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Serialization: Are You Ready For Changing Regulations?

By John Hannon, April 12, 2016

If the pharmaceutical distribution network is at risk, so is patient safety. With counterfeit drugs on the rise, serialization programs are being implemented to safeguard the integrity of product reaching the market. Serialization also provides better controls to communicate recall information should it become necessary.

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Do You Have Rouging Problems?

By Nissan Cohen, April 10, 2016

Recently rouging of two process vessels at a blood fractionation facility shut down production. 

The tanks of concern were derouged and passivated just 10 days before the rouge was observed on product contact surfaces prompting great concern.

The tanks are configured with baffles and stirrers connected to a main shaft.  “Staining” was noticed by the operators on several of these product contact surfaces.

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How to Understand ASTM E2500