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
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
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
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
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