Ensuring the safety and effectiveness of blister packs is key in pharmaceutical manufacturing. Leakage testing plays a vital role in this process, acting as a necessary safeguard against compromised packaging. While dye ingress testing is commonly used to assess package integrity, there are innovative methods available that exceed the limitations of traditional testing. Below, we will explain how the VisionScan 3D offers a superior and more accurate leakage test for blisters compared to dye ingress testing, as well as highlight the rapid return on investment achievable with this cutting-edge technology.
Cost Savings Compared to Dye Ingress Testing
The infographic shows that the initial investment in a VisionScan 3D can be recovered within a year, showcasing its rapid return on investment. These calculations are based on conservative estimates, which are outlined below.
Calculation assumptions:
- Production hours per day: 8
- Destructive test per hour: 2
- Destroyed packs per test: 5
- Tablets in each pack: 10
- Sales value of each tablet: € 0.50
- Working days per year: 260
In our calculations, we have made the assumption of conducting only 2 batch tests per hour with 5 blister packs each, based on a 5-day work week. However, it is important to note that achieving a return on investment can be even faster by testing more blister packs at regular intervals or when dealing with higher-value drugs. In fact, we have had the pleasure of working with manufacturers who saw a return on investment in less than 3 months.
Quick ROI with VisionScan 3D
The VisionScan 3D is a non-destructive and deterministic leak test solution that can identify defects as low as 5µm in individual blister pockets. The system offers significant cost savings compared to dye ingress testing, making it the ideal choice for pharmaceutical manufacturers. Manufacturers of expensive drugs, like oncology drugs, can potentially save significant amounts of money every week during batch testing. By implementing this cutting-edge technology, you can not only save time and money but also ensure the highest quality of your packaging.
Furthermore, with an increasing focus on sustainability, pharmaceutical manufacturers are actively seeking ways to minimise their environmental impact. Switching to non-destructive methods could be a much greener choice as it significantly reduces product waste and eliminates the need for incineration. Unlike traditional methods, non-destructive testing does not require a daily supply of water, avoiding any potential contamination risk and eliminating the associated costs of water treatment and disposal. The article below describes the drawbacks of destructive leak test methods and highlights how alternative, non-destructive methods are a much greener choice: 'Is blue dye letting you down in your green efforts?'
User-friendly and Reliable
The VisionScan 3D is easy to use and reliable, making it the perfect choice for manufacturers. The system is user-friendly and intuitive, and provides reliable and accurate results. You can trust that your blister packs are being tested to the highest standards.
Features
- Vacuum deflection method (ASTM F3169-16): The VisionScan 3D utilises vacuum deflection, a non-destructive and deterministic method that is capable of detecting defects in individual blister pockets, channel leaks and weak seals as small as 5µm, dependent on the pack and material.
- Large test area: With a test area of 297x210mm, the VisionScan 3D can identify gross and micron holes in multiple blister packs per test cycle, providing high throughput.
- Tool-less design: The device is tool-less, which makes it ideal for production lines running multiple products.
Benefits
- Non-destructive and deterministic testing method: The VisionScan 3D offers a reliable and cost-saving alternative to traditional destructive leak tests for blisters. As a tool-less, non-destructive, and deterministic method, it does not affect the integrity of the blister pack, allowing the tested packs to be returned to the production line.
- Flexible and high throughput testing: The machine is capable of testing blister packs that contain tablets or capsules in multiple material and design formats. With a large test area and tool-less design, the VisionScan 3D provides a flexible and high throughput testing process.
- Streamlined validation process and compliance: The VisionScan 3D offers a streamlined validation process for different foil types and language versions. The device is also designed to meet 21 CFR Part 11 requirements and can be easily integrated with a Manufacturing Execution System (MES) via its MES connector MESConnect. This enables manufacturers to document data and activities, control production, and monitor and analyze processes, thus improving efficiencies.
