Infrastructure
The fermentation facility of Sterling Biotech Ltd. is one of the largest in the country:
Microbiology Lab
- Sterling biotech has State-of-the-art Microbiology facility for development of inoculum for the production fermentors.
– Facility for Isolation and selection of microbial strains
– Shake flask facility for isolation of more potent strains.
– Dedicated area for storage and testing of the strains.
- Pilot Plant
– Lab fermenter/ pilot plant facility for scale-up fermentation process development.
and Identifying & Initiation of new Fermentation based products.
– We have battery of 150 L,40L and 20L fomenters and allied downstream equipments.
Fermentation based API Plant
- Main Fermentors 160 KL, 6 No.s
- Fermentation capacity: 960 KL
- Seed Fermentor 16 KL, 4 No.s
– Sugar Sterlisation /Addition Vessels, Substrate Vessels and Harvest Tanks
– DCS based automated Fermentation and downstreaming
process
Fermentation based Oncology plant
- Main Fermentors 16 KL, 2 No.s
- Fermentation capacity: 32 KL
- Seed Fermentor 2 KL, 1 No.s
– Sugar Sterlisation /Addition Vessels, Substrate Vessels and Harvest Tanks
– DCS based automated Fermentation and downstreaming
process
Quality control
- Well Equipped QC lab to perform the analysis as per requirements with well defined documentation systems.
- The laboratory is well equipped with top of the line instruments such as:
– Waters Alliance HPLC and UV detector
– Agilent HPLC with UV detector
– Perkin-Elmer Dual Detector Clarus 600GC
– Shimadzu HPLC with auto-sampler and UV detector,
– FT-IR , Shimadzu 8400S
– UV-Vis Spectrophotometer Shimadzu
– Perkin-Elmer 341 digital polarimeter
– Mettler Toledo Instruments {Micro Balance, KF Titrator)
– San system Skalar instrument. Atomic Absorption Spectrophotometer
Quality Assurance
- Comprehensively designed and well implemented QA system to ensure that the products are manufactured to specified quality requirements
- Compliance to cGMP at all phases of manufacturing
- Quality procedures documented, designed and controlled to take into account the basic attributes of drugs viz. efficacy, safety & stability
- The quality system documented – Quality Policy Quality Manual, Validation master Plan Standard Operating Procedures Quality Records and Logbooks
Solvent Recover Plant
- Capability to distill various solvents like Hexane, acetone, methanol, butyl acetate, toluene etc.
- 13 distillation columns of various capacities, plate and packed type
- Solvent Recovery : 95 %min (on net basis) & purity 99%.
- All vents from condensers, storage tanks are well equipped with Flame arrestor & breather valves to ensure environment.
Utilities
- Process Air 42000 NM3/Hr (4 Machines @9000 NM3/Hr & 1 @ 6000 NM3/ Hr)
- Cooling water 6000 M3/ Hr (4 Cells @ 1500 M3/ Hr)
- Chilled water 2800 TR (4 chillers @ 700 TR)
- Brine (MEG) 416 TR (2 Chillers @ 208 TR)
- Boilers 30 TPH (3 Boilers @ 10 TPH)
- Nitrogen 200 NM3/Hr (2 Plants @ 100 NM3/ Hr)
- DM water 4 M3/Hr
- RO water 25 M3/Hr
- Purified water (WFI) 80 Ltr /Hr
- Purified water 100 Ltr/Hr
- Electrical connection At 66 KV, 5 MVA
- Contract Demand DG Power Plant 3 DG sets @ 2270 KVA
Safety
- Committed to providing a safe and healthy workplace
- Safety Policy
- Fire Hydrant Network
- Fire Tender and Emergency Vehicle
- Safety Procedures and training
- Health Monitoring
- Compliance with all applicable HSE legislation.
Effluent treatment plant
- 600 m3 Large capacity treatment facility.
- Comprises of primary flocculation, secondary two stage aerobic biological treatment and tertiary activated carbon tower
- Large anaerobic digester
- Meeting environmental norms on pollutants
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