Let us test your medical device pouches in our lab

Testing your medical device pouches by a third party accredited ISO/IEC 17025 medical device pouch testing laboratory is a great way to help you stay compliant. With our monthly SPOT Program™ (sterile packaging on track) we can help you verify that your medical packaging and in house testing plan is on track.

Seal performance study instructions and submission form

Please take a few moments to read our seal performance study SOP and disclaimer.  Our standard test program includes a 30 specimen seal strength test per our peel study SOP as well as a 2 pouch dye penetration evaluation. It is important that you understand and agree with our test methodology and protocol to be sure that it meets your internal requirements as well as any 3rd party requirements before commissioning a study with our laboratory. Van der Stahl Scientific does not interpret data as to the value of pouch seals as it relates to your medical device packaging validation. The scope of this study is to provide raw data for your interpretation. For additional questions contact our engineering group, 800-550-3854.

Prepare samples

Seal your pouch samples or gather samples from production that you wish to have evaluated. Be sure to note the sealing machines serial number that created the samples. If you require pouch normalization periods longer than our standard 48 hours, please indicate your normalization dwell preferences.

Mark samples

Provide us with adequate seal samples (35 for our standard test program) as well as additional buffer samples. If you are sending samples sealed at various times and temperatures settings, please mark specimens individually to thwart confusion. Please indicate any special conditions on this form.

Ship samples

Be sure to read our peel study SOP and disclaimer to be certain that our testing methodologies are in sync with your regulatory and internal requirements. Please fill out the form below and provide us with any additional comments in the comment field below. Send in sturdy box to our Laboratory.

  • Customer Information

  • Material

  • Sealing Unit Information

  • Test Limits (If predetermined)

    1. Ensure that the number of samples that you are sending is sufficient to perform the tests. Remember that some of the material may be sacrificed during the process of determining the upper and lower limits of the material.
    2. For every different type of material, or different size of pouch, an individual form must be filled out with the required information so that the test report can be completed properly.
    3. Our test method is the following method as stated in the ASTM F88/F88M-15:
      4.2.1 Technique A: Unsupported — Each tail of the specimen is secured in opposing grips and the seal remains unsupported while the test is being conducted.
    4. Please agree to the terms of which we will perform this test
  • View Medical Pouch Test Terms

Our complete line of medical device packaging support services

Range Calibration

The best medical device packaging validations are built on a machine calibration that explores the usable range of thermal performance. With our range calibration we will verify packaging machine compliance to set temperatures over 3 temperature settings. Stay compliant with better calibrations.

Force Calibration

The amount of force that is being applied to your pouch needs to be understood to develop a cogent medical device packaging validation. With our precision transducers and advanced meters, we can verify critical machine pressure. Our accredited laboratory will provide easy to read reporting.

Time Verification

When developing your DOE (design of experiments) it is vital that you understand the value of all measured attributes. With our laboratory developed system we can verify our machinery’s adherence to time set points. Understand all critical points on your packaging machinery for a solid validation.

Dye Penetration

Under our ISO/IEC-17025 scope of accreditation we can now perform dye penetration studies using the ASTM 1929 standard. We will provide you with 2 Dye Penetration reports that include a technician’s summary as well as photographs of the study for your records and a better packaging validation.

Performance Study

The ASTM F-88 tensile test is still the workhorse standard for understanding medical device pouch seal strength. We will perform a 30 specimen study on your pouches expressing the data to a plot graph as well as a histogram for interpretation. This is the most important study we perform in our lab.

Validation Support

Our founder comes from a surgical device background and understands the challenges facing medical device makers. Call and speak with our on-staff CPP and take advantage of all we have learned from over 20 years of sterile device packaging. Certified support from a team of dedicated professionals.

Service Training

If you have one of our pouch sealers, then this course is for you. We cover the full spectrum of maintenance issues from inspection, parts replacement and machine adjustments. With this course, you will also have full access to our online Calibration and technician certification course.

Calibration Training

The final step in maintenance is machine calibration. Our calibration training will demonstrate how to select the proper meters and tools for your unique sealing machine. You will learn from our highly trained senior technicians as they guide you through each step in the calibration process.

Supporting Documents

A medical device validation is only as good as the verified documents that chronicles each step of the process. Our comprehensive support documents help you develop a needed audit trail for a medical packaging validation. Easy to understand and interpret, our documentation is just the support you need.

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…”

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…”

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.”

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!”

Our customers are talking

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

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.”

Look who is behind our calibration and testing services

Charlie A. Webb CPP, CKF

After graduating with a Business and Management degree from The University of Redlands, Charlie continued his education at the Anderson Graduate School of Management at UCLA, focusing on an expanding interest in medical devices. Charlie holds two US patents for medical packaging equipment as well as two additional pending patents.

Cord Burnham, CKF

Cord understands the complexities of layered systems. Cord is a keen diagnostician with mechanical and electrical systems and has been an important addition to our metrology lab. The center of a well run lab is organization, and that has been the key contrabution that Cord has made to the Van der Stahl Scientific organization.