ABI consists of professional engineers who have many years experience with large scale mechanical and electrical systems. We know proper construction standards, building code requirements and life safety regulations. Whether inspecting air handling units with associated ductwork and HEPA filtration, motor control centers and power distribution systems, Water-For-Injection sanitary piping systems, or building structural support, ABI will provide the secure comfort of knowing your systems are installed correctly.

But Alpha Building Inspectors do not stop there. The Code of Federal Regulations, Part 211 addresses current Good Manufacturing Practice. ABI is particularly concerned with Subpart C - Buildings and Facilities. Although brief and inconcise, paragraph 211.42 is very explicit about cleaning, maintenance and operations to prevent contamination and mix-ups. ABI is very familiar with cGMP and other regulatory requirements such as room classifications per Federal Standard 209E, the European Commission and the British Standards Institution regulations. Cleanability is paramount to microbial control. Room finishing as well as equipment fabrication always receive our strict attention. We are equally familiar with aseptic facility requirements for parental fill processes.

ABI performs quality assurance checks on vendor equipment at the factory before shipment and after installation. Written field reports of Factory Acceptance Tests may be conveniently referenced in the Operation Qualification protocols. ABI professionals are equally familiar with both process and utilities equipment.

 

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