Introducing new PAT sensors may reduce the risks of contamination during upstream and downstream processes

Improving manufacturing bioprocesses implies the need for cutting-edge technologies for Advanced Process Controls (APC). But, is it a real progress if they introduce other issues due to the lack of compliance with GMPs?

Contamination of cell cultures and downstream products is a real issue, generating batch rejection, unexpected cleaning operations and long investigations that are regularly unsolved. A basic idea to avoid complicating this issue is probably to use new technologies that have been specially designed to fulfill GMP requirements, in particular in terms of cleaning and sterilization.

In the case of RESOLUTION Spectra Systems ProCellics bioprocess Raman analyzer, the rational for a GMP design has been based on three main principles:

  • the immersion probe shall be sterilized under the most demanding autoclaving conditions or with CIP/SIP  processes with unlimited cycles (no glue used during the fabrication process)Procellics_bioreactor
  • the immersion probe shall have no geometry that would retain spots
  • each part of ProCellics outside the bioreactor shall be easy to clean, including during exceptional operations of decontamination.

Achieving these goals with ProCellics has required a special caution to be taken, but not limited, to the following elements:

  • bonding process of the optical window of the immersion probe without glue
  • special care to its surface finish
  • stainless steel material for the probe parts inside and outside the bioreactor
  • robust and long cable which withstands aggressive cleaning
  • IP65 analyzer housing coated with an anti-microbial painting.

At the end, using such an in-line analyzer will reduce the risks of contamination with less sampling for off-line analysis.

Christophe BONNEVILLE

President of RESOLUTION Spectra Systems