More than 4 million pounds of refined sugar was at stake!

More than 4 million pounds of sugar was quarantined by the FDA after a warehouse fire raised fears of product contamination from heat, smoke and gaseous vapors.

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.

Over 4 million pounds of refined sugar was stored inside – bagged and stacked on pallets.

The Challenge

The fire had started in an adjacent building, with smoke and fumes entering the sugar warehouse through the HVAC system.

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.

FDA officials rejected each submission citing “data not indicative of what a fire produces”.

The Timing

More time was wasted when the in-house team insisted on testing for “volatile compounds” and “solvents”.

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).

A highly detailed protocol citing specific techniques and compounds was then submitted to the FDA.

The Approach

Proposing an analytical strategy and protocol that was accepted by the FDA, Quantum was able to fast-track the testing results.

The Insight

“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.

The Result

The sugar was safe! The resulting evidence lifted the quarantine.

Every pound was removed from the warehouse and allowed to safely go to market.

The Value

The sugar company was able to recover millions of dollars through the sale of the unscathed sugar.

The value of an experienced and consultative CRO can grow dramatically – especially when things don’t go as planned! Raw materials are easily compromised. Is your lab up to the challenge?

Call (800) 448-2968 to Speak with One of Our Experts or for more information on our Consulting and Testing Services