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.
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.
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.
  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:

"Teaming our talent with yours to meet your requirements."

Phone: (302) 834-3344 or (800) 207-7647 FAX: (302) 834-5157
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