You are invited to submit expressions of interest for the design, supply, installation, commissioning, and validation of a fully GMP Compliant production scale Centrifuge. The equipment will require integral CIP, SIP, be of semi automated operation and fully compliant with the requirements of GAMP and 21CFR pt 11. The project will include removal/disposal of the existing legacy unit once the new unit has been successfully installed, Validated and brought into beneficial use. The scope shall replace an existing 600mm bowl centrifuge currently capable of holding a 32kg load, and include integration with the pharmaceutical process and validated systems including Pure Steam, and an existing automated CIP Skid.
The successful bidder will be expected to fully review existing operating requirements, develop a user requirement specification by engaging with senior stakeholders, undertaking site surveys, designing a new installation that complies with operating needs, cGMP, CDM and building regulations. The scope of this project includes project management, supervision and coordination of all contractors, and undertaking of the necessary building works within the site works boundary. The successful bidder will also be required to fully commission and validate the system in accordance with cGMP.