Cleanroom Specialist Contractor and Design Company

Description

This project is likely to be split into multiple requirements. Phase 1 will be split into 2 stages and our requirements are: The appointment of Principle Designer to oversee, co-ordinate the design and implementation of the project, advising the Client on risks, and compliance to regulations. Support, prepare and administer - the BSA (Building Safety Act) submissions (2 Stage) to the regulator, including co-ordination of the comments/feedback, and validation. Works scope Phase 1: Cleanroom Specialist Company to refurbish and / or design (if any needed) and qualify the existing St Thomas’ Lower Ground Floor Aseptic unit. The Aseptic Unit is to provide cytotoxic chemotherapy preparation for children and Adults. The Unit comprises 6 rooms of which includes: 2 change rooms (D and C Grades), 1 support room (D) and 2 manufacturing rooms (C Grade). New Isolators and may be gassing isolators are to be installed. The contractor must provide a detailed specification that addresses the requirements of this URS. Comply with cGMP & GMP chapters 3 annex 1, annex 15 and Quality Assurance of Aseptics Preparation Services (QAAPs). The qualification of all classified clean rooms is to be synchronised with Isolators in accordance with EUDRALex Volume 4, Annex 15.