Propofol (2,6-diisopropylphenol) is the most commonly used intravenous agent for induction of anesthesia. It is also used for maintenance of anesthesia and sedation in both Intensive Care Units and outpatient procedural settings. Its success in the clinical setting has been a result of its rapid onset, short duration of action, and minimal side effects despite disadvantages associated with its oil emulsion formulation.
With the global market for Propofol expected to grow by 5% every year, there is need for more facilities to manufacture Propofol. And it is this need our client were looking to serve by setting up a Propofol Emulsion manufacturing plant.
However, our client had limited process knowledge of Propofol Emulsion manufacturing and needed a partner who could own and design the entire process.
The project scope involved complete process design, CIP and SIP of process vessels, transfer lines and holding vessels and high pressure and inline homogenizers. Another hitch was that the client needed this plant to be a multiproduct facility with 24/7 operations, allowing for an easy switch to small volume parenterals while being cGMP compliant.
With our prior experience and process expertise, these challenges were not that difficult to resolve.
Our client’s first ask was to find out the Homogenizers required for Propofol Emulsion. Our process team identified the exact makes and models of both the High Pressure Homogenizer and In Line Homogenizer and integrated both in our design to ensure smooth process operations.
We began with a complete process flow diagram along with CIP and SIP of the plant and generated a P&ID. At the design stage itself, we planned it as a multiproduct facility, ensuring that when demand for Propofol stalls, the same facility can easily switch to making other small volume parenterals. The system is designed to be fully automatic with complete CIP and SIP of the process vessels along with transfer line up to final filling. This ensures fewer operator interventions are needed. The plant is designed as per current cGMP standards and can clear any national and international audit.
We also delivered PW/WFI/Pure Steam Generation system to the client.