medical device packaging standards

 

Medical device packaging quick start program

Medical device packaging validation can be a daunting task, get help today with our medical device packaging “quick start program”. Our catalog of accredited medical pouch testing and calibration services will fast track you to a successful sterile device packaging program. Partner with our team of medical device package professionals.

Vendor Support Makes the Difference in Validation

Medical device packaging compliance begins with competent vendors and compliant machinery.

Our robust line of medical device packaging machines can be found in nearly every cleanroom in the country sealing millions of pouches annually. Our certified packaging engineers (CPP) have helped thousands of customers reach the point of care with their device sterility intact. Our ISO/IEC 17025 accredited laboratory develops traceable machine calibrations as well as pouch performance studies to help our customers build their packaging validation. Take advantage of our 20 plus years of front line sterile device packaging experience and learn from seasoned packaging professionals. Not only have we ridden the regulatory wave in medical device packaging, we have literally created a shifting paradigm in sterile device packaging with our patented pouch testing integration. Remember it is far more than the machinery you are purchasing; it is more about the team that can support your sterile packaging program. Certified engineers backed by our accredited lab, a winning team.

Look at what is included with our Quick Start Program

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.

ServiceTraining

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.

Fast track packaging validation with our “Installation Qualification” support

The headwater of a solid medical device packaging validation begins with the foundation of a clear “IQ” Installation Qualification. The standard is clear, to develop a cogent medical device packaging plan we must explore packaging machine capabilities and limits, let us help.

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

ACCREDITATION MATTERS

Partner with professionals who understand your business, Van der Stähl Scientific

As medical device packaging processes become more rigorous, it is essential to choose accredited and competent vendor partners. We deliver our machinery through our ISO 17025 accredited calibration laboratory to give you a solid start on your installation qualification for your packaging validation. In our Laboratory we can develop seal strength values so you can better understand your aggregate packaging plan. We will continue to add to our scope to provide our customers with more services from our accredited testing and calibration laboratory.

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