Clatterbridge Cancer Hospital Aseptic Suite

Grade B, C and D

Bassaire Cleanrooms delivered a design and build of the new Aseptic ATIMP and Gene Therapy Suites at Clatterbridge Cancer Hospital. Bassaire also successfully completed the validation of the entire suite, including all DQ/IQ/OQ activities to comply with MHRA requirements. 

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• The facility covers an area of just under 600m2

• Consists of; two Isolator rooms, Inner Support, Outer Support, Change rooms, Release room, Admin room and a Cold Store.

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The new aseptic suite has a sophisticated P&EMS which monitors, records, and displays the environmental parameters and compares the measured values against fixed alarm limits. The P&EMS has been designed, installed, and tested in compliance with the GAMP guidelines and will enable Clatterbridge Cancer Hospital to meet the requirements FDA 21CFR part 1, plus Annex 1 and Annex 11 of the EU GMP guide.

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