Cleanroom and Containment Facilities (CCF) has completed the delivery of a new NHS aseptic pharmacy unit (APU) in Portsmouth, which will serve as a specialist pharmaceutical manufacturing infrastructure for the health service.
The turnkey facility has been taken from concept through to a compliant, operational environment and is now entering the final stages of commissioning, validation and handover.
Acting as design and build contractor, CCF was responsible for the delivery of the complete facility, including the cleanroom and support areas, architectural works, mechanical and electrical services, HVAC systems, process integration, an Environmental Monitoring System (EMS), and validation support.
The APU has been designed to support aseptic compounding operations, including the preparation of cytotoxic and biological medicines.
Developed in accordance with EU GMP Annex 1 requirement, the facility has also been configured to support future Medicines and Healthcare products Regulatory Agency (MHRA) licensing and long-term operational compliance.
A key element of the project was the structured collaboration between CCF and independent validation consultant CCTech.
A user requirements specification established at the outset was carried through the design qualification, installation qualification, and operational qualification stages, which provided a compliance framework that informed both design development and site delivery.
According to CCF, this approach reduced project risk by aligning validation requirements with the design process and minimising the need for late-stage changes.
The company said the facility has been engineered to operate as a fully integrated system rather than a collection of individual packages.
The project included a risk-based HVAC and pressure cascade strategy, integration of specialist isolator systems within the cleanroom environment, coordinated EMS and building management system (BMS) controls to support monitoring and data integrity, GMP-aligned layouts and zoning, and a commissioning programme sequenced to support validation activities.
CCF said it will continue to support the project through the remaining commissioning, validation and handover phases before the facility becomes fully operational.
