Application automated laboratory manufacturing validating
Consequently, it is risky to presume that performance should be the same…
and it’s important to consider the potential variables.
Some argue that the data lacks statistical validity and, more importantly, the method would be better suited if it provided a baseline dataset for future integrity testing.
There are many factors that can affect the interpretation of the SMEPAC test results, including the following: Placebos: The SMEPAC guide recommends a variety of particle sizes and levels of detection of placebos during validation testing, including lactose, paracetamol, mannitol and naproxen.
Critically, containment needs to be achieved while not hindering productivity and operability, which can sometimes be challenging.
Testing protocols: As detailed by SMEPAC, the testing protocols allow for a certain amount of inconsistency.This has led to an increased need for the development of potent compounds and an increase in conventional drug manufacturing using HPAPIs.The HPAPI market stood at a valuation of .64 billion in 2014 and, as a result of these trends, it is projected to be worth .11 billion by 2023 (Figure 1).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.