Extensive workshops with stakeholders helped to establish the optimum location for the Sterile Compounding Facility within the parent healthcare facility and achieve the best use of space to provide maximum productivity from the available area.
The SEC (secondary engineering controls) of the SCF comprised:
- Buffer Room (ISO Class 7)
- Support Ante Room (ISO Class 8)
- Gowning Lobbies (ISO Class 7 & 8)
- Wipe Down/Store/Despatch
- Plant Space
Enabling Works
Prior to installation, there were extensive strip out works to create the required building shell space.
Cleanroom Structure
The SCF was created with the Nano Clean System 1200 flush finished modular panel system, including walls, doors, windows, walkable panel ceiling and aluminum profile coving to all internal junctions. The floor was finished, with fully welded sheet vinyl floor finish and self-form coving.
Mechanical Services
A dedicated Cleanroom HVAC system was installed, with:
- Hygienic AHU located in a new adjacent plant space to supply conditioned air to the SCF through a range of pre-insulated phenolic ductwork and ceiling mounted gel seal H14 terminal HEPA filters:
- Constant volume control maintained air change rate and positive differential pressure cascade, by mixing fixed proportions of fresh air and return air.
- Temperature and relative humidity control within the SCF was achieve by cooling/dehumidifying the mix of return and fresh air in the AHU and reheating with duct mounted electric zone heater batteries. Cooling and dehumidification effect was provided by site chilled water connection.
Electrical Services
Mains power was supplied from the existing SMDB to a dedicated local DB and the to the control panel:
- Light fittings were recessed LED with maintenance access from above.
- Process socket outlets were integrated through a PVC trunking system for flexibility.
- The control system was based around a Trend BMS outstation with embedded webpages for end-user monitoring and BacNet connectivity to the parent hospital BMS. Customised control strategy was provided by Nano Clean to maintain environmental parameters.
- Access control was integrated with parent building security.
Ancillary Fitments
- The direct compounding areas were within ISO Class 5 vertical laminar flow workstation PECs (primary engineering controls) located in the were provided in the ISO Class 7 Buffer Room SEC to protect the critical point..
- Pass-Through transfer hatches with interlocked doors were provided at the Wipe Down/Sport Ante Room, Support Ante Room/Buffer Room and Buffer Room/Support Ante Room interfaces for component and product transfer.
- Pass-Through Fridges were provided at the Support Ante Room/Despatch interface.
- A variety of Cleanroom ancillaries were integrated into the facility, including; handheld particle counter, handwash-station, changing booths, lockers, benches, trolleys, mobile shelving/racking and chairs.
