Industries

Biotechnology

A Challenging Technology
Biotech is probably the most challenging technology to put into a facility. There are many reasons for this. Consider:

• Sterility: The front end of the process (the bioreactor) and the back end of the process (purification/bulk fill) both have to be sterile (or possess adequate control of contamination) so that control of the process can be demonstrated.

• Cleaning: All the processing vessels and the associated piping must be cleaned between batches. At a production level, the Clean in Place (CIP) system design becomes an effort almost as large as the process design itself.

• Validation: The validation challenges are greater in Biotech than other types of pharmaceutical process because of the large number of different product contact unit operations and sanitization/cleaning cycles to be validated