Amongst the many notable engagements we have undertaken we are currently working two very exciting and challenging projects.
At GSK we are working with the MES implementation team to help finalise the configuration and validation of an EBRS to support their new, “Pharma 4.0” sterile manufacturing facility. The EBRS is fully interfaced with the
Process Control System, automated sterile filling line as well as ancillaries such as the parts washer and autoclave. When complete, the EBRS will provide a full, integrated batch record supporting efficient production and release of much new and much needed oncology treatments.
At Koura we are really pleased to be part of their journey in developing “Next Generation” Metered Dose
Inhalers that will use a novel propellant (152a) to reduce the carbon footprint of these very common devices by
approximately 90%. We are assisting them with their journey in two key areas:
- Delivery of compliant IT systems (LIMS, CDS, EQMS & SCADA) to support their small-scale manufacturing of MDIs
for clinical trials and
- Delivery of compliant IT Systems (LIMS & CDS) to support their new pilot site for the production of medical grade