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.

(Click image to enlarge)

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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