FLOW CHEMISTRY
Figure 4 - Example of modular approach to continuous process development
Note - Each element encased in a square with dotted line is a module
part is qualified , it is only necessary to qualify the complete assembly , i . e . PLC , historian , I / O interface , modules and HMI .
This is no different from the qualification of a process in a multipurpose batch facility and it can be done rapidly . The assembly of modules is documented in a quality document , such as a work instruction , a master batch record or any quality document specified in the company quality system .
Therefore , if the process is coming back for additional campaigns , the recipe for the set-up is already available . So , converting a set-up for a given process to another process is trivial . The change over only requires
Validated system
Process-specific HMI layout of qualified modules
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Figure 5 - Structure for validation & qualification of modular approach
modifying the module set-up , changing the piping and connections , and adapting the HMI . The new assembly can be qualified in a matter of days .
Ampac offer
Ampac Fine Chemicals , a subsidiary of SK Pharmteco , has developed and demonstrated a four-step continuous process from bench to CGMP manufacturing using this module concept . The library includes a variety of pumping modules , plug flow reactors , pressure control units , continuous phase separations , continuous and distillations , and more are being developed for use .
The technology is now used routinely in association with other
MFG-WI set-up and system calibration
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Qualified units processes . For example , a continuous racemisation of the undesired rotamer produced from the separation of two atropisomers performed using a simulated moving bed unit is currently conducted . This new process uses high temperature and pressure , employing a simple assembly of four modules ( pump module , high and ambient temperature PFR and back pressure regulator ).
The demand for continuous processes and the pressure to develop faster and better processes are both increasing . The need for flexibility and compliance is paramount to supplying the clinical trial material and the modular concept solution is a key to achieving both objectives while maintaining the cost of development .
By building a library of modules , the expansion of this capability can be attained while maintaining a reasonable investment . This gives SK Pharmteco the ability to provide a rapid , flexible , robust and scalable solution to the pharmaceutical community . ●
Dr Olivier Dapremont
EXECUTIVE DIRECTOR , PROCESS TECHNOLOGIES
AMPAC FINE CHEMICALS k + 1 916 978 6489 J olivier . dapremont @ apfac . com j www . apfc . com
38 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981