Laboratory Equipment Calibration (PVT)

dissolution testersLaboratory equipment Performance Verification (PVT): Starting from December 1st 2009, the use of salicylic acid tablets RS is no longer mandatory for USP Dissolution Apparatus 1 and 2 during the Performance Verification Test (PVT). However, Prednisone tablets RS still have to be used for apparatus 1 and 2. There are currently no requirements for PVT testing of USP apparatus 3.

The new acceptance criteria is based on the geometric mean and %CV of the dissolution results per PVT. USP’s current approach for the PVT calls for the performance of two consecutive runs including all positions of a dissolution instrument (single stage test approach).The combined results for both runs will be evaluated and compared with the acceptance criteria corresponding to the single stage approach.

Moreover, USP has implemented a two stage test approach that allows the analyst to evaluate the results of the first run and compare it with the acceptance criteria corresponding to the first stage (run) of the two stage approach. If the results are within the first stage acceptance criteria, the PVT test can be stopped at this stageIn case of an assembly with 12 positions, a single run (with all positions tested) is required for the PVT.

Full documentation is supplied by TLS and can be agreed in advance with the customer to meet individual requirements. In case the user would prefer to perform the PVT in house, USP Calibrator tablets and standards are available from TLS. Full training is also available.

TLS will bring with them to the customer, Prednisone Tablets and Standards, Sample tubes, filters and a media degasser. All that is required from the customer is a UV, DI Water, Ethanol and associated laboratory glassware.

Re-Calibration is normally required at 6 or 12 month intervals. TLS service engineers are experienced in providing calibration advice for further methods and custom designed systems. Please call the TLS laboratory equipment servicing department and they will be happy to assist you. Alternatively you can click on the icon below to register your enquiry directly.

 

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Hardness, Friability and Disintegration

An increasing number of customers are looking to perform PVT testing on their Hardness, Friability and Disintegration Testers. TLS can supply calibrator tablets with a certificate showing expected results for these parameters. Please follow the links below to view current certificates.

We can supply SOP’s and PP’s for approval prior to the visit, Tablets can also be purchased from TLS where testing in house is required. Please call the TLS service department and they will be happy to assist you. Alternatively you can click on the icon below to register your enquiry directly.

 

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