Application automated laboratory manufacturing validating
All manufacturing equipment must be validated prior to its use in the manufacturing process.
Data: Data is an integral part of any test, and manufacturers often use the data from this laboratory validation test to qualify the selection of the required containment technology for their process.It was formalised as SMEPAC and later adopted and revised by the ISPE.Although it is widely welcomed by the industry to ensure good practice within the validation of containment performance, the random nature of the guidance on sampling methods and distribution has been questioned by some who feel that it is challenging to achieve a specific measure of containment for equipment or devices.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.
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Some of which, however, can be reliant on operator technique to achieve performance, thereby increasing variability even further.