BES designed and commissioned a sterile production facility within an 18-month schedule. Challenges included completing sterile areas early for testing while construction continued, marking a first for such tests at this stage. The project included architectural, HVAC, electrical, and process utilities, with extensive validation support.

Complex services like laminar airflow systems and air pressure control were installed, alongside a new 11kVA sub-station. Maximizing pre-fabrication ensured high-quality, safe installations, resulting in high customer satisfaction and timely project delivery.

While the facility shell was being constructed on-site, we built a full-size mock-up of the aseptic area (approximately 500m2) in a nearby disused building. Over 12 months, this mock-up evolved into an exact timber and plasterboard replica of the sterile area.

This allowed our team to thoroughly optimise the size and design of containment devices, considering the challenging aseptic operating conditions. Equipment suppliers could trial their equipment within the mock-up RABs (Restricted Access Barriers), starting with cardboard cutouts and progressing to full 3D-printed prototypes of state-of-the-art equipment.

The operational team played a crucial role in developing the sterile processing area design. They proactively used the mock-up to tailor the final layout, train operators, complete safety risk assessments, and finalize operational SOPs. Transitioning from open cabinets to glove ports was the most challenging aspect for operators. However, by engaging with the mock-up and leveraging experience from operators at existing plants, we ensured engagement and achieved the right physical size for the equipment.

Additionally, we built a mock-up of a fully finished single room to allow production, maintenance, and QA teams to finalise and sign off on the finished product.

A great example of a collaborative and innovative approach!