Colchester Hospital University

NHS Foundation Trust APU






Main Contractor:     Strood's

Contract Value:     Circa £10m

Opening:                2020


Due to predicted increases in demand, the Trust had identified a need to increase the size of its existing capability to manufacture chemotherapeutic preparations from an existing two isolator boxes to four isolators.

The new facility will serve the needs of increasing numbers of patients and retain compliance under GMP for licencing with the MHRA.

Project Implementation

CCTech worked with Colchester to develop and implement a process to ensure that the delivered facility met with MHRA regulatory requirements:

•  A detailed User Requirements Specification was developed
   to ensure that all aspects of the process were represented
   in the design and operation of the facility.

•  We developed  the validation process to ensure that the
   facility will achieve compliance under GMP, a prerequisite
   for licencing with the MHRA. The validation process forms
   an integral part of the construction programme.

•  CCTech worked with the design team to advise on
   compliance with GMP. We ran workshops to ensure the
   design met with user requirements and addressed any
   inconsistencies or concerns with the client.

•  CCTech deliver and manage the validation process including
   the Validation Master Plan consisting of Scope, Process
   Details, Validation Strategy, Acceptance Criteria Guidelines,
   Validation Programme, Document Format and Control,
   Change Control and Re-validation Policy and the
   Validation Team. 

 • Soft Landings. CCTech proposed to develop and manage this
   process in line with Government Soft Landings policy to
   develop a full building aftercare process, ensuring that the
   facility continues to meet its designed capability after

Project Stage

The project has been tendered and is expected to commence construction in April 2019.