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Our Outcome
CV™ (Commissioning Validation)
product takes the validation and commissioning processes into
account, starting in the planning and design phase of a project.
Outcome CV™ was developed by specialists from Syska Hennessy Group’s
Commissioning Team along with Validation Team experts from BioMetics,
Inc.
By knowing what systems and equipment require validation, and
exactly what the performance of those systems and equipment should
be, a supporting commissioning plan can be developed early in
the game. Uncovering problems before the validation process starts,
means smooth sailing once it does.
Research Findings: There is confusion
around start-up style commissioning and true commissioning
in the industry today. While commissioning is an integral part
of utilizing the building support systems and process systems,
it is currently jammed in between the end of construction and
beginning of validation. As a result, any commissioning that
is performed does not support validation. Many firms are using
in-house commissioning teams, who have limited experience.
A myriad of problems are, consequently, uncovered during validation – further
delaying and complicating this important process. Costs skyrocket
and put pressure on an already strained budget. These costly
delays also affect a drug’s speed to market, and eat
away at valuable patent time.
In the chart shown below, we can see a comparison between anticipated
costs (shown in black), and the unexpected additional costs (shown
in red) when problems were not uncovered before the validation process
began. This chart represents an actual case study of an East Coast
pharmaceutical manufacturing facility. Note that the project time
was extended from 8 months to 28 months before they could even start
manufacturing their product.
Why We’re Different: We design, construct
and operate facilities, making our commissioning method one of the
most comprehensive in the industry. Outcome CV™ allows for
a smooth hand-off of required documents to the validation team much
sooner during a project. Where possible, tests can be performed
jointly, eliminating duplication of testing and, in some cases,
paperwork. The commissioning process has been redesigned to ensure
more in-depth testing to wring out problems and make immediate changes
while the construction team is still on-site. Problems are not uncovered
late in the project, thus eliminating the costly time and money
impacts seen in traditional commissioning and validation methods.
For further information on this process, please contact:
800.328.1600
Paul
Liesman, PE, Senior Vice President
Markus
Yakren, PE, Senior Vice President
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