Advanced Microprocessor
The core of the ISO-11607 is the nomenclature "repeatability". The headwater of any repeatable process is electronic control systems such as microprocessors

The heart of the MS-350 series sealers is a precision microprocessor that tightly controls the platen temperature in order to engender repeatable seals. This is not a PLC but rather a microprocessor that has been completely developed for the purpose of creating accurate temperature profiles for medical bags and pouches (see actual datalogging session on this sealer). This microprocessor was created with two distinct results in mind. First and foremost, the processor's mandate was to tightly manage the pouch environment through an accurate thermal feedback system utilizing a K-type thin-film thermocouple. #2, the system was developed understanding the regulatory challenges and therefore we developed this processor with a 3-axis design of experiment in mind and incorporated valuable attributes such as a quality assurance lockout feature that prevents operators from changing critical machine settings that were developed during your design of experiment. The unit also features a simple to use calibration mode that allows quality teams and maintenance to adjust offsets during calibration sessions. You can count on the exacting features and the quality of this Hitachi microprocessor. To find out more information about this advanced control system or the MS-350 medical pouch sealer, contact customer support at 1-800-550-3854.

Seals a Variety of Films
Although this sealer is primarily used in the sealing of clear film such as mylar or poly to TyVek®. It is also well-suited for a variety of other films such as clear film to clear film and foil pouches.

The MS-350 series sealer is configured with the heating element on the upper jaw so operators have clear visual acuity to the device on the packaging line. Many of our customers have had challenges with other sealing machines. These customers report the inability to repeatably create the needed seal strength or seal integrity and after switching to our machinery were able to create constant seal strength. Also, under the new sterile barrier system, seal integrity must also be evaluated. The MS-350 series sealer will typically exceed the manufacturer's seams and create a visual result that is devoid of pleats and wrinkles. To find out more information regarding your specific film or to have your pouch tested for free in our lab, contact customer service at 1-800-550-3854.

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.

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).
  

Manage Throughput
Many of our customers who were considering large, automated sealers costing deep into the 6-figures have chose to utilize standalone workstations with our MS-350 series sealers.

Medical device manufacturers can manage the ebb and flow of the packaging line by utilizing several sealers and simply adding on or taking offline workstations as production dictates. This has been a great choice for companies that use per-diem workers as production can finely tune packaging costs. Learn more about flexible production. Call tech support at 1-800-550-3854.



New Password Feature
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.

Viú™ Calibration Software
From the software development team at Van der Stähl Scientific, we are excited to introduce the new Viú™ Calibration Software. This software allows easy data capture from a variety of popular

data loggers, such as Fluke™, Agilent™ as well as machine data from some of our medical device medical packaging machines for in-process evaluation. To find out how to get a free copy of Viú, contact technical support at 1-800-550-3854, option 3.
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Free Seal Integrity Lab
Not only does Van der Stähl Scientific's package integrity lab utilize the state of the art machinery (some, in fact we have invented and have patents on), we also have

highly trained and certified personnell to interpret the data. With the purchase of a Van der Stähl Scientific packaging machine, you'll receive a comprehensive seal strength study at no additional charge.
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