1. Sterling Healthcare Limited The Company Presentation
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2. Sandesara Group Pharmaceuticals Infrastructure Engineering Healthcare
Oil & Gas
Pharmaceuticals
Sandesara Group
Healthcare
Business interests in: Healthcare, Oil & Gas, Engineering, Pharmaceuticals, Infrastructure, and Oil trading
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3. Plant Overview Manufacturer of Oral Solid Dosage Formulations
Plot Size: 21,000 m²
Built-up area : 5,100 m²
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4. Site Layout
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5. Facility & Capacity INSTALLED CAPACITY Per month (2-Shifts) (Million)
Two Granulation suites
Two Blending suites
Four Compression areas
Two Encapsulation areas
Three Coating areas
Five packaging lines Including Bulk Packing
INSTALLED CAPACITY
Per month
(2-Shifts)
(Million)
Per annum
Tablets
150
1800
Film Coating
100 % of the above total Capacity
Capsules 50
600
Blister Packing
100
1200
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6. Tablet Manufacturing Granulation : 2 Blending : 2
Compression Machine : 4
Coating Machine : 3
Equipment
Capacity
Make
Rapid Mixer Granulator
Liters
Saral Engineering
Fluid Bed Drier
250 Kgs
Fluid Bed Processor
500 Lts
Pam-Glatt
Compression Machine
81 Station
45 Station
Legacy 61 station
45 station mark IV
40-60 RPM
10-30 RPM
20-90 RPM
30-60 RPM
Fluid
CIP Machinery
Pam Pharmaceuticals
Cad mach
Auto coater 48 Inch
60 Inch
150 Kg Kg
600 Kg
Gansons Limited
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7. Capsule Manufacturing
Blending : 1 Octagonal blender
Encapsulation : 1 AF 90 T with latest features installed like Empty capsule sorter, Check weigher, Polisher, Filled Capsules and Metal detector
Equipment
Capacity
Make
Capsule Filling Machine AF 90T
90000 Cap/Hr
Pam Pharmaceutical
Octagonal Blender
1250 L
Global Pharmaceutical Equipment
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8. Packaging Area Bulk packing area : 1 Primary packing area : 4
Inspection Area : 2
Equipment
Capacity
Make
BQS
136 blister/min
Pam Pac
EPI 2500
100 blister/min
Elmach
EPI 3010
68 blister/min
EPI 2300
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9. Unique Features of Formulation Plant
Individual processing areas serviced by dedicated AHU’s and differential pressure maintained to prevent cross – contamination
Tablets manufacturing areas : Temp. NMT 250 C and RH NMT 60%
Capsules manufacturing areas : Temp. NMT 250 C and RH NMT 45%
HEPA filtered air is provided to Manufacturing areas. Total 37 numbers of AHUs, 05 Numbers of Dehumidifiers and 07 Numbers of Ventilation Units are provided in the HVAC system.
AHUs are provided with 10 micron pre-filter, 3 / 5 micron Intermediate and 0.3 micron HEPA filters.
Total 5 numbers of Dust collector Units are provided in powder processing zone
RO and EDI for generation of Purified water and circulated to the Manufacturing area through UV and zero dead leg distribution system. The return loop of the distribution system is connected with the TOC analyzer.
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10. Utility Power Supply Central Utilities
2 Numbers of 126 Ton Chiller Plant with eco-friendly Technology.
Purified Water Plant with 500 Liters/hour capacity.
Two oil free Air Compressor of 136 CFM & 412 CFM capacity.
One Boiler with 600 kg/hr Capacity.
One boiler with 850 kg/hr Capacity.
750 KVA Transformer.
250 KVA and 500 KVA DG Set with Automatic change over system for back up of facility.
UPS backup for QC equipments /Instruments.
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11. REGULATORY STATUS
Regulatory Status and Conforming to most stringent GMP Standards
Approved by MOH, Germany
Approved by WHO, CDSCO
Approved by MOH, Namibia
Inspected by NAFDAC certificate expected by July 2016.
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12. Organogram 11/11/2018 Mr. Satish Shah CEO Ashok Todwal VP -Operations
Mr. Avinash Deshmukh
Manager-Production
Pankaj Kulkarni/Avinash Kulkarni Asst. Manager-Production
Execuive-03
Officer-24
Trainee-02
Technician-34
Mr.Shyam Panchal Manager -Warehouse
Executive-01
Officer-08
Trainee-01
Technician-01
Mr. Sushim Jain
Sr. Manager -Engineering
Mohan Kumbhar
Asst. Manager-Enginnering
Officer-03
Trainee-03
Technician-06
Mr. Rajendra Kadam
DGM -HR
Sr.Executive-01
Mr. Santosh Mahatme Head-Commercial
Officer -02
Mr. Anish Nair Manager-Purchase
Laxminaryan Patar
Asst. Manager-Purchase
Officer-02
Mr. Rajendra Nehete VP-Quality
Mr. Vishwesh Inamdar
Asst. Manager-QA
Mr. Tushar Deore/Ms.Sadhana Shinde
Officer-15
Mr. Manojkumar Kumbhar
Asst..Manager-QC
Executive QC- 05
Officer-20
Trainee-05
Sr. Exceutive (Microbiology)-01
Executive - 01
Officer-01
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