German designed and engineered advanced medical device packager.

This sealer represents years of development and utilizes the most advanced technology for the sealing of terminally sterile flexible packs. Continuous Film Sealing Machine MD-850 with integrated, microprocessor controlled printing unit. Optimum sealing safety for packing sterile goods e.g. in clinics and laboratory environments. Under the new sterile barrier system, medical device packagers will be asked to evaluate not only seal strength but seal integrity. That has put higher demands on the machinery utilized for the process of packaging terminally sterile goods.

 

[MD-850]

 

The MD-850-US medical pouch sealer represents the most advanced microprocessor-controlled packaging offered in the medical device arena, with finely tuned pressure transducers and thermal probes with high accuracy and acuity. The MD-850 medical device sealer is an excellent choice for packaging your sterile product against this new robust standard.

 

Precision is paramount in medical device packaging, so use a medical device sealer that is up to the challenges and controls of the sterile device packaging process.


 

The sterilization of medical instruments begins with the packaging. That is to say that the packaging, and therefore also the validation of the packaging process, is crucial for guaranteeing sterility up to the point of use and for meeting quality standards. It is through the precision controls of the triad of accurate temperature monitoring, transducer-managed pressure and microprocessor-monitored drive speed that a clear validation program can be engendered.

 

The ISO 11607 standard demands explicitly reproducible processes in order to achieve optimum and constant results at all times during Operation Qualification. The critical process parameters must be monitored continuously. If there is any deviation, the device must immediately switch itself off and indicate what the problem is. The sealing of a sterile package is only possible with a sealing device that can be validated in accordance with

ISO 11607.

 

The MD-850-US medical rotary sealer is the ideal sealer for the packaging of sterile goods in clinics and laboratories, satisfying the highest quality and safety standards. Call and speak with a validation engineer. We will be glad to generate a pouch study with your pouches to determine machine settings to generate compliant seals.

 

Superb German engineering delivers accurate seal to seal consistency. Backed by Van der Stähl Scientific's world class validation support program. Remember NIST traceable calibration, free preventative maintenance software, free package integrity studies in our comprehensive pack lab and toll free validation support from our on-staff CPP. Contact technical support or customer service now toll free at 1-800-550-3854.

 

 

Additional Product Photos

[MD-850 Medical Rotary Sealer]
_Click For Larger View
[MD-850 Medical Rotary Sealer]
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[MD-850 Medical Rotary Sealer]
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[MD-850 Medical Rotary Sealer]
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Machine Specifications

Feed and Sealing System
  • Guide plates made of chromium steel
  • Double intake protection against foreign objects prevents machine malfunctions
  • Roll Automatic temperature controlled on/off function
  • Flexible and adjustable sealing and stamping
  • Safe distance to DIN 58953-7, min. 30 mm

Printer
  • Sterilization date and use-by date available in various formats with automatic updating Batch number
  • Personnel number Print format rotateable
  • Digital display of temperature through symbols in accordance with EN 980
  • CE mark with follow-up text
  • Adjustable print start margin in mm
  • Simple front access ribbon

Heating
  • Computer controlled sealing temperature
  • 80-220°C, infinitely variable
  • Digital display of temperature
  • Temperature accuracy to DIN 58953-7 < ± 2%
  • Motor starting cut-out in the event of 5°C deviation
  • Thermal safety switch from the temperature set point value

Suitable Films
  • Laminated paper
  • Plastic films (aluminum coated)
  • Transparent foil compound film (PETP/PE) EN-868-5
  • Transparent foil TyVek+ (PETP/PE) EN-868-9/10




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.





Menu-Driven Controller
This simple-to-use menu-driven controller allows users to easily set not only machine's operational settings, but printer settings as well. Operators can select a host of pouch print functions such as ISO compliant symbolization. Operators can also select date of manufacturing, expiration dating, lot and product numbers.
[MS-451PV Player]

The intuitive, simplified, membrane buttons create a comfortable and sensible user interface. A maintenance alert will flash on the display when the sealer is due for annual calibration. The calibration intervals can be determined at the time of calibration for any future date to better serve the quality team's needs.

 

The easy to read display can also be set up in multiple languages in order to thwart language barrier issues in a multi-national firm.

 

Upgrade to the MD-3010

Under the expanded ISO-11607, medical device manufacturers are asked to develop robust monitoring of this critical process. The MD-3010, designed for the European market, truly takes bold steps forward in managing the sterile barrier system. This rotary sealer uniquely features on-board X-Y graphical real-time monitoring, which does so in-process.

[MS-451PV peel tester]

This advanced microprocessor-controlled sealer monitors feed speed (tach), temperature at the platen, and further utilizes an advanced transducer-controlled monitoring of pressure roller. These functions assure that parameters that were set during the design of experiment (DOE) are being managed at all times in the spirit of the life-cycle approach of the sterile barrier system.

The advanced performance of the MD-3010/3020 assures that your product will make it safe to the surgical theatre. This unit also allows medical device manufacturers to print all required symbolization on the non-sterile side of the seal. Date of manufacturing, expiration dating and lot numbers can be imprinted on the pouch as well as their ISO symbolization. There's no better way to seal and print a package for a sterile medical device.

 

At Van der Stähl Scientific, we understand the challenges facing medical device packagers and that's why we're excited to offer our IQ pack. With each machine, we will custom-calibrate your sealer and provide you with an NIST traceable certificate, raw data collected during your calibration session as well as a calibration sticker for the sealer.

 

Also remember that Van der Stähl Scientific has taken a maverick position providing our medical device customers with toll-free support with a certified validation engineer as well as audio educational programs providing updated information about sterile device packaging.

 

Seal Check System
Van der Stähl Scientific and HAWO are excited to bring you this powerful sterile packaging validation tool.
[HAWO Seal Check]

In accordance with ISO 11607, Part 2, the sealing seams must show the following quality characteristics within the Operational Qualification (OQ)

 


Visual 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 Viú® in our packaging 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.