PHSS best practice guidance on Bio-contamination

The PHSS Bio-contamination monograph has four principle sections namely;              

1) Bio-contamination Profiling and Characterisation.

2) Bio-contamination control principles.

3) Environmental monitoring, data recording, interpretation and reporting.

4) Bio-contamination Deviation management including Root cause analysis (RCA) plus  corrective and preventative action (CAPA).

James covers the outline of this important new PHSS best practice guidance on Bio-contamination and considers the sections covering Rapid and Real time micro biological methods. Considerations are presented on implementation strategies for real time micro biological monitoring methods, in particular:

• Relationship of Classification and monitoring in controlled environments.
• How real time monitoring relates to profiling and characterisation of Bio-contamination defined in the PHSS monograph.
• Implementation strategies for RMM in monitoring of controlled environments.
• The strategies for use of RMM in root cause analysis studies and CAPA efficacy checks.