Basic Design for a plasma product new production site

Challenge

ILS has supported for the Basic Design phase, an engineering company, working as the EPCMV service provider for a ‘New blood plasma fractionation plant’ in Europe. The customer company, in collaboration with the National Red Crescent, further aims to domestically produce plasma products from domestic blood plasma, and to consequently ensure the country becomes a self-sufficient country in terms of producing plasma products. The customer company has set out to produce specific blood products that have already been manufactured by a few centers in the world, however not yet been produced. Therefore, the design -as well as the construction have already been started to build the very first biological production facility for blood plasmaproducts in this country. The facility will produce 4 main plasma products (Immunoglobulin, Albumin, and the coagulation factors F-VIII and F-IX) as finished products in various sizes and concentrations. These drugs are used to treat e.g. hemophilia, certain infections, rheumatoid arthritis, leukemia and other immune system diseases, and will be made available nationwide for all patients in this country.

Mission

ILS has taken in charge the Basic Design of the Purification process consisting of 4 process lines with mid scale capacity of production of IVIG and Albumin products and small scale cpacity for production of FVIII and FIX products. Design team has defined general specification for the process, URS, P&ID, 3D model of equipment in respect with project standard and guidelines and especially in compliance with the process provider. Work has been done in close cooperation with process team working on fractionation and fill&finish process, process automation.
Cost estimation has also been done.
ILS has then worked on the Tendering by preparing Tender package documentation to be submitted to vendor, evaluating vendor offer and making a recommendation.
ILS team has also prepared Design qualification document to anticipate C&Q activities.