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
Snapshot
Multiproduct API Manufacturing Facility
Built up Area = 15,800 sq.m.
Project Brief
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
Snapshot
Oncology API Manufacturing Facility
Built up Area = 6,502 sq.m.
Project Brief
Oncology API facility OEL Band-5 (Potency between 0.1 to 1.0 micro-gm/m3/ 8 hrs. TWA).
Two clean room crystallization and powder processing zones.
Utilities, QC and warehouse as part of production block.
The facility has high pressure hydrogenation area within the plant, segregated from other areas with RCC walls & airlock.
Sai Life Sciences Ltd - Bidar, India
Snapshot
Hi-Potent API Manufacturing Facility
Built up Area = 2,000 sq.m.
Project Brief
Capacity 10 to 25 kg per batch.
Total number of rectors - 6 No's.
NFD Isolators - 3 No's with 75 litres.
Isolation for Product process and Micronization.
Deactivation room provided.
Utilities, QC and warehouse as part of production block.
Cadila Healthcare Ltd - Vadodara, India
Snapshot
Multiproduct API Manufacturing Facility
Built up Area = 6,040 sq.m.
Project Brief
This was a Brownfield project comprising of API Intermediate suit, Intermediate Drying Area having two granulation suits and 5 powder processing units.
Tank farm Area was design to handle critical storages.
Plant Capacity: 98 KL
Equipment: Reactors, ANFD, RVPD, BDCF, FBD
Gulbrandsen Technologies India Pvt Ltd - Vadodara, India
Snapshot
Multiproduct API Manufacturing Facility
Built up Area = 6,691 sq.m.
Project Brief
This was a Greenfield project having plant reactor capacity of (30 KL, 2 reactors) and (10 KL, 2 reactors).
The Phase 1 manufacturing output is (500 tons/annum), and Phase 2 manufacturing output is (1500 tons/annum).
Below were some of the few process equipment
ANFD – 7.5 Kl.
Spin Flash Drier – 200kg/hr.
Nauta Blender
Navin Fluorine International Ltd - Dewas, India
Snapshot
API Intermediate Manufacturing Facility
Built up Area = 3,546 sq.m.
Project Brief
This was a Greenfield project consisting of four sections.
The facility was built to manufacture API Intermediate.
The facility had typical process conditions like High pressure area & Distillation section.
The facility also had Powder processing section (5-micron section).
Dr. Reddy's Laboratories Ltd - Vizag, India
Snapshot
Oncology API Manufacturing Facility
Built up Area = 2,100 sq.m.
Project Brief
The facility comprises of three dedicated Modules.
The facility comprises of special containment zone of PBOEL of 500 ng/cu. category.
Isolators were used for charging and powder processing area.
The facility is approved by US FDA
Automation in process utility.
Special arrangement of Kill tank for deactivation of toxic waste.
Navin Fluorine International Ltd - Surat, India
Snapshot
API Intermediate Manufacturing Facility
Built up Area = 4,182 sq.m.
Project Brief
The facility was built up to produce 11 Products mapped on campaign basis.
The facility comprises of following process reactions like Halogenations, Hydrolysis, Diazotisation and Hydrogenation reaction.
Liquid product is separated by distillation unit operation.
The entire facility is DCS controlled.
We were also involved in HAZOP and Prestart up safety review.
Emcure Pharmaceuticals Ltd - Kurkumbh, India
Snapshot
API Intermediate Manufacturing Facility
Built up Area = 2,230 sq.m
Project Brief
This facility is designed for producing Oncology APIs.
The facility comprises of Cytotoxic & Non- Cytotoxic intermediate processing areas manufacturing Kilo Lab volume.
Critical reactions like Hydrogenation reactions area were designed.
Two clean room crystallization and powder processing zones for Cytotoxic.
The facility has high pressure hydrogenation area within the plant, segregated from other areas with RCC walls & airlock.
SRF Ltd - Dahej, India
Snapshot
Specialty Chemicals Manufacturing Facility
Built up Area = 8,679 sq.m
Project Brief
This was a Greenfield Facility for manufacturing of Fluorochemicals & Specialty Chemicals
The facility was built for (G+3) structure.
Products manufactured at this site are Perchloroethylene and Trichloroethylene.
Glenmark Generics - Dahej, India
Snapshot
Multiproduct API Manufacturing Facility
Built up Area = 9,293 sq.m.
Project Brief
This facility is greenfield facility spread over plot of 17 Acre.
The facility consists of Manufacturing block Warehouse, Utility block, Administrative, QA and QC Block, Effluent treatment plant, solvent store, and other ancillary structure.
The Manufacturing block has manufacturing sections Consisting of Intermediate manufacturing and two dedicated powder processing facilities to manufacture two products simultaneously.
The production block has 20 reactors ranging from 100 Lit to 5000 Lit. and other equipment required for producing API.
The Effluent treatment facility was design for handling 100 KL per day of effluent with zero liquid discharge facility
Warehouse was designed for future expansion with dedicated area for raw material, finished goods, Intermediate and Packing material storage area.
The facility is designed for regulated market and is USFDA approvable.
Enaltec Laboratories Pvt. Ltd - Ambernath, India
Snapshot
Multiproduct API & Kilo Lab Manufacturing Facility
Built up Area = 1,672 sq.m.
Project Brief
This was a Green field Facility in which Kilo lab and Pilot plant are in same building.
The QC and Warehouse are in separate building.
The facility is approved by US FDA.
Various DMF Filed
Granules India Ltd - Vishakhapatnam, India
Snapshot
Multiproduct API Manufacturing Facility Built up Area = 20,312 Sq.m
Built up Area = 4,410 sq.m
Project Brief
Client has completed the concept design and civil construction for said facility.
The Project comprises of following sections:
Intermediate Area
Powder Processing areas
Solvent recovery System
Plant Capacity: 168 KL
Equipment: Reactors, Columns, ANFD and Centrifuge
Planned, designed, and engineered as per current GMP standards.
Dr. Reddy's Laboratories - Hyderabad, India
Snapshot
Oncology API Manufacturing Facility
Built up Area = 2,800 sq.m
Project Brief
G+ 1 Structure with feasibility to expand reactor volume 10-fold.
Use of Isolators for handing High potent compounds.
Kill tank for deactivation of toxic waste.
Completed in 10 months.
Plant capacity: 15 KL
Equipment: Reactors, Isolators, NF, Fume hoods
Enaltec Laboratories Pvt. Ltd - Indore, India
Snapshot
Multiproduct API Manufacturing Facility
Built up Area = 3,000 sq.m
Project Brief
The facility was built on a greenfield Industrial plot with provision for future expansion.
Greenfield Multiproduct API Facility has Plant Capacity: 63 KL.
Reactor capacity: 0.5 to 4 KL.
Equipment: Reactors, CF, Tray Dryer, Fluid Bed Dryer.
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