Confidential Pharmaceutical Manufacturer Lyophilization and Utilities

Salas O’Brien provided comprehensive commissioning and qualification packages for a new manufacturing suite and IMA Lyomax lyophilized, and all associated utilities (HVAC, compressed air, nitrogen, chill water, heating/hot water skid, and CIP skid), support equipment (blenders and tanks), and computerized systems (BMS, data historian, and automated formulation processing system) . The project comprised the development and execution of 175 commissioning, qualification, and turnover package documents. The documents included change control, vendor assessment, URS, system classification, system risk assessment, design review and qualification, SAT, IQOQ, TM, SR, and TOP related to area suite, processing, utility/mechanical, and data integrity. Salas O’Brien completed the project on time and within budget, increasing the client’s lyophilization capacity and process efficiency.

SERVICES

Commissioning

SIZE

3,000 square feet

PROJECT CAPITAL

$160,000

COMPLETION YEAR

2021

My team has been working with Salas O’Brien on several projects. Feedback from team members is Salas O’Brien is easy to work with, provides great quality documents, are conscientious of cost and schedule and communicates well with all team members. We look forward to continuing to work with the Salas O’Brien team.

Manager, Capital Projects, and Technology Engineering