Case studies

Silver Hydrocel and Tank Farm Capacity Increase

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Our client required the modification of their facility, where they chemically convert cellulose based fibres into a gelling fibre for antimicrobial wound dressings which contain ionic silver. Such products are registered as Class III medical devices, so the facility is required to operate under cGMP guidelines and is auditable by BSi, FDA and MHRA.

Grade D

Cleanrooms

21±3

temperature control

130

tonnes/year output

They required the capacity increase of a Silver Hydrocel manufacturing suite and an additional Industrial Denatured Alcohol (IDA) and Solvent Effluent storage capacity increase, that could be integrated with minimal disruption to ongoing operations. The capacity increase needed to include provision of Grade D cleanrooms fitted-out with manufacturing equipment, all of which would be designed, commissioned and validated in compliance with corporate and regulatory standards.

Our Solution

Bouygues Energies & Services were required to adopt the design for the facility in its current form and complete the necessary detail to facilitate two operational suites, supporting facilities, utilities, services and equipment within the annex building.

The Grade D suites were provided with a discreet HVAC system, comprising of air handling units and extract fans to allow independent operation. The air flows were designed to achieve a minimum air change rate of 20 per hour and the technical spaces are served by natural ventilation.

Room pressures were designed to maintain GMP and solvent vapour containment requirements; pressure differentials can be monitored and an alarm is raised if an area does not retain pressure within a specified delay time. Temperature can also be controlled to 21±3.

Our solution included chemical storage and distribution systems capable of handling industrial denatured alcohol (IDA), silver nitrate, brine, BeCl and Tween. Presence of IDA was a particular challenge, as it is a highly flammable liquid. A range of measures were put in place to reduce risk of fire or explosion, adhering to DSEAR and ATEX 137 regulations.

Client Benefits

A single point of contact to boost performance
Providing detailed design, procurement, construction, commissioning and validation to offer seamless engineering solutions to the challenges facing our client.

Efficiency delivered long-term
Successful demonstration of the client’s target silver hydrocel production rate of up to 130 tonnes per year.

Quality as priority
Through the provision of suitably qualified and experienced personnel, effective planning and effective document management, the client received a high quality project with 0 product quality deviations.

Seamless execution and handover
No unplanned interruption to existing operations during delivery, plus a maximum of 8 days planned outage for tie-ins to existing systems (including shutdown, cleaning and restart).

High productivity from the very start
Plant availability of greater than 95% in the first 12 weeks of routine manufacturing following process validation.

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