GW Pharmaceuticals

Phase 2 – Large Scale Manufacturing Facility B750

The Opportunity

Austin were approached by GW to provide a large-scale manufacturing facility to meet their future requirements.

Austin initially developed a conceptual design (Step 1a). This was then developed into a preliminary design (Step 1b) to include 3 No. additional large scale extraction units. On conclusion of the Step 1b, the projected product demand was increasing, so the design was further modified to incorporate extraction plant similar to their current operations.

The additional developments were incorporated into the detail design (Step 2) in parallel with starting construction, a GW Critical Success Factor. The project was to be developed and completed in two phases to allow early start-up of manufacturing in Phase 1.

Phase 2 included complex processing and manufacturing equipment with Automation, Manual Handling systems, Clean in Place, Waste Handling and Collection systems. This was to support the specialist large scale CO2 Extraction Systems and the Separator Streams. These were all located within ATEX zoned and environmentally controlled rooms, to align with the agreed operation and Basis of Safety.

The installation required dedicated safety and process vents for all streams.

The operations had to be integrated and automated with vacuum and gravity fed transfer system over two process streams.

The extraction equipment selected needed the capability to extract large scale quantities of product.

The facility was to be automated and controlled from a centralised process control system.

The Solution

The facility layout was developed to meet key adjacencies, personnel and material flows and other operational objectives defined over two storeys with a floor space of 3,570m2 comprising of: 1,987m2 on the ground floor and 1,883m2 on the first floor.

Austin worked with specialist consultants, vendors and subcontractors to ensure that all requirements were integrated and delivered to the highest standard whilst maintaining efficient operations using best practices.

With the varied manufacturing equipment, process engineering services and complex nature of the installations, the requirements were modelled using different platforms. These were all integrated in Revit (CAD) to provide a single overall coordinated model.

The new infrastructure includes HV supplies, steam, 2 No. 3,000 kVa transformers, 3 No. 800kW (-5 to 0°C), 2 No. 200kW (-10 to -5°C), 1 No. 600kW (-5 to 8°C) Process Chillers, 1 No. 1,300kW (6 to 12°C) Thermal Chiller and 5 No. Air handling units (2,000 to 8,000 l/s).

The facility comprises of non-classified and controlled and not classified accommodation. Although not a requirement, the facility has been designed generally to meet GMP requirements.

Austin worked with GW in delivering the new capabilities and integrating these with no disruption to ongoing operations.

“Austin provided GW team excellent support throughout the project, and we are proud of delivering this world class facility.”

Mr Manuel Loureda – Site Director

GW Pharmaceuticals

Phase 1 – Small Scale Manufacturing Facility B750

The Opportunity

Austin were approached by GW to undertake the design and construction of a new production and processing plant for the development of Cannabinoid medicines. In order to expand their existing manufacturing capabilities to meet increased demand, this new request was to be incorporated into a facility for which the Preliminary Design had already been concluded.

Austin undertook a conceptual design (Step 1a), which was then developed into a preliminary design (Step 1b) and followed by detail design and construction (Step 2).

Delivery had to focus on GW’s Critical Success Factors agreed at the commencement of Step 1a. This included a requirement to deliver the facility in two distinct phases to meet operational, production and business commitments.

The first phase included small scale extraction similar to GW’s current operations with new Decarboxylation system; Drum Handling; Basket Filling; CIP extraction booth and a dust extraction system. These required ATEX zoning and environmentally controlled rooms to align with the existing proved operation and Basis of Safety.

The Phase 1 works also included two specialist Supercritical Liquid Carbon Dioxide Extraction Units, each with its own independent control system for final extraction.

All operations had to be undertaken in controlled conditions utilising an efficient UV odour control system, sophisticated weighing equipment and material transfer systems to reduce manual handling.

The Solution

To reduce project time scales, Austin commenced groundworks very early in the design process whilst the remainder of the overall design was still progressing and being developed with users. This required close coordination with GW and their specialist vendors to meet their long-term objectives.

The design was developed to harmonise the existing building and site features, yet enhance the overall development so both existing and new buildings operate as one.

Phase 1 was developed using the same principles as the previous installations, incorporating lessons learnt with refinements to improve overall operations.

With the varied manufacturing equipment, process engineering, building services and the complex nature of the installations, the new extension was modelled using several platforms, all integrated in a single overall Revit (CAD) model to allow accurate coordination.

Integration of the new and existing buildings was undertaken during agreed shutdown periods to avoid disrupting ongoing production.

Phase 1 was successfully handed over for operations whilst construction of the larger Phase 2 project progressed.

“Phase 1 has been delivered on time and to a very high standard in terms of quality expectations.”
Noel Fenwick – Associate Director, Capital Projects, GW Pharmaceuticals.

Progress video of one of our major projects

A time-lapse video showing progress of a typical large scale project, from ground clearance to completion.

Click here to view the video.

For more information call Austin on Tel: +44 (0) 1923 432 658
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Macfarlan Smith Ltd, Edinburgh

As part of a planned expansion of their Bulk Active Pharmaceutical Ingredients (API) capacity, Macfarlan Smith Ltd commissioned Austin to design and construct a new production facility on their manufacturing site in Edinburgh, Scotland.

The building occupies a total area of 1,000m² on four floors and produces a multiple range of primary pharmaceutical products.

The process equipment includes five 2.5m³ reactors, each controlled by a dedicated single fluid heat/cool package. Finished product is dried and packaged using pressure filter drier technology in a controlled environment.

The new plant is designed and constructed to meet cGMP requirements and is fully validated.

In addition, the plant has been designed to comply with the requirements of the relevant authorities in respect of the control of emission into the atmosphere and drainage system.

Central Veterinary Laboratories, Weybridge

To meet the standards of its own Directorate of Veterinary Medicine, as well as those of the European Union, CVL (formerly MAFF), upgraded a laboratory building that functions as a Biological Production Operation.

The renovated building contains facilities for media preparation and sterile processing. It also houses culture and incubation areas, cold rooms and microbiology and chemistry laboratories. Other areas are provided for wash-up, labelling and packaging.

The facility’s clean rooms were designed to achieve Grade B of the EU Guide to Good Manufacturing Practice for Medicinal products.

Two of the four sterile suites were designed to create aseptic environments to contain Category 3 pathogens by negative pressure. The other two suites, used for media preparation and filling, are maintained under positive pressure.

A pressure cascade functioning throughout adjacent areas attains Grade C and Grade D levels of cleanliness.

The Austin Company designed, engineered and constructed the entire renovation project. Austin also provided project management services for the validation of both the facility and its production equipment.

In addition, Austin purchased and installed specialty equipment including autoclaves, safety cabinets, centrifuge, filling machine, drying oven, mobile mixing tanks and clean-in-place systems.

ConvaTec – New Hydrocell Development Rig – Deeside

Austin were appointed to design and construct a specialist new Hydrofibre® building and Process Rig in Deeside. The brief extended to designing the facility to comply with agreed hazardous area classification.

The new standalone facility was completed, with the building incorporating specialist process equipment housed within a separate internal structure designed to be blast resistant and ATEX rated.

The structure incorporates blast relief panels to outside, together with supporting control room, changing and plant areas.

Balkanpharma (Actavis) – Production Facility – Bulgaria

Balkanpharma (Actavis) - Production Facility - Bulgaria Balkanpharma, the largest pharmaceutical manufacturer in Bulgaria needed to increase production capacity by three million tablets per year with the construction of a new facility on an existing site in Dupnitza.

Essential requirements included:

  • The creation of an efficient and pleasant professional working environment
  • Flexible space with expansion potential
  • Cost effective construction with low maintenance and energy costs
  • Full compliance with cGMP standards
  • Visible confirmation of the company’s commitment in Bulgaria

The appointment of Austin as a single-source service provider ensured co-operation and co-ordination of the team members.

An optimum layout of 4,6002m was produced on two floors based on UK experience and incorporating Bulgarian building components where possible.

The facility was designed to be the first cGMP and MHRA compliant facility in Bulgaria.

Construction work was completed in 12 months.

The project was completed with a budget saving of 7.5%.

  • architecture
  • mechanical
  • electrical
  • structural
  • public health
  • construction
  • management