medical packaging begins with accredited calibrations
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 force is within spec or we perform a multi-zone force calibration on the force transducer.
Service and Repair
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 manufacturers 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
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.
Additional services and support from our laboratory
A medical device validation is only as good as the verified documents that chronicle each step of the process. Our comprehensive support documents help you develop a needed audit trail for a packaging validation. Easy to understand and interpret, our documentation is just the support you need.
If you have one of our pouch sealers, then this course is for you. We cover the full spectrum of maintenance issues from inspection to parts replacement and machine adjustments. With this course, you will also have full access to our online Calibration and Technician Certification course.
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 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.
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. She is Kaizen and Six Sigma certified and understands critical process.
Speak with a packaging expert
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...