All of our bi-active (top and bottom heat) Audionvac vacuum chambers can have a validation option added to them for use in medical device packaging. These validatable medical vacuum chamber sealers are designed to comply with the stringent guidelines of ISO 11607 terminally sterile packaging requirements. These validatable chamber style vacuum sealers are intended for medical and other industrial applications where control of process parameters is critical, seal validation is required, and the highest level and consistency of vacuum is needed.

Audionvac medical vacuum sealers are capable of producing quality hermetic seals in a wide range of materials with consistency and repeatability. They allow for precise control of sealing process parameters with constant monitoring and alarm when there is a deviation from predetermined tolerances.

Sealing Features:

  • Seal Length: depends on specific Audionvac model
  • Seal Width: 5/16″
  • Bi-active sealing jaws (top and bottom heated jaws)
  • Pneumatically operated sealing jaw for high pressure sealing
  • Sealing Time: Max 20 seconds
  • Temperature controlled to 350°F

Vacuum and Gas Flush Features:

  • Busch Vacuum Pump (size varies by chamber model)
  • Dual gas flush nozzles with bag gripper to maintain bag position on sealing bar (optional)
  • Sensor controlled vacuum pressure and gas pressure with monitoring to detect any deviation

Medical Validatable Control Features:

  • ISO 11607 Compliant
  • Monitoring of process parameters with alarm function and cycle abort if deviation from validated settings occurs (seal temperature, seal pressure, vacuum pressure, and gas pressure)
  • Seal time begins when set temperature is achieved to prevent inconsistencies with heat build-up in the sealing jaws, ensuring repeatable seals.

User Benefits:

  • PLC with touchscreen HMI
  • Data logging with export capability to PC via USB drive
  • Controlled access level with password protection
  • Easy to operate, cycle automatically begins when chamber lid is closed

Versatility:

  • Stainless steel construction (VMS models) to mitigate particle contamination
  • Chamber filler plates to accommodate various pouch and product thicknesses
  • Designed to effectively vacuum package medical devices in a wide variety of bag materials
  • Calibration with certificate
  • 220 volt operation
  • Gas flush with multi-cycle (multiple vacuum / gas cycles)