Pack Seal Strength & Integrity

 

Quality assurance services must ensure that medical device packages perform to specification. Seal strength and integrity testing is important both as a validation process and for ongoing QA. Sterility barriers are challenged using a variety of methods.  Burst testing and tensile peel tests are used for checking seal strength. Flow tests may be used to test impermeable packs for integrity.
MET provides a variety of pack test equipment for all types of medical device packaging. The equipment is supplied calibrated with qualification programmes being available.
  1. Healthcare packaging we can test
  2. Methods and technologies used for sterile pack testing
  3. Carbon dioxide trace gas test machine
  4. Sensitor hydrogen trace gas packaging tester
  5. LPC 820 medical package burst tester

Packaging We Can Test

     
  • Polythene porous pouches
  • Paper pouches
  • Foil pouches
  • Porous blisters
  • Non porous blister
 
  • Tablet / capsule blisters
  • Fluid vials (requires air space)
  • Tablet and capsule bottles
  • Tubes and other containers
  • Header and patch bags
 

 

Testing Methods & Technologies

  • Tracer gas · Leak into a vacuum (ASTM F-2095, ISO 11607)
  • Inflate to burst (ASTM F-1140, ISO 11607)
  • Vacuum burst
  • Restrained burst (ASTM F 2054)
  • Creep test 
     

Burst Testing of Permeable Packs    (PDF printer version)

Burst testing of permeable packs is a destructive test, which may be used to validate the seals on pouches and blisters in production. It is generally used on packs with paper or other permeable materials used in gas sterilisation.

A pair of needles is inserted into the pack. One is used to monitor the pressure inside the pack the other to inflate the pack. The pack is inflated at a controlled rate above its permeability. Eventually a catastrophic failure occurs, usually a split seam. The monitoring equipment records the maximum pressure attained and delivers a pass or fail signal according to the preset parameters of time and pressure.

  • Twin needle for separate filling and monitoring
  • Protective needle cover for safety when not in use
  • Tuohy needle option for extended life
  • Easy change needle system
  • Optional heavy weight stand with height adjustment clamp

Tracer Gas Testing of Impermeable Packs


Impermeable pouches and blisters can be tested by a burst technique or, non destructively, by pressure decay or tracer gas analysis.

Tracer gas testing of impermeable medical packs is a non-destructive test, which may be used to validate the seals on pouches and blisters in production. It is a rapid and sensitive test that provides quantitative data.

To conduct this test an inert gas is introduced into the pack at sealing. The pack can later be analysed in a chamber for the presence of this gas. Several gases can be used; carbon dioxide is the most common but helium and hydrogen are also used. Testing is sensitive and holes as small as 10 microns can be detected with CO2, even smaller holes with lower molecular weight gases. Package testing is extremely fast, down to a few seconds in most cases.

Witt Leak Master


Witt Leak MasterThe Witt Leak Master is ideal for conducting audit testing of packaging production for sealed foil pouches or gas impermeable medical blisters.

Technical Features

  • Quick response times
  • Rapid product selection from database
  • Networking (wifi) and data handling available
  • Suitable for use in all industrial environments
  • Testing media: carbon dioxide
  • Simple to operate bar code reader available

Witt In-Line Gas Leak Master


Witt In-line Gas Leak TesterContinuous process for 100% leak testing of package production. Compatible with foil pouches and gas impermeable medical blisters.

Technical Features

  • Operates at 15 cycles per minute
  • Can detect holes down to 10 micron
  • Stainless steel construction
  • Rapid product selection from database
  • Networking (wifi) and data handling available
  • Testing media: carbon dioxide
  • Simple to operate bar code reader available

H2000 Hydrogen Leak Detector


H2000 Hydrogen Leak DetectorThe Sensistor H2000 is ideal for conducting audit testing of packaging production for sealed foil pouches or gas impermeable medical blisters. It also provides an extremely sensitive leak test for medical devices with leak location identification.

Technical Features

  • Very rapid response times
  • Non explosive (low cost) ISO 10156 5% hydrogen in nitrogen used
  • Extreme sensitivity
  • Leak location identified

Lpc 820 Combined Pack Burst Tester / Leak To Vacuum Test Computer

Print Version (PDF printer version)


LPC820 Burst/Leak TesterThe LPC 820 tester system is multifunction.

It is ideal for audit testing of packaging production for permeable pouches and medical blisters by burst testing.

It is also perfect for non-destructively testing non porous medical packaging. Vacuum is applied to the package and the rate of leakage is accurately monitored from the pack into a vacuum. Similarly to testing described in ASTM F 2095-01, Test Methods for Pressure Decay Leak Test for Nonporous Flexible Packages with and without Restraining Plates.

It can also operate as a package burst tester or pressure decay leak test for medical devices.


Technical Features

  • Burst test machine for gas sterilisation and other permeable packs
    • Definable pressure change to identify burst event
    • Pressure increase can ramp up at preset rate
    • Pressure creep test
  • Accurate vacuum decay test for impermeable packs
  • Data recorded, printed, downloaded
  • SPS program available