The Enterey Blog

4 Rules to Facility Start-up. Looking Deeper Into Rule #2

Posted by Tita Tavares on Fri, Jul 01, 2011 @ 02:09 PM

Rule #2: Keep your air in balance

Keep your air in balance” – This rule is part metaphor, part tactical; we’ll start with tactical.

Tactically, air balancing activities are critical to any GMP facility build out.  In fact, you cannot obtain clean room classification by any standard (FDA, EU, or ISO) without performing air balancing.  Room to room pressure cascades, room air changes, particle counts, etc. are all critical to the different clean room classifications and air balancing allows you to prove that your air handling units are capable of maintaining the room classification designation (for more detail on comparisons of the different room classifications, visit: ). 

In order to have a succesful “right first time” air balancing, multiple building systems need to be fully operational and qualified (AHUs, clean utilities, building management system, etc.) and all equipment should be in place.  This means that air balancing should be one of the final activities in a start up schedule.  In fact, I would recommend that air balancing occur just before static and dynamic room PQs for two reasons.

  1. This will ensure all construction activities are complete so that there isn’t an open cavity into wall space that should not be there, that makes air balancing all but impossible (I’ve seen it happen).
  2. Once a room is qualified personnel must be gowned according to the room classification.  This not only requires that you train all personnel entering the room but it also significantly reduces productivity of equipment qualification.  Put simply, gowning slows people down and the room classification may limit the number of personnel that can be in the room at any one time.

Given the two reasons above, it’s best to leave air balancing as one of the final activities that is completed for facility start-up schedule, despite the temptation to do it earlier.  If you follow this rule it will also go a long way to helping you build your start-up schedule.  In short, target when your air balancing work will occur and build backwards from there for the building systems and equipment qualification activities, and build forward from there for all room qualification activities.

Facility Start Up Air In Balance

Metaphorically, “keep your air in balance” is relatively straight forward; air balancing requires just that – balance; and so should your start-up team.  There should be a balance between start-up functions and priorities; meeting schedule deadlines should be important but never “at all costs,” similarly regulatory compliance is of the utmost importance but a risk based approach to decision making should always be employed.  Keeping things in balance at all times will go a long way towards allowing a smooth facility start-up.

Published by: Carlo Odicino, Enterey | Director, Client Services

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Facility Start Up in Biotech

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Tags: FDA, FDA guidelines, Facility Start-up, EU, ISO, GMP Facility Build Out, Construction Activities, Clean Room