Technological know-how and design tools

FWI Pharma Division has a broad range of experience in different types of production and biopharmaceutical such as:

• Vaccines
• Plasma Fractions
• Antibiotics
• Enzymes
• Hormones
• Monoclonal antibodies
• Recombinant proteins
• Proteins obtained by transgenic animals

Furthermore Foster Wheeler Italiana Pharma Division has developed an effective approach to the selection of bioreactors and of downstream process techniques (e.g. nanofiltration, ultrafiltration, chromatography, etc.).
As a result we have developed a thorough understanding of the special needs of such facilities and we can make sure that these are designed and built according to current international regulatory requirements.
Foster Wheeler Italiana Pharma Division regards the design of a bioprocess and that of its surroundings as inextricably linked.
We can implement maximum flexibility in the design of a facility taking into account the fluctuating success rate within bioproduct portfolios as each product advances through development.

Foster Wheeler Italiana Pharma Division has specialists with specific process technology knowledge in the chemical pharmaceutical industry and who have developed experience in unit operations used in bulk chemical plants such as:

Foster Wheeler Italiana Pharma Division experts also have a thorough knowledge of high containment systems (such as isolators), as well as in the technologies for charging and offloading of highly active compounds.

Secondary pharmaceutical manufacturing facilities are buildings that contain complex processes and use sophisticated control systems.
People also operate in these buildings and are recognized as being a major potential source of product contamination. The requirements of a facility handling active pharmaceutical ingredients are to:

• Protect the product from contamination
• Protect the personnel and the environment from the product

Foster Wheeler Italiana Pharma Division is well aware of such requirements and has developed an effective methodology to master their relevant design implications.

Our design processes focus on process architecture, to make sure that product, people and material flows are optimized to achieve these goals in a cost-effective manner.
Our process engineers have also a remarkable experience in technologies and equipment necessary for the production of any type of dosage forms:

• Oral solids (incl. effervescent forms)
• Oral liquids
• Large volume parenterals
• Small volume parenterals
• Topicals
• Inhalations
• Medical devices
• Diagnostics systems

The use of simulation techniques can lead to significant optimisation as far as process equipment / lines, utilities systems and factory logistics are concerned. In consideration of type of process and of complexity, Foster Wheeler Italiana Pharma Division can propose a range of simulation tools (e.g. Witness, Superpro or others).

In this respect, Pharma Division has a long track-of-record in using appropriate simulation tools to validate sizing of equipment and plants, derived from standard design, and/or to size in details complete systems (such as huge clean utilities distribution loop).

A key feature of the Pharma industry is that production campaigns are based on batches of products.
As a consequence, the engineering of automation requires adopting a structured design approach, as defined in the international standard ISA S88. Following the ISA S88 modular approach, a process can be modelled in a Physical Model and a Procedural Model. The Physical Model describes the entities of the process with a top-down approach, starting from the plant itself and getting down through process cells (such as the fermentation area), units (such as the bioreactor), equipment modules (such as the bioreactor jacket service).
The Procedural Model defines correspondingly recipes for the plant, procedures for the process cells, operations for the units and eventually phases for the equipment modules.
This method leads to a consistent and modular design, which is consequently reflected in the configuration of the automation systems.
On the other hand, the implementation of the S88 standard requires considerable efforts and specific skills to the Engineering Company. That is why Foster Wheeler Italiana Pharma Division adopts a design support tool named "ControlDraw", that is a software product specifically designed for batch systems definition according to ISA S88 std. by Automation and Process Engineers.

CAD in 3D format provides a powerful tool for engineering during all project phases. Foster Wheeler Italiana Pharma Division has extensive experience in using 3D CAD as an engineering tool for the development and coordination of a project in all aspects of the design operation. The tools used by Pharma Division (such as Intergraph PDS, Aveva PDMS, TriCAD Venturis and other systems) provide the following advantages:

• A guaranteed clash-free design
• High quality documentation
• Automatic generation of bills of quantities
• Integration of design disciplines with access to current status of model development
• Consistency and uniformity of design from a common data base
• Extensive report generation capabilities from the data base