The technical solution included new AHU, chillers, pump sets, utility modifications, clean & process steam, ductwork modification and Building & Environmental management system extending to power and controls wiring.

This overall solution included:

• New air handling unit being installed onto a new roof mounted steel platform together with a packaged chiller unit.
• Ductwork routes being carefully chosen and coordinated around the facilities to allow it to pass through heavily congested existing services. This extended to routing across the roof and dropping through the existing structure into the service floor.
• Site measure was required for most of the ductworks during the day with drawings issued to the manufacturer to fabricate and deliver the next day for installation to continue.
• All ductwork was installed prior to the shutdown and the connection left ready for the final stage.
• The final works was undertaken during a twelve day engineering maintenance and operations shutdown scheduled for works to change over the systems from the existing to the new. The required works was carried out during this period with 50 other trades onsite undertaking other maintenance and project works.
• The planning extended to twice daily meetings with all trades to monitor, track progress, coordinate installation quality and agree the finer details.
• Works were completed on time and the systems validated by the BPL’s independent team with the facility operational on programme as scheduled by production.

‘Austin delivered this highly critical project for BPL and completed the works within the planned shutdown to meet BPL’s stringent production schedule, overall cost budget and quality parameters’ – Mr William Lewis, BPL.

Ipsen is a global specialty-driven pharmaceutical group selling in excess of 20 drug types in more than 115 countries with an R&D expenditure of around €193 million.
Ipsen’s ambition is to be a leader in specialty healthcare solutions for targeted debilitating diseases. This strategy called for the consolidation of their research in the heart of leading biotechnological and life sciences hubs.
Ipsen had undertaken a preliminary study which sought to define broad proposals for accommodating their Oxford research group, at Milton Park. They then appointed Austin to undertake a critique of these proposals, to develop them into a viable detailed design and to deliver this 2700m² prestigious science facility.

`Austin’s team have delivered a superb new laboratory and office space in which Ipsen’s UK R&D team are now located. From the design process and through the construction Phase, Austin have listened to the needs of the Ipsen team and understood the vision for the new site.  The laboratory requirements were challenging, and yet the construction phase has been completed within eight months, on time to accept the personnel transferring from other Ipsen UK sites.’ – John Chaddock, VP Neurology Site Head, Ipsen Bioinnovation.

Wrafton Laboratories, a manufacturer of over-the-counter and prescription medicines for branded pharmaceutical and own label customers, called upon Austin to provide a new updated area within its existing plan.

The new layout streamlines the production process and, in order to maximise operational space, safe-change HEPA filters were sited on a new maintenance walkway within the existing roof void.

The construction activities were carried out in four distinct phases, programmes in close cooperation with Wrafton’s manufacturing department to maintain production and minimise disruption to the surrounding areas.

This extensive refurbishment is part of Wrafton’s continuous development strategy and has been designed to allow expansion of these operations into adjacent areas.

Austin provided a complete service which included concept design, detail design, project management, construction and validation.

Austin was given the opportunity to develop concept and preliminary study for user and management approval.  The project included refurbishment of existing HVAC plant, resetting of pressure regimes, addition of new HVAC plant, installation of secondary packing machines, provision of new finishes, air locks, redesign of change areas and product of dispensary.

Subsequently Austin were asked to take the project to the next stage which entailed the management and execution of the detailed design, procurement, programming, construction, installation, cost reporting, commissioning, DQ, IQ and OQ qualification through to handover of GMP upgraded solid dose manufacturing areas.

At the heart of this project was an extremely complex phasing strategy.  Hence, the work was divided into 30 separate phases to match the works with production down times within a constantly changing production schedule.

Each phase was independently validated to allow continuous production. Areas in which work was to take place had to be formally handed over to Austin before any work could commence. Work was subsequently carried out and the areas cleaned, works validated and then formally handed back to Novartis with all completed documentation in place, for them to begin production.

Much of this work was out of necessity, undertaken outside of normal working hours due to site manufacturing schedules. Work was often carried out in the evenings or at the weekend with release to Austin at lunch time on Friday and handed back to Novartis for production at lunch time on Mondays.

Flexible attitude, teamwork and quick response required by Austin and their subcontractors to accommodate changing scope and program. Procurement and installation of new plant and equipment was carried out within very short timescales as performance testing of existing systems to establish relevant criteria was not possible before commencement of the project on site. All work was carried out in strict observance of cGMP.

In addition using the Austin Total Air System the high bay warehouse was temperature controlled not to exceed 24ºC with a temperature difference between floor and roof of 1ºC.

The Austin Company have under taken a number of projects and studies over the last 13 years for 3M in order to expand and upgrade their major Production, & Pharmaceutical Development site.  Some of these projects included:

Pharmaceutics Pilot Plant Upgrade

This project provided 3M with the opportunity to fulfill a strategic decision to remodel the interior of their Pharmaceutics Pilot Plant Building, while allowing production to be maintained without disruption

The resultant design was developed in phases to allow the site work to be undertaken with limited impact on the existing production activities. The new facility comprises Class 10,000 and 100,000 areas’s being a mix of both positive pressure rooms and negative containment rooms.

The installation of a temporary change area and airlocks, allowed production to be maintained in a safe cGMP environment whilst the upgrade works continued around them. This included the creation of a plant room above the clean room ceilings.

The upgrade provided a new process facility complying with current GMP recommendations and Good Engineering Practice, together with:

• A suite of clean rooms, clean corridors and material and personnel change areas.
• Improved temperature control for operations
• Improved quarantine storage space
• Improved segregation of materials and equipment

Austin provided full design service commencing with Concept through to Detail design, project planning, project management, CDMc Coordinator and on site supervision to coordinate, inspect and validate the construction and services work.

Single European Manufacturing & Distribution Facility

Austin were appointed to provide a new 10,000 sq.m Manufacturing Facility, to centralise 3M’s European operations on one site at Loughborough.

The new facility incorporates clean rooms for liquid, creams production and packaging areas together with solid dose packaging lines.  In addition a 6,000 pallet narrow aisle warehouse and low bay warehouse were part of this Project.

The building also accommodates distribution support offices, a marshalling area, flammable liquids storage with picking and packing areas in the low bay area.

Existing lines were upgraded and vessels relocated to the new single facility whilst maintaining production throughout.

During the course of the work the existing Aerosol Packaging Areas were remodelled, placing great emphasis on safe working, and special precautions were taken to minimise the impact of the construction work on the adjacent clean room areas.

Austin provided preliminary engineering, detailed engineering, procurement, project management and construction services.

Process services and clean rooms were commissioned, qualified and validated to meet FDA requirements.

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%.