Application automated laboratory manufacturing validating


16-Aug-2020 12:56

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However, this could prove to misrepresent reality, especially as the comparison isn’t like for like.

There are variations in the way the containment performance tests are done in the laboratory, and the interpretation and utilisation of the results obtained can be inconsistent with the real environment.

It’s well documented that the biopharma market is continuously expanding, largely thanks to the global demand and growth in the oncology market.

Subsequently, as these containment strategies evolve, so too does the role of containment verification and there is a clear need to understand the potential variations in testing and differing interpretations of results.Critically, containment needs to be achieved while not hindering productivity and operability, which can sometimes be challenging.Containment validation testing must also reflect operator intervention to ensure that the containment device is tested accordingly.For example, a charging application that has not undergone contained dispensing prior to being in the laboratory environment cannot be compared measurably with its normal application within the manufacturing area.

Preventive maintenance: Ensuring frequent monitoring and preventive maintenance helps to safeguard the reliability of the containment solution.All manufacturing equipment must be validated prior to its use in the manufacturing process.