PET production cleanroom facility and support areas
Cleanroom case study: IBA Molecular (Guildford and Dinnington)
The purpose of these projects was to produce a PET (Positron Emission Tomography) facility for the production of the positron-emitting compound Flucis. The radioactive substance decays quickly and is effective for a short period of time and so must therefore be produced in a manufacturing site near the PET scanner.
The facility was required to comply with MHRA guidelines for Pharmaceutical Manufacturing, the Radiation Protection Advisor (RPA) and the Environmental Agency (EA).
Facility building
Nuclear filters
Accessible distribution system
Preparation isolator
Lead lined isolator
Chemistry cells
Cleanroom
GMP corridor
Pressurised filtered transfer hatch
" The facility design and functionality allowed us to control the environments within the critical areas to suit the demands of the regulatory bodies successfully, thus allowing us to achieve complete compliance throughout "
Ian Dyson
Facilities Manager (Dinnington Facility), IBA Molecular
- Main case studies index page
- Cleanrooms:
- New aseptic compounding unit - grade C and D
- Project gemini new QC laboratory facility - grade D
- GMP facility - inhaled and oral solid dose products
- ISO 6 precision manufacturing cleanroom
- ISO 8 packaging cleanroom
- Aseptic preparation facility
- Aseptic manufacturing facility
- 150m² NHS Aseptic Pharmacy Suite
- PET production cleanroom facility and support areas
- Turnkey QC laboratory facility
- cGMP Grade B Cleanrooms c/w Grade A Aseptic Processing Facilities
- Cytotoxic Facility and Sterile Facility
- ISO Class 7 Medical Device Suites for manufacture of stent-grafts
- cGMP Lozenge Manufacturing Facility - Grade D at Rest
- ISO Class 7 Compounding Suite with ISO Class 8 background areas
- ISO Class 6 Medical Device Facility
- Pharmaceutical Compounding Suite for Aseptic Products
- ISO Class 7 Medical Device Cleanroom
- Beagle II Mars Expedition Facility
- Laboratories:
- GMP Laboratory Refurbishment
- ISO Class 4 Cleanrooms c/w Analytical Laboratories
- Products:
- Custom Laminar Flow Cabinet
- Vaccine Isolator
- Sterile Filling Line