Process Control & Automation

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Ethel Bryant
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Process Control & Automation 803 West Ave Suite 320 Rochester, NY 14611 (585) 295-2105 Phone

1 Process Control & Automation 803 West Ave Suite 320 Rochester, NY (585) Phone (877) Toll Free (585) FAX Revision Date: Jan, 2015 Revision 9

2 Overview Core Competencies Special Capabilities Q & A, General Discussion

3 OVERVIEW: Process-Logic: Specialists in process design, instrumentation, t ti and process control of specialty chemical and pharmaceutical manufacturing processes & plants. Process Design PFDs, P&IDs, Equip. Layouts Piping and Mechanical Design Electrical Design Instrumentation specs and custom applications PLC & HMI Software Development System Integration Commissioning / Qualification Testing

4 Process Design PFDs, Equipment Lists, Heat & Material Balances P&IDs, Instrument Lists, Control Narratives Equipment Layouts Instrumentation specifications Heat Transfer Calculations Vessel Configurations Mixing Studies Turnkey Systems

5 Process Skids Piping and Mechanical Design Tempered Water Systems High Purity Water Systems 3D Modeling B ASME grade piping i Double Wall Tubing and Pipe Sanitary / BPE Design

6 Electrical Design Power Distribution Power Factor Correction Arc Flash Studies Lighting Hazardous Area Design Control Panel Design IO Subsystems Control Network Architectures

7 Control Panel Design

8 Control Panel Design

9 Control Panel Design

10 Control Panel Design

$Refractive Index Mill Fire$

11 Instrumentation ISA style Instrument Specifications Calibrations Process Analytical / Custom Applications FTIR Analyzers GC / Mass Spec Refractive Index Mill Fire Detection Safety Instrumented Systems

12 PLC & HMI Programming Rockwell all platforms Schneider / Modicon Mitsubishi GE Fanuc Factory Talk View Wonderware Iconics Genesis 32 & 64 GE Proficy EZ Automation

System Integration Integration of separate vendor

Custom Instrument Applications : [Trasar, Mettler

13 System Integration Integration of separate vendor skids 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 Ethernet/IP LON Bacnet

14 Commissioning & Qualification Testing GAMP V-Model approach to system design URS FRS DDS FAT SAT IQ / OQ / PQ

15 OVERVIEW: SPECIAL CAPABILITIES Special Capabilities: Engineering Studies / Plant Optimization Batch Reactor Controls 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

stainless steel vessels Precise temperature,

and totalization for ph, DO & foam S88-compliant

16 SPECIAL CAPABILITIES: Batch Reactor Controls: Batch chemical reactor design Glass-lined steel and stainless steel vessels Precise temperature, pressure, & vacuum controls Accurate flow additions and totalization for ph, DO & foam S88-compliant batch control and recipe management. Data Historization and analysis tools

17 SPECIAL CAPABILITIES: Design of cgmp compliant systems: Test Protocols are written as specs are prepared GAMP Lifecycle Development Model (V-model) Members of the International Society of Pharmaceutical Engineers (ISPE) USER REQUIREMENTS Specifications are written in incre easing detail DESIGN QUALIFICATION / ENHANCED DESIGN REVIEWS FUNCTIONAL DESIGN DETAIL DESIGN Designs compliant with cgmp regs for Active Pharmaceutical Ingredients and Bulk Pharmaceuticals Designs compliant with 21 CFR Part 11 for storage & handling of electronic data. Process Designs and System Software, thoroughly documented and fully capable of being validated. PQ TEST PLAN OQ TEST PLAN IQ TEST PLAN IMPLEMENTATION INSTALLATION QUALIFICATION OPERATIONAL QUALIFICATION PERFORMANCE QUALIFICATION Test Protocols exe ecuted during Startup and Commi missioning

Hazardous Areas: Proficient in all aspects of

explosion-proof electrical methods Proficient in

18 SPECIAL CAPABILITIES: Design of Instrumentation/Control t ti t systems for use in Hazardous Areas: Proficient in all aspects of intrinsically safe, non-incendive, and explosion-proof electrical methods Proficient in design of X-, Y-, and Z-type purged enclosures for maintaining electrical safety. Active membership in NFPA and ISA All systems designed to be fully compliant with applicable standards published by the NEC, CEC, IEC.

19 SPECIAL CAPABILITIES: Design of Safety Instrumented Systems: Perform Risk Analysis using Process Hazard Analysis techniques: HAZOP, FEMA, Event Tree Analysis. Select Safety Integrity Level to meet a specific Probability of Failure on Demand. Design Safety-Instrumented System to provide required levels of risk reduction in the most cost-efficient i t manner possible. Likeliho ood of Proc cess Hazard PROCESS EXAMPLE: Uncontrolled Release of Flammable Liquid due to Over-Pressurization and Rupture of Tank lihood High Likel Low Likelihoo od SIS Risk Reduction via SIL-3-SIF Baseline Risk after Non-SIS mitigation SIS Risk Reduction via SIL-1-SIF SIS Risk Reduction via SIL-2-SIF Acceptable Risk Region Low Severity Risk Value = 10 Non-SIS Consequence Reduction e.g. Containment Wall Risk Value = 100 Risk Value = 1,000 Initial Process Risk with no mitigation Risk Value = 10,000 Non-SIS Likelihood Reduction e.g. Relief Valves High Severity Consequence of Process Hazard Unacceptable Risk Region

20 THANK YOU! Process Control & Automation Revision West Ave Suite 320 Rochester, NY (585) Phone (877) Toll Free(585) FAX com Revision Date: Jan, 2015

Addressing Challenges in HIPPS Design and Implementation

Addressing Challenges in HIPPS Design and Implementation Valve Manufacturer s Association Afton Coleman, CFSP March 11, 2016 Agenda SIS and SIL basics HIPPS Purpose Increased demand for HIPPS, why? The