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|Wood Pallet & Pharmaceutical Industries Working Together|
By David Ulrich, Jorgelina González and Edgar Deomano
This is the third article in a series meant to further the conversation and cooperative efforts between the pharmaceutical industry and wood packaging suppliers related to taints. These taints can migrate from wood pallets and fiberboard box materials to pharmaceutical products that are transported on pallets.
We recommend that pharmaceutical manufacturers make pallet management part of their Good Manufacturing Practices/ Good Distribution Practices (GMP/GDP) quality management system.
As a brief reminder, 2,4,6 tribromophenol (TBP) and 2,4,6 trichlorophenol (TCP) are fungicides that are used in hot/humid climates to retard fungal growth. It can be used on many surfaces – and in this case on wood pallets, and sometimes on the lumber before the stringers/runners are cut for pallet assembly. TBP/TCP have a typical phenol smell, (note: one of the active ingredients in Lysol is phenol), and the smell can be described as medicinal or similar to the smell of a doctor’s office.
However, if after the lumber component or assembled wood pallet is treated with TBP or TCP but is not properly handled, the phenol can convert to an “anisole”, specifically TBA or TCA, and anisoles smell musty. This musty/moldy off-odor is what triggered the complaints that caused the thousands of units recalled. (Note: for more background on this issue, see part one of the series.) The controls discussed in parts one and two stated to avoid this family of fungicides at the mill or the pallet companies, this is where pharmaceutical manufacturer’s supplier quality assurance (SQA) program needs to be engaged.
Basically, pharmaceutical manufacturers, as part of their GMP/GDP, already have SQA programs that “audit and assess” controls needed by all of their suppliers, from critical third party manufacturers (TPMs), to critical raw material suppliers, to commodity suppliers (e.g. plastic bottles, labels) and service providers (e.g. testing labs). So taking their “current” SQA program and adding pallet controls to the already established program is a relatively short jump. The first step is to know from whom you purchase your pallets. This effort should engage purchasing, supply chain/transportation/ distribution operations and the SQA group.
Note: when this issue started to occur in 2009, most pharmaceutical manufacturers did not have pallets as part of their SQA program and most quality assurance and supply chain groups were unaware of where their pallets came from.
Once you understand where your pallets come from, the next steps are: 1) adding the pallet companies to the SQA program; 2) developing “user requirements”; and 3) implementing these user requirements or specifications through QA and purchasing into the purchase order (PO). In other words, what specifications do you want for your pallets? Historically, it was basically size and weight-bearing capacity. Now these specifications need to include not using fungicides. An important “potential” additional specification is moisture content (MC). When fresh wood is used to construct pallets, the MC can be 30- to-50 percent. This MC, with proper airflow, will drop down to less than 20 percent but in an area with poor airflow (e.g. storage in a truck with no airflow), mold can grow very quickly. So for high volume pallet lanes, implementing a moisture spec of less than 20 percent will substantially reduce the likelihood of mold growth.
When the specifications mentioned above are implemented, the next set of controls are purely part of the pharmaceutical manufacturer’s GMP/GDP program. The recommendations for pharmaceutical manufacturers to implement are as follows:
Integrating these recommended “pallet management controls” and including pallet management as part of the pharmaceutical manufacturers GMP/ GDP and part of their SQA and Supply Chain Integrity (SCI) plans are relatively easy steps to reduce the risk of supply chain taints.
For high volume pallet lanes, implementing a moisture spec of less than 20 percent will substantially reduce the likelihood of mold growth.
(Article published in PalletCentral Magazine, November-December 2012)
David Ulrich holds the title of QA director Pharma Supply Chain at Abbott Laboratory. Jorgelina González is the Technical Lead at Paleteras Unidas & Caribe Recycling. Edgar Deomano is former Technical Director at NWPCA.