assembly of the finest talent available working in unison to meet
a project’s requirements.
By joining forces between client in-house and out-sourced capabilities
with Alpha Engineering, its divisions and associates, Team
Alpha takes on ownership and meets project challenges
using the Team Alpha
To identify project requirements, find the best path forward and
implement solutions with efficiency; In a way that meet current
Good Manufacturing Practice; So that the facility and product is
in full regulatory compliance, and the product to market time is
concept through construction, commissioning, validation and license
submittals, Team Alpha provides a well planned, executed
and documented approach to completing projects while never losing
sight of its final objective: regulatory compliance! Here
is further clarification of the illustrated steps in the project
Concept - Team Alpha
begins with the client by identifying project objectives.
Alpha Engineering provides early technical assistance with facility
lay outs, provisions for utilities services (critical and non-critical),
Master Plans (people, product, equipment flows, room pressures
and classifications), process flow diagramming, cGMP and regulatory
requirements, environmental issues and permitting requirements.
- The B.O.D. documents are developed by the owner/client to
give direction to an Architectural and Engineering group. These
documents establish the parameters a new or renovated facility
must meet. Such things as room environments, equipment needs,
plot plans, specialty needs (such as Locally Controlled Environments),
and other macrocosm limits are developed at this stage. The
B.O.D. is often the basis on which architects and engineers
bid the design and specification package. Alpha Engineering
knows this process and will lead or assist with the development
- Once the architectural and engineering group is awarded the
project, Engineers, Architects, Designers and Detailers are
mobilized. This is when coordination among disciplines becomes
critical. Correcting interferences is simpler on a CAD machine
than in the field. It is also necessary that the site utilities
and the new facility service requirements be coordinated with
each other. Alpha Engineering strives to assure that all services,
room finishes and equipment needs are engineered appropriately.
Before the building and utilities designs are committed, Team
Alpha performs a value engineering analysis to assure
"Minimum Essential Design" is achieved.
- Very often a third party contract administrator is employed.
They award subcontracts, track expenditures and construction
progress, procure equipment, and perform various other construction
duties. These people are very good at meeting project requirements,
but tight budgets and fast track schedules typical of today’s
projects only add to the already demanding challenges. Because
of this, many important installation details get overlooked
until the final days when they become highly burdensome punch
list tasks (i.e., steam heating coil traps piped with drains
elevated, duct penetrations after the leak test is complete,
incorrect material installed, etc.). Team
Alpha, with the help of Alpha Building Inspectors
(ABI), identifies missed or mistakenly installed mechanical
and electrical components early; making the punch list more
manageable. These same team members become key to systems commissioning,
protocol development and execution, and documentation control.
Furthermore, ABI witnesses Factory Acceptance Tests (FAT’s),
as well as Site Acceptance Tests (SAT’s), for all equipment
and skids used in critical and non-critical services. Clean-In-Place,
Steam-In-Place, Water For Injection stills (multi-effect and
vapor compression), reverse osmosis water pretreatment systems
as well as more common equipment such as air handling units,
dehumidifiers, Building Automation Systems, compressors, vacuum
pumps, etc. are familiar devices to Alpha Building Inspectors.
Development - Every FDA regulated facility and process
must comply to strict qualification and validation tests before
being granted a license. Qualification documents must be written
and approved that describe - what is installed, how it is to
operate and what performance parameters the equipment/process
must meet. These documents are called: Installation Qualification
(IQ), Operation Qualification (OQ) and Performance Qualification
(PQ) protocols. Other documents such as Standard Operating Procedure
(SOP) and Preventive Maintenance (PM) are also required. In-house
personnel are best suited to author and execute protocols, but
fast track projects do not permit this luxury for those with
limited resources. Thus, out-sourcing is required to supplement
the project team. This is where Team
Alpha plays an essential role. Alpha Engineering
and its associates know protocols and are ready to assist or
lead the development effort on all fronts. IQ/OQ/PQ formats
for building services and process equipment have become somewhat
routine but customized for each application. The
Team Alpha approach uses proven techniques and
computer software applications to manage and control an otherwise
All instruments must be calibrated using National Institute
of Standards and Testing (NIST) traceable calibrated instruments.
Subsequent periodic calibrations are required as well. Team
Alpha assumes this responsibility by timely scheduling
appropriate team members to the task.
Up & Commissioning - As systems near completion,
more attention is given to incomplete items. Operators and/or
selected mechanics are key members on the team since they are
essential in bringing the systems on line. Very often these
are the same people who assume responsibility for system operations.
Thus, they have a natural interest in receiving properly functioning
equipment. With their needed input, many details that affect
future performance are addressed early enough to avoid consequent
modifications or even repairs. Team
Alpha’s commissioning effort focuses on taking finished
workable systems and drives them to working systems within the
scheduled window so that qualifications may begin at the system’s
- Executing protocols is labor intensive.
Team Alpha executes the IQ while installation
progresses. Using an information request procedure, inefficiency
is minimized by catching mistakes as they occur while avoiding
construction interference. Once a system is documented to be
substantially complete and commissioning proves it to function
properly, OQ execution may begin. Control loop checks, software
test plans, safety interlocks and other operational tests are
executed according to cGMP requirements leading to Performance
Qualification testing. PQ protocol executions validate equipment
capability to meet user requirements.
- This is Team Alpha’s ultimate
objective. All protocols must be completely executed and signed
off with exceptions and deviations addressed. All supporting
documentation must be referenced and properly stored with the
protocols in a project library, under control and in a way that
documents can be easily retrieved when a regulatory agent requests
it. Team Alpha gathers all
pertinent data (Operation and Maintenance manuals, test reports,
equipment list, etc.) from vendors, subcontractors and other
sources. Design changes must also be documented and approved
per a prescribed procedure. One or more team members maintain
the library while the project is in progress. Control is a key
factor in a successful documentation turnover.
life cycle does not end here. There are many issues that must
follow, such as training, preventive maintenance files, as-built
drawing revisions and license application development to name
a few. Team Alpha
is a total support approach that continues through quality
assurance and facility, as well as product, licensing.
Team Alpha philosophy is a culmination of successfully
used tasks and techniques all brought together to help you achieve
a successful project. Alpha Engineering, its divisions and associates
team their talent with yours to meet your requirements. Thus,
our motto: "Teaming with Talent".
Alpha has elevated "team building" to a new level.
We supplement and support a project to the extent that best fits
your needs throughout the project life cycle. Everyone on the team
plays a significant role that is vital to the project’s success.
This is made obvious to each team member at the project kick-off
and as each subsequent member joins the team. Also, as interim goals
are achieved, congratulations are given by way of small social functions
such as a "pizza lunch". Praise and salutations provide positive
feedback to all team members and perpetuate team synergy.
Phone: (302) 834-3344
or (800) 207-7647 FAX: (302) 834-5157
Send comments to: [email protected]