Validation of cytometry method for the quality control and release of non obligatory sterile pharmaceutical products

Specialised in the manufacture of raw materials for pharmaceutical industry, SPI Pharma has recently set-up a rapid microbiology system based on flow cytometry for the release control of non obligatory sterile pharmaceutical products. The manufacturer describes in this article the different stages and the results of the validation of this protocol allowing to obtain presence/absence results in 24 hours.

By Denis Solinas, QC Manager, Safety and Environment SPI Pharma Company.

Extract from "Salles Propres" Magazine