DESIGN & ENGINEERING


1. FEASIBILITY STUDY

A feasibility study is an analysis that takes all of a project’s relevant factors into account-including economic, technical, legal, and scheduling considerations-to ascertain the likelihood of completing the project successfully.

A feasibility study include as follows:-

  • Details of the project
  • Technological
  • Market Study
  • Technical Study
  • Financial Study
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Feasibility Study report includes the following:-

  • Capital cost for the plant.
  • Plant Production Capacity.
  • Raw Material Cost.
  • Primary & Secondary Packaging material cost.
  • Variable cost for running of the plant.
  • Cost of utilities per unit of manufacturing.
  • Manpower requirements and cost associated with it.
  • Return on Investment.


2. CONCEPTUAL ENGINEERING SERVICES

  • Plant Basis of Design, International Guidelines & Standards for Dosage Form, Production Volumes, Market Targeted & Automation Level
  • Personnel & Material Flow Concept Layout.
  • Process Flow Diagrams.
  • Clean Room & HVAC Zoning.
  • Process/Utility Equipment’s Sizing.
  • Overall Project Time Schedule.
  • Budgetary Cost Estimates.
  • Concept Note.


3. BASIC ENGINEERING

Basic Design is done on the client agreeing to proceed with the project on the budgeted costs and resources as outlined in the Concept Design.

  • Project & Quality Plan.
  • Process flow charts with Time & Motion study.
  • Preliminary process equipment list.
  • Equipment arrangement Layout.
  • Utility requirement data sheet to establish the utilities consumption.
  • Utility equipment sizing & User Requirement Sheet.
  • Establish Design criteria for all disciplines. This will include room environmental basis, Conceptual details on Electrical and Mechanical activities.
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  • Prepare material, personnel flow diagrams.
  • 3D Presentation Video
  • Prepare Master plot plan indicating the existing building structure / proposed Plant Building along with other structures like Utilities, ETP, STP, Electrical HT Yard along with Transformer, Metering Room, Guardroom, Underground Water Tank, etc.
  • Statutory approval drawings
  • Priority wise procurement monitoring chart
  • Underground water Tank & Pump house Conceptual layout.
  • Electrical HT & transformer yard Conceptual layout
  • Door/Windows schedule & Layout.
  • Floor Finishing Finish Layout.
  • False Ceiling Schedule Layout.
  • HVAC Area Classification Layout.
  • HVAC System Zoning Layout.
  • Pressure Gradient Distribution Layout.
  • Pressure HVAC Room Data Sheet
  • Pressure Purified Water system PFD
  • Storm water, Industrial drain & STP drainage, Fire hydrant piping & other external services like street lighting, earth system & power cable routine scheme.
  • Establish design criteria for all disciplines. This will include room environmental
  • Pressure Electrical load sheet, present and future.
  • Electrical power distribution system single line diagram.
  • Pressure Lighting Lux level distribution layout.
  • Specifications for Process Equipment’s.
  • Project Time line.


4. DETAILED ENGINEERING

Detail Engineering is followed in parallel to the Procurement of the Project requirements. worked out along with precise BOQ’s and Technical specifications of all the items involved for various disciplines.

Detail engineering is designed with the help of state-of-the-art 3D CAD systems for the subsequent implementation of your project. It builds on the results of the basic engineering phase and translates these into hardware and software engineering, as well as systems, erection, Commissioning & Validation”

GENERAL:-

  • Detailed General Layout.
  • Detailed Equipment Layout.
  • Sectional Layout.
  • Utility Block Layout.
  • Utility Calculation
  • Process Calculation.
  • Equipment Calculations Along with Capacity Planning.
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LAYOUT PLANNING:-

  • Building a Site Master Plan.
  • All departments layout, section and floor plans.
  • Flooring Details.
  • False ceiling details.
  • Drainage details.
  • Room Data Sheet.

HVAC:-

  • HVAC Room Conditions Chart
  • System wise Heat Load for a basic design.
  • Room wise air distribution to have uniform conditioning Infiltration and ex-filtration calculation to have perfect pressure Differential between areas.
  • Development of detailed Air flow diagrams.
  • AHU location drawing.
  • Chilled water & hot water manifold schematic.
  • RCP (Reflected Ceiling Plan) layout.
  • Ducting layout.
  • Split/Ducted etc. unit refrigerant & drain piping routine with equipment layout.
  • Specifications for chilled water system includes the following:
    • Water Chiller
    • Cooling Tower
    • Chilled Water & Cooling Water Pumps
  • I/O (Input/Output) Sheet for HVAC automation.
  • HVAC (BMS-EMS) system schematic Diagram
  • HVAC (BMS-EMS) Instrument location layout plan
  • Review shop drawings of following HVAC Items :
    • HEPA filter box.
    • Return air Riser.
    • Differential Pressure gauge boxes.
  • Detailed Bill of Quantities.
  • Detailed Tender Document formation.
  • Floatation of tender.
  • Techno commercial comparison of bids.
  • Technical Discussion.

CLEAN ROOM & OTHER:-

  • Clean Room wall panel layout with electrical, HVAC return air riser & other services
  • Bill of Quantities for supply & installation of cleanroom wall panels, Ceiling panel, doors & view panel, windows, wall to wall & wall to ceiling coving, etc.
  • Bill of Quantities for epoxy flooring work & wall to floor coving work
  • URS for pass boxes
  • URS for Sampling & Dispensing booth
  • URS for Ceiling suspended & Mobile LAF units.
  • Bill of Quantities for SS304 Clean Room furniture.
  • Bill of Quantities for Laboratory furniture.
  • Bill of Quantities for Air Curtains, Fly Insect killer fixture, and hand sanitizer, etc. items.
  • Bill of Quantities for warehouse racking system & material handling equipments.

PURIFIED WATER PLANT (GENERATION & DISTRIBUTION)

  • Scheme Preparation.
  • Capacity Calculation.
  • Peak Load Calculation.
  • Line Sizing.
  • Pipe routing drawings.
  • Process & Instrumentation Drawings.
  • Isometric drawing for Purified water system distribution Piping.
  • Specification Sheets – Pipe & Fittings, Valves, etc.
  • Thickness Calculation- Insulation.
  • PW Generation & Distribution Tender document.

MECHANICAL & PIPING ENGINEERING

  • Utility consumption chart based on Equipment /room list. Sizing utility equipment’s based on the approved utility consumption chart.
  • Utility equipment layout based on the utility equipment sizing.
  • Process & Instrumentation Drawings.
  • Responsible for development of equipment’s & pipe routing layout drawing.
  • Drawings for pipe racks and supports.
  • Equipment foundation drawings
  • Develop accurate PID & Piping Layout drawings applying practical design knowledge.
    • Raw Water & Soft Water distribution system
    • Steam & Condensate drain piping system
    • Air Compressed Piping system
    • Nitrogen & other Laboratory gas distribution piping system
  • Piping isometrics for pipelines above 50mmdia and above 100 Deg. Cel.
  • Bill of Quantities for installation, testing and commissioning of piping (as mention above), Hot & Cold insulation work, and steel fabrication work.
  • Bill of Quantities, item specifications for following utility equipment:
    • Steam Boiler
    • Boiler Stack (Chimney)
    • Boiler Bulk Fuel storage tank
    • Boiler Day Fuel tank
    • Boiler Day Feed water tank
    • Compressed Air System (Air Compressor, Air Receiver, Air Dryer, etc)
    • Raw Water/Soft water pump URS.
    • Effluent treatment Plant URS.
  • Piping Tender Documents.
  • Techno Commercial comparison of Bids.

ELECTRICAL:-

  • Electrical load estimation.
  • Electrical layout and circuiting diagrams for lighting,
  • Electrical Earthing, lightning arrestor, etc.
  • Power layout and its circuiting.
  • Cable Tray Layout.
  • Single line diagram for Lighting & Power Distribution boards.
  • Single line diagrams for PCC, APFCR & LT distribution power Panels
  • HT substation, metering room & transformer yard layout with cable routine & all other detain as per electrical inspector / statutory requirements.
  • Cable Schedule
  • Earthing Schedule
  • LV system layouts & Schematic diagram as follows:
    • Fire Alarm system
    • Data/LAN distribution system
    • Voice/Telephone distribution system
    • Door Interlocking system
    • CCTV system
    • PA (Public Addressable) system

  • Bill of Quantities, item specifications for the following:
    • Electrical Light Fixture & Lighting distribution system
    • Electrical Raw & UPS power socket distribution system
    • Earthing system
    • Electrical cable tray, Power & control cables.
    • PCC, APFCR & LT distribution power Panels system.
    • HT Substation system
    • Fire Alarm system
    • Data/LAN distribution system
    • Voice/Telephone distribution system
    • Door Interlocking system
    • CCTV system
    • PA (Public Addressable) system
    • Specification for UPS
    • Specification for Transformer
    • Specification for Servo Voltage Stabilizer
    • Specification for DG set

  • Electrical Works Tender Documents.
  • Techno Commercial comparison of Bids.

EFFLUENT TREATMENT PLANT

  • Prepare ETP scheme with Process Flow diagram.
  • Prepare layout and hydraulic flow diagrams based on the approved flow diagram.
  • Size all tanks and pumps and other equipment
  • Prepare layout for ETP house to include lab, Panel room, and chemical storage.
  • Prepare Specifications of tanks, pumps, etc.
  • Bill of Quantities, item specifications for ETP

FIRE SAFETY:-

  • Study of Fire hydrant scheme as per local regulations or as per regulations to be followed by Client based on their EHS (Environment, Health and Safety) requirements.
  • Prepare the scheme for Fire Hydrant system and pump house.
  • Prepare layout of fire extinguishers, fire alarms, communication system and emergency sirens, etc.
  • Prepare piping layout as per rules for Fire Safety as per their EHS requirements.
  • Prepare item specifications, Bill of quantities.


5. PROJECT & SITE MANAGEMENT

Project & Site management is the key to the success of a project. Our Project managers have mastered the art of timely completion of the project as per the laid down detail engineering drawings. There are various challenges that we have successfully encompassed in site management of various sites.  The key effectiveness of our site management team has been,

  • Safety
  • Integration
  • Communication
  • Timely Delivery
  • Quality
  • Cost Effective.
  • Site feedback

“Our Site Project manger’s are responsible for preparing sites prior to the commencement of construction work. This includes setting out the site and organizing activities. They plan projects and ensure that they meet agreed specifications budgets, timescales. They are on hand throughout the build to assess progress and solve problems that arise”


6. QUALIFICATION & VALIDATION

Qualification & Validation are an integral part of pharma projects. They are done to give a high level of assurance to the inspection authorities

Qualification means “The documented verification that all aspects of facility, utility or equipment that can affect product quality,

Validation “Establishing documented evidence which proves a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.”

Validation Documents includes the following

  • Area qualification – All Department
  • Validation Master Plan
  • Equipment Qualification
  • Site Master file
  • Purified water Qualification
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  • Utilities Qualification
  • Design Qualification
  • Factory Acceptance Test.
  • Installation Qualification.
  • Operational Qualification.
  • Performance Qualification.
  • Supplementary Qualification.
  • Process Validation
  • Packaging Validation
  • Cleaning Validation
  • Third party Validation
  • Analytical Method Validation
  • Computer system Validation
  • Hold time studies
  • Temperature mapping
  • Product storage and Distribution validation
  • Training Protocol
  • Stability
  • Standard Operating Procedure – All department
  • Vendor Qualification


7. cGMP & TECHNICAL DUE DILIGENCE

  • cGMP compliance.
  • Mock inspections/GAP analysis, and inspection readiness assessments
  • Upgrade existing facilities to meet GMP Standards and International Regulatory authorities.
  • Compliance audits as per current and updated statutory pharma regulations.
  • GMP regulatory compliance issues with respect to current facility infrastructure and documentation practices.
  • GMP compliance training.
  • Quality systems development and support.
  • Audits and quality assurance services.
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