As well as the exacting regulatory compliance demanded from this sector, the need to develop new product lines within ambitious timescales at minimum cost has never been greater.
R B Plant has proven capability in the very specific technical and regulatory expertise required for this sector and have worked in partnership with clients, often with our engineering staff seamlessly integrating into the client project team and working at the client site.
We liaise with the client to select the most appropriate balance of expertise – thereby complementing the client project team and avoiding duplication of roles.
The result? Delivery of new engineering projects and product delivery lines to a high standard within the target timescales, and long-term alliances and repeat business developed with many pharmaceutical and life-sciences manufacturers.
Examples of our expertise in this sector:
- FEED and conceptual studies.
- CAPEX justifications.
- Project Management, CDM procurement and site supervision services.
- Regulatory compliance (cGMP, FDA, MHRA, ATEX, DSEAR, CDM, HAZOP, COMAH, Functional Safety).
- Facility, Equipment, Automated Process Control, Process commissioning and full validation life cycle.
- Support with Lab scale, pilot plant development and conversion of batch to continuous manufacture.
- Office/Laboratory/Cleanroom/Process area design, specification, upgrade and contamination control.
- Building & Equipment Services including Clean-In-Place (CIP), HVAC/Environmental control & fire protection.
- Design and installation of equipment to manufacture and pack API and finished dose, liquids, powders, capsules and tablets.
- Potent and controlled drug facility and equipment including containment and security.
- Clean water systems – including WFI + USP/BP purified water.
- Sterile manufacture (including by microfiltration).