TCI provided construction support, on-site project engineering along with commissioning, qualification and validation services for a new manufacturing facility located in Lexington, MA. This facility includes approximately 6,000 square feet of ISO classified laboratory space and 14,000 square feet of office and utility support space. Stereopure nucleic acid therapeutics, oligonucleotide modalities including antisense, exon-skipping and single- stranded RNAi Required.
Provided CA Support and closeout
Full CQV system development and documentation Complete CQV execution
Project management of all CQV activities
Onsite Engineering support during construction for project closeout
There were 45 commissioning packages prepared ranging from GEP,GMP, building management systems to solvent delivery, waste distribution and fume/exhaust hoods.
In regard to the MEP/FP & Process scope of this project, included were not only hazardous areas and life safety considerations for the sensitive and complex nature of the product developed in this facility, but also a detailed array of mechanical, plumbing, electrical and process systems in place to support these efforts. TCI was tasked with insuring the proper installation, review of GMP qualifications, commissioning and operational support of a facility at the highest standard expected in the industry. While providing commissioning services, TCI worked very closely with the client and the construction team on a daily basis to provide support in solving a wide range of tasks, both troubleshooting existing concerns and also responding to issues that arose throughout the construction and installation process.
TCI also provided additional support services for future planning for an upcoming expansion within the remaining footprint of the building.