MEDICAL PACKAGING DATA SERIES

Understanding

heat sealing

technologies

When packaging medical devices, it is important to understand the different methodologies and how they interact with your flexible film. Take a moment to read the below overview in order to gain a better grounding for packaging your medical device.

The term heat sealing is used to describe a variety of bag sealing methodologies however when referring to a heat sealer it’s important to understand the different types of heat sealing. It’s valuable to understand the difference between the two most common bag sealing methods. Let’s quickly explore these two methods so you can make a more informed decision when selecting which packaging machine is best for your application.

 

Constant heat

As the name implies constant heating applies a predetermined temperature to the pouch or bag but it does not cool the sealed area when the packaging machine Jaws are closed.

van der stahl scientific teams up with hospital packagers

Impulse heat

Impulse heat sealing conversely applies predetermined heating and cooling temperature when the jars are closed in order to control two critical parameters.

Heat sealing your medical device pouch with the impulse method is favored for medical device packaging applications as once again you control critical parameters allowing for a measurable design of experiment when developing your medical device pouch sealing validation. There are other ways to bond thermal plastic such as ultrasonic sealing however these typically are not employed for flexible films that are utilized for medical device packaging and the sterile barrier system. Therefore, it is important that you choose a heat-sealing process that is going to give you repeatable controls of your outcome.

Our in-house application engineers are a terrific resource for guiding you to the best sealing process based on your specific film and the expected throughput you wish to package each day. When discussing your medical device packaging process with one of our application engineers they can also fine-tune your selection by understanding what class of medical device you are packaging and how it will be delivered in the sterile field. We can also best guide you if we understand other issues such as which sterilant will be used on the device and pouch and what are your expected seal strength values.

In closing when considering a heat sealer, it’s important that you develop a simple purchase specification that meets the requirements for your process. ISO 13485 medical device manufacturers also Shall maintain an Approved Supplier List (ASL) and only work with the vendors that provide the high level of process controls that are commensurate to the purchase. Our company is ISO 17025 accredited in order to meet the calibration and testing requirements of medical device manufacturers. The right product and the right vendor are paramount in order to assure a successful medical device packaging validation process.

Explore our medical device packaging equipment and testing systems

IMPULSE POUCH SEALERS

Our robust solenoid-actuated sealing bar engenders seal to seal force by gating voltage through our advanced microprocessor. With our airless system, you do not need to manage the complexities of validating the air source. Just plug into a standard 110 volts and you’re ready to package your medical device
ptt 100v medical device pouch testing machine

POUCH TESTING SYSTEMS

Testing and inspecting are some of the quality steps your company can take to avoid a packaging recall. With the PTT-100V the process of testing and inspection is quick and easy. Learn more about all of our medical pouch testing and inspection solutions. Request a no-cost pouch study from this testing system.
Van der Stahl Scientific md series rotary pouch printer sealer

ROTARY POUCH SEALERS

With the MD-series packaging machines, the sealing process is managed with tight thermal controls and a highly accurate transducer that monitors sealing force. Fixed pressure and conveyance speed allow for a simple design of experiment. Print and seal with a single step with the MD-series rotary sealer.

Testing integration, the future of medical device packaging

Medical device packaging engineers agree the pathway to compliant device packaging is through regular testing and inspection. With our patented MS-451-PV medical device pouch sealing machine, seal performance is verified with the onboard testing and inspection system.

Your medical device pouch is not just packaging; it is an integral part of your medical device…

The sterile presentation of your medical device is equal to device efficaciousness. Stay compliant to the sterile barrier system requirements with better packaging machinery and market leading educated support. We are here to help you with our on-staff engineers and our accredited IEC/ISO 17025 testing and calibration laboratory.

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, CPPL

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…