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Production Batch Stability Trials

Production Batch Stability Trials comprise of:


1) Production Batch Preservative Efficacy Test (PET)
2) Production Batch Accelerated Stability Trial
3) Production Batch Real Time Stability Trial (Monitoring)


Once a product has passed an R & D stability trial, it is recommended that an accelerated stability trial and a real time stability monitoring program on a production batch in the final packaging be performed.


Please note theoretically the production batches should pass PET and stability testing however in the scale up from laboratory to production there are other variables which may impact on product integrity and stability.


What is Production Batch PET
?

We recommend that PET be performed on at least one production batch of a new or high risk product formulation/category at the start and end of an accelerated stability trial.    This confirms that the preservative system on the production batch is effective.  We recommend performing a PET at the start and end of an accelerated stability trial and towards the end of a real time study.


What is Production Batch Accelerated Stability?

The process, as the term ‘accelerated’ suggests, involves subjecting a formulation in it’s final pack or packaging material (that has passed an initial PET) to elevated temperatures (40°C, 45°C) and checking physical and chemical attributes at predetermined time intervals. At the end of the predetermined accelerated time interval the stability samples are checked for the physical parameters such as pH, viscosity, colour and odour. This information is reviewed and the time is extrapolated to predict an expiry date.


What is Production Batch Real Time Stability (Monitoring)?

Once an accelerated stability study has provided an indicative shelf life for a product, it is recommended that a real time (retain samples stored at ambient temperature) stability monitoring program is followed using samples from a production batch in the final packaging.

Please note adjustments to stability protocols such as additions /deletions of tests and time points may be required or requested based on customer, formulation or regulatory requirements. Such adjustments need to be communicated to all parties prior to commencement.


For a more full and comprehensive overview of our best Product Stability and PET testing please Contact Us