Sterile packaging on track

Monthly

Pouch

Testing

With our accredited SPOT™ (sterile packaging on track) program, we will test your device pouches each month to help assure that your medical pouch sealing program is on track.

STAY COMPLIANT WITH MONTHLY MEDICAL POUCH TESTING

Our ISO/IEC 17025 accredited laboratory is your partner in sterile packaging compliance. There is no better way to confirm that your medical device packaging is conforming to your requirements than with our new SPOT program™ (sterile packaging on track). With our monthly subscription SPOT program™, you simply drop your pouches into the provided prepaid shipping envelope and send it off to our accredited packaging laboratory. We will perform a 30 specimen ASTM F-88 m-15 seal strength study as well as an ASTM F-1929 dye penetration evaluation on your medical device pouches. We will then promptly send you back a comprehensive report evidencing your seal performance from our ISO/IEC 17025 accredited laboratory. Why risk a packaging recall, let’s get started?

Step one

Just click the packaging study link under resources on the bottom of this page and fill out the questionnaire. Tell us about your pouch material and process so we can perform the most accurate testing. Now one of our quality system certified packaging lab technicians will evaluate your form and be on standby.

Step Two

Now just seal 30 of your pouches on your packaging machine with settings you wish us to evaluated or just randomly pull samples from a specific medical pouch run. Then simply drop the pouches into our prepaid envelope and ship it back to our laboratory and we will begin working on your medical pouch study.

Step Three

We will complete your medical device pouch seal strength study and send you a comprehensive report for your evaluation and interpretation. You can now evaluate your internal pouch strength testing to develop a simple round-robin to evaluate your testing, or to verify your packaging is not creeping out of spec.

Peace of mind Delivered

A solid medical device packaging validation is supported by layers of double checks to make sure that the process is sound. When you fail to look outside of your own testing and calibration functions you risk data bias that may cause a loss of sterility of your device. Help is here from our ISO/IEC 17025 accredited Laboratory and with our SPOT™ (sterile packaging on track) program, we will test your pouches each month.

Let us take a second look at your sterile barrier systems

The value of testing

Commissioning a medical device pouch study with an independent third party accredited empirical laboratory is a great first step for your packaging validation. Under our ISO 17025 scope we can perform an ASTM F-88 tensile test to determine seal strength and express the study data into an easy to interpret color waveform and scatter graph. Call to learn more about our expanded services.

DYE PENATRATION TESTING

Let us perform an ASTM F1929-15 dye penetration test on your pouch so you can better understand the value of the seal surface. We will provide comprehensive reporting for your records to better serve your quality archiving and audit path. Our testing technicians are quality system certified to assure the most accurate testing.

High resolution pouch performance reporting…

With our testing services you will receive a high resolution data report that includes waveform data to better evaluate the performance of your pouches. Our state of the industry laboratory is backed by our ISO/IEC 17025 accreditation. Click the link below to learn more about additional services from our laboratory.

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...