Plant layout designingCivil DesigningClean Room designHeat Ventilation & air conditioning (HVAC) designingElectrical EngineeringPlant Utilities designCapacity designing & machinery selectionEnvironmental EngineeringPlant safety engineeringTurnkey Project ServicesDocumentationFeasibility study report of Pharmaceutical projectsThird Party/External Audit
- Pharmaceutical project designing as per regulatory requirement of USFDA, MHRA, TGA, WHO GMP, Schedule-M guidelines
- Man & material flow drawings.
- Machine Placement drawing
- Architectural Drawing of facility
- Civil & Structural drawings of plant building considering GMP requirement.
- Construction management.
- Preparation of Bill of quantity(BOQ) & estimate
- Specifications for floor, wall & ceilings in plant.
- Specifications for clean room partition panels,doors,windows.
- Designing of clean room from ISO Class 1 to ISO Class 9 (FS209E Class 1 to Class 100,000)
- Designing of modular wall partition, walk able/non walk able ceiling, Doors, windows, clean room light fittings.
- Preparation of specification for clean room modular partition, Bill of quantity(BOQ),tender documents.
- HVAC single line air flow diagrams as per GMP requirement.
- AHU piping & ducting layout drawings with proposed location of HVAC equipment’s.
- AHU grouping, AHU filtration level drawings, Room classification, pressure zoning.
- Design qualification (DQ) & HVAC validation
- Preparation of Bill of quantity(BOQ) & estimate
- General Arrangement (GA) drawings
- Design Engineering of electrical distribution in plant.
- Drawing & designing of high tension yard (HT yard).
- Single line diagram (SLD) of electrical panels, earthing.
- Cable specification, cable tray layout.
- Prepare specification for motors, clean room light fittings, cables (LV & HV) panels, push button station, socket outlets, substation equipments.
- Prepare drawings for transformers, DG sets, MCC,PCC, LDBs, motors, cables, VFDs, UPS etc.
- Generation of bill of quantity(BOQ) & estimate
- Selection of suitable utilities for plant
- Preparation of P&ID for purified water generation & distribution system, compressed air system, Vacuum system, GAS system, CIP & SIP system
- BOQ generation & Quotation procurement of various utilities like Purified water system, WFI system, Central Vacuum system, Dust Extraction system.Compressed Air System ,Gas System, CIP System, SIP System.
- Checking & approving of working drawing of vendor / contractor
- Plant productivity based machinery selection
- Preparation of User requirement specification (URS) of machinery, lab instruments & utilities
- Preparation of tender documents, call of quotation, selection of suitable machinery & vendor
- Identification of effluent (solid/liquid) likely to be generated.
- Designing of complete effluent management system like preliminary storage tank, decontamination, pumping of neutralized effluent to main stream of ETP plant etc.
- Concept & detailed engineering for handling of exhaust air through Scrubbers/incinerators.
- Liquid/solid waste disposal treatment & handling methodology.
- We provide specification for machinery required for controlling air & notice pollution’s.
- Designing of safety plans required for plant safety, product safety, personal safety, spill /dust contaminants measures, gaseous contaminants measure, static electric discharge etc.
- Preparation of design philosophy for fire/smoke detection and fire protection system
- Designing for fire fighting systems & fire water tank, hydrants system & water sprinkler system.
Apart from engineering design solutions our company is providing turnkey solution which includes follows:
- Supply,instalation,testing and commissioning of HVAC system including Air handling unit, chiller,air ducting,HEPA filters,HEPA boxes, return air filter,HVAC validation etc.
- Supply,instalation,testing and commissioning of electrical item including electrical control panels, clean room lighting, transformers,DG set, etc.
- Supply,instalation,testing and commissioning of clean room wall panel, ceiling panel, doors,windows etc.
- Supply,instalation,testing and commissioning of pharmaceutical plant machineries as per URS
- Supply,instalation,testing and commissioning of mechanical piping including MS and SS piping, piping racks etc.
- Complete plant documentation like SOP, Batch manufacturing records, CTD dossiers, Qualification, validation etc.
- Product dossiers in CTD format as per different country requirement
- Preparation of feasibility study report including technical & financial calculations of pharma project
- market study of products
- Technical Audit of pharmaceutical plant , which includes assessment of infrastructure, existing machineries setup, and expansion capabilities.
- To check GMP,GLP compliance status of plant and its capability for further regulatory
compliance. - Review of Record, documentation, previous regulatory audit and compliance report.
- Prepare GAP analysis report