Specializing in clinical-nutrition and infusion-therapy products, Fresenius Kabi decided it needed to build a new cleanroom production facility to keep up with the rapid growth of its pharmaceutical compounding and dispensing business. The resulting cleanroom, which is reportedly the largest compounding and dispensing facility in the United Kingdom, was developed by Clean Modules Ltd. (Castle Donington, Leics, UK). Located in Runcorn, Cheshire, the high-efficiency cleanroom production facility was designed to minimize installation costs while supporting high levels of workflow. The room uses new cleanroom technology to guarantee patient safety in the preparation of medication and clinical nutrition products.
The new facility also enabled Fresenius Kabi to merge its production facilities with those of its subsidiary, Calea UK. The two companies formerly had facilities spread across three sites between Runcorn and Birchwood, both of which are located in Cheshire. Distributing a range of products to support the care of critically ill patients, Calea UK provides clinical home-care technology to patients throughout the United Kingdom.
Keeping Costs in Check
Clean Modules reports that it achieved a 15% saving on typical installation costs using its proprietary modular cleanroom construction method. The modular cleanroom construction also ensured that the build was completed within the agreed timetable of eight months. The use of System I composite cleanroom panels allowed Clean Modules to deliver a versatile and space-efficient facility to help protect Calea UK’s and Fresenius Kabi’s competitive positions within the pharmaceutical compounding and dispensing markets.
Production efficiency from the first few weeks was significantly ahead of expectation. The work flow of raw materials and the daily dispatch of individual orders was a major element of the design phase. Clean Modules was integral to this process and developed several bespoke technologies including process flow, the overall conveyor layout, and trolley hatches.
The aseptic services cleanroom production facility houses a Grade B total parenteral nutrition compounding suite, a Grade B batch compounding suite, and a Grade B fast compounding suite with a total of 10 laminar airflow cabinets and two three-glove isolators. The compounding suites are supported by a 395-m² assembly area, a 542-m² packing and dispensing room, and a 300-m² Grade C support area. In addition to the large-scale production facilities, the new facility also houses a prescription-only pharmacy.
Design Achieves 31% Energy Savings
To help defray rising energy costs and comply with stringent environmental policies, Clean Modules incorporated an energy-efficient design of the air-handling plant and installed a novel recirculating piggyback system. The company reports that it has achieved a 31% energy savings by using these technologies. This, coupled with the latest facility monitoring system of major parameters including particles, temperature, and humidity, provides an efficient facility complying with recent regulatory requirements.
“Fresenius Kabi is focused on the growing demand for compounding services within the healthcare market and we understand the importance of uncompromising quality in the service that we offer,” says Guy Topping, international compounding manager for Fresenius Kabi. “By combining both companies’ experience and expertise, we have created a facility that will provide the needed capacity in an efficient way. We are delighted with Clean Modules’ management of the project and are very proud of our new unit.”
“By allowing us to challenge the initial design, the team at Calea UK and Fresenius Kabi gave us a wonderful opportunity to develop a new high-efficiency cleanroom facility,” says John F. Robinson, managing director at Clean Modules. “Through an open and collaborative approach to the design phase we were able to use our skills in design, project management, and construction to their fullest and deliver a cleanroom production facility that exceeds expectations.”