The regulatory environment for medical device production
dictates that packaging processes be validated. To help you guarantee that sterility
is maintained throughout shelf life, control vapour transfer or simply achieve
the required cosmetic looks for your products, MET supply a range of highly-engineered
yet affordable medical package integrity testers.
Stand-alone pack test equipment for off-line and development use are complemented
by in-line automated integrity test systems suited to high-speed production. Calibration
is simple and IQ, OQ, PQ validation packages are available at installation.
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
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 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
The
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
Continuous
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
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
The
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. Just like in ASTM F 2095-01, Test Methods for Pressure
Decay Leak Test for Nonporous Flexible Packages with and without Restraining Plates.
It can operate as a package burst tester, package pressure decay to vacuum test
system for packages or pressure decay leak test for medical devices.
Technical Features
Burst test machine for gas sterilisation and other permeable packs
