Blister pack testing using LFPlus materials tester
The LFPlus universal materials testing instrument and Nexygen MT control software provide the perfect platform for performing a variety of physical property tests on blister packs
The LFPlus universal materials testing instrument and Nexygen MT control software from Lloyd Instruments provide the perfect platform for performing a variety of physical property tests on blister packs.
According to a report by the Freedonia Group (Cleveland), the demand for blister packs will grow to USD1 billion by 2006 in the US alone.
This massive market demands quality testing to the highest level.
The LFPlus 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 must also be measured.
The LFPlus is a single column universal testing machine designed for material testing and force measurement applications up to 1 kN (225 lbf).
Test speeds range from 0.05 to 1270 mm/min with an accuracy greater than 0.2%.
Manufacturers must have total quality control programs that monitor each step of the process, employing detailed validation procedures, records and complete documentation.
Nexygen materials testing and control software features a vast test library of test set-ups to allow international industry standard tests to be performed.
In addition, powerful security and data audit tracking features have been included, allowing manufacturers to test in accordance with the requirements set out in the FDA standard CFR 21 Pt 11.
Supervisors can select appropriate operator access levels, who must login at all times, and safeguard 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.
The LFPlus also has a key role to play in pack product development, by allowing the evaluation of new pack film materials.
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