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Sterling Healthcare Limited ( A Sandesara Group Company) Company Presentation. Pharmaceuticals. Infrastructure. Engineering. Oil & Gas. Sandesara Group. Healthcare. Business interests in: Healthcare, Oil & Gas, Infrastructure, Engineering, Pharmaceuticals. Vision. - PowerPoint PPT Presentation
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Sterling Healthcare Limited ( A Sandesara Group Company)
Company Presentation
104/20/23
04/20/23 2
Pha
rmac
eutic
als
Infr
astr
uctu
re
Eng
inee
ring
Oil
& G
as
SandesaraGroup
Business interests in: Healthcare, Oil & Gas, Infrastructure, Engineering, Pharmaceuticals
VisionVision
Supply of Quality Drugs
Strategic Alliances
Joint Ventures
To become a global player in generic pharmaceutical business with:
304/20/23
Plant Overview
404/20/23
Pharmaceutical Contract Manufacturing of Oral Solid Dosage Formulations (Tablet / Capsule / Granules)
Plot Size: 21,000 m² Facility with built-up area of 5,077 m²
04/20/23 5
Sterling Healthcare
Limited
Location Layout Corporate Office Mumbai
Baroda
API Manufacturing Facility
Urse, Talegaon
Site Layout
604/20/23
Regulatory Status :
Audited & Approved by Germany (July 2013)
Audited & Approved by WHO, CDSCO (February 2012)
Audited & approved by MOH, Namibia (August 2010)
704/20/23
Approvals WHO GMP Certificate EU GMP Certificate
04/20/23 8
Approvals
04/20/23 9
Republic of Namibia GMP Certificate
04/20/23 10
Organogram
Facility & Capacity
04/20/23 11
Two granulation suites (Approx. 219 Sq.m) Two blending suites ( Approx. 47 Sq.m) Four compression areas ( Approx. 130 Sq.m) Two encapsulation areas ( Approx. 80 Sq.m) Two coating areas (Approx. 124 sq.m) Five packaging lines : 4 Blister and 1 Bulk
Packing ( Approx. 134 sq.m)
CAPACITIES Per month (Single Shift)(Million)
Per annum(Single Shift)(Million)
Tablets 110 1300
Capsules 15 180
Blister Packing
65 780
Sachet Packing
0.33 3.6
Tablet Manufacturing
04/20/23 12
Equipment Capacity Make
Rapid Mixer Granulator 180-480 Liters Saral Engineering
Fluid Bed Drier 250 Kgs Saral Engineering
Fluid Bed Processor 500 Lts Pam-Glatt
Compression Machine37 Station45 StationLegacy 61 stationCadpress IV 45 station with CFC
10-30 RPM10-30 RPM20-90 RPM10-70RPM
CIP MachineryCIP MachineryPam PharmaceuticalsCadmach Machineries
Auto coater 48 Inch 60 Inch
150 Kg150-350 Kg
Saral EngineeringGansons Limited
Granulation : 1200 kg / shift ( 2 granulation suites) Blending : 1680 kg / shift ( 2 blenders ) Compression Machine Coating Machine
Capsule Manufacturing
04/20/23 13
Equipment Capacity Make
Capsule Filling Machine AF 90T
90000 Cap/Hr
Pam Pharmaceutical
Octagonal Blender
1250 L Global Pharmaceutical Equipment
Blending Octagonal blender Encapsulation
AF 90 T with latest features installed like Empty capsule sorter, Check weigher, Polisher, Filled Capsules and Metal detector
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%
Manufacturing area classification complying to Grade D/Class 100,000.
HEPA filtered air is provided to Manufacturing areas. Total 36 numbers of AHUs, 05 Numbers of Dehumidifiers and 07 Numbers of Ventilation Units are provided in the HVAC system.
1404/20/23
Quality Systems
All activities as per laid down SOPs and protocols
Training program (Induction, Need based, Systems and Incident based)
Batch manufacturing through controlled Batch Manufacturing records
Deviation Management, Change Control Management and CAPA
Use of approved and validated test procedures with controlled work sheets
Investigation of Out of specification results
Structured stability program
Handling of Market complaint and Product recall
Annual Product Quality Review
Self Inspection
Quality Risk Management
1504/20/23
Thank You !
1604/20/23