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Process Improvement Award Winner with Global 500 Biotech Company

  
  
  

 

Austin Srejma Enterey Senior Consultant

Austin Srejma, Enterey Senior Consultant

 

"Enterey Project Wins Process Improvement Award From Global 500 Biotech Company"

See how we introduced a more efficient change control process to help the growth of a current biotech client. Congratulations to Austin Srejma for being awarded a process improvement award. 

"Austin Srejma has served as Senior Consultant with Enterey since July 2009. This is the second time one of her projects has received a process improvement award. Enterey Life Sciences Consulting, founded in 2002, provides Life Sciences Consulting expertise across both process and system-related projects. Enterey provides solutions for a wide range of client needs, from strategic planning to business-integration activities, implementation and specialized efforts, such as clinical and commercial facility start-ups. Enterey has a proven track record for successfully delivering projects within the biotech and pharmaceutical space"

Read further current press details highlighted in LA Daily News.

 

 



4 Rules to Facility Start-up. The Final Rule of Facility Start-up.

  
  
  

We’ve reached our final rule for facility start-ups:

The law of “The Jungle”
 

This rule is a play on two literary references that are applicable to a Life Sciences facility start-up.  The first is a reference to the book The Jungle by Upton Sinclair.   This book, published in 1905, exposed unsanitary conditions in the Chicago meat packing industry and served as a catalyst for the Pure Food and Drug Act passed in 1906.  This act is a pre-cursor to today’s current good manufacturing practices (cGMPs) that govern Life Sciences companies.  These cGMPs are non-negotiable and must be followed regardless of impact to the schedule of the start-up.  I know for most this goes without saying, but it is worth driving home the point.  Yes cGMPs are guidelines, and yes most companies go above and beyond cGMPs but in the thick of some of the financial pressures that occur during a highly visible capital projects like a facility start-up these sometimes can and do get forgotten. 

I realize in rule #3 we stressed not placing invisible boundaries to problem solving, cGMPs are very real boundaries and should always be followed.


 
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The second literary reference is to the last line of Rudyard Kipling’s poem The Law of the Jungle which is as follows

 

“…For the strength of the Pack is the Wolf, and the strength of the Wolf is the Pack.”

 

This one line summarizes the type of teamwork that is required through a successful start-up.  There is no one individual or functional area that is more important than another.  All groups / individuals play their part and need to work together to both solve problems and drive towards success.   There will be problems, there will be delays but a start-up team will always succeed if they focus on the appropriate level of detail, are balanced in their approach, don’t create artificial boundaries, all while adhering to cGMPs and working as a TRUE team.

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Published by Carlo Odicino | Former Director, Client Services

 

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Next week’s blog:
Laboratory Information Management System (LIMS) toward Streamlined Biotechnology and Pharmaceutical Operations

 

 

4 Rules to Facility Start-up. Looking Deeper Into Rule #3

  
  
  

Rule #3: A deeper look into facility start-up.

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Remember Humpty Dumpty”

Now I’m sure you’re wondering what this rule has to do with facility start-ups, but before we go down that path let’s start with a simple exercise: draw Humpty Dumpty.  Go ahead, get out a sheet of paper and draw Humpty Dumpty.  It doesn’t need to be a masterpiece, just draw what you think of when you hear Humpty Dumpty…I’ll wait.   How many of you drew something that resembles an egg?  Before we go further, go ahead and read the typical version of the nursery rhyme “Humpty Dumpty”

 

Humpty Dumpty sat on a wall,
Humpty Dumpty had a great fall.
All the king's horses and all the king's men
Couldn't put Humpty together again

Facility Start-up


After reading the rhyme, I’ll ask a simple question, where does it say that Humpty Dumpty is an egg?  Obviously it doesn’t but we’ve been trained to think of Humpty Dumpty as an egg because someone drew him/her/it (I’ll use him for ease) that way many moons ago.  If you didn’t draw him as an egg; bravo!  I know I would have drawn him as an egg.  The point I’m trying to make is that it is important not to set artificial boundaries, particularly when trying to solve a problem.

 

 

During facility start-up the only thing you can count on is that things will change.  Issues will arise that are unexpected and that will require creative solutions.  When trying to come up with a solution just remember; Humpty Dumpty does not have to be an egg.  In other words, question everything and don’t set artificial boundaries for yourself.  Life sciences is already a regulated industry and you certainly don’t need to add more “artificial” regulations.

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Published by Carlo Odicino | Former Director, Client Services

 

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Next week’s blog:
4th Rule of Facility Start-up

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

  
  
  

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


4 Rules to Facility Start-up. Check Out Rule #1

  
  
  

Rule #1: Don’t lose the forest for the trees

Manufacturing facility start-up is a fact of life in the lifecycle of any biotech, pharmaceutical, or medical device company.  Whether it be a parent company that does manufacturing in house or a CMO, at some point in time during the lifecycle of a life sciences company a manufacturing facility will need to be built/acquired in order to manufacture the product.  When it comes to growing life sciences companies that have focused on small scale R&D type manufacturing, large scale facility start-up can seem like a daunting task.  To be sure, facility start-ups are large scale, complex projects that require careful coordination between multiple stakeholders both internal and external to life sciences companies.  However, the task can be much more manageable and much less daunting if you keep in mind these four simple rules.    

1)      Don’t lose the forest for the trees  

2)      Keep your air in balance  

3)      Remember Humpty Dumpty  

4)      The law of “The Jungle”  

Now you’re probably thinking, “What in the world do these 4 rules have to do with facility start-up?”  Over the next four weeks we’ll explore what each of these rules means and how they can set you up for a successful facility start-up.  We will start with the rule that is probably easiest to interpret:    

Don’t lose the forest for the trees”This oft used colloquialism is especially apropos of a start-up.  Due to the inherent complexity of start-ups there is a tendency to want to detail every activity and put it in a project plan so that nothing “slips through the cracks.”  While it is certainly beneficial to have a detailed project plan it is important to keep in mind that it must have an APPROPRIATE level of detail – that is, be detailed, but not too detailed.  Let’s explain further.  

It easy to understand why having too little detail allows for things to be missed since a lack of detail inherently implies that something is missing.  But how can too much detail be negative?  Often times an overly detailed schedule leads to too much schedule management (which is a non-value added activity) and detracts from project execution which is value add.  But even in the case where there are sufficient resources to manage a schedule, “over detail” leads to a false sense of security that everything is in the schedule and therefore nothing has been missed when something important truly is missing.

Take a look at the following 2 pictures as an example of this principle:

Facility Start-Up Pixel      Facility Start-up Mona Lisa

Suppose you were told that the picture on the left was an art masterpiece and you were asked to identify it.  You are unable to, because there is too much missing; there is not enough detail.

Now take a look at the picture on the right.  At first glance you may still feel like there still isn’t enough detail in order to identify it, but try stepping back from your computer screen.  The farther back you go the clearer the picture becomes until it is easily recognizable as Leonardo da Vinci’s Mona Lisa.  The picture on the right has an appropriate level of detail for you to recognize it for what it is and your facility start-up project plan should do the same.

You don’t want your project plan to be so simple that no one on the project team recognizes it as a project plan but you also don’t want to require so much detail that you are unable to take a step back and see the forest for the trees.

For more fun examples of “appropriate detail” go to:
http://www.moillusions.com/2010/11/our-brain-is-truly-wonderful.html

Published by Carlo Odicino | Director, Client Services

 

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Next week’s blog:
4 Rules to Facility Start-up. Keep Your Air in Balance Rule #2

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