Consumers expect a certain consistency in quality and taste from the food and beverage brands they love. But many factors can influence the way a product tastes when it reaches the consumer – ranging from the manufacturing process to seasonality of ingredients to storage temperatures. Similarly, a number of other factors may influence the overall quality attributes that matter, such as alcohol content of beer or stability of the whiskey aging process.
In the midst of a global crisis, many industrial manufacturing operations— including those in the chemical industry— are faced with shortages of supplies and equipment, or staff reductions, and finding it difficult to keep operations working as normal. Are there process improvements or tools that can be used to manage production more efficiently during this time of COVID-19 (and moving forward)?
While many other industries have implemented multivariate data analysis software for process optimization and control, it is still not very common in the pulp and paper industry. However, multivariate data analysis has a very promising potential for both cost reductions and quality improvements in pulp and paper mills. No capital investments are needed, the implementation can be done remotely, and the software typically requires no permits.
Out of control processes in pharma manufacturing are not something to take lightly. If your production runs are seeing frequent deviations, leading to expensive batch losses or frequent rework, it’s time to take a look at ways to correct any process deviations in a more expedient manner. Uncorrected deviations or processes that vary from approved process parameters can lead to costly and dangerous mistakes.
Advancements in cell and gene therapy hold promise for the future of personalized medicine, especially for cancer treatments. However, bioprocessing methods for autologous cellular therapies, and CAR-T in particular, often present unique challenges in manufacturing due to the variability of the starting material and unique nature of each batch. Is there a way to create more efficient processes in order to bring down costs and make personalized medicine a viable option for more patients?
In a manufacturing setting where consistent quality matters, variability in how individual technicians and operators perform their jobs can be frustrating for managers. Companies need a way to achieve consistent quality, without reducing the capacity for innovation and improvement.
In bioprocessing today, a shift is happening that takes the ability to monitor, optimize and control processes to the next level. Whereas in the past manufacturers aspired to measure data in order to find out why a bioprocess action happened (using descriptive and diagnostic analytics), today we are able to use predictive analytics to determine what will happen in a bioprocess based on specific process data measured in real-time. This migration “up the food chain” to a higher level of data analytics requires automation, ongoing process monitoring and the ability to make adjustments in real-time.
For manufacturing companies, process control is essential— even for those producing low-cost items such as small plastic parts. That’s because even when units are small and inexpensive, the cost of defects becomes exponentially higher when they reach the next manufacturing step at another plant.
In manufacturing and other industries that have complex processes, knowing which variables have the most impact on quality and at what point, or knowing which combination of variables to change in order to improve your process, can have a huge impact on the overall quality or profitability of your manufacturing process. But without making expensive and time-consuming changes in the physical processes in order to test all possible scenarios, how can you identify and predict the variables that have the most significant impact on your outputs?
Using a Quality by Design (QbD) Approach for DOE Supports ICH Q8 Compliance
In pharmaceutical development, manufacturers must be able to demonstrate product robustness and deliver the intended quality of the product within allowable ranges for the claimed shelf-life period. Both international and country specific regulatory agencies, such as the FDA, pay close attention to these claims.
