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Alpha Engineering,
Inc. clearly understands the difference between plant commissioning
and validation. Not every system needs to be validated, but without exception
every system must be fully functional and challenged to verify its operation.
Only the critical utilities in direct contact with an FDA or European regulated
product, or having an indirect impact must be validated. The Baseline
Pharmaceutical Engineering Guide for New and Renovated Facilities, Volume
5, Commissioning and Qualification clearly delineates facility systems
and equipment requiring only commissioning. |
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AEI
engineers and technicians have developed a Commissioning Master Plan
approach, or Impact Assessment, designed to maximize project success for
a smooth turnover with minimal start up costs. Installation/Operation
Qualification protocol development and execution is only a part of the
Master Plan. Equipment and system start-ups routinely require manipulation
and debugging. AEI personnel are field seasoned, hands on troubleshooters.
HVAC systems, environmental controls, support utilities as well as critical
utilities are all familiar systems to us.
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The Commissioning and
Qualification Baseline Guide defines Good Engineering Practice (GEP) as
"established engineering methods and standards
that are applied throughout the project lifecycle to deliver appropriate
cost-effective solutions". Alpha Engineering, Inc. subscribes
to and has practiced GEP since it began business in 1981. |
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AEI also subscribes
to Team Alpha Philosophy,
a personnel-orchestrated approach to project lifecycles with a track record
for success. AEI and its divisions, Alpha
Pharm Tech and Alpha
Building Inspectors, team with your personnel to assure total success
for your new or retrofit projects. Hence our slogan: |
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"Teaming
our talent with yours to meet your requirements."
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