(684a) Applications of Process Analytical Technologies to Ensure Controlled Processes

To ensure the transfer of robust and well controlled processes from the lab to manufacturing, extensive knowledge of the chemistry and unit operations is required. With the current push to implement PAT in pharmaceutical manufacturing, new tools are now available to obtain this knowledge from all phases of the process (liquid, gas, and solid).

This presentation focuses on the use of PAT in the lab to gain understanding of complex processes and how this understanding can allow better decisions in designing a control strategy based on in-process measurements. In general, the alternatives for in-process measurements to control a process, in order of preference, include:

1. Time.

2. Time in combination with temperature, pressure, or flow.

3. The simplest, most reliable PAT measurement that minimizes sample handling and turnaround time.

4. Repeatedly obtain and analyze samples off-line until the desired result is achieved.

Rationale for these priorities will be provided along with examples, with an emphasis on how PAT is used in the lab and pilot plant to help make the appropriate decision. Examples will include the monitoring of all phases in a heterogeneous process as well as multiple reactions in series in a complex batch process.