Was it some moldy ceiling tiles? The dusty shoes of a careless employee? Or did the contamination ride in on one of the ingredients? There are lots of ways fungus could have gotten inside the Massachusetts compounding pharmacy whose steroid medication has been linked to a lethal outbreak of a rare fungal form of meningitis.
The outbreak has killed at least 16 people and sickened more than 200 others in 15 states. Nearly all the victims had received steroid injections for back pain.
Criminal investigators from the Food and Drug Administration were at the Framingham firm Tuesday, company spokesman Andrew Paven said. He had no further comment.
The New England Compounding Center of Framingham, Mass., has not commented on its production process or what might have gone wrong, so outside experts can only speculate. But the betting money seems to be on dirty conditions, faulty sterilizing equipment, tainted ingredients or sloppiness on the part of employees.
Compounding pharmacies aren't as tightly regulated as drug company plants, but they are supposed to follow certain rules: Clean floors and other surfaces daily; monitor air in "clean rooms" where drugs are made; require employees to wear gloves and gowns; test samples from each lot.
High-volume production of the sort that went on at New England Compounding also raises the chances of contamination, experts said.
"I don't see it as appropriate for a community pharmacy to do a batch of something preservative-free in numbers in the thousands" of doses, said Lou Diorio, a New Jersey-based consultant to compounding pharmacies. Diorio, who has no connection to the investigation or the company, said it is harder to keep everything sterile when working with large amounts.
To make the steroid, a chemical powder from a supplier is mixed with a liquid, sterilized through heating, then pumped into vials, according to Eric Kastango, another consultant from New Jersey who helps compounding pharmacies deal with contamination problems. He is not connected to the company either.
Perhaps the powder was contaminated, either at New England Compounding or another location. Maybe the fungus was in the liquid, some experts said.