Decision by Cellysis to include the oxidant gases Hydrogen Peroxide and Peracetic Acid to the core Acetic Acid gas phase technology has been justified by the first challenge study on Rock melons.

Unlike the initial acetic acid L. mono bench scale challenge this Rock melon challenge was a real world, scalable Pilot plant challenge. Challenge organism was Lactobacillus plantarum a beneficial non-pathogen, resistant to acid and peroxide chemistries, so a good challenge. Swab sampling method was used as it is the NSW DPI industry standard. 0.1ml inoculum at 10e6 proved to be too great a volume for the 5cm2 swab area resulting in a low control recovery of 10e4 and 10e5 which limited the process efficacy assessment.

ALS C of A FM2425248-AB shows results for these first two trials. 005 20240404T1 gases were Hydrogen Peroxide and Peracetic Acid. 006 20240404T2 gases were Hydrogen Peroxide, Peracetic Acid and Acetic acid.

Control inoculum and final serial dilution were insufficient to challenge the process parameters and identify which trial had the greater efficacy.

Considering typical environmental loadings under good manufacturing practices are approximately 10e3 this first challenge can be deemed adequate and in accordance with GMP consideration should be given to a reduction in process surface concentrations.

Still a long road for adoption by industry.