Medical Device News

The MET water immersion test (‘blue dye test’) for pharmaceutical blisters is now available with a choice of pumps. Packs under test are immersed in water whilst a vacuum is drawn in the test chamber. Leaking blister pockets are identified by a stream of bubbles leaving the leak site. Also, the offending pocket will fill with water following release of the vacuum. The vacuum is generated by a venturi pump in the zero electronics version of the equipment. Alternatively, a clean electric vacuum pump can be applied.

MET has published a leak testing guide to help packaging and medical device engineers make decisions on what equipment would best serve their needs. The key methods for testing the integrity of pharmaceutical and medical packages are discussed. Equally, methods of examining leaks and flows in devices and in vitro diagnostic products are presented. You can down load here…

Leak Test Guide

Have you ever wondered how to get the most sensitive leak testing in a simple hand held box? We now have a new technical sheet describing the method and equipment used for hydrogen leak testing. It is suitable for testing devices for leakage and package integrity. Click here to download the information sheet.

Further Information

Medical Device Packaging Hydrogen Leak Tester H2000

The Belco blister tray sealer for medical devices has now been delivering reliable and robust sealing for over 25 years. The machine still has the same rigid frame and platen structure to deliver even sealing pressure. It still has the same high thermal density platen and heater blanket to deliver an even sealing temperature and it is still easy to use and validate. The electronic control systems have evolved allowing a variety of options for operating and monitoring. At the simplest level are solid state temperature, pressure and time controllers. More sophisticated machines have PLC control, RFID tool recognition and networking.

Device manufacturers and hospitals are required to demonstrate that their packages and procedure trays maintain the sterility of the contents throughout their claimed shelf life. To assist hospital CSSD departments MET are now offering a microbial challenge test combined with accelerated ageing. The microbial challenge uses an aerosol of Bacillus atrophaeus and delivers an equivalent of over 10 years typical hospital exposure.

The most sensitive method for leak detection and measurement is now available from MET. Hydrogen is extremely effective as a trace gas because of its very low viscosity and low natural abundance. We can test your products in our laboratory or on your premises.

Cleaning studies for re-useable medical devices are carried out quickly and efficiently at MET. We offer a variety of protocols for instruments and devices. Please contact us for details.

Hydrogen trace gas testing is the most sensitive, readily accessible method for detecting and quantifying leaks. Hydrogen has low natural abundance, is has extremely low viscosity and low mass and size, making it the ideal trace gas. It is perfect to QA testing and validation studies. Typical examples are catheter, pouch, chamber and other product integrity tests. It is also perfect for testing hermetically sealed packaging. Equipment can be purchased or rented from MET. Our laboratory is also fully equipped for your validation and qualification studies.

Our laboratory validation team has been expanded to allow us to support customer requirements throughout Europe. We can provide installation and operational qualification for a wide variety of equipment. This includes incubators, ovens and fridges, transport systems, storage systems and much more. Contact us progress your projects efficiently.

MET has released mark 3 of its new and inexpensive Mini Burst dedicated burst test machine, ideal for QA testing of medical pouches and blisters. This machine offers a go/no-go gauge which is really simple to use and well within everyone’s budget. Training is provided, but it could not be simpler to use. Testers are delivered calibrated, and validation services are available from MET. They can be efficiently used on the production line and in QA department.

A twin needle technique is used to separate inflation and pressure measurement. The minimum required burst pressure is pre-set and the displayed pressure changes from green to red if this is not achieved.

MET’s solutions include wide range of leak and pack testers. Alternatively, we offer packaging validation and shelf-life studies to provide independent product support. Details of our medical device testing equipment and services are available at www.medical-engineering.co.uk

Medical Engineering Technologies Ltd., 41 Seabrook Road, Hythe, Kent CT21 5LX, UK.
Tel.: +44 (0)8454 588924 Fax: +44 (0)8700 562153
E-mail: solutions@met.uk.com Web: www.medical-engineering.co.uk