This facility is to make easy access of life – saving plasma drugs to patient at affordable prices. This is historic facility of plasma fractionation which was created under the guidance of well known world renowned European Plasma technology expert. However over a period of time, the facility has under gone various difficult phases with respect to the cGMP requirements which created necessity to rebuild the facility with latest technology under current GMP norms.
Accordingly, an existing civil structure has been selected to implement the project. The plan is to have plasma fractionation facility with the end product as Albumin, IgG (Immunoglobulin G) and PCC (Prothrombin complex concentrate).
The annual plasma processing capacity is approximately of 20,000 Litres with each batch size of approximately 125 litres. This facility is linked to reputed government hospitals in Mumbai. This project started with multiple major challenges as in any case wherein the existing civil structure is to be redeveloped re-developed to address the current GMP requirements of a Biologics or Plasma facility with respect to the minimum height requirement in clean rooms, man-material movement, room classification, zoning, containment philosophy, disposal of the biowaste and many more.
Elomatic has been selected after rigorous evaluation about the expertise on biologics and plasma as single window engineering and consultancy company. So this project match 100% the very purpose of Elomatic, India which is “Engineering the affordable Healthcare”. Also on project planning, design, engineering & implementations, this is in true sense Idea to commercializing which is Mantra at Elomatic !
So our work started with review of the existing infrastructure and various reports which are incomplete in many sense. Navigating the design & engineering from conceptual design stage up to the successful implementation of project inclusive of successful trial batches of the various products.
Since the technology transfer has happened few decades back and from an European institute which is proven authority body in such projects, it was mandate given to us to follow the same technology and couple of proprietary set of equipment. Major critical equipment were imported and with their own conditions which were creating additional challenges to keep track on time and investments. There were multiple machines which were kind of under monopoly due to restricted proven application in the industry.
The huge challenges came as surprise on table due to lack of competent trained resources at the client place. We had been asked to support client in identification of competent resources and new recruitments etc. This was something different & interesting challenge of building team at client place.
The major challenge of the project was to accommodate the complete upstream and downstream of the process along with formulation fill finish section inclusive of freezer dryer in the limited existing civil structure without compromise on the frame work of regulation & GMP requirements.
In the entire journey of project implementation, We at Elomatic, owned this project with full ownership and handholding the client till the start of production. Elomatic dealt not only with design & engineering matters but also with multiple regulatory officers and local statutory officers.
Documentation is the key wherein Elomatic has used its own patented proven software Elodoc, wherein each document created by different technical expert is being stored inclusive of the documents / drawings from various contractor & vendors. So the integration and composite drawings of the various section and facility as a whole could be achieved without errors and without much hassles.
The complete documents of the project are always available for audit and could be used in future for any modification/ expansion, Elomatic is playing the role of custodian of such important documents.
With complete in-house capabilities on design & engineering of various disciplines/ support function and with previous rich experience on plasma regulatory qualified facilities, Elomatic could realised the dream of client and build a state of the art facility which is dedicated to the Nation poor people.