Have an inquiry?
Need more information?
Contact Us!
t +44 (0)8454 588924
f +44 (0)1303 813952
e solutions@met.uk.com
Consult with our experts
Medical Pack Testers
Medical Device Packaging Testers
Packaging forms an integral part of all sterile medical devices. CE technical files and FDA submissions both require testing to ISO 11607-1:2006 Packaging for terminally sterilized medical devices. Leak testing is used to assess the integrity of impermeable packs and burst testing is used with all types of packs to measure seal strength.
MET supply a variety of pack test equipment for all types of medical device packaging to ensure that it performs to specification on an ongoing basis. Testers are supplied calibrated, with qualification programmes being available.
- Mini Burst Tester
- LPC Leak & Burst Testers
- Examples of devices tested
- Further reading on testing methods
Mini Burst Tester
Packaging Mini Burst Tester
Packaging Strength Tester
Seal Strength Tester
The Mini Burst Tester has been designed for simple operator use in the clean room. Packs can be taken directly from production and tested on this economic go/no-go gauge in seconds. It uses the "twin needle technique" to evaluate pack seal strength according to ASTM F1140-00(2005), Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages for Medical Applications.
Key Features
- Compact - requires very little of your expensive clean room space
- Red or green display clearly indicates pass or fail
- 2 pneumatic ports
- Very simple to operate
- Delivered fully calibrated
- 12 months guarantee
| Property | Data |
|---|---|
| Testing property | Package seal strength to consensus standards. |
| Test technique | Single or dual needle |
| Typical substrates | Paper / foil / Tyvek® / polythene pouches and blisters. ® Tyvek is a trademark of Dupont. |
| Pressure range | 0 - 1 Bar variable ramping rate |
| Pressure resolution | 0.001 Bar |
| Timer range | 0 - 100 seconds |
| Calibration | 5 pressure points |
| Actuation | Single latch |
| Electrical protection / supply | 90 - 240V 50/60Hz single phase |
| Weight | 2.5 Kg |
Mini Burst Tester
MiniBurst 5 Set up Instructions
Operating Instructions for the MiniBurst 5
Process Flow for the MET Mk 5 Burst Tester
LPC Leak and Burst Testers
LPC leak testers deliver outstanding performance with machines suited for clean room use, exceptional accuracy of detection and readings and compact footprint. From the value-line 450 to leading edge 820, there have been no compromises on functionality or ergonomics. The 820 is the ultimate "all-round tester": incredibly flexible and capable of testing all medical packaging (and devices too!), it is perfect for audit stations. Added to this, on-board statistics and a multitude of features make it an extremely high-performing and versatile piece of testing equipment.
LPC 450
LPC 796
LPC 820
Summary of Key Features
| Model | LPC 450 | LPC 796 | PC 820 |
|---|---|---|---|
| Capabilities | Absolute pressure | Absolute & differential pressure, flow measurement | Absolute & differential pressure, flow measurement |
| Pressure range | 0 to 10bar | -999mbar to 100bar | -999mbar to 100bar |
| Test media | Air and nitrogen | Air and nitrogen | Air and nitrogen |
| Programmes | 8 configurable | 120 | 120 |
| Data communication | Serial/parallel/CAN bus | Serial/parallel/CAN bus | Serial/parallel/CAN bus |
| Digital I/O | 4 inputs and 4 outputs | ||
| USB port | no | 1 | 1 |
| Operation | 1 touch for menu & settings | 1 touch for menu & settings | 1 touch for menu & settings |
| Screen results display | Colour, graphical | Plain text ml/min, Pa, 0.1mbar | Large multiple displays |
| Dimensions WxHxD | 257 x 106 x 316mm | 360 x 150 x 400mm | 360 x 150 x 400mm |
| Options | Multi-channel Customer-specific tests Customised features | Multi-channel Temperature compensation Leak test connection Customer-specific tests Customised features | Multi-channel Temperature compensation Leak test connection Customer-specific tests Customised features |
Packaging Tested on our Machines
- 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
- Inflate to burst (ASTM F-1140, ISO 11607)
- Vacuum burst
- Restrained burst (ASTM F 2054)
- Creep test
Burst testing of permeable packs is a destructive test used to validate the seals on pouches and blisters, generally made of paper or other permeable materials suited to gas sterilisation. A pair of needles is inserted into the pack; one is used to monitor the pressure inside the pack and the other to inflate the pack. The pack is inflated at a controlled rate above its permeability. A "catastrophic" failure eventually 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.
