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  Small Volume Parenteral Manufacturing Facility
Provided construction management services in the development of a new 75,000 sf parenteral manufacturing facility. The facility included utilities such as clean steam, WFI, CIP and RO. Services included: obtaining governing agency approval, scheduling, material selection, contract negotiation, equipment and construction coordination, construction review for quality and completion, interface between owner, engineers and contractors.
Provided commissioning and validation services of equipment and systems including: Writing of Protocols and SOP’s, IQ, OQ, PQ execution for utility systems, depyrogenation tunnel, bottle cappers, bottle washer, temperature control units, spray dryers, homogenizers, vacuum tumblers, bottle labelers, laser marking systems and participation in media fills for process validation of liquid and lyophilized products.Critical Utility Systems Replacement
Provided project management, design, construction management and commissioning and validation coordination of water pretreatment, RO, WFI, pure steam and compressed dry air equipment and systems. Project replaced existing WFI production and expanded WFI storage while maintaining existing systems in operation. Process Equipment Replacement (Filler, Autoclave, Spray Dryers)
Provided design, construction management and oversight of commissioning and validation coordination of replacement process equipment such as BOC Edwards vial filler, Fedegari autoclave and Niro Spray Dryers.Client Confidentiality is Protected. Please call our office for more information or a timeline of events.

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