PARTNERs for your
Stellar packaging machinery and engineering support is the cornerstone of medical device packaging compliance. Van der Stähl Scientific and Packaging Compliance Labs are here to support your validation plan.
So Many Reasons to Choose our End-to-End program
PACKAGING COMPLIANCE LABS
FOR MEDICAL DEVICE
Medical device packaging validation is an exacting process that requires high levels of engineering support to conform to the validation requirement of ISO 11607-2. Our program is turnkey, we do all the leg work, from writing the protocols to performance testing and final installation at your facility.
Medical package testing takes place in our ISO 17025-accredited, state-of-the-art facility. From transit/distribution conditions to shelf life and sterile barrier integrity tests, we are a turnkey resource for validation.
we can help you deliver your medical device to market, learn how…
Partners For Your Packaging Success…
Van der Stähl Scientific
Our ISO-17025 accredited Laboratory delivers exacting calibrations from our staff of six-sigma certified technicians. Our “quick ship” parts and service center backs our machines for years of trouble-free packaging.
The Six Tiers to Medical Device Packaging Success
Medical Device Pouch Sealer
- Choose either a ROTARY or IMPULSE
medical pouch sealer
- Calibratable airless actuated force/pressure
- Verifiable and alarmed rotation speed
- Robust build for 24/7 packaging lines
ISO-17025 Accredited Calibration
- Calibrated force/time/temperature (impulse sealer)
- ISO/IEC 17025 Accredited Calibrations
- Range Calibration algorithm for tighter thermal performance
- Pre-ship equipment inspection and performance testing
Accredited Pouch Testing
- ASTM F-88 Peel study with waveform reporting
- Visual pouch inspection with our patented VIU system
- Validation technical support from our on staff CPP
- All of our Laboratory technicians are quality system certified
Validation Documentation Toolkit
- IQ / OQ / PQ protocols, ready to execute
- Built-in work instructions specific to using your equipment to build samples
- Process Failure Modes & Effects (PFMEA) document specific to your machines
- Guidance literature to support the various work outlined above
Material Technical Data Sheets
- PCL performs benchmark testing on 6-8 of the most common material combos your customers tend to be working with.
- We develop a seal curve analysis to characterize and demonstrate the potential seal strength and seal quality that can be achieved per each material
- That testing can be conducted using 3-4 common seal strength test methods
- We provide recommended settings and process limits for each
Hands On Support
- We develop a turnkey program that would involve a seamless transfer to one of our packaging engineers
- Our packaging engineer works with the customer to assist them in navigating the validation process
- That program can include us traveling to support the customer on-site
- Sealers can be shipped to PCL for debugging, DOE, and OQ; we then travel with the sealer to install at customer site, train them, and help facilitate the PQ
Medical Device Packaging begins with accredited calibrations
Impulse or Rotary sealer options backed with validation support.
To accommodate your workflow and your pouch material you can choose either an impulse sealer or a rotary sealerr that best suits your application. No matter which machine platform you select you can be assured that our industry-leading sealers can be backed by our End-to-End validation solutions. Contact customer care and let’s get started…
BEHIND OUR SEALERS A MEDICAL PACKAGING DREAM TEAM
Meet our Six Sigma master black belt, patented inventor and medical device packaging guru, contact Charlie for validation support.
The master of solutions, our Laboratory and Service Manager Cord Burnham guides our service, testing and calibration effort.
Hector is the master of media; he has a fresh eye on industrial design born from his time in the LA design district.
Our customers best friend, our General Manager Lisa Wassberg creates magic at every touch point for our medical device clients.
Sarah’s intuitive eye can solve machine issues with ease. Sarah is a Six Sigma Black Belt and understands the critical process.