Icheme Symposium Series No. 124 Process Validation and Safety in Biotechnology

A br ie f su rvey of c u r r e n t inf luences on the implementat ion safety in fermentat ion process is made. The role of v a l i d a t ion, as in tended by the Food and Drug Adminst ra t ion of USA, in improv ing the safety of the process is d iscussed, wi th a case s tudy . I t is concluded tha t the va l idat ion exercise wil l improve the safety of the p roduc t to the consumer and in do ing so wil l ensure a degree of opera tor safety t h r o u g h mutual requ i rements . However, i t is f u r t h e r concluded tha t the re is s t i l l a need f o r devices to be invented which are capable of de tec t ing small leakages from the fe rmenta t ion , fo r complete operator safety . Some of the research address ing t h i s problem is rev iewed.