Greenfield facility which comprises of intermediate area for carrying out the chemical synthesis processes the downstream activities like chromatography, acylation, filtration, drying & packing is carried out in ISO class 7 & 8 clean rooms facilities.
Plant Capacity: 125KL/annum.
Equipment: Reactors, Lyophilizer, CF, VTD
The manufacturing facility is planned as a G+3 story building.
Material transfer has been planned to avoid contamination of the production environment.
The facility is designed to comply with cGMP manufacturing standards of international regulatory bodies like US FDA & EU
Almelo Ltd - Hyderabad, India
Multiproduct API Manufacturing Facility
Built up Area = 15,800 sq.m.
Bar Coded Bin transfer system from warehouse to plant PTS with load cell for weighing.
Dry material form ANFD is discharged in bin and then transferred to the required location.
Vertical gravity flow to ensure material transfer from the centrifuge to dryer to milling and sieving followed by blending.
Blended material is transferred through metal detector to packing line to fill the material in 25 Kg Bags.
The PLC system was configured to carry out recipe management and material traceability through bar coding.
Biocon Ltd - Vizag, India
Oncology API Manufacturing Facility
Built up Area = 6,502 sq.m.
Oncology API facility OEL Band-5 (Potency between 0.1 to 1.0 micro-gm/m3/ 8 hrs. TWA).