De Risking Aseptic and radiopharmacy production capacity with better GMP know how!
In 2016 Lord Carter released his report “Operational productivity and performance in English NHS acute hospitals” in which it was identified the need for NHS Aseptic facilities to transform its delivery for a future-ready, resilient, high quality, safe and efficient service.
The report further identified the growing demand for aseptically prepared products increasing at over 5% per annum alongside meeting the growing needs for patient centred prescriptive aseptic manufacture for chemotherapy preparation, parental nutrition (PN), Advanced therapy medical products (ATMP), Central intravenous additives (CIVAs) and monoclonal antibodies (MAbs).
Currently whilst future demand for aseptic production is growing there is a real problem with the NHS sourcing competent specialised contractors who are familiar with cleanroom and aseptic production and this has led to new facilities being delayed or being of low quality and not being approved by the Medicines and Healthcare products Regulatory Agency (MHRA).
The presentation will inform and guide clients from initial concept and feasibility design through to the full turnkey project delivery, commissioning and validation in accordance with GMP and MHRA regulatory guidelines.
In this presentation BES would outline the key design principals adopted in the design of an ergonomic modern aseptic facility and would explain the MHRA requirements for accreditation to allow centralized facilities to manufacture and prepare drugs which can be distributed to other hospitals outside of the facilities trust to provide an additional revenue stream.
The topics covered would include:-
What are Aseptic and Radio pharmacy production facilities
Room ergonomic design, key attributes and GMP finishes
Energy efficient HVAC design, airflow rates / Clean up rates and room pressure cascades
Commissioning & Validation techniques and requirements
MHRA / The Orange Guide