medical device pouch testing

PRECISION

POUCH

TESTING DEVICES

There is no better way to manage the risk of a package failure and sterility loss than with regular pouch testing and inspection. The PTT-100V is a test lab for your desktop. ce-marking mark available.

the future of medical pouch testing and inspection

Van der Stahl Scientific continues to imagine and create patented innovations that are designed to help medical device manufacturers stay compliant and avoid potential device recalls. With our quick-loading grips and precision specimen cutting solutions you can test often to manage pouch failure risks. The PTT-100V can output data via the system’s USB port to archive seal strength and visual inspection data. Accurate daily pouch testing is the new expectation for medical device manufacturers creating the sterile barrier system. Stay compliant and thwart contamination risk to your medical device. Call our engineering group and learn more about the PTT-100V pouch testing and inspection device for your desktop.

High Resolution

The PTT-100V has a data capture rate of 100 readings per second in order to achieve detailed information for each peel session. Data can be sent to a computer via a USB cord for generating a graphic waveform for further peel data evaluation and recored archiving.

Calibration Check

With the included calibration spring and “Check Mode” the load cell can be tested daily to be certain that the device is still in calibration. This is a vital tool that assures the PTT-100V testing system is in tolerance between annual calibrations cycles.

Loading Tool

Human load behavior and inconsistent sample size can impact peel results. Our included specimen cutting jig and specimen loading tool reduce user bias to assure repeatability and enhance testing accuracy. These innovative tools encourage pouch testing.

PTT-100v drawing

regular testing matters

Why risk a potential medical packaging recall? Pouch testing and inspection is the most vital piece of your sterile device packaging plan. With our PTT-100V medical pouch testing and inspection lab, you can thwart compromised pouches reaching the sterile field. Your PTT-100V ships with a full ISO 17025 calibration from our accredited lab. Stay compliant and manage recall risks.

PTT-100V Packaging Laboratory

Click the video link above and learn how the PTT-100V medical pouch testing and inspection device can transform your quality program. Stay compliant with the PTT-100V countertop laboratory.

Complete testing laboratory on your desktop

The PTT-100V is an invaluable medical device packaging laboratory designed to keep your packaging validation on track. This amazing system incorporates a host of features to assure your testing results are sound. Our “Spring Check” system allows quality teams to check the load cell to verify that the machine is running as expected between calibration cycles. The easy-to-read display and simple menus encourage regular use. “Quick load” thin-film grips require only a quarter turn to tighten, and our paddle style handles create maximum user ergonomics.
  • Password protected admin controls
  • Data output via USB to included software
  • Includes loading tool and specimen cutter
  • Daily load cell calibration check
  • Optimized for ASTM F-88
  • Quick load paddle grips

Microprocessor managed testing

Inside the PTT-100-V is an advanced microprocessor that manages testing speed and senses peel values 100 times per second. The internal motherboard also integrates a USB data capture port in order to utilize the included software for data interpretation. The PTT-100-V is loaded with our high-level firmware that includes our industry-changing internal calibration mode.
ptt 100 components

ASTM F-88 Test Ready

Most tensile/peel test systems are not optimized for the delicate and accurate demands of the ASTM F-88 test procedure. The PTT-100V testing laboratory was designed exclusively to quickly and accurately peel test medical device pouches. With compliant speeds, stops and capture rates you are ready to load your specimens into the quick load grips and gather seal strength data.

machine features that matter

Manage the risk of “Out of Calibration” events.

With our new “daily inspection spring” operators can verify that the PTT-100V calibration is valid between annual calibration cycles. Every time your system is calibrated, we will reverify your “daily inspection spring” in our ISO/IEC 17025 accredited calibration laboratory for your in-house use. Why risk a packaging recall with invalid seal strength data from out of calibration testing equipment?

Quick load grips

Pouch testing can be fatiguing, our quick load thin film grips are fast and ergonomic.

Easy Setup

Intuitive menu steps and paddle keys make machine setup fast, accurate and simple.

Accurate loading

Our loading tool removes human loading behavior that can risk test outcomes.

Visual inspection

Visual inspection integration allows both destructive and nondestructive tests.

“I have spent the last years guiding and advising medical device manufacturing clients through the regulatory and engineering labyrinth of sterile packaging. Through data I have gathered from hundreds of audits I can say with great conviction, regular output seal quality testing will be your savior.”

— Charlie A. Webb CPP, Six Sigma master black belt, ISO-17025 director of quality

Powerful medical pouch testing laboratory in your cleanroom

The PTT 100V medical device packaging laboratory is designed to keep your packaging validation on track. This amazing system incorporates a host of features to assure your testing results are sound. The easy-to-read display and simple menus encourage regular use, and our “Quick load” thin film grips require only a quarter turn to load.

medical pouch testing tools from van der stahl scientific

dye penetration testing

Our DP-150 and DP-195 Pro-kits use premixed dye solutions that are ready to go right out of the box. With the included laminated reference guide, you can quickly identify a host of seal failures. No more mixing and measuring messy dyes that shorten essential pouch testing cycles. Stay compliant with regular dye testing.

enhance test accuracy

Tensile/peel testing your sealed pouches is an effective way of monitoring your packaging machines performance, and to avoid potential creep in your seal values. With our all new SPC-2 pouch specimen cutter, you can quickly and safely prepare test samples to encourage regular medical device pouch testing.

Visual pouch inspection

Enhance your medical device pouch seal inspection with our VIU system. Visual cues can be an important first step in identifying critical seal issues on your medical device pouch. Our patented side lighting array can identify a host of nonconforming seal issues such as pleats, channeling, and narrow seals.

“Even the most efficacious medical devices can be rendered poisonous if sterility is compromised. Partner with vendors that share your commitment of total quality at every touchpoint. Let us help you deliver your device sterile to the point of care.”

— Charlie A. Webb, CPP Director of Quality

Key Features From Our Medical Pouch Testing System

Visual inspection

Our patented side lighting can help reveal anomalies on the sealed portion of your pouch and can store inspection data on the systems onboard memories for event archiving.

Calibration check

The PTT-100 comes to you with a check spring that can be fitted to assure that the device is operating as expected. This is a great way to prevent out-of-calibration events.

Loading tool

Seal strength tests can vary greatly due to inconsistent operator behavior. With our loading tool, every pouch is loaded straight with even spacing for greater repeatability.

Testing integration, the future of medical device packaging

Medical device packaging engineers agree the pathway to compliant device packaging is through regular testing and inspection. With our patented MS-451 medical device pouch sealing machine, seal performance is verified with the onboard testing and inspection system.

Our customers are talking

"...The Van der Stähl name has become a fan favorite within our metrology department because of the certification Van der Stähl performs on the units. When we receive the machines in, the metrology department needs to do very little to get these active..."

― MATT SMITH, MANUFACTURING ENGINEER

Our customers are talking

"Amazing company to work with. The information is exactly what we need to complete our IQ OQ PQ. Thank you! Your company is a leap above the rest…"

― AARON, DIRECTOR OF QUALITY CONTROL

Our customers are talking

"We have found Van der Stähl products and services to exceed our expectations. The sealers, test equipment and calibration services have been robust, efficient, and competitively priced. Van der Stähl is a key contributor to our continued success."

― RICHARD DAVIS, DIRECTOR OF ENGINEERING

Our customers are talking

"I just wanted to send a quick note to thank you and all the Van der Stahl Scientific team for going above and beyond to resolve the issues we had with our pouch sealer. Even though the issues were not of your doing, you took it upon yourself to make things right so we could meet the commitments that we made to our customers. We were blown away by your response and greatly appreciate you, not only for expediting the build, but for completely replacing the machine!"

― ALAN SCOTT, PACKAGING ENGINEERING COORDINATOR

Our customers are talking

"High level of customer service by a group of technicians and sales staff that know their product."

― MARY ANN GREENAWALT, DIRECTOR

Our customers are talking

"Your customer service is even better than the great equipment you provide. Even on the other side of the world I know we can count on your team. We are customers for life. Van der Stähl has the best combination of equipment and people."

― THOM TRIMNAL, GENERAL MANAGER

Explore our additional testing products

SPC-2 Specimen Cutter

Cutting your pouch samples with a razor knife is time consuming and poses safety risks.  The robust build of the SPC-2 prevents device flexing that could affect pouch sample consistency.

DP-150 Dye Pen Kit

There is no longer any need to mix messy dyes and surfactants when developing a dye solution for the ASTM F 1929 protocol. The DP 150 is premixed and ready to use right out of the bottle.

Seal Check Seal Test

Ready to use out of the box. Simply seal your pouch as usual, with the Seal Check strip as the middle film, and visually evaluate the seal event you just performed for known seal issues.

BEHIND OUR SEALERS A MEDICAL PACKAGING DREAM TEAM

Meet our Six Sigma master black belt, patented inventor and medical device packaging guru, contact Charlie for validation support.

Charlie A. Webb, CPPL

Director of quality, new product development

The master of solutions, our Laboratory, and Service Manager Cord Burnham guides our service, testing and calibration effort.

Cord Burnham CKF

Director of laboratory and Calibration services

Our customers best friend, our General Manager Lisa Wassberg creates magic at every touch point for our medical device clients.

Lisa Wassberg, CKF

General manager, customer relationships

Sarah’s intuitive eye can solve machine issues with ease. Sarah is a Six Sigma Black Belt and understands the critical process.

Sarah Deputy, CKF

Testing and Calibration services

Speak with a packaging expert

800-550-3854

Skip the salesman and speak with a certified packaging engineer like our support team leader Charlie A. Webb CPP, CKF. Charlie is a certified packaging engineer, a patented innovator and a six sigma master black belt with more than 20 years of sterile packaging experience. Fill out the form below and request a quote or give us a call, we would love to chat…