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.

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.

 

• 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

• 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
• 2-line printing on MD-3020

• 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

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