BI has been the original promoter of kill step validation in the industry, developing a validated kill step steam sterilisation method long before the elimination of ethylene oxide and irradiation techniques by the Federal Drug Administration
With other companies now following suit in the movement towards the reduction and elimination of microbial loads, BI continues to champion the validation of test methods.
In 2002, BI’s Protexx HP Green Steam became the industry’s only species-specific, organic steam sterilisation system with a validated kill step.
Protexx HP utilises more than 40 settings, which control heat, moisture, time and pressure parameters, tailored for each individual species.
BI has fine-tuned more than 350 product-specific, validated protocols across its five steam units that utilise the highest pressure and temperature settings in the industry, resulting in shorter treatment times to eliminate pathogens that help maintain the product’s characteristics.
BI also has the only steam unit in the industry validated using the USP method, which is the most stringent test on the market for sterilisation methods. BI’s USP method is tested and retested annually to ensure effectiveness.
“BI has steam treated more than 90 million kilos of herbal botanicals and food ingredients since Protexx HP was implemented,” said George Pontiakos, President/CEO of BI.
“For this reason, it is critical that our validation methods are failsafe. While its promising suppliers are joining the conversation on kill-step validation, we need to maintain a hardline on the validation of test methods to protect consumers and the industry at large.”
BI has long emphasised the urgency on industry participants to be vigilant in the implementation of the FDA’s Hazard Analysis and Critical Point plan, as well as validation of supply chain testing because of the variance of ingredients found in nature.