BT1000 – Leak + Burst Tester
A package leak detection system and burst tester primarily designed for testing the seal integrity of the packaging of medical devices. Designed for use on pouches, bottles, blister packs and sealed trays including those made of Tyvek. Security key protection of supervisor selectable test protocols. Sensitive to very small leaks over extended test times. Uses a unique and patented package system system for a leak proof interface with the pack.IQ/OQ/PQ are available on installation.
The BT-1000 automated package tester is designed to test flexible packaging and provide both seal strength and leak testing in one instrument.
Standards
Complies with test standards – ISO 11607, ASTM F-1140, F-2054
Suitable for testing both porous and non-porous materials. Control of critical variables and quantitative measuring methodology gives highly repeatable and accurate results.
IQ OQ PQ validation available to meet the requirements of the medical device and pharmaceutical industries.
The statistical package provides instant analysis of up to the last 1000 tests in the datalog. The results may be analyzed using histogram, mean, control charts and standard deviation statistical tests. Graphically, the BT-1000 displays the burst graph for each individual test, giving the operator complete control over the testing process.
Seal strength testing
Seal strength testing with the BT-1000 is quantitative in presenting results, fast and simple to perform, repeatable and applicable to both porous and non-porous materials. Seal strength testing is specified in ISO-11607 Standards for Packaging of Terminally Sterilized Medical Devices: 6.3.2.1 Seal strength shall be determined at the upper and lower [process] limits… and shall be demonstrated to be suitable for the intended purpose.
Leak testing with the BT-1000 provides assurances the integrity of non-porous packages of film, foil and laminate materials in pouch or tray form. Using TME’s exclusive Package-Port © technology to provide leak tight access to the package, the BT-1000 performs a pressure decay leak test by charging the package volume with air, and then precisely measuring (to 12.7 mm water) the change in pressure due to leaks.
Even products that are contained in the packages, such as filters, tubes or other devices, can be leak tested with suitable adaptions. Accept and reject limits are set and automatically indicate to the operator the final status of the test with a visual and audible indicator.
Features
- Simple and repeatable
- Graphic test plot display
- Seal strength testing for porous paper, Tyvek © or non-porous materials
- Leak testing for non-porous film, foil or laminate materials
- Security key lock for data and test settings
- Eight test modes for leak testing and seal strength testing on the same non-porous package
- Models available for HIGH PRESSURE or LOW PRESSURE applications
- Fixed variables and full automation yield high repeatability
- Application-specific fixtures can be supplied to suit your specific testing application
Physical specifications
- Dimensions: 33 x 38 x 16.5 cm (W x D x H)
- Net weight: 13 kg
Options
- Restraining plate fixtures for leak testing pouches have semi-porous surfaces to stabilize expansion during pressurization without blocking any holes in the surface material. Restraining plate fixtures for seal strength tests provide consistent stress loading on all seals.
- LA-05 filter drying assembly dries and removes water, oil and particulate matter from pressurized air. The TME BT-1000 requires clean, instrument quality air in order to maintain the warranty on the instrument.
- TS-02 closed package test fixture in conjunction with an entry system such as the TME Package Port © system, allows you to test completely sealed flexible packages. A variety of probe sizes is available to further customize your test system.
- TS-01 open package test fixture provides a pneumatically driven clamp that will seal the open end of a flexible package during inflation testing. Both 30.5 and 61 cm clamp bar models are available for most industrial, medical and food packages.
Physical specifications
Tests
- Single tests burst, creep, creep-to-failure, leak
- Dual tests creep/leak, creep/burst, leak/burst, leak/creep-to-failure
Test units
- Psig, inches of H2O
Controls
- Electronic pressure control, electronic flow control in 16 steps for porous and airtight package, push buttons, keylock, power on/off switch, key pad
Memory
- Datalog memory saves up to 1000 test results
- Program memory saves up to 40 test programs
Statistics display
- Mean and range control charts with UCL & LCL, histogram, mean, standard deviation, max, min, range, number of tests
Port
- Female / male connector for automatic output of current test results, for PLC, for RS-232
Calibration
- NIST traceable
Timer ranges
- 0.1 to 1000 sec
Pressure range
- 0.2-50 psig and 1-100 psi, oil and moisture free clean air
Overall resolution
- < 10 psig 0.05 psig, > 10 psig 0.25 psig
Power supply
- 230 V, 50/60 Hz, 150 W