Team Alpha Philosophy

Team Alpha is an 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 Philosophy.

Team Alpha Mission
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 minimized.

From 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 life cycle:
  1. 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.
  2. Basis of Design - 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 effort.
  3. Design and Engineering - 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.
  4. Contract Management - 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.
  5. Protocol 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 monumental chore.
  6. Instrument Calibration - 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.
  7. Start 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 use points.
  8. Qualification & Validation - 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.
  9. Regulatory Compliance - 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.

The project 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.

The 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".

Team 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]