THE ASSIGNMENT
Recommended as a “consultative problem solver” Quantum Analytics Group was asked to meet with the stakeholders of this major US sugar manufacturer.
AT THE MEETING, QUANTUM AGREED TO PROVIDE INITIAL CONSULTING, TESTING, ANALYSIS AND A COMPLETE REGULATORY DATA PACKAGE.
THE CHALLENGE
The fire had started in an adjacent building, with smoke and fumes entering the sugar warehouse through the HVAC system.
OVER 4 MILLION POUNDS OF REFINED SUGAR WAS STORED INSIDE – BAGGED AND STACKED ON PALLETS.
THE ISSUES
The sugar company tried, on their own, to get the FDA to lift the quarantine.
BUT RESISTANCE TIGHTENED AS INSUFFICIENT TEST DATA WAS SUBMITTED.
THE TIMING
More time was wasted when the in-house team insisted on testing for “volatile compounds” and “solvents”.
FDA OFFICIALS REJECTED EACH SUBMISSION CITING “DATA NOT INDICATIVE OF WHAT A FIRE PRODUCES”.
THE SOLUTION
Success was quickly achieved through Quantum’s knowledge of the chemistry of fire itself, along with a deeper understanding of what the FDA was actually looking for.
THE FDA WAS SPECIFICALLY LOOKING FOR POLYCYCLIC AROMATIC HYDROCARBONS (PAHS).
THE APPROACH
Proposing an analytical strategy and protocol that was accepted by the FDA, Quantum was able to fast-track the testing results.
A HIGHLY DETAILED PROTOCOL CITING SPECIFIC TECHNIQUES AND COMPOUNDS WAS THEN SUBMITTED TO THE FDA.
“Knowing what the FDA was really looking for was critical, but proving that our method was suitable for intended use when there was no existing methods geared towards testing sugar for PAH’s was the key”.
SIMPLY TESTING THE SUGAR SAMPLES WASN’T ENOUGH TO PROVE THE METHOD WORKED. GC MASS SPEC SPIKE SAMPLES WERE UTILIZED TO VALIDATE THE METHOD.
