medical device packaging standards

Medical device vacuum packaging systems

Many medical device manufactures have found that vacuum packaging their devices has several important benefits. The V 402 medical device pouch sealer is an amazing yet affordable solution for keeping your medical device viable to the point of care. No outside air supply required, a standard 110v power source and you are ready to package.

Your advanced medical device packaging solution

The value of even the most stellar medical device is lost if sterility is compromised. Packaging your medical device with confidence with a medical device pouch sealer from Van der Stähl Scientific. We serve the worlds largest and smallest medical device firms with equal care and support. We invite your to explore our site today and see why we are the first choice in medical device packaging.

Value of standard vacuum packaging critical medical devices

Many medical device manufactures have found that vacuum packaging their devices has several important benefits. The V 402 medical device pouch sealer is an amazing yet affordable solution for keeping your medical device viable to the point of care. No outside air supply required, only a standard 110v power source and you are ready to package. The V 402 medical device packager is also available as a gas flush sealer that allows better management of the pouch gas environment.

Vacuum Purge

Embedded drugs or chemistry can be compromised in the presence of an ambient environment. Flushing the pouch with a nitrogen or inert gas helps mitigate changes that can impact device efficacy. Operators now have great flexibility with the gas flush cycles using intuitive inputs on the V 402 microprocessor.

Rugged Performance

The V 402 is built on a solid platform and will serve your packaging line for years to come. With our thin film thermocouple we sample data at the pouch environment for exceptional temperature control. The steel machine case provides rugged protection for the unit and is an attractive addition to your cleanroom.

Calibrated System

Our sealers ship to you from our fully accredited ISO-17025 calibration laboratory. We can also perform temperature calibrations at multiple thermal zones for better accuracy. To provide additional accuracy we run a second redundant data logging session with a different meter and test probe.

Simplicity in vacuum Packaging

Now you can better manage the delivery outcome of your medical device with advanced vacuum packaging machinery from Van der Stähl Scientific. Systems like the V-402 can quickly remove the ambient air in order to help thwart precipitation of moisture within the pouch.

Spec Sheet  View Video

Medical Device Vacuum Packaging

Click the video link below and learn how the V-402 vacuum sealer can transform your packaging workflow. Our sealers small footprint keeps counter tops open for a cleaner workstation. Contact our engineering group to learn more about vacuum packaging.

Vacuum or gas flush medical device packaging

The V 402 medical device pouch sealer can seal most flexible films and is a great way to managed the environment of the medical device pouch. Operators can toggle through preset pouch specific recipes for fast job change setups. The steel machine case provides rugged protection for the unit and is an attractive addition to your cleanroom. Microprocessor-controlled sealer attributes deliver exceptional seal to seal performance for your medical device packaging program. This sealer is gentle on consumable parts keeping cost of ownership extremely low.

  • Microprocessor controlled temperature
  • Release temperature control
  • Manufactured for long duty performance
  • Requires no air supply to operate
  • Cleanroom-friendly design
  • Thermal calibration from our accredited lab

Cradle your medical device safely to the point of care

Vacuum packaging your medical devices has value beyond controlling unwanted gases. Vacuum packaging can hold tight your device to help thwart movement of the device in transit, less movement means less risk of device damage. To learn more about the value of vacuum packaging your device contact our engineering group at 800-550-3854.

Here’s more about the V 402 Medical Pouch Vacuum Packager

The V 402 medical pouch sealer has been an industry favorite for nearly 20 years. This powerful packager is built on a solid industrial platform and ready to serve your medical device packaging line for years to come. The V 402 utilizes our thin film thermocouple to sample thermal data in the pouch environment for exceptional temperature control. Operators can toggle through preset pouch specific recipes for fast job change setups. The steel machine case provides rugged protection for the unit and is an attractive addition to your cleanroom. Microprocessor-controlled sealer attributes delivers exceptional seal to seal performance for your medical device packaging program.
The V 402 medical device packager is also available as a gas flush sealer that allows better management of the pouch gas environment. Many of our customers have discovered that sensitive devices like those with embedded drugs or chemistry can be compromised in the presence of ambient environments. Flushing the pouch with a nitrogen or inert gas helps mitigate product change that can impact device efficacy. Operators have great flexibility with the gas flush cycles using intuitive inputs on the V 402 microprocessor.
All functions are controlled by a precision microprocessor. Users can control vacuum levels with the integrated electronic sensor. Simply set the KPA (Kilopascal) value and once the preset vacuum is reached, the nozzle automatically withdraws. The V 402 will then start the heating process finishing the cycle by cooling while under pressure. After the vacuum and sealing process is complete the jaws will open revealing a perfectly vacuumed and sealed pouch. A calibration algorithm helps fine tune the temperature performance for your critical medical device packaging process. Send us your device and packaging and we will vacuum package and return for your evaluation.

Laboratory vacuum Packaging

The V-300 is completely self-contained and can seal heavy foil or nylon bags right out of the box. This compact sealer can create a wide 10mm seal and can seal bag widths up to 300mm. This sealer is ideal for laboratory use and even non-sterile production of several thousand pouches per day.

Here’s more about the V 300 Medical Pouch Vacuum Packager

Take advantage of all of the known benefits of vacuum packaging with the powerful yet affordable V 300 vacuum sealer. The V 300 vacuum sealer is portable and rests nicely on your workbench or production table. The V 300 has a powerful captive pump so no external air source is needed, simply plug the unit into 110v power source and you’re ready to begin vacuum packaging. The V 300 uses a table actuated sealing jaw that is extremely ergonomic for workers and is completely safe. Operators can control vacuum time with an integrated analog timer in order to achieve a perfect-vacuumed environment each and every time. A heat timer can be tuned to accommodate a variety of pouch materials and thickness.
The V 300 vacuum sealer ships with a robust parts kit to keep your sealer operating at peak performance. The parts kit fits neatly under the machine in the parts tray so your parts are always where you need them, when you need them. The V 300 sealer is known for its rugged design and long duty performance, which is why it has been in daily use in our lab and shipping department for over a decade. This sealer endures rough treatment with multiple users and still performs like a champion every day. The multi-use, multi-industry V 300 vacuum sealer has found its home with companies ranging from food processing to medical laboratories worldwide.
The V 300 sealer is also available in a double heating element configuration in order to seal heavy foil gusseted bags. You could spend well over $10,000 dollars on a vacuum sealer and still not match the long duty performance of the V 300 vacuum sealer. It is backed by our solid warranty and supported by our knowledgeable tech support staff and parts and service center. When you’re looking for vacuum packaging solutions, whether it is a laboratory product, food or confection, choose the sealer that performs, the V 300-10. See for yourself why this sealer has gained such a great reputation from users worldwide.

Introducing the V-460 stainless steel cleanroom ready vacuum packager

The Microprocessor controlled V-460-10 incorporates a powerful electronic solenoid, this advanced pressure system enhances reliability and streamlines validation. The V-460-10 sealer can also be ordered with a gas/flush configuration in order to nitrogen flush your medical device pouch for better control of the pouched environment.

Specifications

Powerful medical device pouch testing and inspection

Rapid pouch testing

Fast load grips and sample aliment tool make testing accurate and easy. Our include specimen cutting template assures test sample constancy. Grips return to home position after testing.

A smarter system

Test your pouch at compliant speeds and start distance and collect test data at 100 data points per second. Our spring check system verifies that the testing system is still running within calibration.

An eye on quality

The PTT-100-V incorporates a visual pouch inspection fixture to help identify seal failure. This patented VIU system help to identify possible seal failure by side lighting and magnification.

Explore other packaging systems

Impulse Sealers

For many types of medical device pouches static impulse sealers are your best choice. If you are sealing a header bag or foil pouches, Impulse sealers will products a clean strong seal seam. Contact our engineering group if you need guidance on machine selection 800-550-3854.

Testing Systems

Testing and inspecting is one of the single most important quality steps your company can take to avoid a packaging recall. With the PTT-100-V the process of testing and inspection is quick and easy. Learn more about all of our medical pouch testing and inspection solutions.

Rotary Sealers

With the MD-series packaging machines the sealing process is managed with tight thermal controls and a highly accurate transducer that monitor 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.

VIU high resolution calibration waveform data

A closer look at machine performance

Your sealer ships to you with a high resolution calibration that includes waveform data to better evaluate your sealers performance. Our state of the industry laboratory is ISO 17025 accredited and ready to serve. Your medical pouch sealer is ready to begin your packaging validation right out of the box.

Meet the people behind the products and services

Our staff of dedicated professionals are all trained and certified in quality system management and understand critical and regulated processes. With over two decades of medical device packaging experience our skilled team is ready to assist you along every touchpoint.

Our customers are talking

"...The Van der Stähl name has become a fan favorite within our metrology department because of the certification Van der Stähl performs on the units. When we receive the machines in, the metrology department needs to do very little to get these active..."
― MATT SMITH, MANUFACTURING ENGINEER

Our customers are talking

"Amazing company to work with. The information is exactly what we need to complete our IQ OQ PQ. Thank you!!!!!! Your company is a leap above the rest…"
― AARON, DIRECTOR OF QUALITY CONTROL

Our customers are talking

"We have found Van der Stähl products and services to exceed our expectations. The sealers, test equipment and calibration services have been robust, efficient, and competitively priced. Van der Stähl is a key contributor to our continued success."
― RICHARD DAVIS, DIRECTOR OF ENGINEERING

Our customers are talking

"I just wanted to send a quick note to thank you and all the Van der Stahl Scientific team for going above and beyond to resolve the issues we had with our pouch sealer. Even though the issues were not of your doing, you took it upon yourself to make things right so we could meet the commitments that we made to our customers. We were blown away by your response and greatly appreciate you, not only for expediting the build, but for completely replacing the machine!"
― ALAN SCOTT, PACKAGING ENGINEERING COORDINATOR

Our customers are talking

"High level of customer service by a group of technicians and sales staff that know their product."
― MARY ANN GREENAWALT, DIRECTOR

Our customers are talking

"Your customer service is even better than the great equipment you provide. Even on the other side of the world I know we can count on your team. We are customers for life. Van der Stähl has the best combination of equipment and people."
― THOM TRIMNAL, GENERAL MANAGER

ACCREDITATION MATTERS

Partner with professionals who understand your business, Van der Stähl Scientific

As medical device packaging processes become more rigorous, it is essential to choose accredited and competent vendor partners. We deliver our machinery through our ISO 17025 accredited calibration laboratory to give you a solid start on your installation qualification for your packaging validation. In our Laboratory we can develop seal strength values so you can better understand your aggregate packaging plan. We will continue to add to our scope to provide our customers with more services from our accredited testing and calibration laboratory.

Speak with an expert

When you are selecting critical packaging machinery for your medical device, skip the salesman and speak with a certified packaging engineer. Our team of experts includes Charlie A. Webb CPP, CKF, who is a certified packaging engineer and a six sigma black belt with more than 20 years of sterile packaging experience. Give us a call, we would love to chat...

800 550-3854

lets talk M-F 9AM – 5PM PST

 

 

Excellence is affordable at Van der Stähl Scientific