GMP Pharmaceutical Facility

GMP Pharmaceutical Facility

TCi construction WORKS has been engaged in site-wide refurbishment and construction project for a major OTC pharmaceuticals producer.

The project includes the conversion of several production areas into a large-scale dry manufacture and packing environment with three main zones.

Preparation and delivery

The project was delivered within a working GMP environment,

  • Metal-framed containment system constructed in GMP conditions, comprising a white, flame-retardant heavy-duty outer sheet, sealed from floor to underside of roof liner
  • Access via dedicated, zipped and sealed containment areas
  • Designated access and site office established to minimise impact of works and prevent contamination paths
  • On-site cleaner provisioned as standard to ensure work areas and access paths kept free from contaminants and debris
  • Sub contractors assessed and selected through competitive tender with emphasis on technical capability
  • Site manager permanently based on site to oversee the entire project with TCi management, H&S and administrative support from head office
  • During the set-up phase, TCi undertook to assess the design for improvements and cost saving
  • Project variations encountered through the project have been assessed and managed via an established change control process

Outcomes

The resulting facility reflects a demand for ultra modern, easy to maintain workspace and efficient, large-scale production. By working closely with the client, we have been able to manage the relocation of offices and production lines in order to cause minimum impact to the daily operation of the plant.

Features

The Altro quartz resin flooring technique developed by TCi with the client has undergone further continuous improvement to include a stainless steel bead which has replaced the hand-worked seams.

TCi is listed and verified as an approved installer for Puracore® clean room partitioning and ceiling systems, SIKA GRP impregnated resin wall & floor finish and altro resin floor finish.

HVAC & Dust Extraction

24/7 air management system was designed an installed, providing negative pressure to transit corridor to maintain containment requirements. The system features a failsafe link between two of the units serving the same room, double deflection grilles and safe change (bag-in-bag-out) filtration.