Positive results on a sterilization dose audit (SDA) does not automatically mean that the sterilization dose is inadequate. However shared knowledge of the types and sources of those surviving microorganisms could aid future sterility failure root cause investigations and improve understanding of the potential causes of microbial contamination.

Investigating the source of these survivors can be labour intensive and expensive for companies to conduct.  There is limited guidance on how to investigate the most common causes of SDA failures.  Nor is there a database of the most common causes of SDA positives

Aim

To collect industry wide examples from Irradiation Panel members of microorganisms surviving sub-lethal doses, dose survived, product recovered from, investigation outcomes and subsequent corrective actions.

Trending and analysis of the data to summarise the microbial types, sources and possible corrective actions to prevent re-occurrence.

Gather case studies and success stories on corrective actions taken for any microorganisms surviving sub-lethal dose exposure in order that the industry can collaborate and share pertinent information to aid future SDA failure investigations.

Key deliverables

Database of microbial identification results of SDA positives
Data analysis of SDA positives and root causes
Identify sources of SDA positives and how they were tracked / discovered
Identify common themes in SDA positives and corrective actions taken
Potential Panel paper - Guidance on SDA survivors, their origins in cleanroom manufacturing areas, investigation planning and corrective action(s)

Preliminary results of early data sharing show there are indeed common isolates surviving SDA doses and therefore learnings on how they were dealt with could be valuable to share amongst industry.