Validatable Medical Heat Sealer

Models TS-4V and TS-4V-ISJ

INTRODUCTION

Testing Machines, Inc. is proud to introduce the 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.

(above) Validation ports on the right side of the unit provide the critical data outputs required to maintain the validation process.

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

STANDARDS

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.

(above) Optional Anti-Stick PTFE Fiberglass cloth saves time and eliminates film sticking to sealing jaws.

COMPONENTS AND OPTIONS

TS-4V Standard Model: Uses a 1-Piece Fixed Seal Design
TS-4V-ISJ Model: Uses a Quick-Change Seal Jaw Insert Design
Precision Seal Jaws and Seal Jaws Inserts with Desired Seal Pattern

1.0" [25.4mm] to 4.0" [101.6mm] Length of Seal
0.25" [6.35mm] – 1.0" [25.4mm] Width of Seal
Flat, Vertical, Horizontal, Standard and Custom Geometry Forms Available
Standard and Special Coatings Available
Seal Jaws and Seal Jaw Inserts: SOLD SEPARATELY

(above)All aspects of the process are controllable on the front panel using digital inputs and displays.

OPTIONAL ITEMS

Shelf Style Film Sample Tray

Stationary 1 Piece Design

Manual Sliding Film Sample Tray

Precision Bearing Guided Slide Table Design
Magnetic Film Sample Hold Down
Repeatable Film Sample Presentation

Digital Thermometer for Temperature Validation

Calibration Documentation
Type "J" M-M Interconnect Cable

Digital Timer for Timing Validation

Calibration Documentation
Interconnect Cable

Digital Pressure Gauge for Seal Cylinder Pressure Validation

Calibration Documentation
Interconnect Line and Fitting

Lower Seal Temperature Control ON/OFF functionality
Anti-Stick Mechanism

The TS-4 Anti-Stick Mechanism provides an Anti-Stick sealing surface to the upper and lower seal surfaces. For use with Polyethylene materials, certain coated materials, or any other sealing applications where material sticking is an issue.

PTFE Coated Fiberglass Woven Cloth, .005" [.127mm] Thickness
Upper and Lower Seal Jaw Face Cover Straps
Spring Loaded Self-Tensioning Strap Mechanism
Easy Strap Replacement

Accessory Seal Jaws and Seal Jaw Inserts

1.0" [25.4mm] to 4.0" [101.6mm] Length of Seal
0.25" [6.35mm] – 1.0" [25.4mm] Width of Seal
Flat, Vertical, Horizontal, Standard and Custom Geometry Forms Available
Standard and Special Coatings Available

TECHNICAL SPECIFICATIONS

Sealing Temperature
Range:	Ambient 205°C (400 °F)	Resolution:	±0.1°C (0.18 °F)
Sealing Pressure
Range:	9 kg - 72.5 kg (20 lbs - 160 lbs)	Resolution:	0.1
Sealing Dwell Time
Range:	100ms - 99 s	Resolution:	10ms
Load Cell
Capacity:	136 kg (300lbs)	Repeatability:	0.09kg (0.2lbs)
Accuracy	0.09kg (0.2lbs)	Calibration:	5-Point Accredited
Sealing Jaw Options
Length:	25.4mm [1.0"] - 101.6mm [4.0"]
Width:	6.35mm [0.25"] - 25.4mm [1.0"]
Seal Surface:	Flat, Vertical, Horizontal, Standard or Custom Geometry Forms Available
Machine Requirements
Power	110V to 240VAC 50/60Hz
Air (clean, dry)	621KPa-827KPa [90PSI - 120PSI] 689kPa [100PSI] Recommended
Physical Specifications
W x D x H:	25.4 cm x 30.4 cm x 54.6 cm [10" x 12" x 21.5"]
Weight::	20.4 kg [45 lbs.] Approximate

ORDERING INFORMATION

Catalog Number: TS-4V Validatable Medical Heat Sealer

Call Us Today

For additional information, or to learn how Testing Machines can help your company profit through testing, please call us at 1-800-678-3221, or e-mail info@testingmachines.com.

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PDF Product Sheet:

Available in PDF format. TS-4V Validatable Medical Heat Sealer