High Containment High Containment Processes in the Solid Drugs Production
Containment of a solid drugs production is incomplete where the production environment is neglected. Closed process equipment and the production environment need to be considered as an integral solution. There should however be a reasonable balance between protective effects and plant productivity.
Apart from personnel and environmental protection, operators of high containment processes put emphasis on product protection. Simultaneously a high productivity of process equipment is required. Problems arise where protection requirements conflict with production capacity and equipment availability. Times for product transfer and cleaning at product change play a decisive role in this conjunction.
The Process Equipment
Project experiences show that the toxic properties of solid drugs are initially often unknown in multi-product plants. That is why containment components are selected according to the criteria functionality, process safety and extent of automation. Detailed process knowledge is required to develop a safe solution. A more differentiated consideration of the process steps pays off by avoiding oversized protective precautions. Provided that the equipment supplier is involved in the development at an early stage, a modular solution can be achieved that can be used by the plant operator in a flexible manner. Finally, there should be a reasonable balance between protective effects and plant productivity.
Isolators and containment valves have long been used in the high containment area. Equipment suppliers can prove their effectiveness by means of standardised test methods (SMEPAC test). There are alternative technologies for lower containment requirements, for the solid material transfer, for example.
Technical protective precautions can be verified using the multi-stage containment model. Containment stages are not standardised in the solid drugs industry. There are different stage models with individual number of stages and concentrations. Generally, a distinction is made between 5 containment stages or hazard classes.