Wooden Pallets in GMP Manufacturing Space

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ricky07

hi

do companies use wooden pallets in GMP areas? if not, how have they managed to take this out and replaced it with what? plastic?

any comments/guidance would be much appreciated.
 

mdurivage

Quite Involved in Discussions
We limited the pallets and cardboard packaging in our ‘controlled’ environmental areas to what was absolutely necessary for the immediate needs of production. This was done as a result of environmental monitoring detecting excursions which was found to be related to the packaging materials.
 
R

ricky07

thanks. We have the same issues of environmental excursions. The challenge is to remove the use of these and replace with suitable material. I am not aware of common approach in the Pharma industry.

:thanx:
 

mdurivage

Quite Involved in Discussions
You could use plastic pallets in the GMP area and transfer to wood pallets before relasing for storage and/or distribution.
 
C

cccp47

We had a separate Warehouse, Mix Room and Production Floor. We received materials in the warehouse and shipped things out the door on wooden pallets, but anything that was brought into either the Mix or Production areas was transferred to thermoformed plastic pallets; I think you can get them for ~$40 apiece from Uline or similar. The reasoning there was to limit chance for particulate matter, debris, or contamination. Plastic could easily be sanitized and does not have the potential for splinters, sawdust, etc.
 

Ajit Basrur

Leader
Admin
In addition to great replies so far, remember that there was a huge Batch recall by McNeil Consumer Healthcare in 2010.

Refer FDA Warning Letter here

The company received "uncharacteristic odor" complaints, some of which were associated with adverse event reports (gastrointestinal distress), for several of your OTC drug products are due to 2,4,6 Tribromoanisole (TBA) contamination in the product and/or bottles. TBA, which has a musty, mildew-type odor, is a known degradant of 2,4,6, Tribromophenol (TBP). TBP is a pesticide and flame retardant used to treat wooden pallets for transporting packaging materials and finished product. TBA is organoleptically detectable at parts per trillion.

The company also inferred that uncharacteristic odor was due to the contamination of the drug product containers from TBP treated wooden pallets, where TBP from the wooden pallets degraded into TBA, which contaminated product containers and the finished product in those containers.

Also refer an existing thread - US Federal Regulation(s) on Wooden Pallets

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