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News

New LFPlus for medical device

Lloyd Instruments : 27 July, 2006  (New Product)
Lloyd Instruments will be showing three of the highly popular LFPlus low force single column materials testing instruments, each equipped with NEXYGEN MT control and analysis software, incorporating powerful security and audit trails to help companies meet FDA 21 CFR Part 11 regulations.
Lloyd Instruments will be showing three of the highly popular LFPlus low force single column materials testing instruments, each equipped with NEXYGEN MT control and analysis software, incorporating powerful security and audit trails to help companies meet FDA 21 CFR Part 11 regulations. The LFPlus is ideally suited for evaluating the mechanical properties and performance of medical devices, components and medical packaging. These versatile instruments can be used for tensile, compression, flexural and friction test applications including high volume automated testing. With hundreds of systems installed in medical device, medical packaging and pharmaceutical manufacturing plants worldwide, Lloyd Instruments experience in medical device testing is immense. Some of the many application examples include evaluation of hypodermic needles for various parameters including bend strength, needle sharpness and the force required for insertion and extraction, as well as tests on special needles with automated covering devices to prevent needlestick injuries. Other components tested include needle-free drug delivery systems and flexibility tests on catheter tubing, valve testing on metered dose inhalers and many more.

NEXYGENMT test and analysis software safeguards data integrity with security audit trails and user level management systems that help manufacturers meet FDA 21 CFR Part 11 compliance requirements. Supervisors can set the desired level of access for operators, who must login at all times, and safeguard against the unauthorised use of passwords. NEXYGEN software also records full details of all operator logins and logouts, and when each test is created, changed, deleted or aborted. Audit trails are time stamped to provide an accurate history of data. Automatic saving and archiving ensures no test data is ever lost, and final reports include the date, time, user ID, system ID, location ID or other supervisor-defined parameters.
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