Main contractor: Cleanroom & Containment Facilities Limited (CCF)
CCTech are pleased to have successfully supported the delivery of a new NHS Aseptic Pharmacy Unit (APU) in Portsmouth. This fully integrated, turnkey facility was developed from initial concept to a compliant, operational environment. The project involved close collaboration with all stakeholders, including procurement teams, project management, design and construction teams, end users, facilities, IT, and vendors. It was a pleasure to work with such an initiative-taking project team.
The facility has been developed to support aseptic compounding operations, including the preparation of cytotoxic and biological products. Designed in line with EU GMP Annex 1 requirements, the APU has been configured to support future MHRA licensing and long-term operational compliance. Once licensed, the APU will support PHU in delivering critical medicines to their patient population.
Acting as Compliance & Validation Consultants, CCTech provided end-to-end technical advice across feasibility, concept design, design review and the validation lifecycle. This included generating validation documentation, delivering structured technical advice and ensuring that every design and construction decision aligned with EU GMP Annex 1 and MHRA licensing expectations. The end result was the complete delivery of the facility.
Collaborating with experienced and reliable contractors, along with a committed end-user team, enabled us to complete this project efficiently. The turnaround time was approximately 18 weeks, demonstrating an effective and timely process that resulted in a ready facility for patient supply.
Our Role
Support provided by CCTech included:
- Change management principles and co-ordinated stakeholder alignment, communication strategy and document control
- Technical and GMP compliance advice throughout the project
- Generation of validation life cycle documentation, including execution and resolution of any related deviations
- Validation summary reports collation
A defining feature of this project was the structured collaboration between CCTech and Cleanroom & Containment Facilities Ltd (CCF), an experienced GMP design and build contractor. The case study highlights that appointing the professionals early and working with experienced teams ensures delivery of a project that is GMP compliant and, most importantly, right first time.
This milestone reflects a strong collaborative effort between the client, project, end-user team, vendors, design & construction, validation, and delivery teams, and we look forward to supporting the final stages of handover.