Trouble shooting microbiological deviations

Purpose

Trouble shooting normally starts with identifying the nature of the microbiological problem to get a first clue to where it might  stem from. This also gives an input to in what environment the organism can survive and grow. Sometimes an extensive sampling all along the production line is perfomed including raw materials and product in different stages, as before and after an inactivation step as for example a heat process.

Method

Depending on the cause of the problem some  or all of the steps below might be used in the trouble shooting process.

The work begins with a joint visit to the facility by a microbiologist and a process technician. The visit is made because it is of the utmost importance to understand the problem on the spot in order to understand it.

Samples might be collected, to find the microorganism causing the issue, not only from the raw mateial and produt in different phases but from all factory environment as open surfaces with product contact, in packaging area, air, rinsing water after CIP-process and more . 

Measuring temperatures  and effective time in any inactivation/heat process inside the actual product might also be needed. Based on the data calculations to determine if the inactivation/heat process is enough to kill the microorganism in focus, will be done.

Routines and observance for cleaning and disinfection are also often looked into.

Review of protocoll from microbiological analysis over some time might also be included to understand how the problem have increased over time.

Deliveries

When the cause of the problem has been found measures are taken to prevent it happening again. Corrective actions are suggested  and monitoring and control are looked over. All work are summarised in a written report.