It's here, the new MS-350-ng. It seems the MS-350 medical device packager has reached celebrity status among medical device engineers and device manufacturers. Centered on its reputation of accurate performance and durability, this sealer has been purchased by the nation's leading medical device makers. It has also become a favorite among medical device startups. The MS-350 sealer, from its baseplate up, has been designed and built for the specific task of sealing flexible medical pouch films such as Tyvek®, foil, poly, mylar, etc.

In the early days of design, it was decided to utilize an electronic solenoid in order to better manage constant pressure at the seal platen. Because the solenoid produces a known amount of inductance/force based on the solenoid's architecture and supply voltage, it was the perfect choice to create seal-to-seal consistency of pressure.

Unlike inexpensive air-driven pistons utilized on some packaging equipment, the MS-350 sealers are not affected by possible fluctuations on supply pressure that may create their own separate validation complexities and, indeed, may compromise pressure consistency at the platen. Also, with the advanced solenoid system, there are no air quality issues in the cleanroom and monitoring alarming of the solenoid system is more precisely managed.

Now with the new MS-350-ng, quality assurance teams can create clear and cogent design of experiments. The advanced Hitachi microprocessor allows packaging engineers to develop a triad of data by simply entering temperature in Fahrenheit, heating dwell in 1/10 second increments and finally by entering release temperature. With this advanced system, there is no operator influence, irregardless of throughput. With a thin-film K-type thermocouple, the microprocessor accurately extracts data from the heat platen in order to precisely manage thermodynamics during the sealing process.

Also, new on the MS-350-ng, quality assurance teams can create a 4-digit numeric code that creates a firewall to all machine functions other than operating the machine for sealing. This helps to thwart possible in-process changes to critical machine settings, either inadvertent or deliberate.

The Hitachi microprocessor utilizes a burnt circuit board designed specifically for the task of sterile device packaging. Unlike some machinery using off-the-rack programmed logic controllers, this microprocessor will not create software validation issues that may occur in a PLC. This advanced microprocessor also monitors a host of functions in the background during the packaging process. This microprocessor delivers highly-accurate heat and cool cycles (see actual datalogging session). This system watches via a position/microswitch to be certain operators' fingers are not harmed in the event of an operator accidentally putting their finger on the heat platen.

The processor is also watching for temperature sensor and heating element functions. This processor is so advanced, it even watches for a clean, non-fluctuating voltage supply line. The new MS-350-ng can be operated in 3 different ways in order to better suit your work flow. The operator can utilize the included footswitch by foot or on the feed table via its magnetic back in order for hand activation. Or, in the case of high throughput, the sealer can be invoked into a semi-automatic mode, which will invoke the machine's operation from 0-5 seconds, with 10-second increments of adjustment.

The MS-350-ng ships with our IQ pack (Installation Qualification). The sealer is calibrated in our lab using a high resolution Agilent datalogger and our proprietary software. This helps us better interpret the metrology performed on your sealer at the time of shipment.

Also, if pouches are provided at the time of purchase, we will perform an ASTM F-88 peel analysis to verify your sealer is creating compliant seals. Each machine ships with a copy of the validation report, an instructional audio CD covering current issues in sterile device packaging. 1-800-550-3854

 

• Multi-parameter validatable intelligence.
• Tyvek®/clear film pouches can be sealed face up.
• Release temperature control.
• Unsurpassed and repeatable seal integrity.
• Designed & manufactured for long duty performance.
• 4-digit supervisor lock-out code.
• Fortified roller-pin assembly.
• Equipped with a 10 mm wide heating element.
• Cleanroom-friendly design.
• Microprocessor controlled temperature with temperature display.
• Auto sealing/cooling cycles for seal-to-seal consistency.
• Silicone solenoid boot.
• Footswitch or auto interval cycling operation.
• Safety Mechanism prevents finger/hand injuries.
• Optional printer available (WP).