(A Government of India Undertaking)
The main production building is designed as per the WHO-GMP guidelines. It encompasses licensed/installed capacity for indigenous production of 100 million doses of OPV, whereas the installed capacity for blending and filling operations is capable of manufacturing 600 million doses. The production facility is distinctly segregated into classified controlled and uncontrolled areas as per the process requirement. All the laboratories are under class 10000 environment maintained at positive pressure and the critical steps in manufacturing process are being carried out in class 100 work stations with non-particle generating epoxy coated internal finishes.
Quality Assurance & Quality Control
The Quality control and Quality Assurance sections are distinctly constructed in a separate wing, away from the production facility. In process quality control for every production batch is being carried out by the Quality Control department. Standard microbiological, biochemical as well as other routine tests are being carried out during each stage of vaccine formulation as well as for the final product. In addition to extensive analyses, samples from various batches of vaccine are routinely sent to Central Research Institute, Kasauli (H.P) for further validation of quality of vaccines. Validation of manufacturing process and equipment are also carried out as per Master Validation Program. The Quality Assurance Department of BIBCOL conduct regular monitoring of controlled environment using very sophisticated MET-ONE paticle counter as per the BIBCOL¡¯s comprehensive environment policy. The instrumentation and accessories used in the production and quality control are calibrated as per schedule by N.A.B.L accredited laboratories.
BIBCOL has very good facility to carry out R&D activity in the area of vaccines and other immunobiologicals. The company has ambitious plan of diversifying into production of other vaccines like IPV, Hepatitis B, Measles and DPT and other nutraceuticals. A dedicated animal house facility is available for the indigenous R&D for vaccine testing and quality control purpose.
The OPV plant is provided with all necessary utilities such as 1100 KVA electrical substation, a Water Treatment Plant with capacity of producing drinking water ࿒ cubic meter/hr), soft water cubic meter/hr), and demineralized water ƕ cubic meter/hr). The WFl plant can produce WFI grade water at the rate of 1 cubic meter/hr. A Central Air Conditioning Plant üž TR), a boiler house with capacity for generating steam at the rate of 4 tones/hr, a work shop and two DG sets of 1000 KVA, 50 KVA capacity for uninterrupted power supply are also available in the OPV plant. Facilities for waste treatment such as Effluent Treatment Plant as well as incinerator are also part of Utility Division.
A dedicated central ware house is used for storage of GMP and non-GMP items such as raw materials, intermediates, finished products and engineering goods are stored as per GMP.