North East Wales NHS Trust, Wrexham Maelor Hospital
| Used as: | Pharmacy Aseptic Unit |
| Location: | Wrexham, Wales, United Kingdom |
| Sector: | Healthcare |
| Solution: | Traditional / In-Situ |
- To relocate and expand existing aseptic services into a new hospital wing at the Wrexham Maelor Hospital
- Used for Total Parenteral Nutrition (TPN), CIVAS and cytotoxic dispensing
- Dedicated gene therapy suite
- MHRA (Medicines and Healthcare products Regulatory Agency) and RPA (Radiation Protection Advisor) approved facility
- Constructed with our novel System I modular panel system, to ensure that the facility is highly versatile and space-efficient
Technical Specification:
After successfully completing a two-storey modular cleanroom facility for Glan Clwyd hospital, part of the North East Wales NHS Trust; Clean Modules was employed to design and build a 405m2 cleanroom facility for the Wrexham Maelor Hospital, also part of the North East Wales NHS Trust. Clean Modules provided a full turnkey cleanroom design and build service, from design, installation, fit-out and installation to sourcing and installing process equipment and facility validation. The facility houses a 70m2 EU GMP Grade B TPN and CIVAS suite and a 30m² EU GMP Grade B cytotoxic suite, fitted with six Class III isolators and a rapid gassing Class III 4-glove isolator bank. Additionally, the facility houses a dedicated Grade B gene therapy suite and a radiopharmacy suite. All the suites are supported by an EU GMP Grade D 175m2 preparation and packing area, a cold store and an EU GMP Grade B sterility testing laboratory.
The facility is MHRA and RPA approved and complies with EU Good Manufacturing Practice (EU GMP). A Facility Monitoring System (FMS), validated to GAMP4 and CFR21 Part 11, was installed for quality assurance. This sophisticated computer-controlled data acquisition and monitoring system continuously checks particle levels, room pressures, temperature and humidity in the cleanrooms.