GMP facility - inhaled and oral solid dose products

Cleanroom case study: Pharmaterials

Bassaire were awarded the contract for the design, build and construction of the Pharmaterials GMP facility for the manufacturing of investigational medicinal products.

Included in the rationale for the facility, the following criteria were assessed and catered for: building finishes and structure, air filtration, air change rate and flushing rate, room pressures, location of air terminals and directional airflow, temperature and humidity, material and personnel flow, equipment movement, processes being carried out, outside air conditions and occupancy.

The new facility allowed the development work for providing a quick and cost effective route into early phase clinical trials covering Pharmaterials areas of expertise, namely:

  • Powder blends filled into hard shell capsules, bottles, or inhalation devices
  • Granules filled into hard shell capsules or bottles
  • Liquids or suspensions filled into bottles
  • Amorphous formulations filled into hard shell capsules
  • Liquid or semi-solid formulations filled into hard shell capsules

" The project met with the inspectors requirements and was fully compliant with the ISPE guidelines for OSD. "

Paul Went
Director of Quality, Pharmaterials Ltd