Cleanroom Technologies UK

Project: Engineering Design & Validation Consultants

We where appointed to build the client a new herbal products factory within an existing preserved building. This building could not be altered on the outside and it was a major achievement by the company to design a factory to the client’s requirements within the structure.

Our Company were employed as the Project Managers, Technologists, Designers, for concept, detailed design, and validation throughout the design, construction, procurement, validation and start up of the facility.

For this were required to prepare the Concept Design, the full engineering design for tender packages, and the Validation Master Plan. The VMP was written for the total project and included all manufacturing equipment, facilities, utilities and HVAC systems. PLC’s and computer systems supplied as part of the equipment and stand alone computer validation packages.

As part of the brief we prepared a co-ordinated project plan that linked all of the activities contained within the VMP to the design and construction of the facility and the equipment procurement.

Although this project was not subject to the regulatory requirements of Good Manufacturing Practice as laid down for the manufacture of medicinal products, the client was aware of the forthcoming regulations and requested the GMP Guides be used for the design and operation of the facility.