B Braun Medical Ltd.
| Used as: | Aseptic Compounding Services Facility |
| Location: | Chapeltown, Sheffield, United Kingdom |
| Sector: | Pharmaceutical |
| Solution: | Modular Panel |
- Used for the production of aseptically prepared products such as 3-compartment compounding bags, to customer tailored requirements
- Facility houses three EU GMP Grade B production suites for the production of chemotherapy, parenteral nutrition, CIVAS and pain management products
- First B Braun Medical facility in Europe to have a cytotoxic suite for the manufacture of both patient specific and batch chemotherapy products
- Blueprint facility design for other B Braun Medical branches throughout Europe
Technical Specification:
B Braun is continuingly looking to strengthen and expand its position on the pharmaceutical compounding market. Both the new-build shell building and the new cleanroom facility at B Braun Medical were designed to accommodate the new production, but also to anticipate future growth. This is ensured through a flexible design, a spacious lay-out, ample plant space for future equipment and available land next door. Clean Modules' modular panel system, and previous experience with designing pharmaceutical compounding facilities, ensured the facility was completed and MHRA licensed in less than 7 months from start on site.
The aseptic compounding facility houses three 30-40m2 EU GMP Grade B compounding suites for parenteral nutrition, CIVAS and cytoxics, supported by a 153m2 preparation area and a packing area with a finished goods and quarantine cold stores area. 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.