MBT-300 Burst Tester for Medical Pouch

There is no question the most proactive pathway to compliance is through regular pouch performance challenges like peel and burst testing. Many of our customers that wish to have a full understanding of the total pouch integrity choose burst testing. This method of testing is well suited for foil and clear film pouches and bags. The MBT-300 burst tester can be used with the ASTM F1140-07 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages. Your quality team can develop a pass/fail threshold for you type and size pouch and burst testing can be an excellent way to evaluate total seal value and pouch strength. This testing method gains even more value when used in concert with peel strength testing using standards such as the ASTM F-88 and visual inspections if performed under the guidelines of the ASTM 1886. Please see our PTT-100-V unit that can perform both of these valuable testing procedures.

View product video

Download product images

According to the ASTM website burst testing is described as followed:

“These test methods provide a rapid means of evaluating tendencies for package failure when the package is exposed to a pressure differential. Pressure differentials may occur during processes such as sterilization and transportation.

These test methods are frequently used to quickly evaluate packages during the manufacturing process and at various stages of the package’ life cycle.

If correlations between pieces of test equipment are to be made, it is important that all parameters of the test method be exactly the same.”

To learn more about this standard or to purchase a copy visit this link on the ASTM website.
We offer a simple through bag fixtures that can be installed on your thin film pouch, although they are admittedly a bit cumbersome to fixture they have worked well in our lab for small D.O.E.’s You can however use any other fixtures you wish that harmonizes with the spirit of standard burst test methods.
Our MBT-300 Burst Tester is a great tool for your quality lab and it is built on a simple to operate platform that is easy on your technicians. The unit can be set up to have a specific pass/fail value and a binary light system quickly tells you that your pouch has pass or failed.  The MBT-300 Burst Tester can also send out test data via an RS-232 port so it can be time stamped on your computer to round out your quality programs record archiving. Stay compliant with advanced testing machinery from Van der Stahl Scientific.

For nearly twenty years, we have heard a host of frustrations from sterile packaging engineers about cumbersome test methods that have discouraged regular testing. Although we clearly understand the value of these codified testing standards, we also have learned in our own packaging integrity lab the value of regular testing.

Our testing inspection devices are designed to simplify the process of seal testing and evaluation in order to encourage regular testing. We have heard too often in the field that medical device packagers have been blind-sighted by a packaging recall due to the perils of infrequent testing. In fact, we have made many of our testing devices so simple that many of our medical device customers’ quality teams have told us that they now went from a monthly, or in some cases, semi-annually testing of their pouches to weekly or even daily testing and inspection.

The machinery that we developed has been a byproduct of the feedback we have heard from our medical device customers, like our VIU system. This system was engendered from our customers’ frustration with inadequate visual inspection tools available in the market. With the VIU system, our customers were able to simplify the process of visual inspection and, most importantly, to be able to record and archive the inspection events in order for the quality group to evaluate the progress of the validation plan.

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

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