Particle Monitoring In Pharmaceutical Cleanrooms

By Morgan Polen, VP of Application Technology, Lighthouse Worldwide Solutions  

Environmental monitoring is an important aspect of regulatory and quality control in the production of pharmaceuticals. The manufacturing environment must be controlled and monitored during the production of drugs. Final drug products must be sterile and free from contamination.

Terminal sterilization and aseptic processing are the two paths taken to produce sterile drugs. Terminal sterilization is the process of sterilizing materials and containers, done with the material in its containers, with the product in its final form.

In aseptic filling or packaging, the individual components are sterilized separately and brought together in the final form in a sterile environment.

Sterile drugs should be manufactured by aseptic processing only when terminal sterilization is not feasible.