Issue link: http://palletcentral.uberflip.com/i/507696
20 PalletCentral • March-April 2015 palletcentral.com • ISPM 15 compliance is necessary, however does not mitigate taints and the need to know what method your pallet manufacturer uses. • Pallets should be inspected for "household cleanliness." • Pallets should be stored high and dry. Pallet Manufacturer Controls Since the "root cause" was determined to be indirectly related to wood pallets, the next step was to look at how pallet manufacturers source their wood and control their processes so that fungicides can be avoided when possible. While controls used in the wood pallet industry were extensive, they were by and largely unknown to the pharma industry. Part Two of this series played an integral part in communicating those control. KD HT (or air drying if feasible) is the most effective process (vs. MB or standard HT) to control for ISPM 15 and prevent the need for fungicides. Finally, Pharma Manufacturer Controls Now that we have an understanding of 1) the life cycle of a pallet 2) what are anisoles, 3) where they come from and 4) how to control them, the final step is pallet management by the pharma manufacturer. Pharma manufacturers have numerous controls based on government regulations on their very complex manufacturing processes, termed GMPs (good manufacturing practices). Recently these GMP controls are expanding out of necessity and by government regulations into supply chain control, termed GDPs (Good Distribution Practices). Treating a pallet manufacturer with the appropriate level of supplier controls AND developing a pallet management program is a relatively simple and effective way to mitigate the risk of TBA/TCA in the pharma supply chain. The following is a summary from Article #3: INDUSTRY Table 2: FDA product recalls based on TBA/TCA taints Date Product Reason/Problem 04/14/2011 06/20/2011 06/29/2011 03/13/2013 5/15/2013 5/22/2013 5/22/2013 5/22/2013 TOPAMAX® (topiramate) 100mg Tablets RISPERDAL, 3mg tablets and risperidone, 2mg tablets TYLENOL, Extra Strength Caplets, 225 count Montelukast Sodium Tablets, 10 mg (base), packaged in a) 30-count tablets per bottle Plavix 75 mg, 30 count bottle Glenmark Topiramate Tablets, 200 mg, 60-count bottle Glenmark Pravastatin Sodium Tablets, 40 mg, 90-count bottle Glenmark Gabapentin Tablets, a) 600mg, 500- count bottle Uncharacteristic Odor Uncharacteristic odor thought to be caused by trace amounts of 2,4,6 tribromoanisole Uncharacteristic odor linked to trace amounts of 2,4,6 tribromoanisole Chemical Contamination: The recall has been initiat- ed based on multiple complaints received from phar- macists and consumers reporting that they detected an off-odor, described as moldy, musty or fishy in nature which has been identified as trace levels of Tribromoanisole (TBA) and Trichloroanisole (TCA). Chemical Contamination: Uncharacteristic moldy odor due to presence of 2,4,6-tribromoanisole (TBA). Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off- odor described as moldy, musty or fishy in nature. Chemical Contamination: Pravastatin Sodium Tablets is being recalled due to complaints related to an off- odor described as moldy, musty or fishy in nature. Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off-odor described as moldy, musty or fishy in nature.