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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
CONTROLLER QUALIFICATION PROTOCOL FOR
CIP / SIP CONTROL SYSTEM
The attached protocol has been approved for format/content and is acceptable for execution.
The attached protocol has been completed, the results reviewed and found to be acceptable.
Prepared By: Date: I.Q. Corporation
Format Approval Content Approval ENGINEERING: SIGNATURE P. PIPER Date: PRINT
ENGINEERING: SIGNATURE P. PIPER Date: PRINT
QUALITY ASSURANCE: SIGNATURE D. NAMED Date: PRINT
QUALITY ASSURANCE: SIGNATURE D. NAMED Date: PRINT
PRODUCTION: SIGNATURE D. NAMED Date: PRINT
PRODUCTION: SIGNATURE D. NAMED Date: PRINT
REGULATORY: SIGNATURE S. NAMED Date: PRINT
REGULATORY: SIGNATURE S. NAMED Date: PRINT
SAMPLE Page 1 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
TABLE OF CONTENTS
1.0 Purpose
2.0 Scope
3.0 Responsibil it ies
4.0 References
5.0 System/Equipment Description
6.0 Rationale
7.0 Procedure
7.1 Controller Qualif ication
7.2 Acceptance Criteria
8.0 Abbreviations
SAMPLE Page 2 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
1.0 PURPOSE
The purpose of this Controller Qualif ication (CQ) Protocol is to verify that the CIP/SIP Control System is installed in accordance with design specifications, manufacturer's recommendations, and applicable vendor/engineering drawings.
2.0 SCOPE
This Controller Qualif ication Protocol wil l be performed on the CIP/SIP Control System, located in Building 88.
3.0 RESPONSIBILITIES
3.1 The Validation Department has overall responsibil ity for the execution of the Validation Program and scheduling of the validation activit ies.
3.2 The Maintenance/Engineering Manufacturing and QA Validation Departments are responsible for provisions of all applicable standard operating procedures (SOPs).
3.3 The Manufacturing/Maintenance Department has responsibil ity for providing the required operators, materials and test equipment for the operation and validation of the system.
3.4 The Validation Committee is responsible for the review of the Qualif ication Protocol for format, content and acceptabil ity approval for execution.
4.0 REFERENCES
4.1 Engineering, validation and manufacturer's documents and drawings used to develop and execute the Controller Qualification Protocol are l isted on the following forms:
4.1.1 Drawings
4.1.2 Manuals
4.1.3 Specifications
4.1.4 Procedures
SAMPLE Page 3 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
5.0 SYSTEM/EQUIPMENT DESCRIPTION
This protocol addresses the Big Pharma CIP/SIP Control System for Building 88. The primary function of the CIP/SIP Control System is to perform the sequencing required to clean the different process piping and equipment in the Big Pharma 88 building. The correct sequencing is verif ied through the use of feedback limit switches on each value and device. CIP/SIP process data is printed on Kaye Digistrip recorders located in each process area. The process data is directly transmitted, as an analog signal, from each instrument to each kaye channel.
5.1 The control system contains three primary hardware subsystems:
A. PLC Subsystem
B. Main Operator Control Station
C. Remote Operator Control Station
5.1.1 The PLC Subsystem contains the primary processing power for the entire system. The other subsystems communicate directly to the PLC Subsystem but cannot operate without it. The PLC Subsystem is directly responsible for the execution of all CIP/SIP logic The components of the PLC Subsystems are as follows:
A. PLC 5/40 Programmable logic controller located in panel CP-01 on the Powerhouse.
B. Action Instruments control coprocessor. This industrial 386 PC handles communication with the Nematron Remote Operator Control Stations and the Thornton Instrument Network. It is located in panel CP-01 on the Powerhouse.
C. Instrumentation: The majority of the input sensors are Thornton instruments. They measure flow, conductivity, temperature and levels. The Thornton 770 PCs are devices which can process four different measurements simultaneously. Each of the 770 PCs transmitters is connected to a two wire local area network (LAN) called T-NET. There are two separate T-NETS within the plant. The instrument readings are digitized and transmitted over these T-NETs to the control coprocessor. The data is then written to the PLC as scaled, floating point values. The few inputs that are not from the Thornton network are wired directly to the PLCs analog input modules. These instrumentation devices are located throughout the plant.
SAMPLE Page 4 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
D. An I/O Subsystem including:
1. Allen Bradley Digital Input/Output Modules
2. Allen Bradley Analog Input/Output Modules
3. SMC Solenoid Valve Banks: These are outputs on the Allen Bradley remote I/O network.
These devices are located throughout the plant.
E. CIP Batch Printer: A single, serial, dot matrix, printer is connected to both the Main Operator Control Station and the Control Coprocessor. It records CIP events as they occur. It is located in panel CP-22 on the Powerhouse.
5.1.2 The Main Operator Control Station Subsystem is located in CP-01 on the Powerhouse. It consists of an Allen Bradley Panelview, model 2711-KCI. This station is primarily for giving the operator an overall look at the system status. Graphic displays provide information on the status of devices being used by the system. No CIP devices can be controlled from this station. It is for monitoring only.
5.1.3 The Remote Operator Control Station Subsystem consists of four Nematron 120 industrial terminals. There is one located in:
A. Suite 100
B. Suite 200
C. Suite 300
D. Suite 400
The Remote Operator Control Stations are the primary interface between the operator and the central system. It is from these consoles that automated cleaning sequences are selected and started. The Remote Operator Control Stations also provide information about the progress of a cleaning sequence.
SAMPLE Page 5 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
6.0 RATIONALE
Where appropriate, testing will be conducted at the field devices and at the PLC to insure proper system functioning. Testing should not be conducted at field devices when equipment or personnel safety could be compromised.
7.0 PROCEDURE
7.1 CONTROLLER QUALIFICATION
7.1.1 The specific requirements for the Controller Qualif ication are provided on the following forms entit led Controller Qualif ication. These data forms have been developed to provide completeness, consistency and accuracy of data collection and inspection required.
7.1.2 The primary purpose of the Controller Qualif ication is to run the process equipment and control systems through its paces and carefully test and document related activit ies. Document operational inspections and test results with black, indelible ink, ball-point pen on the forms incorporated or attached to this protocol. Unless instructed by the protocol, test and operational steps may be performed out of sequence.
7.1.3 Testing performed by a third party approved by Big Pharma is acceptable. The results shall be affixed to the appropriate attachment as directed by the protocol.
7.1.4 Proper completion and review of the Controller Qualif ication forms by a second, independent validation person will constitute completion of the Controller Qualif ication activity.
7.1.5 CONTROLLER QUALIFICATION TEST METHODOLOGY: The installation data sheets will contain but not be limited to the following document forms:
A. Controller Qualif ication Prerequisites
B. Purchase Order Inspection
C. Programmable Logic Controller Verification
D. Ancil lary System Specification Verification
E. Hardware Configuration Verification -Jumpers
F. Input/Output List and Points Verification
G. Major Hardware Component Verification
SAMPLE Page 6 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
H. Util it ies - Electrical
I. Supply Voltage and Circuit Protection Verification
J. Software Component Verification
K. Software Application Code Verification
L. Security Code Test
M. Functional Test Verification
N. Alarm Verification
O. Power Failure Test
P. Environmental Operating Parameters Verification
Q. Test Equipment
R. Drawings
S. Spare Parts List
T. Manuals
U. Standard Operating Procedures
V. Amendment(s) and Deviation(s)
W. Summary and Conclusions
SAMPLE Page 7 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
7.2 ACCEPTANCE CRITERIA
The Acceptance Criteria are the specific set of standards or design specifications that each piece of equipment or system must meet in order to demonstrate a high level of confidence that the system/equipment is capable of consistently operating within established limits or tolerances.
Acceptance Criteria for Controller Qualification (CQ) may include, but is not limited to, the following requirements: Instrumentation: Verification that the controllers and components are appropriately identif ied
and installed according to manufacturers specifications. Verification that all configurable switches and jumpers are documented for
baseline information. Verification that wiring of the control system hardware components to the
field devices have been properly identif ied and functional per specified drawings.
Verification that the input and outputs modules are properly installed per specified drawings.
Verification that the ancil lary control system(s) and association components have been properly installed and identif ied per specified drawings.
Utilities: Verification that the supplied uti l i t ies meet the vendors specified
requirements. Verification that the individual system components are supplied with uti l i t ies
that meet the vendors specified requirements. Verification that the circuit protection devices are installed and identif ied per
specified drawings. Security: Verification that the program security functions as specified by the vendor.
Software: Verification that the application software is the specified revision and that
any subsequent changes made are supported by Change Control SOP 214.
SAMPLE Page 8 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
Verification that the application code currently operating in the controller is in a controlled and secured fi le location in both hard copy and computer disk form.
Verification that the application code is properly annotated and all input and
output software variables have a unique point descriptor assigned to the point.
Drawings and Manuals:
Verification that current drawings and applicable manuals, such as vendor
installation, operation and maintenance manuals, are properly documented and are accessible to the appropriate personnel.
Functional: Verification that the control system operates as designed and in accordance
with the application software and applicable manufacturers specifications. Alarm and Interlocks: Verification that all f ield device alarms and interlocks are properly identif ied,
function as specified, and where applicable the appropriate response is observed.
Power Failure: Verification that the CPU and operator interface modules do not experience
a failure due to the removal of power. Verification that during the Power Failure test, all devices default to a fail-
safe mode. Verif ication that when power is restored, the CPU restarts the program
safely, or returns to an initial condition from which the operator can restart the operation, and the operator interface panel recovers from the power failure and is fully functional.
Environment: Verification that the environmental conditions for the control system
components are documented and that the temperature and relative humidity are within the manufacturer's specification.
SAMPLE Page 9 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
8.0 ABBREVIATIONS
A Ampere mg Mill igram AC Air conditioning mHz Mill ihertz A/C Alternating Current MHz Megahertz amp Ampere, also A mm Mill imeter atm Atmosphere mmHg Conventional mill imeter of
mercury BTU British Thermal Units kVA Kilovolt ampere C Degree Celsius cfm Cubic feet per minute NBS National Bureau of
Standards cGMP Current Good Manufacturing
Practices NIST National Institute of
Standards & Technology cfu Colony forming unit N.V. Not Visible - requires
disassembly CQ Controller Qualif ication OD Outside diameter DPU Distributed process units ohm/ The SI unit of electrical
resistance e.g., For example; such as OK Okay F Degree Fahrenheit OQ Operational Qualif ication ft./min. Feet per minute P&ID Piping and Instrumentation
Diagram GMP Good Manufacturing Practices PH Phase (3 PH) gph Gallons per hour psf Pounds per square foot gpm Gallons per minute psi Pounds per square inch HEPA High efficiency particulate air psig Pounds per square inch,
gauge hp Horsepower RH Relative humidity hr. Hour rpm Revolutions per minute Hz Hertz RTD Resistance temperature
detection i.e., That is s Second in Inch SOP Standard Operating
Procedures IQ Installation Qualif ication sq. ft. or
SF Square feet or foot
k Kilo SS Stainless steel kg Kilogram Micro kV Kilovolt g Microgram kW Kilowatt V Volt (240 V) kWh Kilowatt-hour W Watt l Liter w.c. Water closet (Arch.) Or
water column (Mech.) lb Pound (avoirdupois) WIF Weld Inspection Form m Meter or mill i WFI Water for Injection mb Mill ibar W.G. Wire gage mfg. Manufacturing w.g. Water gauge
SAMPLE Page 10 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
CONTROLLER QUALIFICATION PREREQUISITES Before execution of Controller Qualification (CQ) Activities, the following prerequisites must be addressed and found acceptable and approved by Big Pharma.
Prerequisites Verified By / Date System has been transferred from construction and start-up is completed.
Construction Punch List and/or deviations documents have been checked and approved by Big Pharma for continuation in system completion.
Software specifications relative to the Controller System of the machine are available.
Instrument Index has been reviewed and updated to reflect current purchased/existing instruments
Current revisions to reference documents and/or drawing have been verified.
Reference documents and/or drawings are available, or assignment to procure them has been documented on System Punch List.
Prerequisites are completed and reviewed prior to execution of Controller Qualification.
______________________________________The Protocol Executor SIGNATURE/DATE
______________________________________Big Pharma SIGNATURE/DATE
SAMPLE Page 11 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
PURCHASE ORDER INSPECTION Verify that the specified component is supplied and installed in accordance with specifications and options indicated by their respective purchase orders. If a purchase order is not available, refer to applicable drawings such as engineering drawings.
Equipment Name: Manufacturer: Equipment ID No.: Model No.: Serial No.: Verified By: Location: Purchase Order: Verified By: Equipment Status (CIRCLE ONE): New Transferred/Used Location of Purchase Order: Equipment Supplied and Installed per Purchase Order: (Yes / No): COMMENTS:
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 12 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
PROGRAMMABLE LOGIC CONTROLLER VERIFICATION
Controller Tag ID No.: PLC CIP Controller Description: Allen Bradley PLC-5 Programmable Logic Controller
Verify the following information about the controller to ensure that it is installed in accordance with design specification.
Installation Verification Items Specified Actual Manufacturer Allen-Bradley Model No. PLC 5/40 Serial No. Not Specified Location CP-01 NEMA Rating Not Specified UL Rated (Yes / No) Yes (UL listed CSA Approved) Number of Inputs Connected 459 used out of 504 available Number of Outputs Connected 91 used out of 124 available Processor Unit, Slot 0 / Cat. No. 1785-L40B 1 Rack 0, Group 0 Spare slot Rack 0, Group 1 Spare slot Rack 0, Group 2 Spare slot Rack 0, Group 3 Spare slot Rack 0, Group 4 Spare slot Rack 0, Group 5 Spare slot Reference Documents Name and No.:
IQC Dwg ESO493-05.B07 Sheet 3 of 23 Enhanced Ethernet PLC5 Programmable controllers users manual (AB #1785-6.5-12)
COMMENTS: 1 Contains the capacity for 48K of programming instructions. 2 CP-01 is on Powerhouse.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 13 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
PROGRAMMABLE LOGIC CONTROLLER VERIFICATION (CONTD)
Controller Tag ID No.: PLC CIP Controller Description: Allen Bradley PLC-5 Programmable Logic Controller
Verify the following information about the controller to ensure that it is installed in accordance with design specification.
Installation Verification Items Specified Actual Rack 0, Group 6 Spare slot Rack 0, Group 7 Spare slot Rack 1, Group 0 Spare slot Rack 1, Group 1 Spare slot Rack 1, Group 2 Spare slot Rack 1, Group 3 Spare slot Rack 1, Group 4: Analog Output Module 4 Analog Output Module
Model 1771-OFE2
Rack 1, Group 5: Analog Output Module 4 Analog Output Module Model 1771-OFE2
Rack 1, Group 6: Analog Output Module 4 Analog Output Module Model 1771-OFE2
Rack 1, Group 7: Analog Input Module 8 Analog Input Module Model 1771-IFE
Reference Documents Name and No.: IQC Dwg No. ES0493-05.B7 Sheet 3 of 23 1771-IFE Analog Input Users Manual (AB #1771-6.5.90) 1771-OFE Analog Output Users Manual (AB #1771-6.5.30)
COMMENTS: 1 These modules are located in CP-01 on Powerhouse.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 14 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
PROGRAMMABLE LOGIC CONTROLLER VERIFICATION (CONTD)
Controller Tag ID No.: PLC CIP Controller Description: Allen Bradley PLC-5 Programmable Logic Controller
Verify the following information about the controller to ensure that it is installed in accordance with design specification.
Installation Verification Items Specified Actual Rack 2, Group 0: 16 Digital Input Module 1771-IBD Rack 2, Group 1: 16 Digital Input Module 1771-IBD Rack 2, Group 2: 16 Digital Input Module 1771-IBD Rack 2, Group 3: 16 Digital Input Module 1771-IBD Rack 2, Group 4: 16 Digital Input Module 1771-IBD Rack 2, Group 5: 16 Digital Input Module 1771-IBD Rack 2, Group 6 Spare slot Rack 2, Group 7 Spare slot Reference Documents Name and No.: IQC Dwg No. ES0493-05.B08
Sheet 4 of 23 1771-IBD 10-30VDC Input Module Installation Book (AB #1771-2.75) 1771-OBD 10-30VDC Output Module Installation Book (AB #1771-2.76)
COMMENTS: 1 These modules are located in CP-01 on Powerhouse. 2 This chassis also contains a remote I/O adapter, model 1771-ASB, in the leftmost slot.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 15 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
PROGRAMMABLE LOGIC CONTROLLER VERIFICATION (CONTD)
Controller Tag ID No.: PLC CIP Controller Description: Allen Bradley PLC-5 Programmable Logic Controller
Verify the following information about the controller to ensure that it is installed in accordance with design specification.
Installation Verification Items Specified Actual Rack 3, Group 0: 16 Digital Output Module 1771-OBD Rack 3, Group 1: 16 Digital Output Module 1771-OBD Rack 3, Group 2 Spare slot Rack 3, Group 3 Spare slot Rack 3, Group 4 Spare slot Rack 3, Group 5 Spare slot Rack 3, Group 6 Spare slot Rack 3, Group 7 Spare slot Reference Documents Name and No.: IQC Dwg No. ES0493-05.B08
Sheet 4 of 23 1771-OBD 10-30VDC Input Module Installation Book (AB #1771-2.76) 1771-ASB Users Manual (AB #1771-2.48)
COMMENTS: 1 These modules are located in CP-01 Powerhouse.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 16 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
PROGRAMMABLE LOGIC CONTROLLER VERIFICATION (CONTD)
Controller Tag ID No.: PLC CIP Controller Description: Allen Bradley PLC-5 Programmable Logic Controller
Verify the following information about the controller to ensure that it is installed in accordance with design specification.
Installation Verification Items Specified Actual Rack 4, Group 0: 16 Digital Input Module 1771-IBD Rack 4, Group 1: 16 Digital Input Module 1771-IBD Rack 4, Group 2: 16 Digital Input Module 1771-IBD Rack 4, Group 3: 16 Digital Input Module 1771-IBD Rack 4, Group 4: 16 Digital Input Module 1771-IBD Rack 4, Group 5: 16 Digital Input Module 1771-IBD Rack 4, Group 6: 16 Digital Input Module 1771-IBD Rack 4, Group 7: 16 Digital Input Module 1771-IBD Reference Documents Name and No.: IQC Dwg No. ES0493-05.C37
Sheet 3 of 44 1771-IBD 10-30VDC Input Module Installation Book (AB #1771-2.75) 1771-OBD 10-30VDC Input Module Installation Book (AB #1771-2.76) 1771-ASB Users Manual (AB #1771-2.48)
COMMENTS: 1 This chassis also contains remote I/O adapter module in the left most slot. Model #1771-ASB
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 17 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
PROGRAMMABLE LOGIC CONTROLLER VERIFICATION (CONTD)
Controller Tag ID No.: PLC CIP Controller Description: Allen Bradley PLC-5 Programmable Logic Controller
Verify the following information about the controller to ensure that it is installed in accordance with design specification.
Installation Verification Items Specified Actual Rack 5, Group 0: 16 Digital Input Module 1771-IBD Rack 5, Group 1: 16 Digital Input Module 1771-IBD Rack 5, Group 2: 16 Digital Input Module 1771-IBD Rack 5, Group 3: 16 Digital Input Module 1771-IBD Rack 5, Group 4: 16 Digital Output Module 1771-OBD Rack 5, Group 5: 16 Digital Output Module 1771-OBD Rack 5, Group 6 Spare slot Rack 5, Group 7: 8 Analog Input Module 1771-IFE Reference Documents Name and No.: IQC Dwg No. ES0493-05.C37
Sheet 3 of 44 1771-IBD 10-30VDC Input Module Installation Book (AB #1771-2.75) 1771-OBD 10-30VDC Input Module Installation Book (AB #1771-2.76) 1771-IFE Analog Input Users Manual (AB #1771-6.5.90)
COMMENTS: 1 These modules are located in Panel CP-01A,
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 18 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
PROGRAMMABLE LOGIC CONTROLLER VERIFICATION (CONTD)
Controller Tag ID No.: PLC CIP Controller Description: Allen Bradley PLC-5 Programmable Logic Controller
Verify the following information about the controller to ensure that it is installed in accordance with design specification.
Installation Verification Items Specified Actual Rack 6, Group 0: 16 Digital Input Module 1771-IBD Rack 6, Group 1: 16 Digital Input Module 1771-IBD Rack 6, Group 2: 16 Digital Input Module 1771-IBD Rack 6, Group 3: 16 Digital Input Module 1771-IBD Rack 6, Group 4: 16 Digital Input Module 1771-IBD Rack 6, Group 5: 16 Digital Input Module 1771-IBD Rack 6, Group 6: 16 Digital Input Module 1771-IBD Rack 6, Group 7: 16 Digital Input Module 1771-IBD Reference Documents Name and No.: IQC Dwg No. ES0493-05.C38
Sheet 4 of 44 1771-IBD 10-30VDC Input Module Installation Book (AB #1771-2.75)
COMMENTS: 1 These modules are located in Panel CP-01A, Mechanical Room 2 This chassis also contains a remote I/O adapter, model 1771-ASB, in the leftmost slot.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 19 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
PROGRAMMABLE LOGIC CONTROLLER VERIFICATION (CONTD)
Controller Tag ID No.: PLC CIP Controller Description: Allen Bradley PLC-5 Programmable Logic Controller
Verify the following information about the controller to ensure that it is installed in accordance with design specification.
Installation Verification Items Specified Actual Rack 7, Group 0: 16 Digital Input Module 1771-IBD Rack 7, Group 1: 16 Digital Output Module 1771-OBD Rack 7, Group 2: 16 Digital Output Module 1771-OBD Rack 7, Group 3 Spare Slot Rack 7, Group 4 Spare Slot Rack 7, Group 5 Spare Slot Rack 7, Group 6 Spare Slot Rack 7, Group 7: 8 Analog Input Module 1771-IFE Reference Documents Name and No.: IQC Dwg No. ES0493-05.C38
Sheet 4 of 44 1771-IBD 10-30VDC Input Module Installation Book (AB #1771-2.75) 1771-OBD 10-30VDC Output Module Installation Book (AB #1771-2.76) 1771-IFE Analog Input Users Manual (AB #1771-6.5.90)
COMMENTS: 1 These modules are located in Panel CP-01A, Mechanical Room
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 20 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
PROGRAMMABLE LOGIC CONTROLLER VERIFICATION (CONTD)
Controller Tag ID No.: PLC CIP Controller Description: Allen Bradley PLC-5 Programmable Logic Controller
Verify the following information about the controller to ensure that it is installed in accordance with design specification.
Installation Verification Items Specified Actual Rack 10, Group 0: 16 Digital Input Module 1771-IBD Rack 10, Group 1: 16 Digital Input Module 1771-IBD Rack 10, Group 2: 16 Digital Output Module 1771-OBD Rack 10, Group 3: 16 Digital Input Module 1771-IBD Rack 10, Group 4 Spare Slot Rack 10, Group 5 Spare Slot Rack 10, Group 6 Spare Slot Rack 10, Group 7 Spare Slot Reference Documents Name and No.: IQC Dwg No. ES0493-05.C39
Sheet 5 of 44 1771-IBD 10-30VDC Input Module Installation Book (AB #1771-2.75) 1771-OBD 10-30VDC Output Module Installation Book (AB #1771-2.76)
COMMENTS: 1 These modules are located in Panel CP-01A, Mechanical Room 2 This chassis also contains a remote I/O adapter, model 1771-ASB, in the leftmost slot. 3 NOTE - Because Allen Bradley uses octal numbering, racks 8 and 9 do not exist.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 21 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
PROGRAMMABLE LOGIC CONTROLLER VERIFICATION (CONTD)
Controller Tag ID No.: PLC CIP Controller Description: Allen Bradley PLC-5 Programmable Logic Controller
Verify the following information about the controller to ensure that it is installed in accordance with design specification.
Installation Verification Items Specified Actual Rack 11, Group 0 Spare Slot Rack 11, Group 1 Spare Slot Rack 11, Group 2 Spare Slot Rack 11, Group 3 Spare Slot Rack 11, Group 4 Spare Slot Rack 11, Group 5 Spare Slot Rack 11, Group 6 Spare Slot Rack 11, Group 7 Spare Slot Reference Documents Name and No.: IQC Dwg No. ES0493-05.C39
Sheet 5 of 44
COMMENTS: 1 These modules are located in Panel CP-01A, Mechanical Room
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 22 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY CONTROL SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents.
Installation Verification Items Designated Actual System Type: Operator Terminal Manufacturer: Allen-Bradley ID No.: Main OCS Model No.: Panelview 1200, 2711-KC1 Serial No.: IMOGN95SK Location: CP-01 Powerhouse NEMA Rating: NEMA type 4 UL Rated: (Yes / No) Yes Firmware Version: 5.0 Reference Documents: See below COMMENTS: 1 Planelview operator terminals users manual (AB#2711-812).
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 23 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents .
Installation Verification Items Specified Actual System Type: Operator Terminal Manufacturer: Nematron Controller Tag ID No.: CP-02 Model No.: IWS-120 Serial No.: Not Specified Location: CP-02 NEMA Rating: NEMA 4X UL Rated: (Yes / No) Yes Firmware Version: 2.00 Unit Rev: E Reference Documents: Nematron series 110/120
installation and terminal guide Doc. IWS-232.
COMMENTS: 1 This unit is configured as an RS-232 industrial terminal.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 24 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents .
Installation Verification Items Specified Actual System Type: Operator Terminal Manufacturer: Nematron Controller Tag ID No.: CP-03 Model No.: IWS-120 Serial No.: Not Specified Location: CP-03 NEMA Rating: NEMA 4X UL Rated: (Yes / No) Yes Firmware Version: 2.00 Unit Rev: E Reference Documents: Nematron series 110/120
installation and terminal guide Doc. IWS-232.
COMMENTS: 1 This unit is configured as an RS-232 industrial terminal.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 25 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents .
Installation Verification Items Specified Actual System Type: Operator Terminal Manufacturer: Nematron Controller Tag ID No.: CP-04 Model No.: IWS-120 Serial No.: Not Specified Location: CP-04 Suite 100 NEMA Rating: NEMA 4X UL Rated: (Yes / No) Yes Firmware Version: 2.00 Unit Rev: E Reference Documents: Nematron series 110/120
installation and terminal guide Doc. IWS-232.
COMMENTS: 1 This unit is configured as an RS-232 industrial terminal.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 26 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents .
Installation Verification Items Specified Actual System Type: Operator Terminal Manufacturer: Nematron Controller Tag ID No.: CP-05 Model No.: IWS-120 Serial No.: Not Specified Location: CP-05 Suite 200 NEMA Rating: NEMA 4X UL Rated: (Yes / No) Yes Firmware Version: 2.00 Unit Rev: E Reference Documents: Nematron series 110/120
installation and terminal guide Doc. IWS-232.
COMMENTS: 1 This unit is configured as an RS-232 industrial terminal.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 27 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents .
Installation Verification Items Specified Actual System Type: Operator Terminal Manufacturer: Nematron Controller Tag ID No.: CP-TT-07 Model No.: IWS-120 Serial No.: Not Specified Location: CP-TT-07 Suite 300 NEMA Rating: NEMA 4X UL Rated: (Yes / No) Yes Firmware Version: 2.00 Unit Rev: E Reference Documents: Nematron series 110/120
installation and terminal guide Doc. IWS-232.
COMMENTS: 1 This unit is configured as an RS-232 industrial terminal.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 28 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents .
Installation Verification Items Specified Actual System Type: Operator Terminal Manufacturer: Nematron Controller Tag ID No.: CP-07 Model No.: IWS-120 Serial No.: Not Specified Location: CP-07 Suite 400 NEMA Rating: NEMA 4X UL Rated: (Yes / No) Yes Firmware Version: 2.00 Unit Rev: E Reference Documents: Nematron series 110/120
installation and terminal guide Doc. IWS-232.
COMMENTS: 1 This unit is configured as an RS-232 industrial terminal.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 29 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents .
Installation Verification Items Specified Actual System Type: Industrial Computer Manufacturer: Action Instruments Controller Tag ID No.: Not Specified Model No.: CMPC-5BOXPC Serial No.: A316J Location: CP-01 Powerhouse NEMA Rating: Not Specified UL Rated: (Yes / No) Yes COMMENTS:
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 30 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents .
Installation Verification Items Specified Actual System Type: Microprocessor Recorder Manufacturer: Kaye Controller Tag ID No.: CP-02 Model No.: Digistrip 4S Plus Serial No.: Not Specified Location: NEMA Rating: Not Specified UL Rated: (Yes / No) Not Specified Firmware Version Not Specified Reference Documents: Kaye Digi 4S Plus users guide COMMENTS: 1 This recorder is used to monitor both CIP/SIP parameters and process parameters.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 31 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents .
Installation Verification Items Specified Actual System Type: Microprocessor Recorder Manufacturer: Kaye Controller Tag ID No.: CP-05 Model No.: Digistrip 4S Plus Serial No.: Not Specified Location: Suite 200 NEMA Rating: Not Specified UL Rated: (Yes / No) Not Specified Firmware Version Not Specified Reference Documents: Kaye Digi 4S Plus users guide COMMENTS: 1 This recorder is used to monitor both CIP/SIP parameters and process parameters.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 32 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents .
Installation Verification Items Specified Actual System Type: Microprocessor Recorder Manufacturer: Kaye Controller Tag ID No.: Model No.: Digistrip 4S Plus Serial No.: Not Specified Location: Suite 300 NEMA Rating: Not Specified UL Rated: (Yes / No) Not Specified Firmware Version Not Specified Reference Documents: Kaye Digi 4S Plus users guide COMMENTS: 1 This recorder is used to monitor both CIP/SIP parameters and dispatch parameters.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 33 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents .
Installation Verification Items Specified Actual System Type: Microprocessor Recorder Manufacturer: Kaye Controller Tag ID No.: CP-40 Model No.: Digistrip 4S Plus Serial No.: Not Specified Location: Suite 400 NEMA Rating: Not Specified UL Rated: (Yes / No) Not Specified Firmware Version Not Specified Reference Documents: Kaye Digi 4S Plus users guide COMMENTS: 1 This recorder is used to monitor CIP/SIP and Lyo parameters.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 34 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents .
Installation Verification Items Specified Actual System Type: Microprocessor Recorder Manufacturer: Kaye Controller Tag ID No.: CP-22 Model No.: Digistrip 4S Plus Serial No.: Not Specified Location: Powerhouse NEMA Rating: Not Specified UL Rated: (Yes / No) Not Specified Firmware Version Not Specified Reference Documents: Kaye Digi 4S Plus users guide COMMENTS: 1 This recorder is used to monitor only CIP/SIP parameters.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 35 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents .
Installation Verification Items Specified Actual System Type: Solenoid Bank Manufacturer: SMC Controller Tag ID No.: Rack 10, Group 0 Model No.: IN313-AB1 Serial No.: Not Specified Location: CP-S-04 NEMA Rating: Not Specified UL Rated: (Yes / No) Not Specified Reference Documents: COMMENTS: 1 This device is connected to the CIP PLC 5/40 via a remote I/O link. The device is directly addressed as 0:100/0-15.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 36 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents .
Installation Verification Items Specified Actual System Type: Solenoid Bank Manufacturer: SMC Controller Tag ID No.: Rack 12, Group 0 Model No.: IN313-AB1 Serial No.: Not Specified Location: CP-S-08, NEMA Rating: Not Specified UL Rated: (Yes / No) Not Specified Reference Documents: COMMENTS: 1 This device is connected to the CIP PLC 5/40 via a remote I/O link. The device is directly addressed as 0:120/0-15.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 37 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents .
Installation Verification Items Specified Actual System Type: Solenoid Bank Manufacturer: SMC Controller Tag ID No.: Rack 12, Group 2 Model No.: IN313-AB1 Serial No.: Not Specified Location: CP-S-08, Area NEMA Rating: Not Specified UL Rated: (Yes / No) Not Specified Reference Documents: COMMENTS: 1 This device is connected to the CIP PLC 5/40 via a remote I/O link. The device is directly addressed as 0:122/0-15.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 38 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents . .
Installation Verification Items Specified Actual System Type: Solenoid Bank Manufacturer: SMC Controller Tag ID No.: Rack 12, Group 4 Model No.: IN313-AB1 Serial No.: Not Specified Location: CP-S-09 NEMA Rating: Not Specified UL Rated: (Yes / No) Not Specified Reference Documents: COMMENTS: 1 This device is connected to the CIP PLC 5/40 via a remote I/O link. The device is directly addressed as 0:124/0-15.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 39 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents .
Installation Verification Items Specified Actual System Type: Solenoid Bank Manufacturer: SMC Controller Tag ID No.: Rack 12, Group 6 Model No.: IN313-AB1 Serial No.: Not Specified Location: CP-S-10, Powerhouse NEMA Rating: Not Specified UL Rated: (Yes / No) Not Specified Reference Documents: COMMENTS: 1 This device is connected to the CIP PLC 5/40 via a remote I/O link. The device is directly addressed as 0:126/0-15
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 40 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents .
Installation Verification Items Specified Actual System Type: Solenoid Bank Manufacturer: SMC Controller Tag ID No.: Rack 14, Group 0 Model No.: IN313-AB1 Serial No.: Not Specified Location: CP-S-01 NEMA Rating: Not Specified UL Rated: (Yes / No) Not Specified Reference Documents: COMMENTS: 1 This device is connected to the CIP PLC 5/40 via a remote I/O link. The device is directly addressed as 0:140/0-15.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 41 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents .
Installation Verification Items Specified Actual System Type: Solenoid Bank Manufacturer: SMC Controller Tag ID No.: Rack 14, Group 2 Model No.: IN313-AB1 Serial No.: Not Specified Location: CP-S-01 NEMA Rating: Not Specified UL Rated: (Yes / No) Not Specified Reference Documents: COMMENTS: 1 This device is connected to the CIP PLC 5/40 via a remote I/O link. The device is directly addressed as 0:142/0-15.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 42 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents .
Installation Verification Items Specified Actual System Type: Solenoid Bank Manufacturer: SMC Controller Tag ID No.: Rack 14, Group 4 Model No.: IN313-AB1 Serial No.: Not Specified Location: CP-S-02 NEMA Rating: Not Specified UL Rated: (Yes / No) Not Specified Reference Documents: COMMENTS: 1 This device is connected to the CIP PLC 5/40 via a remote I/O link. The device is directly addressed as 0:144/0-15.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 43 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents .
Installation Verification Items Specified Actual System Type: Solenoid Bank Manufacturer: SMC Controller Tag ID No.: Rack 14, Group 6 Model No.: IN313-AB1 Serial No.: Not Specified Location: CP-S-02 NEMA Rating: Not Specified UL Rated: (Yes / No) Not Specified Reference Documents: COMMENTS: 1 This device is connected to the CIP PLC 5/40 via a remote I/O link. The device is directly addressed as 0:146/0-15.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 44 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents . .
Installation Verification Items Specified Actual System Type: Solenoid Bank Manufacturer: SMC Controller Tag ID No.: Rack 15, Group 0 Model No.: IN313-AB1 Serial No.: Not Specified Location: CP-S-03 NEMA Rating: Not Specified UL Rated: (Yes / No) Not Specified Reference Documents: COMMENTS: 1 This device is connected to the CIP PLC 5/40 via a remote I/O link. The device is directly addressed as 0:150/0-15.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 45 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents .
Installation Verification Items Specified Actual System Type: Solenoid Bank Manufacturer: SMC Controller Tag ID No.: Rack 16, Group 0 Model No.: IN313-AB1 Serial No.: Not Specified Location: CP-S-05 NEMA Rating: Not Specified UL Rated: (Yes / No) Not Specified Reference Documents: COMMENTS: 1 This device is connected to the CIP PLC 5/40 via a remote I/O link. The device is directly addressed as 0:160/0-15.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 46 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents .
Installation Verification Items Specified Actual System Type: Solenoid Bank Manufacturer: SMC Controller Tag ID No.: Rack 16, Group 2 Model No.: IN313-AB1 Serial No.: Not Specified Location: CP-S-05 NEMA Rating: Not Specified UL Rated: (Yes / No) Not Specified Reference Documents: COMMENTS: 1 This device is connected to the CIP PLC 5/40 via a remote I/O link. The device is directly addressed as 0:162/0-15.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 47 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents .
Installation Verification Items Specified Actual System Type: Solenoid Bank Manufacturer: SMC Controller Tag ID No.: Rack 16, Group 4 Model No.: IN313-AB1 Serial No.: Not Specified Location: CP-S-06 NEMA Rating: Not Specified UL Rated: (Yes / No) Not Specified Reference Documents: COMMENTS: 1 This device is connected to the CIP PLC 5/40 via a remote I/O link. The device is directly addressed as 0:164/0-15.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 48 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents .
Installation Verification Items Specified Actual System Type: Solenoid Bank Manufacturer: SMC Controller Tag ID No.: Rack 16, Group 6 Model No.: IN313-AB1 Serial No.: Not Specified Location: CP-S-07 NEMA Rating: Not Specified UL Rated: (Yes / No) Not Specified Reference Documents: COMMENTS: 1 This device is connected to the CIP PLC 5/40 via a remote I/O link. The device is directly addressed as 0:166/0-15.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 49 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents .
Installation Verification Items Specified Actual System Type: Instrument Network Transceiver Manufacturer: Thornton Controller Tag ID No.: Gateway 1, T-NET-2 Model No.: 770 PC Serial No.: Under front bezel Location: CP-TT-05 NEMA Rating: Not Specified UL Rated: (Yes / No) Not Specified Reference Documents: 770 Network Interface
Instruction Manual
COMMENTS: 1 Environmental operating specification: 32-122 F 2 Relative humidity specifications: 0-95% Non condensing 3 This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the printed circuit board. 4 The Thornton instrument network address for this device is 2:128
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 50 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents .
Installation Verification Items Specified Actual System Type: Process Controller / Temperature
Meter
Manufacturer: Thornton Controller Tag ID No.: TT-035/036 Model No.: 770 PC Serial No.: Under front bezel Location: CP-TT-05 NEMA Rating: Not Specified UL Rated: (Yes / No) Not Specified Reference Documents: 770 PC Process Controller
Instruction Manual PP.57-58
COMMENTS: 1 Environmental operating specification: 32-122 F. 2 Relative humidity specifications: 0-95% Non condensing. 3 This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the printed circuit board. 4 It has four individual software controlled set-points which can be set as a high or low limit. Any set-point can be programmed to operate one of two output relays. 5 The Thornton instrument network address for this device is 2:56.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 51 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents .
Installation Verification Items Specified Actual System Type: Process Controller / Temperature
Meter
Manufacturer: Thornton Controller Tag ID No.: TT-034/044 Model No.: 770 PC Serial No.: Under front bezel Location: CP-TT-05 NEMA Rating: Not Specified UL Rated: (Yes / No) Not Specified Reference Documents: 770 PC Process Controller
Instruction Manual PP.57-58
COMMENTS: 1 Environmental operating specification: 32-122 F. 2 Relative humidity specifications: 0-95% Non condensing. 3 This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the printed circuit board. 4 It has four individual software controlled set-points which can be set as a high or low limit. Any set-point can be programmed to operate one of two output relays. 5 The Thornton instrument network address for this device is 2:55.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 52 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents .
Installation Verification Items Specified Actual System Type: Process Controller /
Conductivity / Flow Meter
Manufacturer: Thornton Controller Tag ID No.: CIT-038 / TT-040 / FT-039 Model No.: 770 PC Serial No.: Under front bezel Location: CP-TT-05 NEMA Rating: Not Specified UL Rated: (Yes / No) Not Specified Reference Documents: 770 PC Process Controller
Instruction Manual PP.57-58
COMMENTS: 1 Environmental operating specification: 32-122 F. 2 Relative humidity specifications: 0-95% Non condensing. 3 This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the printed circuit board. 4 It has four individual software controlled set-points which can be set as a high or low limit. Any set-point can be programmed to operate one of two output relays. It has temperature compensation with automatic reference to 25 C conductivity. 5 The Thornton instrument network address for this device is 2:51.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 53 of 211
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BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents .
Installation Verification Items Specified Actual System Type: Process Controller /
Conductivity / Flow Meter
Manufacturer: Thornton Controller Tag ID No.: CIT-041 / TT-043 / FT-042 Model No.: 770 PC Serial No.: Under front bezel Location: CP-TT-05 NEMA Rating: Not Specified UL Rated: (Yes / No) Not Specified Reference Documents: 770 PC Process Controller
Instruction Manual PP.57-58
COMMENTS: 1 Environmental operating specification: 32-122 F. 2 Relative humidity specifications: 0-95% Non condensing. 3 This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the printed circuit board. 4 It has four individual software controlled set-points which can be set as a high or low limit. Any set-point can be programmed to operate one of two output relays. It has temperature compensation with automatic reference to 25 C conductivity. 5 The Thornton instrument network address for this device is 2:52.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 54 of 211
-
BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents .
Installation Verification Items Specified Actual System Type: Process Controller /
Conductivity Meter
Manufacturer: Thornton Controller Tag ID No.: CIT-048 / TT-047 Model No.: 770 PC Serial No.: Under front bezel Location: CP-TT-05 NEMA Rating: Not Specified UL Rated: (Yes / No) Not Specified Reference Documents: 770 PC Process Controller
Instruction Manual PP.57-58
COMMENTS: 1 Environmental operating specification: 32-122 F. 2 Relative humidity specifications: 0-95% Non condensing. 3 This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the printed circuit board. 4 It has four individual software controlled set-points which can be set as a high or low limit. Any set-point can be programmed to operate one of two output relays. It has temperature compensation with automatic reference to 25 C conductivity. 5 The Thornton instrument network address for this device is 2:53.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 55 of 211
-
BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents .
Installation Verification Items Specified Actual System Type: Process Controller / Temperature
Meter
Manufacturer: Thornton Controller Tag ID No.: TT-045/046 Model No.: 770 PC Serial No.: Under front bezel Location: CP-TT-05 NEMA Rating: Not Specified UL Rated: (Yes / No) Not Specified Reference Documents: 770 PC Process Controller
Instruction Manual PP.57-58
COMMENTS: 1 Environmental operating specification: 32-122 F. 2 Relative humidity specifications: 0-95% Non condensing. 3 This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the printed circuit board. 4 It has four individual software controlled set-points which can be set as a high or low limit. Any set-point can be programmed to operate one of two output relays. 5 The Thornton instrument network address for this device is 2:54.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 56 of 211
-
BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents .
Installation Verification Items Specified Actual System Type: Process Controller / Temperature
Meter
Manufacturer: Thornton Controller Tag ID No.: TT-625/626 Model No.: 770 PC Serial No.: Under front bezel Location: CP-TT-01 NEMA Rating: Not Specified UL Rated: (Yes / No) Not Specified Reference Documents: 770 PC Process Controller
Instruction Manual PP.57-58
COMMENTS: 1 Environmental operating specification: 32-122 F. 2 Relative humidity specifications: 0-95% Non condensing. 3 This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the printed circuit board. 4 It has four individual software controlled set-points which can be set as a high or low limit. Any set-point can be programmed to operate one of two output relays. 5 The Thornton instrument network address for this device is 2:11.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 57 of 211
-
BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents .
Installation Verification Items Specified Actual System Type: Process Controller /
Temperature Meter
Manufacturer: Thornton Controller Tag ID No.: TT-623/624 Model No.: 770 PC Serial No.: Under front bezel Location: CP-TT-01 NEMA Rating: Not Specified UL Rated: (Yes / No) Not Specified Reference Documents: 770 PC Process Controller
Instruction Manual PP.57-58
COMMENTS: 1 Environmental operating specification: 32-122 F. 2 Relative humidity specifications: 0-95% Non condensing. 3 This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the printed circuit board. 4 It has four individual software controlled set-points which can be set as a high or low limit. Any set-point can be programmed to operate one of two output relays. 5 The Thornton instrument network address for this device is 2:12.
Verified By: ___________________________________________Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 58 of 211
-
BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents .
Installation Verification Items Specified Actual System Type: Process Controller /
Temperature Meter
Manufacturer: Thornton Controller Tag ID No.: TT-683/695 Model No.: 770 PC Serial No.: Under front bezel Location: CP-TT-01 NEMA Rating: Not Specified UL Rated: (Yes / No) Not Specified Reference Documents: 770 PC Process Controller
Instruction Manual PP.57-58
COMMENTS: 1 Environmental operating specification: 32-122 F. 2 Relative humidity specifications: 0-95% Non condensing. 3 This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the printed circuit board. 4 It has four individual software controlled set-points which can be set as a high or low limit. Any set-point can be programmed to operate one of two output relays. 5 The Thornton instrument network address for this device is 2:13
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 59 of 211
-
BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents .
Installation Verification Items Specified Actual System Type: Process Controller /
Temperature Meter
Manufacturer: Thornton Controller Tag ID No.: TT-699/700 Model No.: 770 PC Serial No.: Under front bezel Location: CP-TT-01 NEMA Rating: Not Specified UL Rated: (Yes / No) Not Specified Reference Documents: 770 PC Process Controller
Instruction Manual PP.57-58
COMMENTS: 1 Environmental operating specification: 32-122 F. 2 Relative humidity specifications: 0-95% Non condensing. 3 This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the printed circuit board. 4 It has four individual software controlled set-points which can be set as a high or low limit. Any set-point can be programmed to operate one of two output relays. 5 The Thornton instrument network address for this device is 2:14
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 60 of 211
-
BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents .
Installation Verification Items Specified Actual System Type: Process Controller /
Conductivity / Flow Meter
Manufacturer: Thornton Controller Tag ID No.: CIT-111 / TT-105 / FT-106 Model No.: 770 PC Serial No.: Under front bezel Location: CP-TT-08 NEMA Rating: Not Specified UL Rated: (Yes / No) Not Specified Reference Documents: 770 PC Process Controller
Instruction Manual PP.57-58
COMMENTS: 1 Environmental operating specification: 32-122 F. 2 Relative humidity specifications: 0-95% Non condensing. 3 This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the printed circuit board. 4 It has four individual software controlled set-points which can be set as a high or low limit. Any set-point can be programmed to operate one of two output relays. It has temperature compensation with automatic reference to 25 C conductivity. 5 The Thornton instrument network address for this device is 2:81.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 61 of 211
-
BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents .
Installation Verification Items Specified Actual System Type: Process Controller /
Conductivity / Flow Meter
Manufacturer: Thornton Controller Tag ID No.: CIT-531 / TT-532 / FT-530 Model No.: 770 PC Serial No.: Under front bezel Location: CP-TT-08, NEMA Rating: Not Specified UL Rated: (Yes / No) Not Specified Reference Documents: 770 PC Process Controller
Instruction Manual PP.57-58
COMMENTS: 1 Environmental operating specification: 32-122 F. 2 Relative humidity specifications: 0-95% Non condensing. 3 This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the printed circuit board. 4 It has four individual software controlled set-points which can be set as a high or low limit. Any set-point can be programmed to operate one of two output relays. It has temperature compensation with automatic reference to 25 C conductivity. 5 The Thornton instrument network address for this device is 2:82.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 62 of 211
-
BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents .
Installation Verification Items Specified Actual System Type: Process Controller /
Temperature Meter
Manufacturer: Thornton Controller Tag ID No.: TT-645/665 Model No.: 770 PC Serial No.: Under front bezel Location: CP-TT-06 NEMA Rating: Not Specified UL Rated: (Yes / No) Not Specified Reference Documents: 770 PC Process Controller
Instruction Manual PP.57-58
COMMENTS: 1 Environmental operating specification: 32-122 F. 2 Relative humidity specifications: 0-95% Non condensing. 3 This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the printed circuit board. 4 It has four individual software controlled set-points which can be set as a high or low limit. Any set-point can be programmed to operate one of two output relays. 5 The Thornton instrument network address for this device is 2:64.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 63 of 211
-
BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents .
Installation Verification Items Specified Actual System Type: Process Controller /
Conductivity Meter
Manufacturer: Thornton Controller Tag ID No.: CIT-621 / TT-622 Model No.: 770 PC Serial No.: Under front bezel Location: CP-TT-06 NEMA Rating: Not Specified UL Rated: (Yes / No) Not Specified Reference Documents: 770 PC Process Controller
Instruction Manual PP.57-58
COMMENTS: 1 Environmental operating specification: 32-122 F. 2 Relative humidity specifications: 0-95% Non condensing. 3 This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the printed circuit board. 4 It has four individual software controlled set-points which can be set as a high or low limit. Any set-point can be programmed to operate one of two output relays. It has temperature compensation with automatic reference to 25 C conductivity. 5 The Thornton instrument network address for this device is 2:63.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 64 of 211
-
BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc., are installed in accordance with applicable documents .
Installation Verification Items Specified Actual System Type: Process Controller /
Conductivity / Flow Meter
Manufacturer: Thornton Controller Tag ID No.: CIT-649 / TT-651 / FT-650 Model No.: 770 PC Serial No.: Under front bezel Location: CP-TT-06 NEMA Rating: Not Specified UL Rated: (Yes / No) Not Specified Reference Documents: 770 PC Process Controller
Instruction Manual PP.57-58
COMMENTS: 1 Environmental operating specification: 32-122 F. 2 Relative humidity specifications: 0-95% Non condensing. 3 This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the printed circuit board. 4 It has four individual software controlled set-points which can be set as a high or low limit. Any set-point can be programmed to operate one of two output relays. It has temperature compensation with automatic reference to 25 C conductivity. 5 The Thornton instrument network address for this device is 2:62.
Verified By: ___________________________________________ Date: ____________________
Reviewed By: __________________________________________ Date: ____________________
SAMPLE Page 65 of 211
-
BIG PHARMACEUTICALS, INC.
Protocol No.: SAMPLE Building/Area: Building 88 Date: November 21, 2006 Room: Powerhouse System Name: CIP / SIP Control System
CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION Verify the controller contact ancil lary system(s), and components, such as, controls, monitors, processors, I/O modules, recorders, etc
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