Validatable Medical Heat Sealer

Listing ID #3842524

TS-4V Medical Heat Sealer with validatable operation to meet ISO 11607-2. This standard covers packaging for terminally sterilized medical devices with Part 2 specifying validation requirements for forming, sealing and assembly processes. This sealer comes in two models: TS-4V Standard and TS-4V-ISJ with Interchangeable Seal Jaws. The TS-4V is a precision heat sealer designed to produce accurate heat seals for peel strength measurement & testing of flexible packaging films, film foil laminates, non-woven materials and other substrates. The TS-4V also provides the capabilities of process validation.
The TS-4V produces accurate and consistent seals utilizing a precision load cell system which measures and displays the total force applied to the film sample. An integrated Digital Electronic Controller displays the sealing force. Load tare functionality and dual selectable timer activation set points are also standard.
The TS-4V process validation capabilities include Upper Temperature Validation Port, Lower Temperature Validation Port, Seal Dwell Timing Validation Port and Seal Cylinder Pressure Validation Port & Digital Pressure Gauge. These ports allow for meeting ISO and other standards that require the heat sealing process to be validated. External, certified and calibrated, instruments can be connected to the TS-4V to carry out the process validation.

FEATURES:

• Digitally Controlled Temperature
• Digitally Controlled Seal Dwell Time
• Digital Seal Pressure Output Display
• Independent Upper and Lower Sealing Temperatures
• Switch Selectable Dual Pressure Set Points for Timer Initiation
• (1) Upper Temperature Validation Port
• (1) Lower Temperature Validation Port
• (1) Seal Cylinder Pressure Validation Port w/ Digital Pressure Gauge
• (1) Seal Dwell Timing Validation Port
• Footswitch Operation
• Safety Guards and Switches for Safe Operation
• Maintenance Hardware Kit

• ASTM F2029 Standard Practices for Making Heatseals for the Determination of Heatsealability of Flexible Webs as Measured by Seal Strength
• Meets ISO 11607-2 Packaging for sterilized medical devices with validation