ISO/IEC 17025 Accredited Laboratory

Calibration

And Testing

Excellence

Our ISO 17025 accredited laboratory upholds to the highest requirements and principles under this exacting quality system and is symbolic to our commitment to precision calibration.

MEDICAL DEVICE PACKAGING BEGINS WITH ACCREDITED CALIBRATIONS

Our ISO-17025 accredited Laboratory is ready to serve our medical device packaging customers. Let us help you get a solid start on your medical device packaging program. Our laboratory can provide a comprehensive machine calibration, a vital foundation for your installation qualification. Our advanced laboratory has even created our own patented technologies for evaluating medical device pouches. Keep your medical device packaging program compliant with calibration and laboratory services from Van der Stahl Scientific. Let our competent staff of trained technicians perform a comprehensive calibration or let us evaluate the seal strength of your medical device pouch.

Machine Calibration

Our sealers ship to you from our fully accredited ISO-17025 calibration laboratory. We perform temperature calibrations at multiple internal thermal zones for better accuracy. We also verify that the pressure is within spec or we perform a multi-zone force calibration on the pressure transducer.

Pouch Testing

Our laboratory not only performs medical device pouch testing, we have actually invented and patented systems that we sell to our customers. We can provide pouch seal strength studies to help you develop nominal settings for your packaging machinery. Count on Van der Stähl Scientific, we invent new ways to test.

Service and Repair

Our highly trained technicians can provide a complete service or repair on your packaging machinery. Every technician at Van der Stähl Scientific is certified in a quality system and understands the critical nature of a medical device packaging machine. Each machine returns with a complete work sheet for your records.

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 and will provide easy to read reporting.

ISO 17025 Accredited

If you are a ISO 13485 medical device organization then your quality team is held to the highest standard in manufacturing. Partnering with vendors that are also ISO accredited is vital to your total quality plan. Why not begin your medical device packaging validation with a company that understands quality systems?

Medical device packaging support laboratory

Our ISO 17025 laboratory means we test, inspect and calibrate to ensure the highest quality standards for the machines we sell. When your customer list includes NASA and the Centers for Disease Control, absolute quality is paramount. We have developed and patented systems to help medical device manufactures reach their goal of precision in sterile device packaging. Our ISO 17025 accredited laboratory upholds the highest requirements and principles under this rigorous and exacting quality system. Our accreditation is symbolic of our commitment to total quality.

  • Thermal mapping and calibration
  • Platen force calibration
  • Tension calibration
  • comprehensive inspection reports
  • Annual preventive maintenance
  • Machine repair services
  • ASTM F-88 seal strength testing
  • thermocouple dry well calibrations

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 3 temperatures zones for a more complete calibration.

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 for a stronger I.Q.

Additional services and support from our laboratory

Pouch Testing

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 professionals.

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.

Calibration 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.

Service 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.

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.

Packaging machine service and accredited calibrations to go

Now you can receive the same high level service and calibration we offer in our laboratory, right in your cleanroom. We can travel throughout the US and we typically offer single day service in Southern California. For our customers that want their services delivered onsite we are here to accommodate. Request a custom onsite quote today.

“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

BEHIND OUR SEALERS A MEDICAL PACKAGING DREAM TEAM

Meet our Sig Sigma master black belt, patented inventor and medical device packaging guru, contact Charlie for validation support. Charlie A. Webb, CPP, CKF

Directory 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. She is Kaizen and Six Sigma certified and understands 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...