Services

Process Design Engineering

Piping & Plant Design Engineering

Instrumentation & Automation

Mechanical Engineering Design

Validation Services

Engineering Consulting & Support

Esenar understands the technical, cGMP and regulatory challenges required for Pharma & biopharmaceuticals. Our objective is to deliver innovative and functional process engineering and systems engineering solutions for your complex projects by taking responsibility for specification, procurement, design and build, and commissioning and validation

Below are the Capabilities of a Process Engineering Team.

Conceptual Design:

Block Flow Diagrams, Process Model and Basic Utility Calculations

Basic Design:

PFD development, Equipment Layout arrangement, CIP, SIP, Process flowpaths and Valve Matrix

Detailed Design:

Interface Automation Matrix, Function Specifications or Operational Description, Equipment sizing calculations, Pressure Drop Calculations, Vendor document reviews

PW, WFI & Pure Steam Design:

Esenar fully understands the requirements of Purified Water, WFI & Pure Steam with multiple industries from initial design and installation, including IQ/OQ/PQ

CIP & SIP Skid Design:

Cleaning & sanitization process for process vessels and interconnecting process piping is one of the most critical process in the Pharmaceutical, Life sciences, Healthcare and Cosmetic to remove residues from the previous batches and ensure contamination-free systems. Esenar designs the skids as per the ISPE,ASME BPE and GMP guidelines

Piping Design Engineers play a vital role in development or re-construction of Plants, related to Oil & Gas Industries, Power Plant, Fertilizers Industries and Food Industries etc

The plant engineering and design industry is gradually evolving and incorporating the latest technological advancements in planning, designing, modifying, installing and maintaining various plant facilities, systems, equipment etc

Plant Design services are especially useful while designing mechanical, structural, instrumental, and piping designs. Our Esenar team will design plant by following Regulations and guidelines like ASME BPE, ISPE,ASME Section 8 Div II and ASME B31.3

2D Design & Drafting

  • Process Flow Diagrams, P&IDs, Layouts, Equipment Layout arrangement
  • Piping GA Drawings & Piping Routing
  • MTO (BOM)
  • Piping Isometric & Support Drawings
  • Piping Specifications
  • Pipe Routing
  • Nozzle Orientation diagrams
  • GA of the equipments
  • Lists: Equipment, Valve, instrument, Special items, Line list

3D Modeling:

  • Equipment Modeling
  • Piping modeling
  • Pipe rack modeling
  • Support modeling
  • Structure or Platform modeling
  • Navisworks 3D Review
  • Clash detections for the plant using reference documents from the vendors
  • Building of 3D plant model from available 2D drawings

Our team is having experience in pharma, Bio Pharma and BMS experience, worked for the major Bio pharma and Bio pharma industries

Instrumentation

Esenar’s highly skilled team from Instrumentation department will assist your organization in planning, selection and procurements, site installations and onsite support.

Instrumentation core working area:

  • Preparation of Instrument Specifications and Data Sheets
  • Instruments List & Logic Diagrams
  • Control System Architecture
  • 3D Modeling of Cable Trays and Instrument Panels
  • Bill of Materials Preparation
  • Cable scheduling

Automation

Esenar’s highly skilled team from Automation department will do the best Automation for your organization by following guidelines and regulations. Below are the some of the examples

  • GAMP
  • 21CFR Part 11
  • 21CFR Part 210/211

Esenar’s Automation Plan:

  • Automation Project Master Plan(APMP)
  • Automation Design Master Plan(ADMP)
  • Computer System Validation Master Plan (CVMP)
  • Network Architecture Diagrams
  • Software and Hardware Specifications
  • PLC/SCADA/DCS

Esenar is a professional engineering consultancy.

We offer engineering design and project management services to the Mechanical, pharmaceutical, biotechnology and Construction industries

2D Design:

  • CAD drafting using 2D softwares
  • PDF to DWG conversion
  • Migration from one CAD platform to another CAD platform
  • Conversion of legacy 2D CAD files
  • Orthographic views

3D Modeling:

  • Product designing
  • 3D Modeling and rendering
  • Exploded and top-down assembly drawings
  • Remodeling, resizing, and scaling of legacy drawings
  • Othographic views

Esenar is expertise in Commisssioning & Qualifications

A typical set of validation deliverables includes:

  • Validation Project Plan
  • User Requirements Specification (URS)
  • Functional Specifications
  • Design Qualifications
  • Factory Acceptance Test (FAT) & Site Acceptance Test (SAT)
  • Installation Qualification (IQ) for each database instance
  • Operational Qualification (OQ) for each solution
  • Traceability Matrix
  • Qualification Summary Report

Eenar specializes in projects involving Process Technologies which must conform to current Good Manufacturing Practices (GMPs) and which require inspection and approvals from the following regulatory agencies:

  • United States Food and Drug Administration (FDA)
  • European Union (EU)

We can provide consulting services for existing, or renovated and new process equipment and systems, in cGMP manufacturing environments regardless of size. Our engineering consulting team have extensive knowledge of the regulatory requirements regarding building design, equipment classifications and product and process flows. We can also assist in drafting User Requirements Specifications (URS), supervise the Installation, Operational and Production Qualifications (IQ/OQ/PQ) of your equipment and production areas.