Single Pot Processing Solution for Oncology Products

Using proven standard components, GEA  can supply both simplicity and flexibility in plant design. User-selected process options, control systems and liquid recovery units combine in a system that meets your process requirements exactly. This approach ensures that qualification and validation work can be kept to a minimum and ensures successful results. As demonstrated in the case study, for example, we have a leading position and a proven track record as a system integrator for high containment projects with single pot technology for oncology and hormone applications.

GEA supplied a complete containment line to Ranbaxy Laboratories Limited (Gurgaon, India) to manufacture highly potent anticancer drugs with an OEL of 1–10 µg/m³. It was essential that the process prevented any cross-contamination in the production area and limited operator Real Daily Intake (RDI) of hazardous substances to well within the Acceptable Daily Intake (ADI).

During the selection process, several key equipment features were specified:

• All units had to provide full containment
• The entire process had to be contained in a single machine to avoid contamination and limit material handling
• The technology had to be flexible enough to adapt to different products and batch sizes
• The process should provide maximum yields with minimum wastage
• There should be a clear and straightforward documentation procedure.

In addition, it was essential that the operators had an in-depth understanding of both the equipment and the relevant containment issues.

To meet the production, containment and whole-life cost requirements, Ranbaxy chose two GEA Single Pot processors: the UltimaPro™ 10 and the UltimaPro™ 75 (10 L and 75 L processing bowl, respectively). The safe, low temperature, vacuum drying technology was augmented with microwaves or Transflo™ (gas-assisted vacuum drying); end-point determination was achieved using a torque sensor (granulation) and NIR (end humidity); a built-in camera allowed operators to view the process without opening the lid; and cleaning was done by a comprehensive fully validatable CIP system.

Exceptional Performance

The new equipment has allowed the company to develop niche oncology products in a contained environment that protects its workforce and the wider environment from toxic compounds. Since installation, predicted levels of production, containment and operational efficiency have been achieved. In addition, factors such as very effective microwave drying for aqueous feeds, more consistent granule sizes and much less operator intervention than had been anticipated have been cited as “areas of exceptional performance.”