Bronkhorst recently had a customer who needed support 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 ensure 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.
Coriolis mass flow controllers bring the solution
The customer required a process that was flexible, capable of monitoring and controlling the flow of different fluids with an inbuilt ability to automatically adjust itself for any pressure variations or disruptions. Additionally the customer required extensive logging of real time flow data and control via their DCS control system.
After careful consideration of the process requirements, we recommended our mini CORI-FLOW mass flow controller combined with a gear pump as the ideal solution to the demanding flow control requirements of the Continuous Pharmaceutical Manufacturing process.
The decisive factor to use the mini CORI-FLOW mass flow controller here were its characteristic features:
- Direct mass flow measurement, independent of fluid properties
- Capability to measure density and temperature
- The ability to switch to volume flow
- High accuracy, excellent repeatability
- Compact design, with stand-alone integrated PID controller for fast and stable control
- Suitable for a wide flow range
- Digital technology allowing interface with DCS systems using Profibus
- Chemically resistant stainless steel and hastelloy wetted parts
- A closed control loop that allows a rapid response by controlling the pump directly to change process conditions
- When coupled with our IN-PRESS pressure controller the system offers the flexibility of flow and pressure control for some critical parts of the process.
- All parameters can be logged, therefore this technology offered excellent traceability of the process