Tolent delivered a 28,000 sq ft three-storey building comprising laboratories, plant rooms, milling suites and offices to strengthen and expand the client's milling, micronisation and solid form capabilities.
The 40-acre site in Northumberland met the growing demand for pharmaceutical API particle size control technology, as well as expanding Sterling’s laboratory capabilities to provide a full solid form offering including polymorph screening, salt selection and particle engineering and crystallisation scale-up.
The development includes 320 metric tonnes of steelwork, 4,653 metric tonnes of concrete, 3,243 separate steelwork items and 6,543 structural connections.
In total, the building houses six ISO Class 8 cleanrooms which housed all process equipment will be housed in ISO class 8 suites (FED STD 209E Equivalent Class 100,000), four discreet milling/micronising systems with washrooms, locker rooms and changing facilities for staff use. The four new milling areas house a range of new technologies, including mechanical milling, spiral jet milling and small lab scale trial mills which were fitted out by Tolent.
To support the handling potent and hazardous materials the facility includes a clean warehouse and workshop to serve particle size reduction suites, a fully-equipped analytical lab and a solid form lab with a write-up area. Additionally, Tolent fitted out the chemistry kilo labs, offices and meeting rooms and all the areas were access-controlled and fitted with CCTV monitoring.
Processing equipment included in the six ISO Class 8 cleanrooms:
- A Frewitt FreDrive 6 over three floors, with three interchangeable heads, a hammer/knife head, sieve head, and conical mill head, a cooling jacket around the knife/hammerhead is provided for heat sensitive products. This equipment is all installed in state of the art isolators across three floors. The isolators offer containment for handling OEB 4 materials, including charge, milling and discharge;
- A Frewitt FreDrive 3 with two heads, a hammer/knife head, sieve head, and conical mill head, was moved from where it was previously based in Dudley 1 and was re-installed in the new facility;
- A Frewitt FreDrive Lab with two heads, a hammer/knife head and a sieve head, capable of pin milling was utilised for scale-up and installed in state of the art isolators across three floors.
The isolators offer containment for handling OEB 4 materials. Further equipment included a Sturtevant 1” microniser for trial/lab use and small volume production, housed in the gloveport isolator. Prevision was also made for future production micronisers or dust collection.