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Comprehensive service offering from concept to commissioning

 

Our company specializes in providing a comprehensive service offering for the pharmaceutical projects. We understand the unique requirements and challenges involved in setting up a pharmaceutical manufacturing facility, and our services are designed to ensure a seamless and efficient process.

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 We work closely with our clients to understand their vision, project objective and requirements for the pharma plant. Our team of experts conducts feasibility studies, assesses market demand, and develops a conceptual design that aligns with the client's goals and budget.

 

Once the concept is finalized, we proceed with the detailed engineering and design phase. Our experienced engineers and architects develop a comprehensive plan within your budget meeting compiance.

 

Here is an overview of our service offering:

Project flow map.jpeg

 

SERVICE OVERVIEW

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Engineering & design

 

Once the concept is finalized, we proceed with the detailed engineering and design phase. Our experienced engineers and architects develop the layout, process flow diagrams, equipment specifications, and facility design plans, ensuring compliance with regulatory standards and best practices incorporating present and future requirements.

  • Develop Plant Layout

  • Man and Material Movement Drawings

  • Preliminary Architectural Drawings of the facility

  • HVAC, Zoning with basis of Design

  • Preliminary Specification for Utility

  • Estimating Electrical Power & ETP Requirement

  • Project Scheduling & Cost Estimating

  • Future Expansion Possibilities with using existing utilities or ease in adding

  • Environmental & Safety with zero discharge

Process engineering & equipment selection

 

  • Based on the process specifics, our process engineering team develop a Process flow diagram PFD with optimum equipment and facility utilization.

  • Production capacity planning & forecast.

  • Synchronizing process with respect to production capacity and hence, capacity calculation of process equipment.

  • Process Equipment:- development of “User Requirement Specification” for selection of make of equipment, supplier evaluation & ordering.

  • Process Equipment F.A.T. (Factory Acceptance Test) and set specifics for its qualification according the process requirements.

We assist in the selection and procurement of pharmaceutical equipment, considering factors such as quality, efficiency, regulatory compliance, and cost-effectiveness. We have established partnerships with reputable suppliers to ensure the highest standards of equipment are sourced.

Architechure & Civil work

 

Our construction team oversees the entire construction process, managing contractors, coordinating timelines, and ensuring adherence to design specifications and regulatory requirements. We employ robust project management methodologies to keep the project on track and within budget.

  • Architectural Working Drawings showing Plans, Elevations and Sections.

  • Preparation of Room Book & Room finishes & material selection for inside and outside.

  • Generation of Perspective views.

  • Complete civil and structural engineering design and general layout as well as detailed drawing for RCC, Structural Steel and Allied Works.

  • Foundation drawings for equipment.

  • Specifications, BOQ’s and detailed tender documents for Civil Construction.

  • Approval of the detailed fabrication drawing for structural members prepared by contractors in compliance as per applicable code, design basis etc

Electrical Engineering design

  • Engineering Design and drawings based on the preliminary line diagram.

  • Electrical Classification.

  • Detailed comprehensive specifications for all electrical requirement including switch boards etc.

  • Design and detailed layout drawings for distributions of power, lighting, earthing lightening protection system, fire alarm, public address systems, and computer network etc.

  • Schedule quantities (BOQs) and specifications for all electrical items such as switch gears, cables, lighting fixtures, fittings etc.

  • Tender document for electrical / instruments installation work laying down the methods of erection, testing and start-up.

  • Checking & Approval of contractor’s / sub-contractors working drawings and vendor’s Certification of work & bill approval / certification.

Utility & Piping  engineering design

  • Drawings and Specifications

  • Steam (Pure and Commercial)

  • Purified Water System

  • WFI System

  • Central Vacuum system and Dust Extraction system.

  • Compressed Air System

  • Gas System

  • CIP System, SIP System.

  • Checking & approving of working drawing of vendor / contractor.

  • Utility flow diagrams based on user’s requirement.

  • Mechanical / piping tender document specifying all requirements.

  • BOQ’s and recommendation of contractor for installation work.

  • Approval of contractor’s and vendor’s working drawings, approval of work & Bill Certification.

HVAC Desgin

  • Identifying air conditioning system based on requirement for different manufacturing function and facilities.

  • Area Classification

  • Clean Room

  • Contamination Control

  • Design and detailed specifications and tender drawings for all items requirement related to HVAC.

  • Detailed specifications, BOQs and Tender Specifications.

  • Invite bids and recommend qualified contractors.

  • Check and approve vendor working drawings & documents as well as checking the Validation Process.

Automation, Validation & commissioning

Regulatory Compliance: We understand the criticality of regulatory compliance in the pharmaceutical industry. Our team is well-versed in current Good Manufacturing Practices (cGMP) and regulatory requirements. We provide guidance and support to ensure the facility meets all necessary regulatory standards and obtains the required certifications and approvals

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Validation and Qualification: We assist in the validation and qualification of the pharma plant, ensuring that all processes, equipment, and systems are thoroughly tested and documented. Our experts develop and execute validation protocols, perform qualification activities, and generate the necessary documentation to meet regulatory expectations.

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Training and Knowledge Transfer: We provide comprehensive training programs for the plant staff, covering various aspects of pharmaceutical manufacturing, safety protocols, equipment operation, and compliance requirements. We also facilitate knowledge transfer to ensure smooth plant operation and maintenance post-commissioning.

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Commissioning and Start-up: We oversee the commissioning and start-up of the pharma plant, working closely with the client's team to ensure a smooth transition from construction to operation. We conduct comprehensive testing, system integration, and performance evaluations to ensure the facility operates optimally from day one.

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Post-Commissioning Support: Our services extend beyond commissioning. We offer ongoing support and maintenance services to ensure the long-term efficiency and compliance of the pharma plant. This includes equipment maintenance, process optimization, periodic audits, and regulatory updates. Few steps our outlined below for reference.

  • Designing of Building Management System as per latest regulatory requirement, which is required for Monitoring, recording and validation of:

  • Process / Utility / HVAC / Fire & Safety

  • Developing Tender documents for Building Management System.

  • Approval of the vendor for BMS.

  • Implementation of Building Management System

  • Validation of HVAC & Utilities.

  • Preparation of IQ,OQ,PQ.

  • Certification and approval of following for final payments.

  • Equipment Inspection at vendor works.

  • Witness and Approval of System Commissioning &

  • Balancing by vendor / contractor.

  • Approval of Validation of the various engineering system supplied and installed by contractors.

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