medical pouch testing

Why risk a packaging recall? Test often, stay compliant

Quality teams agree, the best way to thwart the risk of packaging failure and loss of medical device sterility is through accurate and regular pouch testing and inspection. A product recall due to packaging failures is a senseless risk that can devastate a medical device company. We invite you to explore our testing and inspection system.

medical pouch testing

Testing and inspection for medical device packaging

We offer a host of medical device pouch testing and inspection systems designed to quickly reveal possible seal issues such as channels or narrow seals. Our precision line of testing system provides both destructive and nondestructive means of evaluation. Let us help guide you to the best testing system for your device and packaging.

Are you confident that your device will arrive sterile?

At the point of care your staff and patients should not need to wonder if medical devices are safe and sterile. Inferior equipment puts an unfair burden on your central processing staff. Join the movement that is championing better packaging systems. Explore the many medical device packaging and testing options from Van der Stähl Scientific.

The Future of Medical Pouch Testing and Inspection

Never has it become more vital that medical device packaging companies test their pouches. Van der Stahl Scientific has created patented innovations that are designed to help medical device packaging companies stay compliant. Learn more about our quick-loading sterile medical packaging test laboratory and our visual inspection device, the Viu and find out how they can become pivotal to manage your sterile package quality plan. The PTT-100-V is designed to quickly test and inspect medical device pouches by eliminating confusing steps that can compromise testing accuracy. With our quick load grips and specimen-loading tool, you can test more often and increase data cycles, learn more about this amazing system 800-550-3854.

High Resolution

The PTT-100-V 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 data evaluation.

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 system is calibrated between annual calibrations.

Loading Tool

Human load behavior and inconsistent sample size can impact peel results. Our include specimen cutting jig and specimen loading tool in order to reduce user bias and assures a repeatable testing workflow for better testing accuracy

Test accuracy you demand

The PTT-100-V desktop medical device pouch testing laboratory can perform both destructive and non-destructive packaging performance challenges. Contact our engineering group and learn how this innovative device can help you prevent seal failures in distribution.

PTT-100-V Packaging Laboratory

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

Complete medical pouch testing laboratory on your desktop

The PTT-100-V 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
  • Load tool for test accuracy
  • Daily load cell calibration check
  • Optimized for ASTM f-88
  • Quick load paddle grips

Powerful medical pouch testing laboratory in your cleanroom

The PTT 100 V 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.

Powerful medical device pouch testing and inspection

Rapid pouch testing

Fast load grips and sample aliment tool make testing accurate and easy. Our include specimen cutting template assures test sample constancy. Grips return to home position after testing.

A smarter system

Test your pouch at compliant speeds and start distance and collect test data at 100 data points per second. Our spring check system verifies that the testing system is still running within calibration.

An eye on quality

The PTT-100-V incorporates a visual pouch inspection fixture to help identify seal failure. This patented VIU system help to identify possible seal failure by side lighting and magnification.

Deliver your medical devices sterile to the point of care

Why risk medical device sterility with inferior packaging machinery? Our line of packaging and testing machinery is designed to make certain that your devices arrive safely into the sterile field. The foundation of patent safely begins with efficacious medical devices that are delivered safe and sterile to the patient.

Here’s more about the PTT 100 V

Medical device companies that utilize visual pouch inspection have historically done so without any set standard. Quality teams find it difficult to write a protocol for the inspection of medical pouch seals when using multiple lighting sources and magnifications. With the VIU® system every operator is inspecting the sealed area under the same conditions so seal pass/fails can be more accurately determined. The VIU system’s integrated event record feature lets operators store date, time, inspector’s name, lot number and the pass/fail status of the inspection event onto the system’s onboard memory.
The human eye is an incredible machine. Despite our advanced electronic 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. 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. With the VIU system, medical device manufacturers can visually inspect medical device pouches for visual anomalies such as pleats, channels and narrow seals. Visual inspection is a simple but effective tool in your total quality plan.
The PTT 100 V 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 paddle style handles create maximum user ergonomics.

PTT-100-V Laboratory

A powerful medical device pouch testing device that integrates both testing and inspection into a single unit. On board testing data can be purged to a computer with included software via USB cord.

VIU Inspection

Enhance medical device seal inspection with the VIU system. Visual cues can be an important first step in identifying seal issues on your medical pouch. Contact our engineering group to learn more.

MS-451 Seal/Test

Our most feature rich system, this sealer is a complete packaging program in a single machine The MS-451 unit is not only an advanced medical pouch sealer it is also a complete testing laboratory.

“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

An eye on quality Assurance

The VIU can be placed in the cleanroom at the point of packaging to encourage regular inspection. Our patented low angle lighting source casts a light wash over the sealed area of the pouch to better reveal peaks on the sealed surface that could indicate a seal risk. Gazing through the lens the operator moves the pouch side to side to better invoke lighting that may provide clues to other pouch issues such as channels or bonding problems. The included seal reference sheet guides operators through the seal inspection process with illustrations of multiple known seal failure types. If the seal fails, operators can enter a failure type and the event will be electronically dated and time stamped.

Spec Sheet      View video

Here’s more about the VIU

Medical device companies that utilize visual pouch inspection have historically done so without any set standard. Quality teams find it difficult to write a protocol for the inspection of medical pouch seals when using multiple lighting sources and magnifications. With the VIU® system every operator is inspecting the sealed area under the same conditions so seal pass/fails can be more accurately determined. The VIU system’s integrated event record feature lets operators store date, time, inspector’s name, lot number and the pass/fail status of the inspection event onto the system’s onboard memory.

The human eye is an incredible machine. Despite our advanced electronic 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. 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. With the VIU system, medical device manufacturers can visually inspect medical device pouches for visual anomalies such as pleats, channels and narrow seals. Visual inspection is a simple but effective tool in your total quality plan.

The VIU can be placed in the cleanroom at the point of packaging to encourage regular inspection. Our patented low angle lighting source casts a light wash over the sealed area of the pouch to better reveal peaks on the sealed surface that could indicate a seal risk. Gazing through the lens the operator moves the pouch side to side to better invoke lighting that may provide clues to other pouch issues such as channels or bonding problems. The included seal reference sheet guides operators through the seal inspection process with illustrations of multiple known seal failure types. If the seal fails, operators can enter a failure type and the event will be electronically dated and time stamped and the event can be purged from the VIU via USB connection for archiving.

DP-150 Dye-Pen Kit liquid quality assurance testing...

Often visual inspection alone can give inconclusive feedback to the quality of a medical device pouch seals. With the DP 150 you can add another tier of nondestructive testing between destructive testing cycles. Small seal anomalies such as channels and narrow seals are quickly revealed with a dye penetration test.

Here’s more about the DP-150

DP 150 dye penetration kits are so affordable that you can purchase multiple kits to facilitate pouch testing throughout your organization. Now you can regularly evaluate pouch and packaging machine performance in all related departments, including manufacturing, quality departments and maintenance. Avoid the mess of mixing dyes that may not conform to the required color mix and contrast of the ASTM standard. The DP 150 eliminates possible testing failures and human error with a “ready to test” system. The DP 150 dye penetration kit includes 20 disposable droppers so no cleanup is needed.

The DP 150 dye penetration kit includes a reference guide so you are able to quickly identify seal failures. The kit also has the ability to work in concert with our VIU system which provides additional visual resolution on your dye penetration inspection. Under our more robust regulatory environment you no longer have the luxury to send pouches to a third party laboratory. In-house packaging testing and inspection performed throughout the day is the new expectation for medical device packaging programs.

The DP 150 dye penetration kit includes a reference guide so you are able to quickly identify seal failures. The kit also has the ability to work in concert with our VIU system which provides additional visual resolution on your dye penetration inspection. Under our more robust regulatory environment you no longer have the luxury to send pouches to a third party laboratory. In-house packaging testing and inspection performed throughout the day is the new expectation for medical device packaging programs.

Explore our additional testing products

SPC-1 Specimen Cutter

Designed to use in concert with the ASTM F-88 peel study, this template specimen cutter can create a 1″ strip. This useful jig can save a great deal of time when performing an expanded DOE.

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 just 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.

VIU high resolution calibration waveform data

A closer look at machine performance

Your sealer ships to you with a high resolution calibration that includes waveform data to better evaluate your sealers performance. Our state of the industry laboratory is ISO 17025 accredited and ready to serve. Your medical pouch sealer is ready to begin your packaging validation right out of the box.

Meet the people behind the products and services

Our staff of dedicated professionals are all trained and certified in quality system management and understand critical and regulated processes. With over two decades of medical device packaging experience our skilled team is ready to assist you along every touchpoint.

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

SPC-2 POUCH SPECIMEN CUTTER

Speed and accuracy for medical device pouch specimen cutting, our all new SPC-2 strip cutter

Tensile testing your medical device pouch is a great way to understand seal strength and quality. Cutting your samples with a razor knife is time consuming and poses safety risks. With our all new SPC-2 pouch specimen cutter you can quickly and safely prepare test samples faster and easier to encourages testing often when preforming the ASTM f-88 tensile test. The robust build of the SPC-2 prevents device flexing that could affect sample consistency. Test more often and stay compliant with our full line of pouch testing systems.

Speak with an expert

When you are selecting critical packaging machinery for your medical device, skip the salesman and speak with a certified packaging engineer. Our team of experts includes Charlie A. Webb CPP, CKF, who is a certified packaging engineer and a six sigma black belt with more than 20 years of sterile packaging experience. Give us a call, we would love to chat...

800 550-3854

lets talk M-F 9AM – 5PM PST

 

 

Excellence is affordable at Van der Stähl Scientific