Wasdell Europe - Dundalk Pharmaceutical Facility - Grade C & D
Wasdell Holdings needed to increase their production capacity and to achieve this they employed Bassaire Cleanrooms to construct a new pharmaceutical facility located within IDA Dundalk Science and Technology Park in Ireland. This new facility forms part of Wasdell Europe Limited and is an addition to the existing sites located in Swindon, Burnley and Newcastle.
The facility covers an area of over 3000m2 and all the rooms are built to a grade D standard, except the Large Line Packing room with is built to a grade C. The project underwent a stringent DQ/IQ/OQ process and was validated by Bassaire’s in house commissioning team to ensure it is fully compliant with the current Good Manufacturing Practice (cGMP) standards.
Curia Cytotoxic facility and sterile facility
Curia is a pharmaceutical company specialising in drug formulation, development and small scale sterile manufacture of liquid fill or freeze dried parental's for phase I and II clinical trials to MHRA and FDA cGMP standards.
For this project, Bassaire were awarded the contract to provide a complete turnkey project for the production facility, which consisted of two modular suites, one non-cytotoxic suites and one cytotoxic suite, which are physically separate and independently serviced. The suite consists of grade A, B, C and D areas, which were all fully validated to MHRA standards.
Ipsen BioPharm QC laboratory facility
The new unit 11 laboratory building comprises of a four-floor building in which the ground floor of the building houses the microbiology laboratories and the first floor houses the analytical.
The new unit 11 quality control laboratories carry out testing to support the control and release of product. The QC analytical laboratories carry out chemical and biochemical testing of raw materials, in-process and finished product samples. The QC microbiology laboratory is primarily used for microbiological testing of in-process samples and the Bulk Active substance, environment and personnel monitoring, sterility testing and endotoxin testing.
ITH Pharma Aseptic suite - Grade B, C and D
Bassaire Cleanrooms were awarded the contract for the design, build and construction of the new Aseptic Suite at ITH Pharma. Bassaire also successfully completed the validation of the entire suite, including all DQ/IQ/OQ activities in order to comply with MHRA regulatory requirements.
The cleanroom has its own dedicated Air Handling System which is capable of meeting the required air changes, room pressures and environmental conditions. The suite spans an area of around 370m2 and consists of two grade B Re-Circulation Cleanrooms. The facility also has a number of grade C and D rooms which include; a 1st and 2nd Stage Change, Preparation Area, Release room, Goods In and Out room and a Packing Area. The suite has been designed with a unidirectional flow in order to eliminate the risk of cross contamination.