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In the pharmaceutical industry, the integrity of packaging plays a pivotal role in ensuring the safety, efficacy, and quality of medications. Packaging serves as a barrier that protects pharmaceutical products from external factors, such as moisture, air, light, and contaminants, which could compromise their stability and effectiveness. Ensuring the integrity of pharmaceutical packaging is not only crucial for regulatory compliance but also for maintaining patient safety and confidence in the products.

Traditional methods of package testing often involve destructive techniques, where samples are opened, punctured, or otherwise altered for assessment. However, these methods come with inherent drawbacks, including product wastage, the need for additional samples, and prolonged testing times. To address these challenges, the pharmaceutical industry has increasingly turned to non-destructive methods for package integrity testing.

What are the Non-destructive Methods Used for Pharmaceutical Package Testing?

Vacuum Decay Technology

Vacuum decay is a non-destructive Container Closure Integrity Test (CCIT) that provides reliable, repeatable, reproducible, and accurate results along with clear pass/fail quantitative data. The basic idea of Vacuum decay technology is to question the integrity of containers based on their fundamental physical properties. Sample packages are initially placed within a tightly sealed evacuation test room with an external vacuum source. Based on the test sample and the needed level of sensitivity, a predetermined vacuum level is selected. The test chamber and test system dead space must be evacuated after that for a certain period of time. To monitor variations in vacuum level over time, differential pressure transducers are utilized. The container is leaking if the pressure rises over the designated pass/fail limit.

Volumetric Imaging Technology

Non-destructive leak detection of blister packages is done using OptiPac One-Touch Tool-less technology. The OptiPac uses volumetric imaging technology to monitor the movements of a blister package while it is under vacuum in order to identify leaks. The interface is practical and simple to set up with new blister package forms, necessitating no tooling changeover or significant parameter revisions as with previous non-destructive blister package inspection systems. In response to different cavity shapes, sizes, and combinations of various blister pack types, the system gathers volumetric data from each cavity.

Airborne Ultrasound Technology

Airborne ultrasound is a deterministic test technique for seal quality inspection in materials including aluminum, foil, paper, plastic, poly, film, and Tyvek. It has been proven to be one of the most effective non-destructive testing techniques for flexible package seals. According to studies, conventional seal inspection methods are ineffective because they miss undetectable defects and incorrectly reject pouches that are tightly sealed. On the other hand, Airborne ultrasound technology has been successful in both online and offline solution options. Airborne ultrasound is a typical test method for evaluating seal quality and integrity in accordance with ASTM F3004-13.

Microcurrent HVLD technology

High Voltage Leak Detection, often known as HVLD, is a deterministic, non-destructive leak detection technique used to evaluate the Container Closure Integrity of vials, cartridges, and other liquid-filled parenteral products. It is one of the most efficient approaches for online container closure testing. MicroCurrent HVLD uses around 50% less voltage and exposes the product and environment to less than 5% of the voltage when compared to standard HVLD systems. This technique doesn't require sample preparation and is non-invasive. Pre-filled syringe testing is one of the main uses of MicroCurrent HVLD, along with vial leak testing.

Non-destructive Package Integrity Testing Method Benefits

Non-destructive package integrity testing holds significant importance in the pharmaceutical industry due to the critical nature of pharmaceutical products and the strict regulatory requirements in place. Here are some key benefits of using non-destructive package integrity testing in the pharmaceutical industry:

• Product Safety: Ensuring the integrity of pharmaceutical packaging is paramount for product safety. Non-destructive testing methods can identify leaks, defects, or breaches in packaging that could lead to contamination, spoilage, or compromised efficacy of the medication.
• Regulatory Compliance: The pharmaceutical industry is heavily regulated to ensure patient safety and product quality. Non-destructive package integrity testing helps companies meet regulatory requirements outlined by agencies such as the FDA (U.S. Food and Drug Administration) and other international regulatory bodies.
• Reduced Risk of Contamination: Non-destructive testing methods can detect micro-leaks or breaches in packaging that may not be immediately visible to the naked eye. This reduces the risk of contamination from external factors like air, moisture, or pathogens.
• Preservation of Sterility: Many pharmaceutical products require a sterile environment to maintain their efficacy and safety. Non-destructive testing ensures that the packaging's sterile barrier is intact, preventing any potential breach of sterility.
• Enhanced Product Quality: Maintaining package integrity helps prevent degradation of pharmaceutical products caused by exposure to light, moisture, or air. This ensures that medications maintain their intended potency and effectiveness.
• Cost Efficiency: Non-destructive testing methods save costs by preventing the need for destructive testing, which would require additional samples for analysis. This also reduces the need for retesting, minimizing waste and resource consumption.

As the demand for stringent quality control and regulatory adherence in the pharmaceutical sector continues to grow, understanding the nuances of non-destructive package testing methods becomes essential. By adopting these innovative techniques, pharmaceutical manufacturers can uphold their commitment to patient safety, product efficacy, and overall excellence in the field.

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.

Packaging plays a significant role in the drug delivery system. Packaging provides information regarding the manufacturer’s name, price, date of manufacturing and expiry, dose or strength, ingredients, etc. Blister packaging is a type of packaging format specially designed for tablets and capsules made by heating and shaping a plastic sheet into the 'blister,' which is entirely covering the object, into a bubble or a pocket. Several types of plastic materials like Polyvinyl chloride (PVC), Polyethylene terephthalate (PET), Amorphous polyethylene terephthalate (APET), High-density polyethylene (HDPE), etc. and aluminum sheets or foils are used in blister packaging. Blister packages can offer barrier protection and some tamper resistance to shelf-life requirements.

Tablets and capsules can be packaged in blister packaging in a regulated manner. The hard and solid-sized tablet or capsule is put in a rigid cavity and the flexible cover material is stamped to finish the package. The lines of tablets and capsules can usually handle the product with constant uniformity, making errors unusual. Interestingly, even though each cavity is independent, it also is reliant on blister packaging. If the seal is broken between two cavities, the sterility or quality of the product will not be affected until a blister cavity leaks outside the package.

Overview of OptiPac technology

OptiPac Leak Detection System is a non-destructive technology particularly intended for blister packages. To identify the existence and location of leaks, this technology uses volumetric imaging under vacuum with topographic imaging. Volumetric imaging is a next-generation technology that replaces expensive dye ingress methods of blister package inspection systems. The package is visually examined for blue dye penetration when submitted to a vacuum cycle immersed in dye during the dye ingress test. Although the approach appears uncomplicated, the method has several conditional factors which might contribute to inaccurate findings and less effective quality assurance.

The OptiPac is meant to accomplish a fast test cycle, without changing or sampling preparation, using One-Touch-Technology. The OptiPac applies controlled inputs and measurable outputs using concepts like those employed during a vacuum dye ingress test without the complications and the dependability challenges of the dye ingress procedure.

Simply place the blister package on the test plate and click START. The vacuum is drawn into a specified vacuum when the start button is pressed. The blisters spread under a vacuum and cause air to flow from the blister to leak. When the blister leaks, the air rushes into the chamber, leaving a blister packing deflated. A volumetric picture and measurement readings are used to detect which blister cavities are faulty during the dynamic vacuum test process. For each test package, there will be a clear pass/fail status and a quantifiable measurement

OptiPac benefits

• A deterministic non-destructive technique
• Auto-orientation of blister packs – test blister packs in any position
• Auto calibration is an integrated one-touch function
• No modification to test various blister formats
• Completely tool-free
• Identifies defective cavity
• Preloaded Recipe Library with simple recipe creation and new blister forms validation
• Advanced batch reporting with audit trail including image of blister pack and defect results