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Board of
Directors
• Mr. Yogesh Bhatt
• Designation: Director
• Years of professional expertise: 27 years
• Academic qualification: Production
engineering
• Mrs. Bobby Bhatt
• Designation: Director
• Years of professional expertise: 25
• Academic qualification: MSc Physics
• Mr. Ganesh Mendon
• Designation: Director
• Years of professional expertise: 20
• Academic qualification: Chemical
Engineering
2.7.2022 4
Gr ouP
7:17 PM
Why Lotus
• A complete one stop solution for
Conceptual Design, Execution and
Validation.
• Successfully done Turnkey Projects
over a decade
• Cost effective solutions
• Timely completion of project
• Pharma Engineering expertise
• cGMP Compliance Assured
2.7.2022 6
Gr ouP
7:17 PM
PHARMACEUTICAL ENGINEERING
CONCEPT DESIGN
BASIC ENGINEERING
DETAIL ENGINEERING
QUALIFICATION & DOCUMENTATION
DESIGN REVIEW / DESIGN QUALIFICATION
INSTALLATION QUALIFICATION
OPERATIONAL QUALIFICATION
PERFORMANCE QUALIFICATION
TURNKEY PROJECTS
EQUIPMENT & PROJECT SUPPLIES
INSTALLATION & COMMISSIONING
STARTUP
VALIDATION OF HVAC, WATER SYSTEMS, CLEANROOMS
TRIAL BATCHES
ORALS
TABLETS
CAPSULES
LIQUID SYRUPS
DRY SYRUPS
DRY SACHETS
SOFT GEL CAPSULES
STERILES
LIQUID VIALS
LIQUID AMPOULES
DRY VIALS
LYOPHILISED PRODUCTS
PRE-FILLED SYRINGES
IV SOLUTIONS
EXTERNALS
CREAMS
OINTMENTS
TRANSDERMALS
ENGINEERING, PROJECTS & DOCUMENTATION
2.7.2022 7
Gr ouP
7:17 PM
PHARMACEUTICAL ALLIED SERVICES
• MAINTAINENCE CONTRACTS & SERVICES
• TECHNOLOGY TRANSFERS & DOSSIERS
• RAW MATERIAL SOURCING
• MANPOWER SOURCING ASSISTANCE
• LABORATORY SERVICES
• PROCESS VALIDATION ASSISTANCE
2.7.2022 8
Gr ouP
7:17 PM
Pharmaceutical Engineering
Services
.
• Time Schedule
• Cost Breakdown - +/- 30%
• Plant Specification / Plant URS
• Design Criteria
• Process Description
• Process Flow Diagrams
• Process / Utility Equipment list
• Plant Layout / Sections / 3D Views
• Equipment Arrangement plans
• Personnel and Material Flows
• Clean Room classifications
• Utility Flow diagrams
• Control Philosophy
• Define Commissioning and Qualification - Systems
• To do list for Manufacturers - Risk Analysis / Define Systems / Impact Assessment
2.7.2022 9
Gr ouP
7:17 PM
CONCEPTUAL DESIGN
2.7.2022 10
• Supplier Master Document list
• Commissioning Master Plan
• Project Plan / Quality Plan
• Time Schedule – Revised
• Procurement plan
• Preferred Supplier list / Equipment list
• Design Criteria
• Plant URS – Revised
• Cost Breakdown - +/- 10%
• Final Process Description
• Process Flow Diagrams
• Capacity and Cycle time analysis
• Define Project Procurement Procedure
Gr ouP
7:17 PM
BASIC DESIGN – GENERAL & PROCESS
2.7.2022 11
• Room Specifications
• Layouts
• Personnel and Material Flows
• Clean Room Classification / Ex classifications
• Equipment Arrangement plans
• Process P and ID’s
• Piping Execution Specifications
• Equipment Specifications, TS.
• Data Sheets
• Utility flow diagram
• Utility Capacity study
• Utility Equipment list
• Basic Design Documentation lists
Gr ouP
7:17 PM
BASIC DESIGN – PIPING & UTILITIES
BASIC DESIGN – LAYOUT
Gr ouP
7:17 PM
2.7.2022 13
Gr ouP
7:17 PM
BASIC DESIGN – CLEAN ROOM CLASSIFICATION
2.7.2022 14
• Detail 3D drawings for HVAC, Equipment, Piping, Valves, Building, etc.
• Checking of EDR [DQ], FDS, IQ, OQ from Vendors and Approvals with respect
to VMP for DIS.
• Execution of IQ and OQ support at site for DIS.
• Writing IQ and OQ reports, Deviation Reports and Change Controls for DIS.
• System Compliance to USFDA / EUGMP check list
• Others,
• Vendor Evaluation
• Delivery Supervision / FAT
• Installation Checks
• Piping Installation Checks
• Commissioning plans and Supervision
Gr ouP
7:17 PM
DETAIL ENGINEERING
TURNKEY
• AHU
• DUCTING
• RISERS
HVAC
• PUF, ROCKWOOL, HPL
• THICKNESS 30,50,80,100
• PPGI/PCGI/SS
CLEAN ROOM PANELS
• TRASFORMER
• CABLING/CABLE TRAYS
• DG SETS
• ELECTRICAL PANELS
• BMS/EMS
ELECTRICALS
TURNKEY
• CLEAN UTILITY
• RAW UTILITY
PIPING
• STATIC/DYNAMIC PB
• SAMPLING/DISPENSING BOOTH
• LAMINAR FLOW UNIT
• BIO SAFETY CABINET
• AIR SHOWER
CLEAN ROOM EQUIPMENT
• RACK STORAGE
• EPOXY/PU FLOORING
STORAGE/FLOORING
Tasa Pharma LTD.
Nairobi, Kenya
Turnkey Projects
1 & 2 ml
PREFILLED SYRINGES
5 & 10 ml
AMPOULE
1 & 2 ml
DENTAL CARTRIDGE
TYPE OF PROJECT :
LOCATION :
PROJECT STATUS :
SCOPE :
STERILE FORMULATION
NAIROBI, KENYA HANDOVER IN
2019 TURNKEY EXECUTION
FROM
CONCEPT TO COMMISSIONING
IV in PP bags – 500 ml
INTRAVENOUS
HVAC-Area Classification
HVAC-Area Classification
HVAC - AHU Zoning
HVAC - AHU GA Drawing
HVAC - Air Pressurization
Utility- Piping Routing
Utility- Piping Routing
Utility- P&ID for FS System
Utility- P&ID for CA System
Utility- P&ID for CW System
Electrical SLD
Clean Room Flooring
Men Material Movements
Men Material Movements
Equipments
Laboratory
Lotus Technicals Pvt. Ltd.
1601 and 1602, Oriana BusinessPark, Road
No. 22, Wagle Estate, MIDC,
Thane – 400604 (West) Maharashtra, INDIA
+91-22-20810798 / 20810598 / 20811050
info@lotustechnicals.com
www.lotustechnicals.com
Lotus East Africa Ltd. Parklands,
P.O.Box– 117-00623 Nairobi,
KENYA
+254-732709985
info@lotus-africa.com
www.lotus-africa.com
Gr ouP
7:17 PM
PROJECT SITES
2.7.2022 41
Gr ouP
7:17 PM
PROJECT SITES – Oman
Gr ouP
7:17 PM
PROJECT SITES
Gr ouP
7:17 PM
PROJECT SITES
Gr ouP
7:17 PM
PROJECT SITES
Gr ouP
7:17 PM
PROJECT SITES
Gr ouP
7:17 PM
PROJECT SITES – Oman
Gr ouP
7:17 PM
PROJECT SITES
Gr ouP
7:17 PM
PROJECT SITES – Oman
Gr ouP
7:17 PM
PROJECT SITES – KENYA
2.7.2022 51
Gr ouP
7:17 PM
STRATEGIC LOCATION
KENYA INDIA
52
Gr ouP
7:17 PM
FEW OF OUR CLIENTEILE
Gr ouP
7:17 PM
THANK YOU
INDIA
LOTUS TECHNICALS,
1601 and 1602, Oriana Business Park,Road no
22, Wagle Estate, MIDC, THANE – WEST.
INDIA. 400606
TEL : +91-22-20810798/20810598/20811050
EMAIL : info@lotustechnicals.com
WEBPAGE : www.lotustechnicals.com
AFRICA - KENYA
LOTUS EAST AFRICA LTD,
A302, MADONNA HOUSE ANNEX,
WESTLANDS ROAD,
WESTLANDS, NAIROBI. 137-00623. KENYA.
TEL : +254-732709985
EMAIL : info@lotus-africa.com
WEBPAGE : www.lotus-africa.com

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Lotus-technicals-PPT.pdf

  • 1. 1
  • 2. Board of Directors • Mr. Yogesh Bhatt • Designation: Director • Years of professional expertise: 27 years • Academic qualification: Production engineering • Mrs. Bobby Bhatt • Designation: Director • Years of professional expertise: 25 • Academic qualification: MSc Physics • Mr. Ganesh Mendon • Designation: Director • Years of professional expertise: 20 • Academic qualification: Chemical Engineering
  • 3.
  • 5. Why Lotus • A complete one stop solution for Conceptual Design, Execution and Validation. • Successfully done Turnkey Projects over a decade • Cost effective solutions • Timely completion of project • Pharma Engineering expertise • cGMP Compliance Assured
  • 6. 2.7.2022 6 Gr ouP 7:17 PM PHARMACEUTICAL ENGINEERING CONCEPT DESIGN BASIC ENGINEERING DETAIL ENGINEERING QUALIFICATION & DOCUMENTATION DESIGN REVIEW / DESIGN QUALIFICATION INSTALLATION QUALIFICATION OPERATIONAL QUALIFICATION PERFORMANCE QUALIFICATION TURNKEY PROJECTS EQUIPMENT & PROJECT SUPPLIES INSTALLATION & COMMISSIONING STARTUP VALIDATION OF HVAC, WATER SYSTEMS, CLEANROOMS TRIAL BATCHES ORALS TABLETS CAPSULES LIQUID SYRUPS DRY SYRUPS DRY SACHETS SOFT GEL CAPSULES STERILES LIQUID VIALS LIQUID AMPOULES DRY VIALS LYOPHILISED PRODUCTS PRE-FILLED SYRINGES IV SOLUTIONS EXTERNALS CREAMS OINTMENTS TRANSDERMALS ENGINEERING, PROJECTS & DOCUMENTATION
  • 7. 2.7.2022 7 Gr ouP 7:17 PM PHARMACEUTICAL ALLIED SERVICES • MAINTAINENCE CONTRACTS & SERVICES • TECHNOLOGY TRANSFERS & DOSSIERS • RAW MATERIAL SOURCING • MANPOWER SOURCING ASSISTANCE • LABORATORY SERVICES • PROCESS VALIDATION ASSISTANCE
  • 8. 2.7.2022 8 Gr ouP 7:17 PM Pharmaceutical Engineering Services
  • 9. . • Time Schedule • Cost Breakdown - +/- 30% • Plant Specification / Plant URS • Design Criteria • Process Description • Process Flow Diagrams • Process / Utility Equipment list • Plant Layout / Sections / 3D Views • Equipment Arrangement plans • Personnel and Material Flows • Clean Room classifications • Utility Flow diagrams • Control Philosophy • Define Commissioning and Qualification - Systems • To do list for Manufacturers - Risk Analysis / Define Systems / Impact Assessment 2.7.2022 9 Gr ouP 7:17 PM CONCEPTUAL DESIGN
  • 10. 2.7.2022 10 • Supplier Master Document list • Commissioning Master Plan • Project Plan / Quality Plan • Time Schedule – Revised • Procurement plan • Preferred Supplier list / Equipment list • Design Criteria • Plant URS – Revised • Cost Breakdown - +/- 10% • Final Process Description • Process Flow Diagrams • Capacity and Cycle time analysis • Define Project Procurement Procedure Gr ouP 7:17 PM BASIC DESIGN – GENERAL & PROCESS
  • 11. 2.7.2022 11 • Room Specifications • Layouts • Personnel and Material Flows • Clean Room Classification / Ex classifications • Equipment Arrangement plans • Process P and ID’s • Piping Execution Specifications • Equipment Specifications, TS. • Data Sheets • Utility flow diagram • Utility Capacity study • Utility Equipment list • Basic Design Documentation lists Gr ouP 7:17 PM BASIC DESIGN – PIPING & UTILITIES
  • 12. BASIC DESIGN – LAYOUT Gr ouP 7:17 PM
  • 13. 2.7.2022 13 Gr ouP 7:17 PM BASIC DESIGN – CLEAN ROOM CLASSIFICATION
  • 14. 2.7.2022 14 • Detail 3D drawings for HVAC, Equipment, Piping, Valves, Building, etc. • Checking of EDR [DQ], FDS, IQ, OQ from Vendors and Approvals with respect to VMP for DIS. • Execution of IQ and OQ support at site for DIS. • Writing IQ and OQ reports, Deviation Reports and Change Controls for DIS. • System Compliance to USFDA / EUGMP check list • Others, • Vendor Evaluation • Delivery Supervision / FAT • Installation Checks • Piping Installation Checks • Commissioning plans and Supervision Gr ouP 7:17 PM DETAIL ENGINEERING
  • 15. TURNKEY • AHU • DUCTING • RISERS HVAC • PUF, ROCKWOOL, HPL • THICKNESS 30,50,80,100 • PPGI/PCGI/SS CLEAN ROOM PANELS • TRASFORMER • CABLING/CABLE TRAYS • DG SETS • ELECTRICAL PANELS • BMS/EMS ELECTRICALS
  • 16. TURNKEY • CLEAN UTILITY • RAW UTILITY PIPING • STATIC/DYNAMIC PB • SAMPLING/DISPENSING BOOTH • LAMINAR FLOW UNIT • BIO SAFETY CABINET • AIR SHOWER CLEAN ROOM EQUIPMENT • RACK STORAGE • EPOXY/PU FLOORING STORAGE/FLOORING
  • 18. Turnkey Projects 1 & 2 ml PREFILLED SYRINGES 5 & 10 ml AMPOULE 1 & 2 ml DENTAL CARTRIDGE TYPE OF PROJECT : LOCATION : PROJECT STATUS : SCOPE : STERILE FORMULATION NAIROBI, KENYA HANDOVER IN 2019 TURNKEY EXECUTION FROM CONCEPT TO COMMISSIONING IV in PP bags – 500 ml INTRAVENOUS
  • 21. HVAC - AHU Zoning
  • 22. HVAC - AHU GA Drawing
  • 23. HVAC - Air Pressurization
  • 26. Utility- P&ID for FS System
  • 27. Utility- P&ID for CA System
  • 28. Utility- P&ID for CW System
  • 35. Lotus Technicals Pvt. Ltd. 1601 and 1602, Oriana BusinessPark, Road No. 22, Wagle Estate, MIDC, Thane – 400604 (West) Maharashtra, INDIA +91-22-20810798 / 20810598 / 20811050 info@lotustechnicals.com www.lotustechnicals.com Lotus East Africa Ltd. Parklands, P.O.Box– 117-00623 Nairobi, KENYA +254-732709985 info@lotus-africa.com www.lotus-africa.com
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  • 41. 2.7.2022 41 Gr ouP 7:17 PM PROJECT SITES – Oman
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  • 47. Gr ouP 7:17 PM PROJECT SITES – Oman
  • 49. Gr ouP 7:17 PM PROJECT SITES – Oman
  • 50. Gr ouP 7:17 PM PROJECT SITES – KENYA
  • 51. 2.7.2022 51 Gr ouP 7:17 PM STRATEGIC LOCATION KENYA INDIA
  • 52. 52 Gr ouP 7:17 PM FEW OF OUR CLIENTEILE
  • 53. Gr ouP 7:17 PM THANK YOU INDIA LOTUS TECHNICALS, 1601 and 1602, Oriana Business Park,Road no 22, Wagle Estate, MIDC, THANE – WEST. INDIA. 400606 TEL : +91-22-20810798/20810598/20811050 EMAIL : info@lotustechnicals.com WEBPAGE : www.lotustechnicals.com AFRICA - KENYA LOTUS EAST AFRICA LTD, A302, MADONNA HOUSE ANNEX, WESTLANDS ROAD, WESTLANDS, NAIROBI. 137-00623. KENYA. TEL : +254-732709985 EMAIL : info@lotus-africa.com WEBPAGE : www.lotus-africa.com