John’s Corner – Insert – 10 May 2017

On May 10, 2017, in Uncategorized, by George Loyer

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Insert – John’s Corner – 26 April 2017

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

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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:

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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.





John’s Corner – Insert – 12 April 2017

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

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We’re making progress!

On April 12, 2017, in Case Study, Problem Solving, by George Loyer

When we started wave three of the Deviation Analysis, we knew that, in each case, Dydramat dust was only found in production rooms 507 and 508.  Next, we discovered it was found during the regular pre-production inspection.  This inspection takes place just before the start of production on the first scheduled production day after the normal cleaning and maintenance days.  During the inspections on 8, 16 and 24 February and on 3 March they found the Dydramat dust more or less evenly distributed all over the floor and on the production equipment.  Although the Dydramat dust was barely visible, a thorough vacuuming produced from a low of 31 grams to a high of 68 grams.  Analysis of each vacuum bag indicated that in each case the dust was virtually pure Dydramat.  Fortunately, no Dydramat dust made its way into the Microcyn production equipment.  If it had, they would have had to shut down production.

We confirmed that since the Dydramat dust was found in rooms 507 and 508 on 8 February, the only time Dydramat dust has been found is during the regular pre-production inspection.  We know that because since 9 February Product Quality has been checking all active Microcyn production rooms on an hourly basis.  They have found no trace of Dydramat dust.  The only time it is found is during the regular pre-production inspection.

Whenever there is a problem like this, lots of Likely Causes start to fly around, mostly from people not directly involved in the Deviation Analysis.  Based upon the information we had at this point in the Deviation Analysis, we could conclusively rule out the following possible causes that were flying around:

  • Incompetent operators are letting Dydramat dust fly around.
  • The sealing equipment in the clean-up room doesn’t work right.
  • The production equipment in question was used in Dydramat production during the previous cycle.

Tip of the day:  When you do a good job of gathering, sorting and organizing information, you can rule out Likely Causes that do not make sense.

Next time we’ll look at the true Likely Cause and how we proved it.



Last time we determined there was documented Dydramat contamination in Microcyn production rooms on 8 Feb, 16 Feb, 24 Feb and 3 March.  That was a good start.  So, we continued our Deviation Analysis by determining if just some, or all of the Microcyn production rooms were contaminated.

Production floors 3 and 5 are dedicated to Microcyn production in 10 functionally identical production rooms.

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The investigation quickly found that production rooms 507 & 508 were the only Microcyn production rooms with the Dydramat contamination.

Floor 4 is dedicated to Dydramat production.  As the Dydramat contamination is limited to rooms 507 & 508, we quickly ruled out anything directly related to floor 4 as the cause.  In addition, we knew something about floor 5 itself was directly related to the contamination problem.

So, we compared floor 5 to the other floors in the production building.  Here’s what we found:

  • Each floor has its own Heating, Ventilation and Air Conditioning (HVAC) equipment.
  • On each floor, except floor 5, there is one HVAC system for the entire production area.
  • All HVAC systems are zone controlled, allowing for HVAC being provided to each production room independently as needed.
  • About 2 years ago, the HVAC on floor 5 was upgraded to provide better HVAC control.
  • Floor 5 now has 3 independent HVAC systems.  One services the offices.  Another serves what is now the Production Equipment Clean-up Room and production rooms 505, 506, and 509.  The third HVAC system is dedicated to production rooms 507 and 508.

The above got us to focus on the HVAC equipment.  Standard procedure is to turn the air conditioner off when there is no sanitation activity or production in a production room.  Because there is no heat being generated by the equipment and because people are not continuously working in the area, air handling is accomplished by turning on the exhaust fan in each production room.  This significantly reduces your electrical cost and is only a minor inconvenience to the people staging the sanitized equipment in the room in preparation for the next production run.

Next time we’ll continue to look at the Deviation Analysis and how we used the information above.




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John’s Corner – Insert – 29 March 2017

On March 29, 2017, in Uncategorized, by George Loyer

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John’s Corner – 15 March 2017 – Insert 2

On March 15, 2017, in Uncategorized, by George Loyer

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John’s Corner – 15 March 2017 – Insert 1

On March 15, 2017, in Uncategorized, by George Loyer

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When we showed up on 8 March, Pharmco had recently completed construction on floor 5.  The construction converted the US FDA Certified Clean Storage Room into the new Production Equipment Cleaning Room.

Although the construction was scheduled to be completed by 29 January, it was not completed until
5 February.  This was due, in a large part, to some modifications to the Heating, Ventilation and Air Conditioning (HVAC) system on floor 5.  The modifications involved the removal of the air lock which was required for the US FDA Certified Clean Storage Room.  The US FDA Certified Clean Storage Room was entered once or twice a month at most.  The Production Equipment Cleaning Room is entered hundreds of times a day.

To go through the air lock people would enter the air lock, close the door behind them and wait for the HVAC system to create a negative pressure in the air lock.  This negative pressure would then release the air lock door to the US FDA Certified Clean Storage Room.  The people could then enter the US FDA Certified Clean Storage Room.  When the people were ready to leave the US FDA Certified Clean Storage Room they would push a button in the Clean Storage Room and wait until the HVAC system created negative pressure in the air lock.  This would release the door allowing them to return to the air lock.

The HVAC experts decided to remove all the air handling equipment from the air lock.  This meant that the entire HVAC system for the new Production Equipment Cleaning Room needed to be reworked.  This extra work delayed the completion of construction by about a week.

Several people blamed that construction on the Dydramat contamination in the Microcyn Production Rooms.  We could eliminate that as a Likely Cause for two reasons.  First, all the Floor 5 Production Rooms were sealed in an FDA approved manner during the entire production process.  Second, the construction was completed by 6 February, yet there was documented contamination on 8 Feb, 16 Feb, 24 Feb and 3 March.  Yes, construction might explain the contamination found on 8 Feb.  But there is no logical way to blame construction for the contamination found on 16 Feb, 24 Feb and 3 March.

Ruling out construction as a Likely Cause opened people’s minds so we started to gather more information.  Next time we’ll start to look at the Deviation Analysis we they did.


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