need sample preparation. For all parenteral and biologic products, MicroCurrent HVLD is one of the most effective CCI methods.

MicroCurrent HVLD Benefits

• Effective in all parenteral preparations, even liquids with extremely low conductivity.
• At high production speeds, inspection can be done both offline and online.
• Non-destructive, non-invasive, and requires no sample preparation.
• High level of accuracy and repeatability.
• Deterministic method for parenteral liquid package inspection.
• A robust technique for a variety of product classes and packaging forms with an estimated 3x Signal-Noise-Ratio.

Ampoules are such little glass bottles containing a sterile pharmaceutical liquid for parenteral administration. Microbes or other harmful pollutants may enter the ampoules through capillary pores or microscopic breaks, or the contents may leak to the outside. This may result in contamination of the sterile contents as well as a deterioration of the appearance of the package. MicroCurrent HVLD technology offered by CCIT can be applied to a variety of pharmaceutical packing formats including ampoules for testing integrity.