Medical Device News

Protomed, our partner for testing and developing medical devices, has published a series of short guides. This guide guide is to assist engineers in the early phase of their project. It discusses ideas for getting a medical device project into action.

Download - Get Your Project Moving

MET has launched a new service to support hospital laboratories with their qualification requirements. These services would be of particular interest to blood laboratories, IVF clinics and HTA licensed laboratories storing tissue samples. Equipment validation covers incubators, fridges and freezers and cryostorage equipment. Specific projects undertaken include transport ‘cold chain’ validation and package integrity verification.

Hospital Laboratory Validation

The new and inexpensive Micro Burst Tester developed by MET has met with
resounding approval from customers. The Miniburst is a 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 the QA department.

A twin needle technique is used for 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. Manual acknowledgement of a failure is required in order to address operator fatigue.

MET delivers integrated solutions to medical device engineers. The Optiburst forms part of wide range of leak and pack testers, offered in
conjunction with complementary shelf-life studies.

MET’s latest news letter is now available. It contains details of the
latest services from MET. Please feel welcome to browse.

Click to download the newslettter

Demand for our packaging validation services is high and MET have invested in new equipment.

Our new environment chamber for accurate long term storage at elevated or reduced temperatures will expand our capacity for packaging shelf life studies.

It is also useful in other laboratory validations such as verification of temperature controlled transport and temperature cycling resistance.

Training is a vital element for ensuring that good practices are followed in medical device quality assurance, GMP and GLP. Manufacturers and laboratories can now take advantage of the on-site training that has been added to the MET shop. The packages are tailored to customer’s needs and cover:

Internal Quality Auditor for Medical Device Companies, Good Manufacturing Practice (21CFR Part 820)-Foundations, Good Laboratory Practice (OECD-FDA)-Foundations.

These training packages and much more support information can be found at the medical device solutions, sales site: sales.medical-engineering.co.uk

Medical Engineering Technologies Ltd we have added new items to our web store. There is a variety of products and a great deal of information to simplify and inform your purchasing activities. The shop is specifically designed to fulfil the needs of engineers and scientists in the Medical Device and Pharmaceutical Industries. We provide secure on line ordering, supported by rapid delivery.

In the coming months we will be adding many more products. Currently on the sales web site you can find:

• Autoclaves
• Biocompatible Assembly Adhesives
• Ethylene Oxide Sterilisation Equipment
• Medical Device Leak Testing Machines
• Medical Device Package Testing Machines
• Pharmaceutical Package Testing Machines
• Medical Pouch Sealers
• Sterilisation Pouches
• Sterilisation Indicators
• Validation Services

All this and much more support information can be found at the medical
device solutions, sales site: www.sales.medical-engineering.co.uk

Checking the MET Web Store

Integrity testing is required for sterile fluids for injection, whether supplied by the pharmaceutical industry or for cosmetic surgery. MET’s range of leak test equipment is ideal for verifying the seals on containers for both animal and human health. A ‘non destructive’ vacuum system is used allowing either 100% or audit testing.

Vial Integrity Testing

At MET we have significantly extended our range of medical device adhesives. Our new manufacturing adhesives include cyanoacrylates with cytotoxicity testing in 4 viscosities from very runny to gel. They are perfect for bonding a number of materials including ABS, styrenes, PVCs and SAN.

Also now available, are UV curing adhesives with cytotoxicity testing.
These materials are particularly well adapted to bonding PVC and polycarbonate as well as acrylic and ABS. Three viscosities are available all with the option of UV fluorescence for QC examinations.

Medical Catheter Adhesives

Thixotropic thread sealer for pipes carrying oxygen is available from MET. Leak free sealing is provided with no loose particles, curing in 30 minutes and easy disassembly. This material has a BMA certificate for oxygen contact up to 145 PSI. Potable water pipe sealant is also available.