Now the air is clear

On April 26, 2017, in Uncategorized, by George Loyer

During the last 4 posts, we looked at a serious contamination problem at a Pharmaceutical Company we’ve called Pharmco.  Not to beat a dead horse, but I’ll say it again.  Before we got on the scene, they were shot-gunning causes.  They blamed everything from the operators, to the product itself, to the production equipment.  They had even, as I said in an earlier post, flown technicians from Germany in to “fix” the equipment.

Once we had Gathered, Sorted and Organized the information available all of the above Likely Causes were summarily dismissed.  Below is the Deviation Analysis Information we developed:

(Click image to enlarge)

When we define a Deviation, one of the things we ask is, “Given the information available, would a knowledgeable person, or group of people, be able to find the cause of this Deviation?”  So, that’s exactly what we did, we gave the above to their technical experts.

Here’s what they determined:

  • When the old storage room was converted to a clean-up room, the air lock was no longer needed, so they eliminated it.  This, combined with the fact that Production Rooms 507 & 508 were at the other end of that old air lock, and that 507 & 508 had their own HVAC, and that when no one was working in 507 & 508 the exhaust fan was turned on (running the exhaust fan as opposed to the HVAC when no one was working in a production room was company policy).
  • Considering that industrial HVAC systems draw “make-up” air from the outside, there is a slight positive pressure in all areas with HVAC.  When running an exhaust fan, that space has a slight negative pressure.
  • Putting it all together, they determined when the doors to both 507 & 508 and the clean-up room were open during non-production or clean-up times, the pressure differential between the two rooms allowed Dydramat dust to migrate from the clean-up room to 507 & 508.  When the doors to 507 & 508 were closed, the dust settled evenly over everything in the room.

And, that was all there was to it!

Next time we’ll look at a new topic.





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