Iq-Oq HCGM - Ab Pakistan

TECHNOPHAR EQUIPMENT & SERVICE LTD.
INSTALLATION/OPERATIONAL QUALIFICATION PROTOCOL

TES DOC 001 Rev 16/04/2005 Page 1 of 39 INSTALLATION # WIN 001
INSTALLATION AND OPERATIONAL QUALIFICATION FOR THE

TES-E (7) HARD CAPSULE MACHINE MODEL HGCM-0 LOCATED AT GELCAPS (PAKISTAN) Prepared By: IOAN BALC SERVICE MANAGER. Date: February 15, 2005
This protocol, when signed below, is approved for execution.
_____________________________________________________ Date: February 15, 2005 Engineering Department Technophar Equipment and Service
____________________________________________________
Form # 1030 01A

Protocol Profile 1.0 PURPOSE

The purpose of this Installation/Operational Protocol is to describe and document the installation and operation of the TES-E (7) HARD CAPSULE MACHINE, MODEL HGCM-0 located at GELCAPS (PAKISTAN) in Taiwan.
2.0 SCOPE
This protocol has been specifically developed for the machine as described and located in section 1, and is limited to this machine and its associated components, as indicated on the technical drawings listed on Form # 1072 (page 41) and on file at Technophar Equipment & Service Ltd.
3.0 RESPONSIBILITIES
3.1 The Engineering Department is responsible for the preparation of this protocol, including descriptions of the mechanical, electrical and controls features. Engineering responsibilities also include completion of the IQ/OQ forms and any corrective action relating to deviations in the acceptance criteria. 3.2 The Production, Technical services and Quality Assurance departments are responsible for the review and approval of the protocol. 3.3 The Plant Manager or designee will assure that appropriate approvals are obtained.
4.0
ACCEPTANCE CRITERIA
4.1 INSTALLATION A. Equipment is installed as per as built drawings and manuals B. All dials and switches are clearly labeled C. All required utilities are labeled
4.2 OPERATIONAL The operational qualification will be considered acceptable when it has been determined that all of the components of the TES-E (7) HARD CAPSULE MACHINE, MODEL HGCM-0 as listed in section 7, are operating as designed.
5.0
DOCUMENTATION AND RECORDS

5.1 5.2 5.3 All data relating to this IQ/OQ inspection, including any test results for the components of the TES-E (7) HARD CAPSULE MACHINE, MODEL HGCM-0 shall be collected and recorded on a copy of this protocol. Each qualification form will be signed and dated by the person executing the protocol, upon completion of the activity. At the completion of each section of the protocol, the Plant Manager or designee will perform a review. All discrepancies found must be addressed with a Deficiency report. Any deficiency reports generated will be completed and attached to the protocol for approval routing. Prior to taking any corrective action, the discrepancies may be subject to review, to determine if the acceptance criteria should be modified. All justified modifications will then be recorded and attached to their corresponding Deficiency Report.
Form # 1030 02A

Protocol Profile (contd) 6.0 REFERENCES

6.1 6.2 6.3 6.4 6.5 GELCAPS (PAKISTAN) INVOICE Project No. N/AV` GELCAPS (PAKISTAN) INVOICE # N/AV Manuals from: Technophar Equipment & Service Ltd., Engineering Dept. Installation drawings from Technophar Equipment & Service Ltd., Engineering Dept. Definitions: Whenever the abbreviation N/AP is used in this protocol, it shall mean Not applicable. Whenever the abbreviation N/AV is used in this protocol, it shall mean Not available. When referring to this document, the abbreviation IQ/OQ refers to the Installation/ Operation Qualification Protocol. Whenever the abbreviation T.E.S. is used in this protocol, it shall refer to Technophar Equipment & Service Ltd.. Whenever the abbreviation B.O.M. is used in this protocol, it shall mean Bill of Materials.
7.0 EQUIPMENT LISTING AND OPERATION DESCRIPTION Equipment List

The TES-E (7) HARD CAPSULE MACHINE MODEL HGCM-0 consists of the following major components: 7.1 7.2 7.3 7.4 7.5 7.6 Dipper Section Greaser Section. Automatic Section. Table Section. Hydraulic Section. Rear Section
Operation Description
Gelatin in liquid form is fed into the machines dishes via hoses from elevated tanks. Pin bars are dipped into the gelatin solution both body and cap and transferred to the upper drying kiln. The bars are then transferred to the lower drying and conditioning kilns via hydraulic elevators. The pin bars are then transferred to the table section where they are flipped and move into the automatic section. In the automatic section the capsules are stripped of from the bars cut to length and joined. The capsules are ejected onto a conveyor belt for discharge. The pin bars move to the greaser section where the pins are lubricated and the cycle begins again. Form # 1030 03A

IQ/OQ Matrix
EQUIPMENT NAME: TES-E (7) HARD CAPSULE MACHINE MODEL HGCM-0 1 1 1 2 3 2 1 2 1 5 1 19 1 1 1 1 1 1 4 4 5 6 7 7 8 12 13 13 14 32 33 33 34 34 35 35 36 36 37 37 38 38
ITEM NAME
Authorizations Page Protocol Profile IQ/OQ Matrix Installation and operational prerequisites Installation (Equipment) Installation (Motors) Test Equipment and Materials Testing Procedures General Data Control Panel(s) Utilities Requirements Manuals Drawings Summary & Conclusion
COMMENTS: _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________
CONDUCTED BY: IOAN BALC REVIEWED BY: IOAN BALC
DATE: 15/04/2005 DATE: 16/04/2005
Form # 1030 04A

INSTALLATION AND OPERATIONAL PREREQUISITES

EQUIPMENT NAME; TES-E (7) HARD CAPULE MACHINE MODEL HGCM-0 INSTALLATION PRE-REQUISITES 1. The system is installed 2. ___________________15/02/05 Signature/Date The IQ/OQ system Matrix has been reviewed and updated as necessary. ___________________15/02/05 Signature/Date OPERATIONAL PRE-REQUISITES 1. The system is operational and the installation qualification is completed. ___________________15/02/05 Signature/Date 2. Standard Operating Procedure documents (S.O.P.s) exist in draft or approved form to support operational testing. ___________________15/02/05 Signature/Date Verify that all of the instruments associated with this system (including those used for testing) have been calibrated, and that the calibration period will not expire before the execution of this protocol has been completed. ___________________15/02/05 Signature/Date All materials and test equipment are available for executing this protocol. ____________________15/02/05 Signature/Date COMMENTS: _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________ CONDUCTED BY: IOAN BALC REVIEWED BY: IOAN BALC Form # 1030 05A DATE: 15/04/2005 DATE: 16/04/2005
3.
4.

INSTALLATION AND OPERATIONAL PREREQUISITES

EQUIPMENT NAME; TES-E (7) HARD CAPULE MACHINE MODEL HGCM-0 1. The equipment has been installed as per the manufacturers specifications. The equipment has been leveled and is properly located, to conform to GMP regulation C.02.005. ___________________15/02/05 Signature/Date 2. The electrical service is complete; electrical connections have been inspected, and all phase motors checked for proper rotation. ___________________15/02/05 Signature/Date 3. Adequate compressed air supply is available and hooked up (performed) by the customer. ___________________15/02/05 Signature/Date 4. The installed components of the equipment have been calibrated (where applicable). ___________________15/02/05 Signature/Date
COMMENTS: The RTD sensors calibration will be checked (performed) by the customer a.s.a.p. ______________________________________________________________________________________ ______________________________________________________________________________________ ______________________________________________________________________________________ ______________________________________________________________________________________
DATE: 15/04/2005 DATE: 16/04/2005
Form # 1030 06A

INSTALLATION AND VERIFICATION (EQUIPMENT) EQUIPMENT NAME: TES-E (7) HARD CAPSULE MACHINE MODEL HGCM-0 COMPONENT: HARD CAPSULE MACHINE
Description Manufacturer Model Number Serial Number Materials of Construction
Data Technophar Equipment &Service Ltd. HGCM-0 04-04 Various, see mechanical B.O.M.
Source of Data T.E.S., Engineering Dept. T.E.S., Engineering Dept. T.E.S., Engineering Dept. T.E.S., Engineering Dept.
COMMENTS:
DATE: 15/04/2005 DATE: 16/04/2005
Form # 1030 07A

INSTALLATION AND VERIFICATION (MOTORS)

EQUIPMENT NAME: TES-E (7) HARD CAPSULE MACHINE MODEL HGCM-0
COMPONENT: DIPPER SECTION BODY SIDE: Dipper Roll Elevat or Servo Motor Data N/AP N/AP N/AP N/AP N/AP N/AP N/AP
Description
Dipper Servo Motor Data N/AP N/AP N/AP N/AP N/AP N/AP N/AP
Water Pump Data MARCH MARCH #TEMDX-MT3 230VAC/ 0.75A/ Three 3000 0.75 HP 60Hz
Dish Motor Data BODINE BODINE #6269
Source of Data
Manufacturer Model Number Serial Number Volt/Amp/Phase Rpm Power Cycle
T.E.S., Electrical Dept. T.E.S., Electrical Dept. Installation
130 VDC/0.25 A 29 1/23 HP -
T.E.S., Electrical Dept. T.E.S., Electrical Dept. T.E.S., Electrical Dept T.E.S., Electrical Dept
Form # 1030 08A


COMPONENT: DIPPER SECTION (CONTINUED) CAP SIDE: Dipper Roll Elevat or Servo Motor Data Manufacturer Model Number Serial Number Volt/Amp/Phase Rpm Power Cycle N/AP N/AP N/AP N/AP N/AP N/AP N/AP
Description
Dipper Servo Motor
Water Pump
Dish Motor
Source of Data
Data N/AP N/AP N/AP N/AP N/AP N/AP N/AP
Data MARCH MARCH #TEMDX-MT3 230VAC/ 0.75A/ Three 3000 0.75 HP 60Hz
Data BODINE BODINE #6269 T.E.S., Electrical Dept. T.E.S., Electrical Dept. Installation 130 VDC/0.25 A 29 1/23 HP T.E.S., Electrical Dept. T.E.S., Electrical Dept. T.E.S., Electrical Dept T.E.S., Electrical Dept
COMMENTS: _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________ CONDUCTED BY: IOAN BALC Form # 1030 09A DATE: 15/04/2005

REVIEWED BY: IOAN BALC
DATE: 16/04/2005

EQUIPMENT NAME: TES TES-E (7) HARD CAPSULE MACHINE
COMPONENT: GREASER SECTION Lower Conveyor Motor Data BODINE BODINE #1573 Upper Conveyor Motor Data BODINE BODINE #6165
Description Manufacturer Model Number Serial Number Volt/Amp/Phase Rpm Power Cycle
Source of Data T.E.S., Electrical Dept. T.E.S., Electrical Dept. Installation
220VAC/0.45A/1 Phase 47 1/45HP 60
130VDC/ 0.71A 417 1/12 W -
T.E.S., Electrical Dept. T.E.S., Electrical Dept. T.E.S., Electrical Dept T.E.S., Electrical Dept
COMMENTS:
DATE: 15/04/2005 DATE: 16/04/2005
Form # 1030 010A


EQUIPMENT NAME: TES TES-E (7) HARD CAPSULE MACHINE
COMPONENT: TABLE SECTION Description Manufacturer Model Number Serial Number Volt/Amp/Phase Rpm Power Cycle Main Drive Data SEW EURODRIVE (W/ BRAKE @110 VAC) SEW EURODRIVE #RX57DT100L4BMG4HF N/AV 208VAC/13.6A/3 Phases 823 5HP 60 Source of Data T.E.S., Electrical Dept. T.E.S., Electrical Dept. Installation T.E.S., Electrical Dept. T.E.S., Electrical Dept. T.E.S., Electrical Dept T.E.S., Electrical Dept
COMMENTS: _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________
CONDUCTED BY: IOAN BALC Form # 1030 011A
DATE: 15/04/2005

REVIEWED BY: IOAN BALC
DATE: 16/04/2005

EQUIPMENT NAME: TES TES-E (7) HARD CAPSULE MACHINE MODEL HGCM-0 COMPONENT: HYDRAULIC SECTION Description Manufacturer Model Number Serial Number Volt/Amp/Phase Rpm Power Cycle 230VAC/20.0A/3 Phases 1760 10HP 60 Hydraulic Pump Data LEESON LEESON #G15014000 Source of Data T.E.S., Electrical Dept. T.E.S., Electrical Dept. Installation T.E.S., Electrical Dept. T.E.S., Electrical Dept. T.E.S., Electrical Dept T.E.S., Electrical Dept
COMMENTS:
CONDUCTED BY: IOAN BALC REVIEWED BY: IOAN BALC Form # 1030 012A
DATE: 15/04/2005 DATE: 16/04/2005

TEST EQUIPMENT AND MATERIALS

ITEM Digital Photo/Contact Tachometer. Multimeter Micro Cal 2+
MANUFACTURER Kleton Hoskin Scientific
MODEL # K4010 DHT920
SERIAL # L270529 960489
CAL. DATE March 10, 2003 Feb 5, 2003
NOTE: The calibration of all test equipment must be NIST traceable
COMMENTS: ______________________________________________________________________________________ ______________________________________________________________________________________ ______________________________________________________________________________________ ______________________________________________________________________________________
CONDUCTED BY: IOAN BALC REVIEWED BY: IOAN BALC Form # 1030 013A
DATE: 15/04/2005 DATE: 16/04/2005

TESTING PROCEDURES
1.0
1.1 1.2 1.3 1.4 1.5 1.3 1.6 1.7 1.8 1.9 1.10 1.11 1.12 1.13 1.14 1.15
Main Screen
Turn the Main Power Circuit Breaker Handle on; the touch screen lights up and Log On screen comes up. __________(y/n) Touch Log On on the screen and the keypad comes up Enter the password and the Main Menu screen comes up __________(y/n) __________(y/n)
Touch the Access Control on the Main Menu screen and, according to the password, one of the following screens comes up: Administrator, Supervisor or Operator screen. __________(y/n) Return to the Main Menu and touch Motors on screen. Motors screen comes up. __________(y/n) Return to Main Menu, touch Dipping on screen. Dipping screen comes up. __________(y/n) Return to Main Menu, touch Hydraulics on screen. Hydraulics screen comes up. __________(y/n) Return to Main Menu, touch Temperatures on screen. Temperatures screen comes up. __________(y/n) Return to Main Menu, touch Viscosity on screen. Viscosity screen comes up. __________(y/n) Return to Main Menu, touch Auxiliary on screen. Auxiliary screen comes up. __________(y/n) Return to Main Menu, touch Production on screen. Production screen comes up. __________(y/n) Return to Main Menu, touch Bad Dip on screen. Bad Dip screen comes up. __________(y/n) Return to Main Menu, touch Lubrication on screen. Lubrication screen comes up. __________(y/n) Return to Main Menu, touch Alarms History on screen. Alarms History screen comes up. __________(y/n) Return to Main Menu, touch Access Control on screen. Access Control screen comes up. __________(y/n) Return to Main Menu, touch Log Off on screen. Log Off screen comes up. __________(y/n) ____________________________ Signature/Date
Form # 1030 014A

TESTING PROCEDURES (contd)

EQUIPMENT NAME: TES-E (7) HARD CAPSULE MACHINE
2.0
2.1 2.1.1 2.1.2 2.1.3 2.1.4 2.1.5 2.1.6 2.1.7 2.1.8 2.1.9 2.1.10 2.1.11 2.1.12 2.1.13 2.1.14 2.1.15 2.1.16 2.1.17 2.1.18 2.1.19
Motors Control Screen General Functions

From the Main Menu, access the Motors Control Screen. Push Main Drive On button. Machine starts running Push Main Drive stopped button. Machine stops running . . __________(y/n) __________(y/n) __________(y/n) __________(y/n) __________(y/n) __________(y/n) ____N/AP_(y/n) ___N/AP__(y/n) __________(y/n)
Push Upper Conveyor On button. The dipper conveyor starts running. Push Upper Conveyor Stopped button. The dipper conveyor stops running Push Lower Conveyor On button. The lower conveyor starts running. Push Lower Conveyor Stopped button. The lower conveyor stops running Push Cyclone On button. The cyclone motor starts running. Push Cyclone Stopped button. The cyclone motor stops running. Push Body Water Pump On button. The body water pump starts running.
Push Body Water Pump Stopped button. The body water pump stops running._________(y/n) Push Cap Water Pump On button. The cap water pump starts running. __________(y/n)
Push Cap Water Pump Stopped button. The cap water pump stops running. __________(y/n) Push Body Dish Drive Off button. The body dish motor starts running. Push Cap Dish Drive Off button. The cap dish motor starts running. Push Speed Ctrl button. Speed Control screen comes up. Push Hydr button. Hydraulics screen comes up. Push Dip button. Dipper Control screen comes up. Push Heat button. Temperature screen comes up. Push Visc button. Viscosity screen comes up. __________(y/n) __________(y/n) __________(y/n) __________(y/n) __________(y/n) __________(y/n) __________(y/n)
Form # 1030 015A

TES DOC 001 Rev 16/04/2005 Page 16 of 39 INSTALLATION # WIN 001 Signature/Date ____________________________

EQUIPMENT NAME: TES-E (7) HARD CAPSULE MACHINE 2.1.20 2.1.21 2.1.22 2.1.23 2.1.24 2.1.25 Push Prod button. Production screen comes up. Push Lubr button. Lubrication screen comes up. Push Aux button. Auxiliary screen comes up. Push Bad Dip button. Bad Dip screen comes up. Push Alarm button. Alarm History screen comes up. Push Main Menu button. Menu Screen screen comes up. __________(y/n) __________(y/n) __________(y/n) _________(y/n) __________(y/n) __________(y/n)
Motors Screen Speed Controls

2.2 2.2.1 2.2.2 2.2.3 2.2.4 2.2.5 2.2.6 2.2.7 2.2.9 2.2.10 2.2.11 2.2.12 2.2.13 2.2.14 From the Motors screen, access the Speed Controls screen. __________(y/n)
Under the heading Main Drive, set to 30.0 RPM. Verify that the actual reading is 30.0 RPM (+ or 6%). __________(y/n) Under the heading Body Dish Drive, adjust to 45%. Verify that the motor is working at that capacity. __________(y/n) Under the heading Cap Dish Drive, adjust to25%. Verify that the motor is working at that capacity. __________(y/n) Under the heading Upper Conveyor, adjust to 50%. Verify that the conveyor is running at that capacity. __________(y/n) Push Motors button. Motors screen comes up. __________(y/n) Push Hydr button. Hydraulics screen comes up. Push Dip button. Dipper Control screen comes up. Push Visc button. Viscosity screen comes up. Push Prod button. Production screen comes up. Push Lubr button. Lubrication screen comes up. Push Aux button. Auxiliary screen comes up. Push Bad Dip button. Bad Dip screen comes up. Push Alarm button. Alarm History screen comes up. __________(y/n) __________(y/n) __________(y/n) __________(y/n) __________(y/n) __________(y/n) __________(y/n) __________(y/n)
Form # 1030 016A

TES DOC 001 2.2.15 Rev 16/04/2005 Page 17 of 39 INSTALLATION # WIN 001 __________(y/n)
Push Main Menu button. Menu Screen screen comes up.
____________________________ Signature/Date

Dipping Control Screen General Functions

3.1 3.1.1 3.1.2 3.1.3 3.1.4 3.1.5 3.1.6 3.1.7 3.1.8 3.1.9 3.1.10 3.1.11 3.1.12 3.1.13 From the Main Menu, access the Dipper Control Screen. N/AP Push Dipping Motors Off button, when in automatic mode (button in Hydraulics screen). The dipping motors start running __________(y/n) Push Dipping Motors On button, when in automatic mode. The dipping motors stops running __________(y/n) If Body Dipping Motor is not home, the button flashes; push Body Dipping Not Home. Body dipping motor is homing . __________(y/n) If Cap Dipping Motor is not home, the button flashes; push Cap Dipping Not Home. Cap dipping motor is homing . __________(y/n) If Dipper Elevators Motors are not home, the button flashes; push Dipper Elevators Not Home. Both motors are homing . N/AP ___(y/n) If an error occurs on Body Elevator Stepper Motor then push Body Elevator Reset Errors. The errors are reset. _N/AP__(y/n) If an error occurs on Cap Elevator Stepper Motor then push Cap Elevator Reset Errors. The errors are reset. _ N/AP ___(y/n) Push Body Dipping Jog Down. Body Dipping Stepper motor jogs down. __________(y/n) Push Body Dipping Jog Up. Body Dipping Stepper motor jogs up . Push Cap Dipping Jog Down. Cap Dipping Stepper motor jogs down Push Cap Dipping Jog Up. Cap Dipping Stepper motor jogs up . __________(y/n) . __________(y/n) __________(y/n) ____N/AP_(y/n) ___N/AP__(y/n)
Push Dipper Elevators Jog Down. Dipper Elevators Stepper motor jogs down . Push Dipper Elevators Jog Up. Dipper Elevators Stepper motor jogs up.
__________________________ Signature/Date Form # 1030 017A


Dipper Control Screen General Functions

3.1.14 3.1.15 3.1.16 3.1.17 3.1.18 3.1.19 3.1.20 3.1.21 3.1.22 3.1.23 3.1.24 3.1.25 3.1.26 3.1.27 3.1.28 3.1.29 If an error occurs on Body Dipping Stepper Motor then push Body Reset Errors. The errors are reset. _________(y/n) If an error occurs on Cap Dipping Stepper Motor then push Cap Reset Errors. The errors are reset. __________(y/n) Push Body Dipping Test button. Body Dipping Stepper motor runs the profile input in Body Dipping Profile screen __________(y/n) Push Cap Dipping Test button. Cap Dipping Stepper motor runs the profile input in Cap Dipping Profile screen __________(y/n) Push Dipper Elevators Down button. Dipper Elevators runs down _N/AP___(y/n) Push Dipper Elevators Up button. Dipper Elevators runs __N/AP__(y/n) Push Motors button. Motors screen comes up. __________(y/n) Push Hydr button. Hydraulics screen comes up. __________(y/n) Push Heat button. Temperature screen comes up. __________(y/n) Push Visc button. Viscosity screen comes up. __________(y/n) Push Prod button. Production screen comes up. __________(y/n) Push Lubr button. Lubrication screen comes up. __________(y/n) Push Aux button. Auxiliary screen comes up. __________(y/n) Push Bad Dip button. Bad Dip screen comes up. __________(y/n) Push Alarm button. Alarm History screen comes up. __________(y/n) Push Main Menu button. Menu Screen screen comes up. __________(y/n) __________________________ Form # 1030 018A

TES DOC 001 Rev 16/04/2005 Page 19 of 39 INSTALLATION # WIN 001 Signature/Date

Hydraulic Movements Screen Hydraulic movements Verification

4.1 4.2 From the Main Menu, access the Hydraulic Movements screen. Push the Hydraulic Pump ON button. The hydraulic pump will start and the button label will change to Hydraulic Pump Running, allowing any hydraulic movement to be performed. __________(y/n) Push the Hydraulic Pump Stopped button. Hydraulic pump will stop and so all corresponding movements. __________(y/n) Push the Hydraulic Manual button. This will change to Hydraulic Auto Mode, meaning that any hydraulic movement will be performed by the setting done in timing screen and based on the absolute encoder position. 4.5 Push the 1-Bar Advance button. One bar is moving forward. __________(y/n) 4.6 Push the 1-Bar Return button. One bar is moving backward. __________(y/n) 4.7 4.8 4.9 4.10 4.11 Push the 7-Bar Advance button. Seven bars are moving forward. Push the 7-Bar Return button. Seven bars are moving backward. . __________(y/n) __________(y/n) ________(y/n) _________(y/n)
4.3 4.4
Push the Dipper Ejectors In button. Ejectors are pushing in Push the Dipper Ejectors Out button. Ejectors are coming out.
Push the Front Bar Push Advance button. Front bar arm is pushing forward. __________(y/n) 4.12 Push the Front Bar Push Return button. Front bar arm is coming back. __________(y/n) 4.13 Push the Middle Bar Push Advance button. Middle bar arm is pushing forward. __________(y/n) 4.14 Push the Middle Bar Push Return button. Middle bar arm is coming back. ___N/AP_(y/n) Form # 1030 019A

TES DOC 001 4.15 Rev 16/04/2005 Page 20 of 39 INSTALLATION # WIN 001
Push the Rear Middle Bar Push Advance button. Rear middle bar arm is pushing forward. _N/AP_____(y/n) __________________________ Signature/Date
TESTING PROCEDURES (contd.)

EQUIPMENT NAME: TES-E (7) HARD CAPSULE MACHINE MODEL HGCM-0 Hydraulic Movements Screen Hydraulic movements Verification 4.16 Push the Rear Middle Bar Push Return button. Rear middle bar arm is coming back. __N/AP__(y/n) 4.17 Push the Rear Bar Push Advance button. Rear lower bar arm is pushing forward. __________(y/n) 4.18 Push the Rear Bar Push Return button. Rear lower bar arm is coming back. __________(y/n) 4.19 Push the Table Elevator Up button. Table elevator is moving up. __________(y/n) 4.20 Push the Table Elevator Down button. Table elevator is moving down. __________(y/n) 4.21 Push the Middle Elevator Up button. Middle table elevator is moving up. __N/AP__(y/n) 4.22 Push the Middle Elevator Half button. Middle table elevator is moving half up. __N/AP__(y/n) 4.23 Push the Middle Elevator Down button. Middle table elevator is moving down. __N/AP__(y/n) 4.24 Push the Rear Elevator Up button. Rear table elevator is moving up. __________(y/n) 4.25 Push the Rear Elevator Half button. Rear table elevator is moving half up. _N/AP____(y/n) 4.26 Push the Rear Elevator Down button. Rear table elevator is moving down. __________(y/n) 4.27 Push the Greaser Heads In button. Greaser heads are moving forward. __________(y/n) 4.28 Push the Greaser Heads Out button. Greaser heads are moving back. __________(y/n 4.29 4.30 Push Dipper Elevators Down button. Dipper Elevators runs down Push Dipper Elevators Up button. Dipper Elevators runs up __________(y/n) __________(y/n)
Form # 1030 020A

4.29 Push Motors button. Motors Control screen comes up. __________(y/n) 4.30 Push Dip button. Dipper Control screen comes up. __________(y/n) 4.31 Push Heat button. Temperature screen comes up. __________(y/n) 4.32 4.33 4.34 Push Visc button. Viscosity screen comes up. Push Prod button. Production screen comes up. Push Lubr button. Lubrication screen comes up. __________(y/n) __________(y/n) __________(y/n) __________________________ Signature/Date TESTING PROCEDURES (contd.) EQUIPMENT NAME: TES-E (7) HARD CAPSULE MACHINE 4.35 4.36 4.37 4.38 Push Aux button. Auxiliary screen comes up. Push Bad Dip button. Bad Dip screen comes up. Push Alarm button. Alarm History screen comes up. Push Main Menu button. Menu Screen screen comes up. Temperature Screen Temperature Verification 5.1 5.2 5.3 5.4 . 5.5 5.6 5.7 5.8 From the Main Menu, access the Temperature screen. __________(y/n) __________(y/n) __________(y/n) __________(y/n) __________(y/n)
Push Hydraulic Tank Off button. Hydraulic oil tank temperature control starts. __________(y/n) Push Hydraulic Tank On button. Hydraulic oil tank temperature control stops. __________(y/n)
Beside the label SV push the button and key in 45C. Verify that the hydraulic oil temperature is 55C ( 3%) __N/AP_(y/n) Push Body Dish Off button. Body Dish temperature control starts. Push Body Dish On button. Body Dish temperature control stops. _________(y/n) __________(y/n)
Beside the label SV push the button and key in 45C. Verify that the body dish temperature is 45C ( 3%) N/AP ___(y/n) Push Cap Dish Off button. Cap Dish temperature control starts. Form # 1030 021A __________(y/n)

TES DOC 001 5.9 5.10 5.11 5.12 5.13 5.14 Rev 16/04/2005 Page 22 of 39 INSTALLATION # WIN 001 __________(y/n)
Push Cap Dish On button. Cap Dish temperature control stops.
Beside the label SV push the button and key in 45C. Verify that the cap dish temperature is 45 C ( 3%) N/AP_____(y/n) Push Motors button. Motors screen comes up. Push Hydraulics button. Hydraulics screen comes up. Push Dipping button. Dipping screen comes up. Push Visc button. Viscosity screen comes up. __________(y/n) __________(y/n) __________(y/n) __________(y/n) __________________________ Signature/Date

EQUIPMENT NAME: TES-E (7) HARD CAPSULE MACHINE MODEL HGCM-0 5.15 5.16 5.17 5.18 5.19 5.20 Push Prod button. Production screen comes up. Push Lubr button. Lubrication screen comes up. Push Aux button. Auxiliary screen comes up. Push Bad Dip button. Bad Dip screen comes up. Push Alarm button. Alarm History screen comes up. Push Main Menu button. Menu Screen screen comes up. __________(y/n) __________(y/n) __________(y/n) __________(y/n) __________(y/n) __________(y/n)
Auxiliary Screen 7.1 7.2 7.3 7.4 7.4 7.5 7.6 Push Machine Lights Off button. The lights on the machine turn on. Push Machine Lights On button. The lights on the machine turn off. Push Main Brake Off button. The main motor brake is released. Push Main Brake Engaged button. The main motor brake is on. Push Motors button. Motors Control screen comes up. Push Hydr button. Hydraulics screen comes up. Push Dip button. Dipper Control screen comes up. __________(y/n) __________(y/n) __________(y/n) __________(y/n) __________(y/n) __________(y/n) __________(y/n)
Form # 1030 022A

7.7 7.8 7.9 7.10 7.11 7.12 7.13
Push Heat button. Temperature buttons screen comes up. Push Visc button. Viscosity screen comes up. Push Prod button. Production screen comes up. Push Lubr button. Lubrication screen comes up. Push Bad Dip button. Bad Dip screen comes up. Push Alarm button. Alarm History screen comes up. Push Main Menu button. Menu Screen screen comes up.
__________(y/n) __________(y/n) __________(y/n) __________(y/n) __________(y/n) __________(y/n) __________(y/n)
__________________________ Signature/Date TESTING PROCEDURES (contd.) EQUIPMENT NAME: TES-E (7) HARD CAPSULE MACHINE MODEL HGCM-0 Bad Dip Bad Dip Table Verification 9.1 9.2 9.3 9.4 9.5 9.5 9.6 9.7 9.8 9.9 9.10 9.11 Push Set Bad Dip Table button. The first table is marked as bad dip every time you push this button. __________(y/n) Verify that the bad dip table is moving to the next position every time the front bar pusher advance movement occurs. __________(y/n) Push Motors button. Motors screen comes up. Push Hydr button. Hydraulics screen comes up. Push Dip button. Dipper screen comes up. Push Heat button. Temperature screen comes up. Push Visc button. Viscosity screen comes up. Push Prod button. Production screen comes up. Push Lubr button. Lubrication screen comes up. Push Aux button. Aux screen comes up. Push Alarm button. Alarm History screen comes up. Push Main Menu button. Menu Screen screen comes up. Form # 1030 023A __________(y/n) __________(y/n) ____N/AP__(y/n) __________(y/n) __________(y/n) __________(y/n) __________(y/n) __________(y/n) __________(y/n) __________(y/n)

Access Control Administrator Screen

12.1.1 12.1.2 12.1.3 12.1.4 12.1.5 12.1.6 Push date button. The key pad comes up allowing the administrator to change the date. __________(y/n) Push time button. The key pad comes up allowing the administrator to change the time. __________(y/n) Push Body Dipping Profile button. The Body Dipping Profile screen comes up. __________(y/n) Push Cap Dipping Profile button. The Cap Dipping Profile screen comes up. __________(y/n) Push Tempearture PID button. The PID Control Screen comes up. N/AP__(y/n) Push Dipper Elevators Profile button. The Dipper Elevators Profile screen comes up. __________(y/n) __________________________ Signature/Date TESTING PROCEDURES (contd.) EQUIPMENT NAME: TES-E (7) HARD CAPSULE MACHINE MODEL HGCM-0 Access Control Administrator Screen 12.1.7 12.1.8 12.1.9 Push Timing Control button. The Timing Setup screen comes up. __________(y/n)
Push Reset Encoder button. The encoder position is set to zero. N/AP ___N/AP___(y/n) Push Tempearture PID button. The Temperature Loops PID Paramenters screen comes up. __N/AP___(y/n) 12.1.10 Push Supervisor Screen button. The Supervisor Screen comes up. __________(y/n) 12.1.11 Push Machine Safeties Off button. The safeties will be validated on the machine. Push Machine Safeties On button. The safeties will be invalidated on the machine. __________(y/n) 12.1.12 Push Clear Alarm History button. All the alarms are cleared. 12.1.13 Push Reset Downtime button. The downtime is set to zero. __________(y/n) __________(y/n)
12.1.14 Push the button that allows the administrator to change the password for any user. The key pad comes up allowing the administrator to change the password for any user. __________(y/n) 12.1.15 Push See Passwords List button. A window comes up allowing the administrator to see al the passwords associated to users. __________(y/n) 12.1.16 Push Reset Production button. The production value is set to zero. 12.1.17 Push Motors button. Motors Control screen comes up. 12.1.18 Push Hydr button. Hydraulics screen comes up. Form # 1030 024A __________(y/n) __________(y/n) __________(y/n)

12.1.19 Push Dip button. Dipper screen comes up. 12.1.20 Push Heat button. Temperature screen comes up. N/AP 12.1.21 Push Visc button. Viscosity screen comes up. 12.1.22 Push Prod button. Production screen comes up. 12.1.23 Push Lubr button. Lubrication screen comes up. 12.1.24 Push Aux button. Aux screen comes up. 121..25 Push Bad Dip button. Bad Dip screen comes up.
__________(y/n) __________(y/n) __________(y/n) __________(y/n) __________(y/n) __________(y/n) __________(y/n) ____________________________ Signature/Date

EQUIPMENT NAME: TES-E (7) HARD CAPSULE MACHINE MODEL HGCM-0 Access Control Administrator Screen 12.1.26 Push Alarm button. Alarm History screen comes up. 12.1.27 Push Main Menu button. Menu Screen screen comes up. Body Dipping Profile General Functions 12.2.1 12.2.2 From the Administrator Screen, access the Body Dipping Profile. __________(y/n) __________(y/n) __________(y/n)
Push Dipper Elevators Profile button. Dipper Elevators Profile screen comes up. __N/AP_(y/n) 12.2.3 Return to Body Dipping Profile. Push Cap Dipping Profile button. Cap Dipping Profile comes up. __________(y/n) 12.2.4 Return to Body Dipping Profile. The indicators on the right side of the Body Dipping Position label indicate the actual position of the Body Dipping Stepper motor. __________(y/n) 12.2.5 Under Downwards Dipper Profile press Add to add a record. Up to 5 records can be added. __N/AP__(y/n) 12.2.6 Under Position (Downwards Dipper Profile) enter a value. ___N/AP___(y/n) 12.2.7 12.2.8 12.2.9 Under Speed (Downwards Dipper Profile) enter a value. Under Downwards Dipper Profile press Delete to delete the record. ____N/AP__(y/n) ____N/AP__(y/n)
Under Upwards Dipper Profile press Add to add a record. Up to 7 records can be added. ___N/AP__(y/n) 12.2.10 Under Position (Upwards Dipper Profile) enter a value. _____N/AP_(y/n) Form # 1030 025A

TES DOC 001 Rev 16/04/2005 Page 26 of 39 INSTALLATION # WIN 001 _____N/AP_(y/n) ___N/AP__(y/n)
12.2.11 Under Speed (Upwards Dipper Profile) enter a value. 12.2.12 Under Upwards Dipper Profile press Delete to delete a record.
_________________________ Signature/Date

EQUIPMENT NAME: TES-E (7) HARD CAPSULE MACHINE MODEL HGCM-0 Body Dipping Profile General Functions 12.2.13 In the record next to Delay label enter a value. _________(y/n) 12.2.14 If an error occurs on Body Dipping Stepper Motor then push Body Reset Errors. The errors are reset. _________(y/n) 12.2.15 Push Body Dipping Jog Down. Body Dipping Stepper motor jogs down . _________(y/n) 12.2.16 Push Body Dipping Jog Up. Body Dipping Stepper motor jogs up . _______ __(y/n) 12.2.17 If Body Dipping motor is not home, push Body Dipping Not Home. The motor is homing . __________(y/n) 12.2.18 Push Body Dipping Test. Body Dipping Stepper motor runs full down and returns to the home position. __________(y/n) 12.2.19 Push Motors button. Motors screen comes up. 12.2.20 Push Hydr button. Hydraulics screen comes up. 12.2.21 Push Dip button. Dipper Control screen comes up. 12.2.22 Push Heat button. Temperature screen comes up. 12.2.23 Push Visc button. Viscosity screen comes up. 12.2.24 Push Prod button. Production screen comes up. __________(y/n) __________(y/n) __________(y/n) __________(y/n) __________(y/n) __________(y/n)
Form # 1030 026A

TES DOC 001 Rev 16/04/2005 Page 27 of 39 INSTALLATION # WIN 001 __________(y/n) __________(y/n) __________(y/n) __________(y/n) __________(y/n)
12.2.25 Push Lubr button. Lubrication screen comes up. 12.2.26 Push Aux button. Aux screen comes up. 12.2.27 Push Bad Dip button. Bad Dip screen comes up. 12.2.28 Push Alarm button. Alarm History screen comes up. 12.2.29 Push Main Menu button. Menu Screen screen comes up.
_________________________ Signature/Date

EQUIPMENT NAME: TES-E (7) HARD CAPSULE MACHINE MODEL HGCM-0 Cap Dipping Profile General Functions 12.3.1 12.3.2 12.3.3 12.3.4 12.3.5 12.3.6 12.3.7 12.3.8 12.3.9 From the Administrator Screen, access the Cap Dipping Profile. _________(y/n)
Push Dipper Elevators Profile button. Dipper Elevators Profile screen comes up. _N/AP__(y/n) Return to Cap Dipping Profile. Push Body Dipping Profile button. Cap Dipping Profile comes up. __________(y/n) Return to Cap Dipping Profile. The indicators on the right side of the Cap Dipping Position label indicate the actual position of the Body Dipping Stepper motor. __________(y/n) Under Downwards Dipper Profile press Add to add a record. Up to 5 records can be added. ____N/AP_(y/n) Under Position (Downwards Dipper Profile) enter a value. ___N/AP__(y/n) Under Speed (Downwards Dipper Profile) enter a value. Under Downwards Dipper Profile press Delete to delete the record. ____N/AP_(y/n) ____N/AP__(y/n)
Under Upwards Dipper Profile press Add to add a record. Up to 7 records can be added. ____ N/AP__(y/n) 12.3.10 Under Position (Upwards Dipper Profile) enter a value. ____N/AP_(y/n) 12.3.11 Under Speed (Upwards Dipper Profile) enter a value. ____N/AP__(y/n)
Form # 1030 027A

TES DOC 001 Rev 16/04/2005 Page 28 of 39 INSTALLATION # WIN 001 ___N/AP__(y/n) _________(y/n)
12.3.12 Under Upwards Dipper Profile press Delete to delete a record. 12.3.13 In the record next to Delay label enter a value.
12.3.14 If an error occurs on Body Dipping Stepper Motor then push Cap Reset Errors. The errors are reset. __________(y/n) 12.3.15 Push Cap Dipping Jog Down. Body Dipping Stepper motor jogs down . __________(y/n) 12.3.16 Push Cap Dipping Jog Up. Body Dipping Stepper motor jogs up . __________(y/n)
12.3.17 If Body Dipping motor is not home, push Cap Dipping Not Home. The motor is homing . __________(y/n) 12.3.18 Push Cap Dipping Test. Body Dipping Stepper motor runs full down and returns to the home position. __________(y/n) 12.3.19 Push Motors button. Motors screen comes up. __________(y/n) _________________________
Signature TESTING PROCEDURES (contd)

EQUIPMENT NAME: TES-E (7) HARD CAPSULE MACHINE MODEL HGCM-0 12.3.20 Push Hydr button. Hydraulics screen comes up. 12.3.21 Push Dip button. Dipper Control screen comes up. 12.3.22 Push Heat button. Temperature screen comes up. 12.3.23 Push Visc button. Viscosity screen comes up. 12.3.24 Push Prod button. Production screen comes up. 12.3.25 Push Lubr button. Lubrication screen comes up. 12.3.26 Push Aux button. Aux screen comes up. 12.3.27 Push Bad Dip button. Bad Dip screen comes up. 12.3.28 Push Alarm button. Alarm History screen comes up. 12.3.29 Push Main Menu button. Menu Screen screen comes up. ______ __(y/n) _________(y/n) __________(y/n) __________(y/n) __________(y/n) __________(y/n) __________(y/n) __________(y/n) __________(y/n) __________(y/n)
Form # 1030 028A

_________________________ Signature/Date

EQUIPMENT NAME: TES-E (7) HARD CAPSULE MACHINE MODEL HGCM-0 Dipper Elevator Profile General Functions N/.AP 12.4.1 12.4.2 12.4.3 12.4.4 . 12.4.5 12.4.6 12.4.7 12.4.8 12.4.9 From the Access Control screen, access the Dipper Elevator Profile. Push Body Dipping Profile button. Body Dipping Profile comes up. Push Cap Dipping Profile button. Cap Dipping Profile comes up. ___N/AP__(y/n) ___N/AP__(y/n) ____N/AP_(y/n)
The indicators on both sides of the Dipper Rolls Position label indicate the actual position of the elevators. _N/AP__(y/n) Under Downwards Body Dipper Elevator Profile press Add to add a record. _ N/AP __(y/n) Under Position (Downwards Body Dipper Elevator Profile) enter a value. Under Speed (Downwards Body Dipper Elevator Profile) enter a value. Under Downwards Body Dipper Elevator Profile press Delete to delete the record. Under Downwards Cap Dipper Elevator Profile press Add to add a record. __ N/AP _(y/n) __ N/AP _(y/n) N/AP_(y/n) __ N/AP _(y/n) _ N/AP _(y/n) __ N/AP _(y/n) __ N/AP _(y/n)
12.4.10 Under Position (Downwards Cap Dipper Elevator Profile) enter a value. 12.4.11 Under Speed (Downwards Cap Dipper Elevator Profile) enter a value. 12.4.12 Under Downwards Cap Dipper Elevator Profile press Delete to delete the record.
12.4.13 Under Upwards Body Dipper Elevator Profile press Add to add a record. Up to 7 records can be added. __ N/AP __(y/n) Form # 1030 029A

TES DOC 001 Rev 16/04/2005 Page 30 of 39 INSTALLATION # WIN 001 __ N/AP __(y/n) __ N/AP _(y/n) ___ N/AP _(y/n)
12.4.14 Under Position (Upwards Body Dipper Elevator Profile) enter a value. 12.4.15 Under Speed (Upwards Body Dipper Elevator Profile) enter a value. 12.4.16 Under Upwards Body Dipper Elevator Profile press Delete to delete a record.
12.4.17 Under Upwards Cap Dipper Elevator Profile press Add to add a record. Up to 7 records can be added. __ N/AP _(y/n) 12.4.18 Under Position (Upwards Cap Dipper Elevator Profile) enter a value. __ N/AP _(y/n) 12.4.19 Under Speed (Upwards Cap Dipper Elevator Profile) enter a value. 12.4.20 Under Upwards Cap Dipper Elevator Profile press Delete to delete a record. ___ N/AP _(y/n) __ N/AP _(y/n)
_________________________ Signature/Date

Dipper Elevator Profile General Functions N/AP

12.4.21 If an error occurs on Body Elevator Servo Motor then push Body Elevator Reset Errors. The errors are reset. _ N/AP _(y/n) 12.4.22 If an error occurs on Cap Elevator Servo Motor then push Cap Elevator Reset Errors. The errors are reset. __ N/AP_(y/n) 12.4.23 Push Dipper Elevators Down button. Dipper Elevators run completely down. __ N/AP __(y/n) 12.4.24 Push Dipper Elevators Up button. Dipper Elevators run completely up 12.4.25 Push Dipper Elevators Jog Down. Dipper Elevators Stepper motor jogs down . 12.4.26 Push Dipper Elevators Jog Up. Dipper Elevators Stepper motor jogs up . __ N/AP _(y/n) _ N/AP__(y/n) _ N/AP _(y/n)
12.4.27 If Dipper Elevators Motor is not home, push Dipper Elevators Not Home. The motors are homing _ N/AP __(y/n) 12.4.28 Push Motors button. Motors screen comes up. __________(y/n) 12.4.29 Push Hydr button. Hydraulics screen comes up. 12.4.30 Push Dip button. Dipper Control screen comes up. 12.4.31 Push Heat button. Temperature screen comes up. __________(y/n) __________(y/n) __________(y/n)
Form # 1030 030A

TES DOC 001 Rev 16/04/2005 Page 31 of 39 INSTALLATION # WIN 001 __________(y/n) __________(y/n) __________(y/n) __________(y/n) __________(y/n) __________(y/n)
12.4.32 Push Prod button. Production screen comes up. 12.4.33 Push Lubr button. Lubrication screen comes up. 12.4.34 Push Aux button. Aux screen comes up. 12.4.35 Push Bad Dip button. Bad Dip screen comes up. 12.4.36 Push Alarm button. Alarm History screen comes up. 12.4.37 Push Main Menu button. Menu Screen screen comes up.
_________________________ Signature/Date

EQUIPMENT NAME: TES-E (7) HARD CAPSULE MACHINE MODEL HGCM-0 Timing Setup Screen Hydraulic movements setup for auto mode 12.5.1 12.5.2 From the Access Control screen, touch Timing Control button to access Timing Setup screen
__________(y/n) On the hydraulic movements selector list select a movement by tapping the screen. Use scroll buttons to browse the whole list. __________(y/n) 12.5.3 Under the heading Occurrence push INC button to increment the occurrences number of the selected movement in the range indicated above the button. __________(y/n) 12.5.4 Under the heading Occurrence push DEC button to decrement the occurrences number of the selected movement in the range indicated above the button. __________(y/n) 12.5.5 Under the heading Start push INC button to increment the start position of the selected movement in the range 0 to 1024 of the encoder. __________(y/n) 12.5.6 Under the heading Start push DEC button to decrement the start position of the selected movement in the range 0 to 1024 of the encoder. __________(y/n) 12.5.7 Under the heading Stop push INC button to increment the stop position of the selected movement in the range 0 to 1024 of the encoder. __________(y/n) 12.5.8 Under the heading Stop push DEC button to decrement the stop position of the selected movement in the range 0 to 1024 of the encoder. __________(y/n) 12.5.9 Under the heading Encoder Value is displayed the actual position of the encoder in the range 0 to 1024. __________(y/n) 12.5.10 Push Motors button. Motors screen comes up. __________(y/n) 12.5.11 Push Hydr button. Hydraulics screen comes up. Form # 1030 031A __________(y/n)

12.5.12 Push Dip button. Dipper Control screen comes up. 12.5.13 Push Heat button. Temperature screen comes up. 12.5.14 Push Visc button. Viscosity screen comes up. 12.5.15 Push Prod button. Production screen comes up. 12.5.16 Push Lubr button. Lubrication screen comes up. 12.5.17 Push Aux button. Aux screen comes up.
__________(y/n) __________(y/n) __________(y/n) __________(y/n) __________(y/n) __________(y/n) _________________________ Signature/Date

EQUIPMENT NAME: TES-E (7) HARD CAPSULE MACHINE MODEL HGCM-0 Timing Setup Screen Hydraulic movements setup for auto mode 12.5.18 Push Bad Dip button. Bad Dip screen comes up. 12.5.19 Push Alarm button. Alarm History screen comes up. 12.5.20 Push Main Menu button. Menu Screen screen comes up. __________(y/n) __________(y/n) __________(y/n)
_________________________ Signature/Date
Form # 1030 032A

COMMENTS _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________
DATE: 15/04/2005 DATE: 16/04/2005
GENERAL DATA
Note:
The purpose of this General Data form is to record any additional data logged during the execution of the protocol and to supplement specific Operational Qualification forms.
Observations: _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________
Form # 1030 033A

DATE: 15/04/2005 DATE: 16/04/2005
CONTROL PANELS
13.1 FRONT CONSOLE is equipped and works according to the Electrical Schematics HGM-2000-0 Revision 1 _________ (y/n) 13.2 MAIN ELECTRICAL PANEL - is equipped and works according to the Electrical Schematics HGM-200-0 Revision 1 _________ (y/n) 13.3 MIDDLE PUSH BUTTON STATION - is equipped and works according to the Electrical Schematics HGM-2000-0 Revision 1 _________ (y/n) 13.4 REAR PUSH BUTTON STATION - is equipped and works according to the Electrical Schematics HGM-200-0 Revision 1 _________ (y/n) 13.5 BODY JOG STATION-is equipped and works according to the Electrical Schematics HGM-2000-0 Revision 1 _________ (y/n) 13.6 CAP JOG STATION - is equipped and works according to the Electrical Schematics HGM-2000-0 Revision 1 _________ (y/n) 13.7 PNEUMATIC CONTROL PANEL - is equipped and works according to the Electrical Schematics Form # 1030 034A

TES DOC 001 Rev 16/04/2005 Page 35 of 39 HGM-200-0 Revision 1 INSTALLATION # WIN 001 _________ (y/n)
COMMENTS All printout of screens will be supplied with the electrical manual.
DATE: 15/04/2005 DATE: 16/04/2005
UTILITIES REQUIREMENTS
EQUIPMENT NAME: TES-E (7) HARD CAPSULE MACHINE MODEL HGCM-0 List below all utilities required by the equipment for satisfactory operation. Electrical AC Voltage 110/220VAC Amperage 200A Phases Three
Compressed Air Yes
Pressure 2 - 5 bars
Flow Rate N/AP
Vacuum N/AP
Inches of Hg N/AP
Volume N/AP
Form # 1030 035A

Water N/AP
Pressure N/AP
Flow Rate N/AP.
Temperature N/AP
COMMENTS: _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________________ _____________________________________________________________________________ CONDUCTED BY: IOAN BALC REVIEWED BY: IOAN BALC DATE: 15/04/2005 DATE: 16/04/2005
MANUALS
EQUIPMENT NAME: TES-E (7) HARD CAPSULE MACHINE The following reference manuals are on file at Technophar Equipment & Service Ltd. Vendor Technophar Equipment & Service Ltd. Technophar Equipment & Service Ltd. . Manual Title Mechanical Components Manual Electrical Components Manual
Form # 1030 036A

COMMENTS:
DATE: 15/04/2005 DATE: 16/04/2005
DRAWINGS
Equipment Name: TES-E (7) HARD CAPSULE MACHINE MODEL HGCM-0
The following reference drawings are on file at T.E.S. LTD. Engineering Dept.
Drawing # 09920 30675 30760 07390 1-00044,1-00046, 1-00047 09688, 09630, 09531 30214 Form # 1030 037A
Drawing Title HGCM General Assembly Bases assembly Dipper General assembly Greaser Automatics Assembly Table Section Assembly Main Drive
Revision # N/AP N/AP N/AP N/AP N/AP N/AP N/AP
Revision Date Jan.20.03 May.03 Jan.10.03 Aug.21 03 Jan.02 Jul.02 Mar.21.03

TES DOC 001 09777 30300 06041, 06512, 06043, 09518, 09486 30550 Rev 16/04/2005 Page 38 of 39 Foundation Layout Frame assembly Transferring Drying Kiln Assembly INSTALLATION # WIN 001 A N/AP N/AP N/AP Sep.29.03 Mar.03.03 Aug.99 Aug.03
COMMENTS: ______________________________________________________________________________________ ______________________________________________________________________________________ ______________________________________________________________________________________ ______________________________________________________________________________________ CONDUCTED BY: IOAN BALC REVIEWED BY: IOAN BALC DATE: 15/04/2005 DATE: 16/04/2005
SUMMARY AND CONCLUSION

All requirements of the Installation/Operational Qualification Protocol have been completed, and the appropriate data forms reviewed. ____________________________ Signature/Date All comments, deviations, exceptions and significant notes related to the Installation/Operational Qualification of this system are listed below in the COMMENTS section. This includes actions taken and/or justification for changes to the acceptance criteria. ____________________________ Signature/Date
2.
Form # 1030 038A

COMMENTS: _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________ 2 This Installation/Qualification has been completed; the results have been reviewed and found to be acceptable. It has been determined that the outstanding items have been addressed, with the corrective actions decided upon and their targeted implementation dates outlined as per the attached reports.
. REVIEWED BY: IOAN BALC
____________________________ Signature/Date DATE: 16/04/2005
Form # 1030 039A

Iq-Oq HCGM - Ab Pakistan

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TECHNOPHAR EQUIPMENT & SERVICE LTD.

INSTALLATION/OPERATIONAL QUALIFICATION PROTOCOL

INSTALLATION AND OPERATIONAL QUALIFICATION FOR THE

This protocol, when signed below, is approved for execution.

Form # 1030 01A

TECHNOPHAR EQUIPMENT & SERVICE LTD.

Protocol Profile 1.0 PURPOSE

DOCUMENTATION AND RECORDS

Form # 1030 02A

TECHNOPHAR EQUIPMENT & SERVICE LTD.

Protocol Profile (contd) 6.0 REFERENCES

7.0 EQUIPMENT LISTING AND OPERATION DESCRIPTION Equipment List

TECHNOPHAR EQUIPMENT & SERVICE LTD.

CONDUCTED BY: IOAN BALC REVIEWED BY: IOAN BALC

DATE: 15/04/2005 DATE: 16/04/2005

Form # 1030 04A

TECHNOPHAR EQUIPMENT & SERVICE LTD.

INSTALLATION AND OPERATIONAL PREREQUISITES

TECHNOPHAR EQUIPMENT & SERVICE LTD.

INSTALLATION AND OPERATIONAL PREREQUISITES

CONDUCTED BY: IOAN BALC REVIEWED BY: IOAN BALC

DATE: 15/04/2005 DATE: 16/04/2005

Form # 1030 06A

TECHNOPHAR EQUIPMENT & SERVICE LTD.

Description Manufacturer Model Number Serial Number Materials of Construction

CONDUCTED BY: IOAN BALC REVIEWED BY: IOAN BALC

DATE: 15/04/2005 DATE: 16/04/2005

Form # 1030 07A

TECHNOPHAR EQUIPMENT & SERVICE LTD.

INSTALLATION AND VERIFICATION (MOTORS)

Dish Motor Data BODINE BODINE #6269

Manufacturer Model Number Serial Number Volt/Amp/Phase Rpm Power Cycle

T.E.S., Electrical Dept. T.E.S., Electrical Dept. Installation

130 VDC/0.25 A 29 1/23 HP -

Form # 1030 08A

TECHNOPHAR EQUIPMENT & SERVICE LTD.

INSTALLATION AND VERIFICATION (MOTORS)

Dipper Servo Motor

Data N/AP N/AP N/AP N/AP N/AP N/AP N/AP

TECHNOPHAR EQUIPMENT & SERVICE LTD.

REVIEWED BY: IOAN BALC

INSTALLATION AND VERIFICATION (MOTORS)

Source of Data T.E.S., Electrical Dept. T.E.S., Electrical Dept. Installation

220VAC/0.45A/1 Phase 47 1/45HP 60

130VDC/ 0.71A 417 1/12 W -

CONDUCTED BY: IOAN BALC REVIEWED BY: IOAN BALC

DATE: 15/04/2005 DATE: 16/04/2005

Form # 1030 010A

TECHNOPHAR EQUIPMENT & SERVICE LTD.

INSTALLATION AND VERIFICATION (MOTORS)

CONDUCTED BY: IOAN BALC Form # 1030 011A

TECHNOPHAR EQUIPMENT & SERVICE LTD.

REVIEWED BY: IOAN BALC

INSTALLATION AND VERIFICATION (MOTORS)

DATE: 15/04/2005 DATE: 16/04/2005

TECHNOPHAR EQUIPMENT & SERVICE LTD.

TEST EQUIPMENT AND MATERIALS

ITEM Digital Photo/Contact Tachometer. Multimeter Micro Cal 2+

MANUFACTURER Kleton Hoskin Scientific

MODEL # K4010 DHT920

SERIAL # L270529 960489

CAL. DATE March 10, 2003 Feb 5, 2003

(y/n) (y/n) (y/n) (y/n) (y/n) (y/n) __(y/n)

(y/n) (y/n) (y/n) (y/n) (y/n) (y/n) (y/n) __________________ Signature/Date

(y/n) (y/n) (y/n) (y/n) (y/n) (y/n) _________________ Signature/Date