Isolator Technology Workshop - Sterility Test Isolator
Im Auftrag der ECA Academy

The consequences of a failed sterility test are enormous. The use of Sterility Test Isolators offers a much safer way to avoid false positive results. That’s why the use of isolators for sterility testing has become a standard in the pharmaceutical industry and in microbiological contract laboratories. But at the same time Isolator Technology requires an increased input with regard to the qualification of these systems and the validation of the decontamination process.

In 2004, Appendix 1 to the FDA Guidance for Industry „Sterile Drug Products Produced by Aseptic Processing“ defined new regulatory requirements on using this technology, as did the PIC/S document PI 014-3 „Isolators used for Aseptic Processing and Sterility Testing“ and the expected revision of EU GMP Annex 1.