MARKET: Pharmaceutical | Biotech | Life Sciences
TAI SERVICES: • Quality & Commissioning • On-Site Services
VALUE CLASS: <$300K
ABOUT: The Client, a global pharmaceutical firm, provides technologies, development, drug manufacturing, biologics, gene therapies and consumer health products.
Download Case Study
TAI’s commissioning team provided direct coordination with the client and Design-Build team to ensure that all systems and components of the facility were designed, installed, tested, operated and maintained according to the client’s operational requirements.
Among the many industries our client serves, the drug manufacturing and consumer health markets are among those with the tightest schedules to get the clients’ technologies to market. Strict schedules and contractual commitments to hit manufacturing target dates are non-negotiables, therefore downtime and/or delays in production represents millions of dollars in lost revenue.
TAI was brought in to supplement the Design-Build team; developing and executing a sound commissioning program, and correcting a number of existing deficiencies with mechanical and facility controls systems.
TAI provided Quality and Commissioning services in support of multiple phases of construction taking place at our client’s facility in Maryland. This Quality and Commissioning support included all phases of new construction activity, as well as retro-commissioning and monitoring-based commissioning of existing facilities. Specifically, TAI’s Commissioning team performed all tasks related to execution of commissioning, including Quality Assurance and Quality Control, Factory Witness Test Observations, Start-up Verifications, Commissioning, and Validation Assistance.
The TAI team reviewed the design drawings and specifications and provided comments on the mechanical, electrical, process, plumbing and fire protection systems. The team maintained a design issues log to document any issues identified and a QA/QC log for all issues identified during. TAI attended factory witness tests for critical mechanical and electrical contractors to develop an equipment startup procedure for all major equipment. Additionally, we worked with the mechanical and electrical contractors to develop an equipment startup procedure for all major equipment and witnessed equipment startups and recorded issues as identified.
In terms of Commissioning, the TAI team provided Functional Performance Test scripts for use during commissioning and completed Verified Pre-Function Performance Test scripts prior to the formal functional performance tests, maintained a corrective action log for issues that arose during the function performance testing, and provided a final commissioning log at the completion of the project including all design, QA/QC, and corrective actions reports.
Additionally, the team provided on-site support to the validation process to provide consistency between the construction and validation phases of the project.
TAI’s Commissioning and Quality Control services corrected deficiencies and brought all system into alignment, positioned for peak performance. Working with the Design-Build team, TAI was able to get all suites up and running on time.