Tyvek Strip Cutter

The Tyvek Strip Cutter is a machine designed by Sabre Medical to aid in package quality control testing.

Description

Background

For medical devices sealed in trays, seal-strength testing is an important component of a sealing validation, as it demonstrates that the sterile barrier will not fail under normal conditions. Used in conjunction with accelerated or real-time aging, seal-strength testing can help prove the effectiveness of a package over time. It can also help determine if a seal is too strong, and therefore likely to cause a user frustration upon opening.

Description

One of the main standards used in package strength testing is ASTM F88, which defines the test method commonly known as the peel test. Strips of a tightly controlled width running perpendicular to the seal line are separated using a tensile testing stand, and the peak tensile force during this separation is recorded.

For test operators, the process of cutting these strips into a tray is quite difficult, time consuming, and prone to error.

This machine is designed to quickly, precisely and repeatably cut the lid of a sealed tray in such a way that it can then be easily peel tested in accordance with ASTM F88. Strips are cut such that their width adheres to the specified 25mm, 15mm, or 25.4mm with a tolerance of +/-5%.

Using this machine, an operator can cut a tray lid approximately once every 6 seconds; which was found to be significantly faster than performing cuts of the same quality and repeatability manually.

Features

  • An optional switch-operated pneumatic clamp to hold the seal lip of the tray in place, with an adjustable clamping force.
  • An easy-to-use operation sequence of: 1) Clamping the tray, 2) Lowering the arm, 3) Sliding the cutter handle to the rear of the arm and 4) Releasing the tray
  • A blade guard designed to expose the blades only during a cutting operation for operator safety.
  • A removable knife block, allowing for easy replacement of the standard, readily available scalpel blades.
  • A spring-loaded cutting head that ensures the downward force applied by the blades to the tray is largely independent of the pressure the user applies to the main arm handle, thereby ensuring more consistent cuts.
  • A spring-loaded and damped arm that ‘floats’ in the raised position.
  • An optional cut counter to help track blade dulling.
FFS TrayActuator Trays Final