NEW MATERIAL TESTERS FOR DRUG DELIVERY SYSTEMS
26 June 2006 - Lloyd Instruments

Universal materials testing machines such as the LFPlus showing at MDT 2006 are finding increased use in the testing of a variety of drug delivery systems ranging from conventional syringes to needle-free injection systems and metered dose inhalers. Applications also include the testing of blister packs and other medical and sterile packaging.

Applications for hypodermic needles include testing for various parameters including bend strength, needle sharpness and the force required for insertion and extraction, as well as tests on special needles with covering devices to prevent needlestick injuries. For single use, handheld needle-free injection systems, test methods range from evaluation of the load required to press the actuation button on the device to the load required to break the tip on the gas micro-cylinder which forces the vaccine through the skin. For one-shot metered dose inhalers, tests include the detection and measurement of the firing load and valve breakdown load of the pressurised canister.

Typically, applications on such devices are carried out using low force testing machines ranging from the LFPlus (1 kN) to the LRXPlus (5 kN) instruments. In addition to highly accurate measurements, the machines offer extraordinary versatility, with an impressive range of different grips and fixings for testing a host of applications in tension, compression or flexure.

In addition, the instruments can be computer controlled using NEXYGEN MT control and analysis software, with the option of ONDIO applications builder. NEXYGEN not only features an extensive library of tests meeting international standards, but also incorporates powerful security and audit trails to help medical devices and pharmaceutical manufacturers meet FDA 21 CFR Part 11 regulations. The addition of the ONDIO application builder software gives added flexibility by allowing multi-stage custom testing and for standard NEXYGEN software set-ups to be modified.

For blister packs, the materials tester can carry out a number of tests to internationally recognised standards, including the tensile strength and the maximum, minimum and average extraction force required to remove the tablet from the pack. Other tests include the compression characteristics of individual blisters. For packs with peelable seals, the seal strength can also be measured.

http://www.lloyd-instruments.co.uk

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