Ensuring package sealing integrity has long been an industry challenge, and one in which the stakes are exceedingly high. Hanging in the balance are the sort of quality control standards that not only mandate pharmaceutical manufacturers’ adherence to strict guidelines and low tolerances, but also define their priceless reputations. This is, of course, because quality control issues are a matter of public safety and brand prestige rather than mere product efficacy.
Given quality assurance’s heightened importance in the pharma industry, the primary method being used today – sampling – is simply archaic. Inspecting a minute percentage of the millions of packaged units rolling off production lines is a process no different from the inspection performed in, for example, a toy factory: every toy sampled is one removed from the marketplace, reducing overall production capacity without entirely proving that its fellow un-inspected toys are free of defects. The huge difference is that pharmaceutical defects can cost not only money but, in the worst-case scenario, lives.
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