12014, Engineering

Latino America

ConsultoresInnovation & Technology to make

your Business Compliant

ENGINEERING

Design Development,

Review & Qualification

22014, Engineering

GEP & GMP

32014, Engineering

CLIENT NEEDS/ INFORMATIONS VALIDATED PLANT

CONCEPTUAL DESIGN

URS

INSTALLATION QUALIFICATION

PERFORMANCE QUALIFICATION

OPERATIONAL QUALIFICATION

FAT/SAT

CONSTRUCTION

DETAIL DESIGN/DETAIL SPECIFICATION

BASIC DESIGN/FUNCTIONAL SPECIFICATION

ENGINEERING

VALIDATION

MIXED PARTICIPATION

PROJECT FLOW

VERIFICATION

EXCHANGED INFORMATIONS

FLOW OF INFORMATIONS

DESIGN QUALIFICATION

GMP Requirements

RISK ANALYSIS

VALIDATION MASTER PLAN

GMP REVIEW

GMP Engineering V-Cycle

42014, Engineering

VMP

DRAFT

URS /

CONCEPTUAL

DESING

CLIENT

NEEDS

RA DRAFT

DQDQ

DETAIL

DESIGN

BASIC

DESIGN

GMP

REVIEW

VALUE

ENGINEERING

CONSTRUCTION IQ

FINAL RA

SYSTEM BUILD

FINAL VMP

PQ

OQ

FAT / SATVERIFICATION

GMP Engineering – Activity Flow

52014, Engineering

Design

Feasibility Study

Conceptual Design

Basic Design

Prj. Plan & Prj. Mngmt.

Detail Design

Procurement Support

Engineering - Main Project Phases

Enhanced

GMP Review

GMP Review

Risk Assesment &

Risk Analysis

Value Engineering

Design Qualification

62014, Engineering

Construction

/ Installation

Project

Quality Plan

Project

Logistic Plan

Project

Quality Control

Commissioning

Planning and

Controlling

Physical Completion

and Checking

Instrument calibration

and Fine Tuning

Set Up and Support to

Start Up

Testing and Reporting

Engineering – Execution & Commisioning

72014, Engineering

Qualification

Plan (SMVP, QMP)

Report & Final

Summaries

Scheduling

Protocols

Execution

Review

Qualification Matrix

Reports

Preparation

Engineering - Qualification

IQ

PQ

OQ

FAT / SATVERIFICATION

82014, Engineering

EngineeringProject Deliverables

92014, Engineering

URSBlock diagram with

material balance

Process flow sheet with

material balance

Utilities characteristics

and consumtion

summary

Equipments Summary

Activities tima-line

Equipments data sheets

A

A

Instruments summary

Process and utilities

P&IDSketch drawings

Instruments data sheetLogic automation

diagram

Equipments functuional

specification

Instrumentation

functional specification

Line list

Input/Output signal list

B

C

Equipments Shops

drawingsB

Control system

specificationC

Piping lay-out Piping material take-off

Instruments lay-out

Preparation and

management of material

requirements

Construction activities

supervisionPower and

instrumentation

specification

Engineering – Flow Diagram Activity

102014, Engineering

Conceptual Design /

Feasibility Study

Basic Design Detail Design

Etude d’Esquisse APS APD

Conceptual Design /

Feasibility Study

Advanced Basic

Design

Engineering – Type of Project

112014, Engineering

Deliverables Basic Advanced Basic

Etude d’Esquisse /

Conceptual -

Feasibility

APS APD

General Documents

Documents List ■ ■ ■ ■ ■

Project Schedule □ ■ □ □ ■

Project Quality Plan □ ■ □ □ ■

Meeting Minutes ■ ■ ■ ■ ■

General Project Technical Report ■ ■ □ ■ ■

Facility General Layout ■ ■ ■ “single-line”

Diagram

■ ■

Project schedule plan ■ ■ □ ■ ■

Material Flow Layout ■ ■ ■ “single-line”

Diagram

■ ■

Personnel Flow Layout ■ ■ ■ “single-line”

Diagram

■ ■

Cost Estimates Summary ■ ± 30% ■ ± 15% ■ ± 30% ■ ± 15% ■ ± 15%

Process Design

URS – Facility ■ ■ ■ Preliminary URS ■ ■

URS – Process Equipments ■ URS - Preliminary ■ □ ■ ■

Equipment List ■ ■ ■ Preliminary ■ ■

Process flow diagram ■ ■ ■ ■ ■

Equipment Layouts ■ ■ ■ “single-line”

Diagram

■ ■

Layouts of area classification ■ ■ ■ “single-line”

Diagram

■ ■

Layouts for pressure differentials ■ ■ ■ “single-line”

Diagram

■ ■

Engineering – Phase Project Deliverables

122014, Engineering

Deliverables Basic Advanced Basic

Etude d’Esquisse /

Conceptual -

Feasibility

APS APD

Civil Works

Civil demolitions & reconstruction Layouts (if

needed)

■ ■ □ □ ■

Waste drains & Process drains Layouts ■ Only Drain’s Point ■ “single-line”

Diagram

□ □ ■ “single-line”

Diagram

Preliminary loading Layouts (if needed) □ ■ □ □ ■

Cleanroom Finishing Works

Cleanroom Finishing Layouts □ ■ □ □ ■

Technical Specification for Walls, Ceilings,

Floors and cleanroom installation

■ Preliminary ■ □ □ ■

Functional Specification for Access Interlocks (if

needed)

□ ■ □ □ ■

HVAC System

URS - HVAC ■ ■ □ ■ ■

Technical Specifications for HVAC (general) □ ■ □ ■ ■

HVAC “Zoning” Layouts ■ ■ ■ “single-line”

Diagram

■ ■

HVAC Diffusers and Grilles Layouts □ ■ □ ■ ■

False Ceiling Lay-out □ ■ □ □ ■

HVAC Single Wire Ducts Layouts □ ■ □ □ ■

HVAC calculations & sizing □documento da

preparare, non

consegnare

■ □ ■ ■

Preliminary P&ID of each Air Handling Unit and

Distribution

■ Process Flow

Diagrams

■ Preliminary P&ID □ ■ Process Flow

Diagrams

■Preliminary P&ID

Installation Layouts of Air Handling Units ■ ■ ■ “single-line”

Diagram

■ ■

Main components datasheets □ ■ □ ■

Engineering – Flow Diagram Activity

132014, Engineering

Deliverables Basic Advanced Basic

Etude d’Esquisse /

Conceptual -

Feasibility

APS APD

Black Utilities (Hot water, Cold Water,

Compressed Air, Industrial Steam, Vents,

Potable Water, Softened Water,

Demineralized Water, Fire Fighting Water,

Waste Water), Process Utilities and Clean

Utilities (Water For Injection, Clean Steam,

Purified Water, Process Nitrogen, Process

Compressed Air)

Utilities List ■ ■ ■ Preliminary ■ ■

Utilities Consumption Summary ■ Preliminary ■ ■ Preliminary ■ Preliminary ■

Utilities Block Diagram ■ ■ ■ ■ □

URS (for Process and Clean Utilities) ■ ■ □ ■ ■

User points Lists (for Process and Clean

Utilities)

□ ■ □ ■ ■

Technical Specifications for Utilities □ ■ □ ■ ■

Utility Components Lists ■ ■ □ ■ ■

Utility Dimensioning Calculation Report (where

applicable)

□ documento da

preparare, non

consegnare

■ □ documento da

preparare, non

consegnare

□ documento da

preparare, non

consegnare

■

Generators and Treatment Skids datasheets

(where applicable)

■ ■ □ ■ ■

Pumps datasheets (where applicable) ■ ■ □ ■ ■

Heat Exchangers Datasheets (where

applicable)

■ ■ □ ■ ■

Tanks datasheets (where applicable) ■ ■ □ ■ ■

Preliminary P&ID of each Utility (Generation

and Distribution)

■ Process Flow

Diagrams

■ Preliminary P&ID □ ■ Process Flow

Diagrams

■ Preliminary P&ID

Utilities Generation and Distribution Layouts ■ Distribution

“single-line”

Diagram

■ Distribution

“single-line”

Diagram

□ ■ Distribution

“single-line”

Diagram

■ Distribution

“single-line”

Diagram

Engineering – Flow Diagram Activity

142014, Engineering

Deliverables Basic Advanced Basic

Etude d’Esquisse /

Conceptual -

Feasibility

APS APD

Electrical Plants

Electrical Loads Summary ■ ■ ■ Preliminary ■ ■

Block Diagrams of Electrical Boards ■ ■ □ □ ■

Single Wire Electrical Distribution Layouts ■ ■ □ □ ■

Automation and Instrumentation

Control System Architecture Layout ■ ■ □ ■ ■

Control System Functional Specifications □ ■ □ □ ■

Instruments Lists ■ ■ □ □ ■

Instruments datasheets □ ■ □ □ ■

Preliminary Input – Output Lists □ ■ □ □ ■

QC Labs

QC Lab Equipment and Instruments List ■ ■ ■ Preliminary ■ ■

QC Lab Furniture Layout □ ■ □ □ □

QC Lab Equipment and Instruments Layout □ ■ □ □ ■

Engineering – Flow Diagram Activity

152014, Engineering

Economic framework

Contracts

Quality plan

General conditions

Chronodiagram

Security Plan

Maintenance Plan

Technical report on prevention and fire

protection

Engineering – Formal Deliverables

162014, Engineering

Architectural

User requirements, Tecnical Specifications

Bill of quantities, List unit prices

Lay-out, Prospectus and Sections

Details, Furniture

Details, schedules of fixtures

Structural

User requirements, Technical Specifications

Bill of quantities, List unit prices

Explanatory memorandum, geotechnical, materials on floors . . .

Structural calculations

Lay-out, Pillars table and Armour

Engineering – Civil Works

172014, Engineering

Conditioning User requirements, Technical Specification

Bill of quantities, List unit prices

Thermal calculation

Aerial sketches, Hydraulic sketches, Automation

Lay-out, Prospectus and Sections

Details

Sanitary Fluids User requirements, Technical Specifications

Bill of quantities, List unit prices

Lay-out, Prospectus and Sections

Technical & Medical Gasses User requirements, Technical Specification

Bill of quantities, List unit prices

Lay-out, P&ID, Sketches

Engineering – Critical Utilities

182014, Engineering

Equipments and Instrumentation summary

P&ID’s

Technical specification for equipments,

instruments, machinery and systems

Controls and automation systems

Process utilities summaries

Consumtion summaries

Piping technical specifications

Engineering – Process

192014, Engineering

User requirements, Technical specification

Bill of quantities, List unit prices

Cables sizing, lighting sizing, comunication

plants sizing

Block diagrams, Board diagrams

Lay-out for lighting, electrical plugs, power

Lighting protection diagrams

Electricals and comunication plants details

Engineering – Electrical & Special Plants

202014, Engineering

Many thanks for

your attention

Leandro Mbarakleandro.mbarak@ctpsystem.com

www.latconsultores.com.ar

Gilberto Rossigilberto.rossi@latconsultores.com.ar

www.latconsultores.com.ar