“Give wooden pallets the sniff test and get certification from suppliers that no halogenated phenolic preservatives have been used in the lumber.” That’s the latest from Fierce Pharma, which is reporting FDA’s advise that the pharma companies should receive certification from their vendors that pallets have not been exposed to halogenated phenolic preservatives such as TBP. Mercifully, it cites guidance from the FDA reminding drugmakers that cGMP compliance requires written procedures for sanitation that prevents the contamination of equipment, components and drug products. In other words, pay attention to process. What a concept.
The story reports that production is shifting to the U.S. where TBA shouldn’t be an issue. “At those sites, pallets made of North American lumber are unlikely to have been treated with TBP.” No kidding, considering that it has been banned as a wood treatment in most of the world for many years.
Interesting, the story also includes a link to a Pfizer summary which discusses the TBA exposure it has experienced, and which does not pinpoint wood pallets as being the cause, although it lobs the possibility that they may have been.
“Earlier this year,” Pfizer states, “a “musty” or “moldy” smell recently reported in bottles of another pharmaceutical company’s products turned out to be caused by 2,4,6 tribromoanisole, or TBA. It results from a chemical change that occurs to another compound, 2, 4, 6 tribromophenol, or TBP, commonly found in wood preservatives, paint, insulating materials and other items. Humid conditions, as in tropical regions, promote mold that can cause TBP to turn into TBA. Plastic bottles can pick up traces of TBA if they are stored in areas where TBP or TBA exist, or on wooden pallets (portable platforms for transport or storage of goods) that are treated with TBP.”
We are left with two plausible alternatives. Either the source of the TBA is not wood pallets (no one has shown that it is), or if the source of the pallets is TBA originating in pallet lumber from South America, perhaps, then the necessary steps haven’t been taken to correct the problem. Pallets are just far too convenient to blame when the alternative is to actually take ownership of supply chain processes.