CONCEPT ENGINEERING

It is a method for determining what features a Pharmaceutical Plants should have, and what metrics can be used to measure the quality or performance of the Pharmaceutical Plants based on analysis of client's needs and preferences. The concept engineering process generally includes framing the project, collect data, analyzing the data and selecting actions.

Concept Engineering will be a crucial document to decide the project plan and will be a base document for Detailed Engineering.

This involves the initial conceptualization of the entire project which helps in forming the foundation on which the rest of the project is built up

The Concept Engineering will define followings:

• Plant Design Concept with respect to various International GMP guidelines like EU GMP, PIC/S, US FDA and WHO.

• Interface with International Process/Regulatory Authorities.

• Man and Material Movements.

• Logical Flow for the Material and Man Movement.

• Utilities and Equipments Balancing.

• Time and Cost Estimates.

man in orange jacket and blue denim jeans walking on sidewalk during daytime

Concept Engineering stages

STAGE 1:

This involves gathering functional requirements of the proposed facility which includes production process together with the required level of automation such as:

• Dosage Forms

• Batch Sizes

• Containment Needs

• Type of Equipment and Machinery

• Inventory Norms

• Expansion Philosophy

toddler's standing in front of beige concrete stair

STAGE 2:

Starts by addressing the following concerns:

• Preliminary Layout based on Availability of Space and Resources.

• Targeted Environmental Cleanliness Category.

• Optimal Water Quality and Water Treatment Facilities

All the above data are finally used to prepare the following:

• An overall Budget for Project Execution.

• The entire Facility Layout for the Preliminary Stage as per National and International Regulatory Norms.

• Conceptualization of Building Construction.

• Drawing out User Requirement Specification (URS).

• Drawing out Project Schedules through Bar Charts.

• Water Generation and Distribution System Design.

• Production Environment Designing like Heating, Ventilation and Air Conditioning.

• Pressure Differential Monitoring.

STAGE 3:

BASIC ENGINEERING

During BASIC ENGINEERING, the following definitions of the Project will be developed:

• Alternative Plant Layouts meeting GMP requirements.

• Men/Material Flow drawings on the approved layout.

• Design of Heating, Ventilation, Air Conditioning and Pressure Differential System with proposed Air Flow Diagram.

• Design on Treatment, Purification, Filtration and Distribution of various Utility Systems like Water, Steam and Compressed Air, etc.

• Estimate Requirements of various Utilities.

• Estimate Electric Power Requirements for the plant and suggest High

Tension and Low Tension Distribution Schemes.

DETAILED ENGINEERING

Detailed Engineering is the essential bridge between the basic engineering and construction phase of a project. It is "Converting Thoughts into reality"

We provide detailed engineering services for a project as follows:

• Process Engineering including selection of the right equipment

• Electrical Engineering

• HVAC

• Instrumentation

• Building Management and Automation Systems

• Preparation of Detailed Specifications, Data Sheets and Bill of Quantities for various Plants, Equipment, Machinery and System

• Supply of various Plant Equipment, Machinery and Systems