Viu Visual Inspection Unit

This patented system greatly exaggerates the topography of the flexible pouch seal area and also records each inspection event

A human eye is an incredible machine. Despite our incredible computer and sensor technologies, we can’t even begin to touch the surface of the human eye’s amazing capabilities. It has a 200 degree viewing angle, can see 2.7 million colors and has a possible contrast ratio of about 1,000,000 to 1 [Wikipedia].  The eye is the ultimate inspection device, and yet we seem to lean away from the human eye’s capability to other empirical data portals. In the medical device packaging industry, inspection and monitoring are king. In order for us to be certain that the medical devices that we cocoon to market are kept viable and efficacious, we need to use all tools available in science.

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In fact, the only broken link in this otherwise spotless methodology is the lack of a repeatble light source and a system of fixed magnification. Because we can visually interpret a host of possible anomalies within the sterile seal, we only then need to assure that a repeatable, mechanized system is in place in order to flatten out possible data scatter due to the inspector’s visual acuity to the sealed area.

The VIU system is designed to manage these variables and further enhance the lighting on the sealed area with the goal of catching possible seal creep. Many of our customers have used the system in low-volume situations due to 100% visual inspection to better assure the medical device will reach the point of use safe and sterile.

Although visual seal inspection certainly has its limits, but when used within the landscape of other quality systems such as burst, creep, dye penetration, etc., it becomes a valuable tool to monitor your process. Our first VIU system was simply a 3x magnification lens with our patented low-angle of light LED array. This system has been incorporated into many cleanrooms as a in-process inspection tool.

Many of our customers told us, through after market survey, that the unit would benefit greatly if it had the ability to store the inspection results on an onboard memory chip that could later be purged for quality teams’ evaluation. Enter the VIU2 system. Now, quality teams can include visual inspection in-process and monitor and record the outcomes of these valuable testing sessions. The system will first of all sense if a pouch is in the visual zone, which will then allow the operator to inspect and then either pass or fail based on the visual feedback of the inspector. If it passes, the system will date and time stamp the event. The operator will also include the lot number as well as the serial number of the sealing machine that was used under the operator’s name for a very complete inspection session reference.

If the seal presents with any of the known failures that are shown on the included laminated reference card, the operator may then select the failure number that corresponds with the type of event and failure, i.e., pleats or channels and all of the above reference tags can also be included. Later, when the quality group wishes to purge the unit for interpretation, they simply connect a USB cable and download the information from the VIU2 to the included VIU software.

Again, this system is not meant to replace destructive pouch testing challenges such as burst and peel. The scope of this device is to simply mechanize the inspector’s point of vision for better repeatable results and to further record that data in order to better manage your sterile device packaging quality plan. We invite you to click the image of the VIU2 or the original VIU in order to watch an informative video. As always, feel free to contact validation support at 800-550-3854 and speak with a certified engineer about your sterile device packaging quality challenges.

Due to the overwhelming positive feedback we've received on the standalone Viu® system, we have now integrated this Viu® system within the new MS-451PV medical pouch sealer. Operators will be able to quickly visually evaluate seal surface by simply lifting a lid on the new MS-451PV sealer. This non-destructive in-process test may provide early clues of possible seal strength failures in between in-process destructive testing. Further, each time an operator performs the visual inspection, he or she can record through the machine's integrated microprocessor a pass or fail score.

Included Data Capture Software

Create your own customized forms, to automatically add data to calibration printouts and reports. A simple, clean interface is all that stands between you and advanced, yet intuitive, reporting capabilities. Easily integrate existing pdf data into reports as needed to meet any regulatory or corporate reporting guidelines.

First page of our printout, complete with custom form data and color-coded data graph. Graphs use colors and different data point shapes to denote different channels in multi-channel devices, such as the Agilent dataloggers, Fluke dataloggers as well as other supported devices.

Running on Windows, Mac OS X and Linux, VIU Calibrate will be there for you whatever platform choices you make in the future. VIU can export data to Microsoft® Excel (both Office 2007 xml and older supported) or Open Document Spreadsheet formats, making both compatibility and the extensibility of xml available to you.

Full printout of captured data. Units can be set to dynamically convert to your preferred settings and numbers dynamically appear in the most consise format between engineering and standard notation. Full data printout or summary statistical output are available to custom forms. more

Original Viu, Without Data Capture

This is where it all began. Our patented visual inspection device, this first iteration set the trend of in-process visual inspection of medical device pouches.

And now with the Viu2 system, all inspection events can be recorded to interpret seal integrity as it relates to visual feedback. We invite you to view both the original Viu video and the Viu2 video by clicking either image with the embedded play button. If you have additional questions regarding visual inspection, contact technical support at 1-800-550-3854 x112.

Need Visual Inspection With Tensile Testing?

Complete package quality lab right on your desktop, the PTT-100V

Quality teams agree - the best way to thwart the risk of a packaging failure in the market is accurate and regular testing and inspection. A product recall due to packaging failures is a senseless risk that can devastate a medical device company.

Van der Stahl Scientific’s package integrity lab understands the value of regular and thorough testing and it is within that spirit that we have developed the all new PTT-100V. This patented medical pouch test and inspection unit has received outstanding reviews from our customers. The PTT-100V’s compact size facilitates the placement of the unit throughout your facility. This system can even be used in the cleanroom for in-process visual inspection of your medical pouches.

This system is designed to harmonize with an ASTM-1886 and will add an important element of seal evaluation. After the operator visually inspects the seal, they can simply tap the pass button or the fail button, depending on the outcome of the visual inspection. If the product fails the visual inspection, the operator is prompted to input one of 10 possible seal failure causations. Once the operator selects the corresponding number of the failure, the unit will date and time stamp the inspection and this information can be purged later on the unit’s included software. more