Success speaks for the process itself

We speak your language! These were Zeb Ahmed's final words at the end of a recent in-house seminar to senior managers and engineers from the pharmaceutical and biotechnology industries. A simple statement, but the head of Thermal Transfer's Process Division (TTPD) was not referring to his team's ability to converse in a foreign tongue, but to 'process speak'. For more than four and half years, the division of this specialist mechanical services contractor has been speaking the language of the pharmaceutical and biotechnology industries, securing projects from a range of blue-chip clients, including AstraZeneca, Glaxo Smithkline, Evans Vaccines, Avecia and Sigma Aldrich. This has resulted in a growth rate of 42% per year over this period. The project package of design, construction, commissioning and validation of process systems is the division's business (Diagram 1), unlike that of its more established competitors such as design companies and similar one-function organisations.

Experienced team The business is supported by an in-house team of 12 specialist process engineers and managers. These team members not only have skills and years of experience within pharmaceutical manufacturing, but understand the process as well as they understand the client's recipe. The advantage of having one supplier, offering a total package and a single point of responsibility, has immediate benefits for its multinational clients. The principal benefit is that the client is able to get its valuable drugs and medicines to market much sooner using TTPD than employing separate sub-contractors for each stage of the project. The key function in the management of this type of project, and especially in fast track contracts, is the validation lifecycle (Diagram 2). In projects where separate sub-contractors are employed, the function of validation cannot start until the design is complete and approved. With TTPD undertaking and controlling all the functions in-house, the generation and verification of the validation support documentation can often commence as soon as the contract has been signed. The risk of starting so soon is very high, but the net effect can be to shorten the length of the project, enabling the client to start manufacturing the product in the shortest possible time. However speed is not everything if the critical quality controls are not in place, not just throughout the life of the contract, but for the life of the manufacturing programme.

Quality at heart of system "At TTPD, we manage quality with the client from the very beginning. With the recent award of ISO 9001 for Process and Validation Services, quality is at the heart of everything we do," says Ahmed, whose enthusiasm, direction and performance have recently been rewarded with his appointment as a regional director of the Glossop, Derbyshire, office. "When you are working with a product, such as a vaccine that will be injected directly into the blood stream of millions of people, product quality, safety and traceability are paramount. Not only do we have to make sure that the production process is technically perfect, we must also guarantee the purity of the product. This guarantee can only be given if the design of the facility and the process meets the necessary MHRA/FDA regulatory approvals," he adds. Price is always a critical factor. TTPD remain competitive because the added value that it can bring to a contract is unique. As an example, the division adopts an enthusiastic life cycle approach to each project. This considers every aspect of the process design, including maintenance, over the whole life of the manufacturing programme, from start to finish. To ensure that all costs are kept tightly under their control, TTPD has an approved chain of specialist equipment and service suppliers, which has evolved through close working relationships and an 'open and honest' policy. Some supplier relationships have been forged over 30 years, working on mechanical services projects with Thermal Transfer's core business, the design and build of cleanrooms, laboratories and containment suites not only for the pharmaceutical and biotechnology industries, but also for healthcare, medical device and semiconductor companies. One client in the biotechnology field that TTPD has worked closely with is Sigma-Aldrich, a leading life science and high technology company. Following a two month feasibility study and a cGMP design review at its Cell Culture facility in Irvine, Ayrshire, by Thermal Transfer's East Kilbride office, TTPD was involved in an £8m turnkey contract for the design, installation and validation of a new 10,000 litre mixing and sterile filling facility for non-animal based products. Process support systems included PLC-based process control systems, mechanical and clean utility services – USP and EP quality water-for-injection, pure steam, purified water and also sterile air and nitrogen – and cleaning/sterilisation in-place systems.

Impeccable reputation The combination of being able to 'speak the language' and produce high quality, fast track validated process systems time after time over the four-and-a-half year period has earned TTPD an impeccable reputation within its specialist markets. In addition, it has a growth rate that many competitors would be delighted with even if they managed to achieve just half the figure.