In the pharma industry, manufacturing operations are routinely in the pursuit of perfection.  There have been a number of initiatives to foster this pursuit; Six Sigma, Kaizen, and many other efforts.  All of them at their core are for the search for one thing:  Process Optimization.  They are looking for the core elements that are needed to efficiently and effectively facilitate the stream-lining of a process.  This process can be a manufacturing operation, a quality release procedure, deviation investigations, and so many other aspects of the life sciences industry.

Some key questions to be asked are:  What are your biggest challenges during a given shift?  What are my biggest sources of downtime? How is this issue tackled across the industry, and what is the best way to stream-line while still maintaining compliance?

Being a heavily regulated industry, a strong justification is needed for changing a process, even when removing potentially redundant aspects of a process.  The life sciences industry is unique in that seemingly mundane process changes require a litany of compliance workstreams, including regulatory filings, change controls, and potentially additional process validations to show that the process change has no impact on the process and product.

An example of process optimization comes with aseptic fill weight targets.  These ranges are critical to providing the correct amount of drug, at the correct concentration to achieve your clinical indication.  This is frequently discussed as a Critical Quality Attribute (CQA) as Dose.  The optimized lower limit of the allowable range is typically the lowest statistically allowable amount of product that will still meet the nominal tolerances associated with the process to ensure that the extractable volume testing is sufficient to release the product.  In reality, this is not usually the case, and fill weight target and ranges are based on legacy fill weights, equipment capability, and other factors.  Kymanox has helped multiple clients with performing statistical analysis of their existing overage in their container closure, and what regulatory requirements are needed to ensure compliance, while still realizing the efficiency and increase in marketable product.  Optimizing manufacturing operations can have a significant realization of financial gains.