There are many medical devices that can benefit from a low moisture and oxygen environment.

Many of our customers that utilize the V-402 Medical Pouch Sealer have chosen this device in order to thwart problems such as oxidation or discoloration on some critical parts. Some of our customers pack medical devices with an optical surface and the moisture has caused the optics to fog or discolor. Also, many of these medical devices, in the presence of oxygen, can change key device chemistry that may be activated by an ambient environment or moisture. Some of our customers have simply found that vacuum packaging their device either alone or with a thermal-formed tray provided needed stability for the device during the shipping and handling process. Whatever your reasons for vacuum packaging your sterile part may be, you'll find the V-402 medical packager a key partner in your success in your packaging program.


 

[V-402 Medical Vacuum Sealer]

 

This versatile microprocessor-controlled vacuum sealer represents the magnum opus of vacuum packaging. The V-402 sealer incorporates an advanced microprocessor that allows for precision fine-tuning of all sealer-controlled functions. Temperature on the microprocessor can be set tightly in order to ensure seal strength compliance against the FDA's QSRs and ISO's 11607. Fully calibratable and easy to adjust, this microprocessor has a few more tricks up its sleeve such as the electronic vacuum gauge. The sealer can be set up for specific vacuum levels. Once those pre-set vacuum levels are achieved, the V-402 sealer will automatically withdraw the vacuum tube and invoke the heat and cool down dwell cycles, netting out a perfectly repeatable vacuum in your pouch in concert with perfectly repeatable seal strength expectations.

The V-402 Medical Pouch Sealer also incorporates its own piston-driven compressor to generate vacuum as well as run the sealer's pneumatic functions. This powerful compressor is designed for hard service and long duty and high throughput utilization. In order to maintain good compressor service over the life of the sealer, the V-402 medical vacuum packager incorporates its own dry filter unit as well as a 5 micron vacuum filter and collection vessel.


During each operation, the Hitachi microprocessor will light indicator lamps for vacuum, heat, and cooling in order to monitor the packaging process. This is designed to ensure seal-to-seal consistency for the critical packager such as medical device manufacturers.

The V-402 sealer is activated with an automatic footswich that incorporates several tiers of safety in order to prevent the possibility of injury to the operator. This 220V sealer includes its own fuseable link circuit breaker upstream of the power switch in order to further provide safety to the system itself. Every V-402 Medical Pouch Sealer is shipped with an NIST traceable certificate of calibration from Van der Stähl Scientific's comprehensive package integrity and calibration lab.


These units are typically in stock and can be shipped usually within 48 hours after purchase. Also, at the time of purchase, if your vacuum pouches are sent ahead to the Van der Stähl package integrity and calibration lab, we can optimize the machine's performance in order to help streamline the IQ process of your validation.

The V-402 will also generate a 10mm or .4" wide seal designed to maintain your product's sterility and vacuum to your customer. The V-402 Medical Pouch Sealer has a two-line print option in order for you to print date and lot coding information on the pouch. The FEP printer option utilizes thermal transfer technology in order to put a smear-proof mark on even the toughest films such as nylon or foil pouches. If you have questions regarding the V-402 or general questions regarding packaging or validation, please feel free to contact one of our certified consultants for quick, comprehensive answers to your questions.

Additional Product Photos

 

[Air Filter]
_Click For Larger View
[V-402 Microprocessor]
Click For Larger View

  • Microprocessor-controlled sealing parameters.
  • Electronic vacuum gauge for seal-to-seal vacuum consistency.
  • Captive dry filter for extended compressor life.
  • In-line 5 micron vacuum filter and collection vessel.
  • Electronic foot operation.
  • Multi-tiered safety functions
  • Wide 10mm heating element
  • Large adjustable integrated front table
  • Optional FEP Printer available
  • Fully calibratable microprocessor

 

 

Specifications

Model
Voltage
Power
Sealing Dimensions
Weight
Machine Dimensions
V-402-10 220V 2,000W 10mm x 400mm 42kg 560mm x 540mm x 340mm
V-402-10D 220V 3,000W 10mm x 400mm 42kg 560mm x 540mm x 340mm

 


Parts and Service
[Parts and Service]
_Parts and Service
Keep production in motion with our parts and service center. Our factory-trained engineering staff are exceptional technicians. Ask about our ship to you in 72™ parts program.
Validation
[Laboratory]
_Important Documents
Lost a manual? Or need calibration information about your sealer? Visit our engineer's area. Call customer service to get your password issued. 800-550-3854.
Validation
_Validation Radio Online
As part of our validation information network, you will soon be able to listen in to validation radio online. Hear important information regarding packaging validation.
Articles
[Validation Report Cover]
Read About our Industry
Read articles on this expanding area of our website regarding issues surrounding our industry. Call customer service if you wish to share your insights with colleages.





The Power to Control
The V-402 features an advanced microprocessor to streamline the packaging process. The user can input up to five different presets (recipes), saving the need to manually change parameters when changing pouch type.
[V-402 Microprocessor]

Three separate vacuuming modes are available, allowing for the ideal vacuum for your product and your process - manual, for stopping the vacuum with the foot pedal, pressure, for setting the suction to stop after a certain pressure is attained (kPa) and time, stopping the suction after a certain length of time has elapsed. These modes can be set per-recipe.

 

The intuitive step-menu makes it easy to switch between different recipes, and adjust settings when needed. Beneath the user-friendly interface lives a powerful, calibratable processor optimized from the ground-up for medical and vacuum sealing.

 

staff spotlight
Charlie A. Webb, CPP, CMC With an ophthalmic surgical background, Charlie understands not only the technical aspects of complex medical devices, but
[Why Van der Stahl]
as a device technologist also understands the rigors of compliance to 3rd part regulatory agencies.. Charlie also is a certified packaging engineer as well as a former independent management consultant. His unique background has gained great praise from our customers.

Process guidance Call and speak with Charlie regarding your packaging program for key regulatory and technology advice.

Package integrity As the director of our empirical laboratory, Charlie can help you discover needed machine processes for compliant seals.
800-550-3854 x112

 

Seal Inspection
During the development of this device, we have had the opportunity to inspect hundreds of sample seals from medical device manufacturers throughout North America and abroad.
[VIU]

Frustrated with the lack of available visual inspection equipment, we developed the Viu® in our packageing integrity lab (learn more about our package integrity lab). Even when utilizing the best available microscopes with both back and front lighting, we were unable to develop the needed visual acuity.

 

This tool has been a great help in our lab and has provided us with the means to develop repeatable protocol for the inspection of terminally sterile seal, visual integrity. Although the Viú® Box is not meant to replace peel or burst testing, it is a powerful tool for in-process seal inspection and will be a welcome tool in your nondestructive technological toolkit.

 


Testimonials

"When we first got into medical manufacturing, we didn't know much about pouch sealing. Charlie took the time to explain the process and the equipment needed to do the "right" job. Through recommendations from my pouch supplier and conversations with Charlie, I knew I didn't need to look anywhere else for my equipment needs."

 

-David Capes, Quality Assurance