My interest in the adoption of continuous manufacturing at pharmaceutical manufacturers was sparked by a customer who contacted us to support them with the exact dosing of pharmaceutical excipients. This customer was planning a continuous pharmaceutical manufacturing facility.
Batch process manufacturing
Traditionally, most human pharmaceuticals are manufactured in a step by step batch process with extensive tests between steps to insure consistent quality and efficacy of the finished medicine.
The manufacture of pharmaceuticals is a highly-regulated process with government agencies inspecting and approving both the process and the facilities where medicines are manufactured. In 2016 the US Food and Drug Administration (FDA) allowed for the first time in its history a manufacturer to switch from the traditional batch manufacturing process to a continuous manufacturing process.
Continuous process manufacturing
Continuous manufacturing is a pioneering technology that has the potential to transform how medicines are made in the future. Improvements in Process Analytical Technology (PAT) has allowed the automation and streamlining of what were previous laborious step by step manufacturing processes. It is now possible to accurately mix ingredients in a continuous reactor, carefully monitor and control the reaction rate and achieve higher yields than what was feasible just 10 years ago.
The liquid flow rates in these new continuous process systems are much smaller than what was traditionally encountered in the older batch processes. Instead of tonnes per hour, typical plants operate at flows of kilogram per hour (kg/hr) and in some areas even grams per hour (g/hr) or volume flow ml/h.
When using Continuous Manufacturing?
New medicines tend to be targeted at niche illnesses and don’t require the large quantities of active pharmaceutical ingredients manufactured in the past. Continuous Pharmaceutical Manufacturing is an ideal solution to manufacture these new drugs.
Since Bronkhorst offer the most extensive product range of low flow mass- and volume flow meters and controllers on the market, we were selected by the customer and charged with finding the optimum flow monitoring and control solution for the new process.