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News

New tensile and calibration testing machine for quality control testing

Lloyd Instruments : 26 July, 2006  (New Product)
New tensile and calibration testing machine for quality control testing and R&D in medical devices manufacturing industries on show at MD&D.
The LFPlus is configured with NEXYGEN MT control and analysis software, which incorporates powerful security and audit trails to help medical devices and pharmaceutical manufacturers 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, ranging from surgical implants to colostomy bags and bone cement. It 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, the company has immense experience in medical device testing.

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 applications include needle-free drug delivery systems and flexibility tests on catheter tubing, valve testing on metered dose inhalers and many more, including adhesives testing for wound management systems, artificial skin testing, aspirators, breathing pacemakers, dental materials, guidewires and prosthetics.

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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