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: http://www.ispe.org/galleries/newjersey-files/Feb21-Clean_Room_Presentation.pdf ). 

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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Next week’s blog:
Facility Start Up in Biotech

Resource link:
http://www.ispe.org/galleries/newjersey-files/Feb21-Clean_Room_Presentation.pdf


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

Facebook and the Pharma Industry

Posted by Tita Tavares on Thu, May 26, 2011 @ 03:17 PM

 Purple Social Media Enterey Blog6 resized 600

Is Social Media
that Important to Pharma Companies?

 

As a follow up to our May 5, 2011 post, Pharma, Social Media and the FDA's Delay, here's an interesting development that just might help push pharma companies to stay on top of the FDA to issue further guidelines on the industry's interaction in the social media world.

By August 15th, Facebook will require pharmaceutical companies to enable and allow public comments on their posts. This could be a huge risk and may be a big problem for pharma marketers, posing whether or not the benefits of Facebook are worth the effort.

Basically, it will take a lot of monitoring to make sure the conversations and dialogues on their company pages remain in a positive light for the manufacturers. Will this solution be cost prohibiting or will it be minor when weighed against the benefits and attraction Facebook interaction creates?

Is this decision made by Facebook a good one or not? This type of action may be what the social media mogul needed to keep their brand and product consistent all the way through. Facebook is created to be a virtul forum for real conversations to take place. It allows people to interact in the comforts of their own environments. Taking away the ability to engage in a virtual dialogue would be like telling someone, "Let's talk but do not say anything. I am the only one allowed to talk here but please listen." That isn't much of a conversation anyone would want to engage in, virtual or not!

Though Facebook's policies may be a hurdle for pharma companies and their marketing teams--if they play it right--they should be able to leap easily over the challenges and continue to use the virtual platform as a vehicle to set a casual tone in relating to their customers and patients. The informal approach could lead to patients feeling like they really matter to these seemingly HUMONGEOUS companies and at that, patient loyalty would be well worth the effort.

Read Article   

From stacyrobin on twitter: New realities for pharma? RT @kbkcomm: Hmmm...@Facebook says: pharmas must enable comments by August 15 http://ht.ly/52X6q (http://twitter.com/stacyrobin/statuses/73827493462806529

To get a better understanding of Facebook’s policies towards the pharma industry, read Intouch Solution’s Blog for their view and comments.

Published by: Tita Tavares, Enterey | Director, Brand Development


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Next week’s blog:
Facility Start Up in Biotech

Resource link:
http://bit.ly/gd70PZ

ambro


 

Tags: FDA, Life Sciences Industry News, FDA guidelines, Social Media, Communication, Social Media and Pharma, Facebook, Risks, Life Sciences Communication, Pharma Marketing