Process Control & Automation

803 West Ave803 West AveSuite 320

Rochester, NY 14611

(585) 295-2105 Phone(585) 295-2105 Phone(877)757-9421 Toll Free

(585) 295-2106 FAXwww.process-logic.com

Revision 9

Revision Date: Jan, 2015

■ Overview

■ Core Competencies

■ Special Capabilities

■ Q & A, General Discussion

OVERVIEW:

Process-Logic: Specialists in process design, i t t ti d t l f i lt h i linstrumentation, and process control of specialty chemical

and pharmaceutical manufacturing processes & plants.

■ Process Design – PFDs, P&IDs, Equip. Layouts

■ Piping and Mechanical Design■ Piping and Mechanical Design

■ Electrical Design

■ Instrumentation specs and custom applications p pp

■ PLC & HMI Software Development

■ System Integration

Commissioning / Qualification Testing

Process Design

CORE COMPETENCIES:

Process Design■ PFDs, Equipment Lists, Heat & Material Balances

■ P&IDs Instrument Lists Control Narratives■ P&IDs, Instrument Lists, Control Narratives

■ Equipment Layouts

■ Instrumentation specifications■ Instrumentation specifications

■ Heat Transfer Calculations

■ Vessel Configurationsg

■ Mixing Studies

■ Turnkey Systems

Piping and Mechanical Design

CORE COMPETENCIES:

Piping and Mechanical Design■ Process Skids

■ Tempered Water Systems

■ High Purity Water Systems

■ 3D Modeling

B31 3 ASME d i i■ B31.3 ASME grade piping

■ Double Wall Tubing and Pipe

■ Sanitary / BPE Design y g

Electrical Design

CORE COMPETENCIES:

Electrical Design

■ Power Distribution

■ Power Factor Correction

■ Arc Flash Studies

■ Lighting

■ Hazardous Area Design

■ Control Panel Design■ Control Panel Design

■ IO Subsystems

■ Control Network Architectures

Control Panel Design

CORE COMPETENCIES:

Control Panel Design

Control Panel Design

CORE COMPETENCIES:

Control Panel Design

Control Panel Design

CORE COMPETENCIES:

Control Panel Design

Control Panel Design

CORE COMPETENCIES:

Control Panel Design

Instrumentation

CORE COMPETENCIES:

Instrumentation

■ ISA style Instrument Specifications

■ Calibrations■ Calibrations

■ Process Analytical / Custom Applications

■ FTIR Analyzers

■ GC / Mass Spec

■ Refractive Index

■ Mill Fire Detection

■ Safety Instrumented Systems

CORE COMPETENCIES:

PLC & HMI ProgrammingPLC & HMI Programming

■ Rockwell – all platforms

■ Schneider / Modicon

■ Mitsubishi

■ GE Fanuc■ GE Fanuc

■ Factory Talk View

■ Wonderware

■ Iconics Genesis 32 & 64

■ GE Proficy

EZ Automation

CORE COMPETENCIES:

System IntegrationSystem Integration■ Integration of separate vendor skids

■ TW Skids, Vacuum Skids, Hydraulic Power packs, Mole Sieves,■ TW Skids, Vacuum Skids, Hydraulic Power packs, Mole Sieves,

Chiller Packages, BMS, Fire Alarms, etc.

■ Custom Instrument Applications :

[Trasar, Mettler Toledo Process Analyzers]

■ Modbus RS-485 & TCP/IP

RS 485 Serial comms■ RS-485 Serial comms

■ Ethernet/IP

■ LON

Bacnet

CORE COMPETENCIES:

Commissioning & Qualification TestingCommissioning & Qualification Testing

■ GAMP “V-Model” approach to system design

■ URS

■ FRS

■ DDS

■ FAT

■ SAT

■ IQ / OQ / PQ

OVERVIEW: SPECIAL CAPABILITIES

Special Capabilities: Special Capabilities:■ Engineering Studies / Plant Optimization

■ Batch Reactor Controls

■ Custom Device Integration Services■ Custom Device Integration Services

■ Design of cGMP compliant systems

■ Design of Instrumentation/Control systems for use in Hazardous Areas

Design of Safety Instrumented Systems

■ Design of Custom Instrumentation Systems

SPECIAL CAPABILITIES:

Batch Reactor Controls: Batch Reactor Controls:

• Batch chemical reactor design

• Glass-lined steel and stainless steel vessels

• Precise temperature, pressure, & vacuum controlsp , p ,

• Accurate flow additions and totalization for pH, DO & foam

• S88-compliant batch controland recipe management.

• Data Historization and analysistools

SPECIAL CAPABILITIES:

Design of cGMP compliant systems:

• GAMP Lifecycle Development Model (V model)

USERREQUIREMENTS

PERFORMANCEQUALIFICATION

PQ TEST PLAN

S

mission

ing

Test Protocols are written as specs are prepared

Design of cGMP compliant systems:

(V-model)

• Members of the International Society of Pharmaceutical Engineers (ISPE)

FUNCTIONALDESIGN

DETAIL DESIGN INSTALLATIONQUALIFICATION

OPERATIONALQUALIFICATION

OQ TEST PLAN

IQ TESTPLAN

DESIGNQUALIFICATION /

ENHANCED DESIGNREVIEWS

Specifications are written in incre ecut

ed d

uring

Sta

rtup

and

Commi

of Pharmaceutical Engineers (ISPE)

• Designs compliant with cGMP regs for ActivePharmaceutical Ingredients and Bulk Pharmaceuticals

IMPLEMENTATION

easing detail

Test

Prot

ocols

exe

g

• Designs compliant with 21 CFR Part 11 for storage & handling of electronic data.

• Process Designs and System Software, thoroughlydocumented and fully capable of being validated.

SPECIAL CAPABILITIES:

D i f I t t ti /C t l t f i Design of Instrumentation/Control systems for use inHazardous Areas:

• Proficient in all aspects of intrinsically safe, non-incendive, and explosion-proof electrical methods

• Proficient in design of X-, Y-, and Z-type purgedenclosures for maintaining electrical safety.

A ti b hi i NFPA d ISA• Active membership in NFPA and ISA

• All systems designed to be fully compliant withapplicable standards published by the NECapplicable standards published by the NEC,CEC, IEC.

SPECIAL CAPABILITIES:

Design of Safety Instrumented Systems:

• Perform Risk Analysis using Process Hazard Analysis d

UnacceptableRisk

InitialProcess Risk

with no mitigationlihoo

d

PROCESS EXAMPLE: Uncontrolled Release of Flammable Liquid due toOver-Pressurization and Rupture of Tank

ytechniques: HAZOP, FEMA, Event Tree Analysis.

• Select Safety Integrity Level to cess

Haz

ard Risk

Regiong

Non-SISLikelihood Reduction

e.g. Relief Valves

Non-SISConsequence Reductione.g. Containment Wall

SISRisk Reductionvia SIL-1-SIF

Hig

h Li

kel

BaselineRisk after Non-SIS

mitigation

• Select Safety Integrity Level to meet a specific Probability of Failure on Demand.

ood

of P

roc

od

SISRisk Reductionvia SIL-3-SIF

Risk Value = 10,000

Risk Value = 1,000

Risk ValueR

SISRisk Reductionvia SIL-2-SIF

• Design Safety-Instrumented System to provide required levels of risk reduction in the

t t ffi i t

Like

liho

Low Severity High SeverityLo

w L

ikel

ihoo

AcceptableRiskRegion

e = 100

Risk Value = 10

most cost-efficient manner possible.

Consequence of Process Hazard

THANK YOU!

Process Control & Automation

803 West AveSuite 320

Rochester, NY 14611

(585) 295-2105 Phone(877) 757-9421

Toll Free(585) 295-2106 FAXwww process logic com

Revision 9

www.process-logic.com

Revision Date: Jan, 2015