END-TO-END MEDICAL PACKAGING SOLUTIONS

PARTNERs for your

Medical packaging

SUCCESS…

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

Van der Stähl Scientific and Packaging Compliance Labs deliver boutique services through two ISO 17025 accredited laboratory’s that upholds to the highest standard of quality control. Our End-to-End turnkey solutions begin with Industry-leading medical device packaging machinery and ends with concierge-level engineering support through Packaging Compliance Labs. If End-to-End support is more than what you currently need you can select from a menu of validation services from Packaging Compliance Labs. Medical device validation is an arduous and challenging process, there is no need to go through the process alone and unsupported. From the industry’s leading pouch sealing machinery to competent engineering support and validation guidance, we will support you through the journey.
Packaging Compliance worker
PACKAGING COMPLIANCE LABS

TURNKEY SOLUTIONS

FOR MEDICAL DEVICE

PACKAGING SUCCESS

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 and Packaging Compliance Labs are here to support your medical device packaging validation plan. Stellar packaging machinery and engineering support is the cornerstone of medical device packaging compliance. Let us help guide you to the right medical device packaging system and validation support, let’s get your medical device sterile to the healthcare marketplace…
Van der Stähl Scientific

VALIDATION

COMMANDS SMARTER

PACKAGING SYSTEMS…

We offer long-lasting, precision-controlled packaging and testing systems designed to meet the expanding challenges of medical device packaging. Our sealers are built rugged for years of solid, trouble-free service and we utilize advanced microprocessors for maximum control and ease of validation.

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.

Woman using the MD 880 medical packaging machine

The Six Tiers to Medical Device Packaging Success

Lab technician holding a medical pouch with scissors inside

Tier 1

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

Tier 2

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

Tier 3

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

Tier 4

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

Tier 5

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

Tier 6

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

TIME VERIFICATION

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.
FORCE CALIBRATION

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 force, and will provide easy to read reporting.
THERMAL CALIBRATION

Thermal 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 at 3 temperatures for a more complete calibration.

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 sealer 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.

Charlie A. Webb, CPP

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

Hector is the master of media; he has a fresh eye on industrial design born from his time in the LA design district.

Hector Garcia

Media services, design and marketing

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. Sarah is a Six Sigma Black Belt and understands the critical process.

Sarah Deputy, CKF

Testing and Calibration services

Sarah understands the complexities of medical device packaging validation and is your first connection transitioning to PCL

Sarah Rosenblum

Director of Sales and Marketing for PCL