Pharmaceutical & Biotechnology

The Client
The client had made a decision to provide toll manufacturing services for active pharmaceutical ingredients (API's) and wanted a full scale production facility to meet a number of objectives.

The Challenge
GSA managed the project with an integrated team of engineers working onsite. The client provided a project director and the client took responsibility for procurement during the initial stages. The production facility needed to meet the following criteria

• Demonstration plant to highlight the capabilities to clients
• Expandable
• Tight timescale to meet production promises

The Solution
GSA were contracted to work on the pre-sanction activities and then awarded the project execution in an EPCM role. Activities undertaken by GSA included:

• Preparation of a URS statement of requirements
• Definition of GMP requirements
• Outline design & review of options
• Sanction cost estimate
• Process requirements
• Building services
• Structural
• E&I
• Validation (jointly with the client)
• Environmental, planning & building control liaison

It was jointly agreed that the most cost effective way to approach this was to award the project to one supplier. GSA were responsible for the overall procurement & smaller contracts supporting the project. The smaller contracts included; civil and building work, mechanical installation package including building services, structural, fume cupboards, process and electrical equipment.

GSA prepared the tender documentation, the tender process as well as placing the equipment orders for the client.

Site Management
Detailed management of the contractors on site was the responsibility of the clients project engineer. GSA provided back-up resources when required.

Feedback:
Awarding one contract to one supplier proved to be cost effective for both the capital and time constraints. The project was delivered on time and to budget.

The Client
The client had the vision to create a high value, high technology manufacturing base for evening primrose oil (omega 6 gamma linoleic acid) on the Isle of Lewis.

The Challenge
At the time, the processing route was unclear and the final products required the development and use of novel processes. The site is in an exposed and sometimes harsh climate adding to the demands of the civil specifications and designs.

To utilise further space in the manufacturing facility, the client also wanted to introduce an Omega 6 manufacturing process using purified fish oil in parts of the existing process unit. The client assumed that the fish oil would be processed in a similar manner to the primrose oil, but at an early stage GSA engineers were able to identify that the fish oil would not crystallise in the same way using the same process. New processes were designed to meet this need.

The Solution
GSA's activities included:

• Fulfilling GMP and regulatory requirements
• Economic assessment
• Process development
• Process design
• Equipment selection, with a review of existing process units
• Procurement advice
• Novel technology investigation
• Commissioning

Feedback:
The project was delivered on time and to budget.

The Client
The client wanted assistance to develop a two stage manufacturing facility. The first production line was to produce a nutraceutical product, the second to purify some of this material into a pharmaceutical under aseptic conditions.

The Challenge
The client contracted GSA to undertake the front end engineering design (FEED) for the facility including the production , labelling, stock quarantine and warehousing areas. All designs had to meet the United States Food and Drug Administration licensing requirements.

The main processes within the facility included:

• Evaporator installations
• Crystallisation
• Filtration plants
• Chromatographic separation post-treatment facilities
• Pharmaceutical grade isomer production plant
• Clean room production facilities

The Solution
GSA's activities to meet FDA approval included:

• Validation of master plan
• Validation of protocols for each stage of the process
• Preparation of function design specifications accordingly
• Impact assessments
• The necessary ground works for automated Manufacturing Practice for the control systems

Feedback:
The project was delivered on time and to budget.