SUP3803–Vol8Issue1 7/29/03 11:16 AM Page 3 THE ...VOLUME 8 ISSUE 1 BioPharma Services Expanding...
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THE SUPERIOR CONTROLLER VOLUME 8 ISSUE 1 BioPharma Services Expanding The Superior Controller is published by Superior Controls, Inc. of Plaistow, NH—the leading con- trols system integrator specializing in the design and implementation of industrial automation and information systems. The purpose of this newsletter is to present project examples to our customers. Your comments are welcome. Write or Fax: TM Continued on page 3. Major LNG Terminal Automated Superior Controls engineers are currently involved in starting up a Maryland-based, liquid natural gas (LNG) terminal with two off- shore loading platforms located 1.25 miles off the coast in Chesapeake Bay. The Cove Point, Maryland, terminal was deactivated in the late 70s and is now being reactivated due to current prices and demands for natural gas. The facility contains four 375,000-barrel LNG storage tanks on shore and is connected by a three-section tunnel to both the north and south offshore loading platforms. Each platform can unload an LNG tanker. After the LNG is pumped to the onshore facility, it is vaporized using ten hot water For ten years Superior Controls has been automating biotech and pharmaceutical facilities. Typically, this meant providing the design and implementation of PLC- and DCS-based systems, control panels, MMIs, databases, validation documentation, start-up, and on-site IQ/OQ assistance. But in the past couple of years, Superior Controls has been providing something more:electrical and mechanical installation and 21CFR Part 11 Gap Analysis. Several biotech companies have hired Superior Controls to review their existing automation systems and documentation to determine if their electronic records and signatures are compliant with the FDA’s 21CFR Part 11 ruling. The result is a report or “Gap Analysis” which lists the deficiencies of each automated system. Likewise, many biotech companies have requested that Superior Controls provide a complete turnkey installation, including electrical and mechanical installation with IQ and OQ validation of their entire automation system.Working with several reputable electrical/mechanical contractors, Continued on page 2. Superior Controls P.O. Box 977 ■ Plaistow, NH 03865 (603) 382-2000 ■ Fax (603) 382-0122 e-mail: [email protected] www.superiorcontrols.com © 1998 Superior Controls, Inc. The Superior Controller & S logo are trademarks of Superior Controls. SUP3803–Vol8Issue1 7/29/03 11:16 AM Page 3
Transcript of SUP3803–Vol8Issue1 7/29/03 11:16 AM Page 3 THE ...VOLUME 8 ISSUE 1 BioPharma Services Expanding...
THE SUPERIOR CONTROLLERVOLUME 8 ISSUE 1
BioPharma ServicesExpanding
The Superior Controller is published by SuperiorControls, Inc. of Plaistow, NH—the leading con-
trols system integrator specializing in thedesign and implementation of industrial
automation and information systems.The purpose of this newsletter is to present
project examples to our customers. Your comments are welcome. Write or Fax:
TM
Continued on page 3.
Major LNG TerminalAutomated
Superior Controls engineers are currentlyinvolved in starting up a Maryland-based,liquid natural gas (LNG) terminal with two off-shore loading platforms located 1.25 miles offthe coast in Chesapeake Bay. The Cove Point,Maryland, terminal was deactivated in the late70s and is now being reactivated due to currentprices and demands for natural gas.
The facility contains four 375,000-barrel LNGstorage tanks on shore and is connected by athree-section tunnel to both the north and southoffshore loading platforms. Each platform canunload an LNG tanker.
After the LNG is pumped to the onshorefacility, it is vaporized using ten hot water
For ten years Superior Controls has beenautomating biotech and pharmaceuticalfacilities. Typically, this meant providing thedesign and implementation of PLC- andDCS-based systems, control panels, MMIs,databases, validation documentation, start-up,and on-site IQ/OQ assistance.
But in the past couple of years, SuperiorControls has been providing somethingmore:electrical and mechanical installation and21CFR Part 11 Gap Analysis.
Several biotech companies have hiredSuperior Controls to review their existingautomation systems and documentation todetermine if their electronic records andsignatures are compliant with the FDA’s 21CFRPart 11 ruling. The result is a report or “GapAnalysis” which lists the deficiencies of eachautomated system.
Likewise, many biotech companies haverequested that Superior Controls provide acomplete turnkey installation, includingelectrical and mechanical installation with IQand OQ validation of their entire automationsystem.Working with several reputableelectrical/mechanical contractors,
Continued on page 2.
Superior ControlsP.O. Box 977 ■ Plaistow, NH 03865
(603) 382-2000 ■ Fax (603) 382-0122 e-mail: [email protected]
www.superiorcontrols.com© 1998 Superior Controls, Inc. The Superior Controller & S logo are trademarks of Superior Controls.
SUP3803–Vol8Issue1 7/29/03 11:16 AM Page 3
Biotech Automation Projects – Third Quarter, 2002
THE SUPERIOR CONTROLLER
GAMP4 Validation &Project Hardware MMI Software 21CFR11 Compliance
CIP AB - SLC 5/05 PanelView GAMP4 OnlyBAS Modicon - Momentum iFIX YesFermentation Reactor AB - PLC5 iFIX YesSpray Dryer AB - ControLogix RSView SE YesBAS Data Acquisition Modicon/Johnson iFIX YesBAS Andover Controls iFIX YesBAS Invensys iFIX YesBAS Johnson Metasys iFIX YesBatching AB - ControLogix iFIX YesBatching AB - PLC5 Wonderware YesBatching AB - SLC 5/05 RSView 32 YesMedia\Buffer Prep Siemens S7 iFIX/SQL YesHarvest & UF Siemens S7 iFIX/SQL YesWeb Line AB - ControLogix RSView SE YesWeb Enabled Reporting DeltaV HTML YesHPLC AB - ControLogix iFIX YesUltra Filtration Siemens S7 iFIX YesCarboy Washer AB - SLC5 PanelView GAMP4 OnlyWaste Water Treatment AB - SLC 5/05 PanelView GAMP4 OnlyUtility Monitoring AB - PLC5 iFIX/Oracle YesUtility Monitoring AB, Andover Controls iFIX/SQL YesSeparation Process AB - ControLogix iFIX/SQL YesWFI - TOC AB-Various iFIX/SQL YesAir Lock Control AB - PLC5 iFIX YesDowntime Tracking AB Wonderware YesAutoclaves AB ControLogix iFIX YesPurification - HPLCs DeltaV DeltaV YesWFI Moore Procidia More iStation YesPlantwide 21CFR
Part 11 Evaluation Yes
KeyWFI - Water for InjectionCIP - Clean in PlaceBAS - Building Automation SystemHPLC - High Pressure Liquid
ChromatographyGAMP4 - Good Automation Manufacturing
Procedures (Ver. 4)21CFR Part 11 - Electronic
Records/Signatures ComplianceRequirements
IQ/OQ - Installation Qualification,Operation Qualification
BioPharma Services Expanding, continued from page 1Superior Controls has been successfully installing these systems, somevalued at more than $2 million.
The list above is a snapshot of the biotech projects beingimplemented during this past quarter. Included are their respectivehardware/software solutions, and validation requirements. Theseprojects range in cost from $40K to $1.8M. They range in size from 56 tomore than 10,000 I/O points, and they range in implementationschedule from eight weeks to 12 months. All of these projects have alsoone thing in common: GAMP4.
GAMP4 or Good Automated Manufacturing Procedures (Ver. 4) areproject methodologies and validation documentation requirementsspecifically for biotech/pharmaceutical automation/informationprojects. During the past 10 years, Superior Controls has developedquick and efficient project implementation strategies to comply withGAMP. We are proud of our project methodologies and publish themopenly on our website. Please visit superiorcontrols.com if GAMP4 is ofinterest to you.
SUP3803–Vol8Issue1 7/29/03 11:16 AM Page 4
THE SUPERIOR CONTROLLER
Pierro Receives Distinguished Engineering Award
THE PEOPLE WHO ARE SUPERIOR CONTROLS
Rick Pierro, president of Superior Controls, was the recipient ofthe Francis Academy of Distinguished Engineers Award at a May 2awards banquet. The University of Mass-Lowell Francis College ofEngineering presents this award annually to outstanding alumni.
Rick received his Masters in Chemical Engineering from UMass-Lowell in 1983 and has been an active member of the College ofEngineering Industrial Advisory Board for the past three years.
Superior Controlsengineers recentlyenjoyed fresh air andsunshine while deep seafishing in August.
Rick Pierro receives Distinguished EngineeringAward from Krishna Vedula, Dean of UMASS-Lowell College of Engineering.
Friends,customers, andempolyees ofSupierior Controlscelebrate at theaward ceremony.
When They’re Not at Work . . .
Major LNG Terminal Automated,continued from page 1
liquifiers and compressed up to 1200 PSIG. It isthen pumped into the pipeline as needed.
Approximately 4500 field instruments andactuated devices are being controlled by an ABBDistributed Control System. The majority of theI/O points are hardwired directly to DCS drops.I/O located in the teo tunnels use FoundationField Bus.Satellite view of the Cove Point, Maryland, LNG facilityand its offshore loading platforms.
SUP3803–Vol8Issue1 7/29/03 11:16 AM Page 5
Superior Controls, Inc.P.O.Box 977
Plaistow, NH 03865
In This IssueMajor LNG Terminal Automated■BioPharma Services Expanding■Pierro Receives Award
TM
Team Superior Victorious—How Sweet It Is!For the eighth year in a row, Superior Controls
entered a team of our fleet-footed engineers in theCIGNA Corporate 5K (3.1 miles) Road Race inManchester, NH, to benefit the Special Olympics.
We are proud to claim victory over our friendlyrivals, Horizon, a NH-based electrical distributor,for the second year in a row. Some attributeSuperior Controls’ win to the two dozen DunkinDoughnuts that were sent by Superior Controls tothe Horizon Team the day before the race. But thecheers of the crowd drowned out the critics asSuperior Controls reclaimed the trophy for anotheryear.
Our top five finishers, from first to fifth were JoeGordon, Chris Krajenka, Ron Pierro, Bryan Graham,and Rick Pierro.
Congratulations to all!
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