Our process engineering services are widely utilized for improving problems with our client's manufacturing processes. These problems generally become evident after evaluating the root causes of manufacturing performance indicators such as:

• Poor product yields.
• Inefficient turnaround of manufacturing systems between batches.
• High frequency of process deviations.
• Lack of consistent process repeatability.

We combine sound engineering theory with experimental verification. This approach occasionally results in the creation of proprietary techniques that may be patented and/or licensed. We have significant experience developing unique processes for:

• Steam sterilization and depyrogenation.
• Equipment and component cleaning.
• Solvent extraction.
• Drying (thermal, vacuum, and lyophilization).
• Filtration.
• UV curing.
• Homogenization and fluidization.
• Mixing.
• Partial rehydration of lyophilized products.
• Aseptic compounding.
• Aseptic filling of liquids and suspensions.

In addition to developing new processes, we also provide services for process optimization to:

• Minimize the impact of a process on finished products or component materials.
• Minimize the processing time.
• Maximize capacity.
• Increase product yields.

In particular, we have significant experience enhancing the reliability and performance of batch processes for aseptic compounding, sterilization, lyophilization, and equipment preparatory processes such as:

• Clean-in-Place (CIP).
• Sterilization-in-Place (SIP).
• Integrity testing (vacuum/pressure leak testing).

We also provide process engineering services to help our clients execute the scale-up of a product from laboratory to pilot or commercial manufacturing. Many processes must become more robust and rely on automation when a process is scaled-up. This is simply a result of the fact that the process recieves much more personal attention at the laboratory level.

PharmSys helps with the scale-up transition by fully evaluating the laboratory scale process to ensure that all critical processes and parameters have been identified. This allows for effective engineering design and direct comparison of the scaled-up processes and control parameters with the laboratory model.

Scale-up activities often result in significant equipment changes. Therefore, reviews of the capabilities of the laboratory equipment coupled with the process demands ensure that new equipment will be properly specified and designed to accommodate the scaled-up process.