The Princess Alexandra Hospital’s new Aseptic Unit is a £2.5million investment to support on-site production of individually prepared chemotherapy treatment doses for oncology and haematology patients. The improved space and equipment will largely eliminate the current intermittent need for external support.
The Aseptic Unit will feature a modern suite of pharmacy clean rooms, and equipment including two negative pressure isolators for the safe handling and preparation of chemotherapy. There will also be space to accommodate cancer services pharmacists, who clinically validate prescriptions, a dedicated dispensary for oral cancer treatments and other medication, together with a dedicated clinical trial medication office.
Our role
CCTech implemented the following strategy to deliver the new facility meeting all regulatory expectations:
- CCTech led a series of client engagement meetings to develop a detailed User Requirements Specification, which in turn formed the basis of the design and validation exercise.
- CCTech worked closely with the client to ensure that the requirements of the design qualification were met.
- The scope of CCTech's involvement included the HVAC system, environmental monitoring system and dispensing isolators.
- CCTech went on to develop a full suite of validation documents and protocols which were peer reviewed and approved by the client. These included the validation master plan, validation plans, design qualifications, installation qualifications and operational qualifications.