iq-oq hcgm - ab pakistan

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TECHNOPHAR EQUIPMENT & SERVICE LTD.

INSTALLATION/OPERATIONAL QUALIFICATION PROTOCOL

TES DOC 001 Rev 16/04/2005 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 A CCEPTANCE CRITERIA

4.1 INSTALLATION

A. Equipment is installed as per “as built” drawings and manualsB. 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 allof 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 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.5.2 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.

5.3 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 takingany 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 (cont’d)

6.0 REFERENCES

6.1 GELCAPS (PAKISTAN) INVOICE Project No. N/AV`

6.2 GELCAPS (PAKISTAN) INVOICE # N/AV

6.3 Manuals from: Technophar Equipment & Service Ltd., Engineering Dept.

6.4 Installation drawings from Technophar Equipment & Service Ltd., Engineering Dept.

6.5 Definitions:

Whenever the abbreviation “N/AP” is used in this protocol, it shallmean “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 thefollowing major components:

7.1 Dipper Section

7.2 Greaser Section.

7.3 Automatic Section.

7.4 Table Section.

7.5 Hydraulic Section.

7.6 Rear Section

Operation Description

Gelatin in liquid form is fed into the machine’s 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 areflipped 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

ITEM NAME1

1

2

3

4

4

5

6

7

7

8

12

13

13

14

32

33

33

34

34

35

35

36

36

37

37

38

38Authorizations Page 1Protocol Profile 2IQ/OQ Matrix 1Installation and operational

prerequisites2

Installation (Equipment) 1

Installation (Motors) 5Test Equipment and Materials 1Testing Procedures 19General Data 1Control Panel(s) 1Utilities Requirements 1Manuals 1Drawings 1Summary & Conclusion 1

COMMENTS:

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

CONDUCTED BY: IOAN BALC DATE: 15/04/2005

REVIEWED BY: IOAN BALC 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 ___________________15/02/05

Signature/Date

2. 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.

___________________15/02/05Signature/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

3. Verify that all of the instruments associated with this system (including those used for testing) have beencalibrated, and that the calibration period will not expire before the execution of this protocol has been

completed.___________________15/02/05

Signature/Date

4. All materials and test equipment are available for executing this protocol.

____________________15/02/05

Signature/Date

COMMENTS:

_____________________________________________________________________________________ _____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________



Form # 1030 05A






INSTALLATION AND OPERATIONAL PREREQUISITES

EQUIPMENT NAME; TES-E (7) HARD CAPULE MACHINE MODEL HGCM-0

1. The equipment has been installed as per the manufacturer’s 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 motorschecked for proper rotation.

___________________15/02/05

Signature/Date

3. Adequate compressed air supply is available and hooked up (performed) by the customer.

___________________15/02/05Signature/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.

______________________________________________________________________________________

______________________________________________________________________________________ ______________________________________________________________________________________

______________________________________________________________________________________



Form # 1030 06A






INSTALLATION AND VERIFICATION (EQUIPMENT)


COMPONENT: HARD CAPSULE MACHINE

Description Data Source of Data

Manufacturer Technophar Equipment &Service Ltd. T.E.S., Engineering Dept.

Model Number HGCM-0 T.E.S., Engineering Dept.

Serial Number 04-04 T.E.S., Engineering Dept.

Materials of Construction Various, see mechanical B.O.M. T.E.S., Engineering Dept.

COMMENTS:



Form # 1030 07A






INSTALLATION AND VERIFICATION (MOTORS)


COMPONENT: DIPPER SECTION

BODY SIDE:

Description

Dipper Roll

Elevat

or

Servo

Motor

Dipper Servo

MotorWater Pump Dish Motor

Source of Data

Data Data Data Data

Manufacturer N/AP N/AP MARCH BODINE T.E.S., Electrical Dept

Model Number N/AP N/APMARCH #TE-

MDX-MT3BODINE #6269 T.E.S., Electrical Dept

Serial Number N/AP N/AP Installation

Volt/Amp/Phase N/AP N/AP 230VAC/ 0.75A/Three 130 VDC/0.25 A T.E.S., Electrical Dept

Rpm N/AP N/AP 3000 29 T.E.S., Electrical Dept

Power N/AP N/AP 0.75 HP 1/23 HP T.E.S., Electrical Dept

Cycle N/AP N/AP 60Hz - T.E.S., Electrical Dept

Form # 1030 08A







COMPONENT: DIPPER SECTION (CONTINUED)

CAP SIDE:

Description

Dipper Roll

Elevat

or

Servo

Motor

Dipper Servo

Motor

Water Pump Dish Motor

Source of Data

Data Data Data Data

Manufacturer N/AP N/AP MARCH BODINE T.E.S., Electrical Dept.

Model Number N/AP N/APMARCH #TE-

MDX-MT3BODINE #6269 T.E.S., Electrical Dept.

Serial Number N/AP N/AP Installation

Volt/Amp/Phase N/AP N/AP230VAC/ 0.75A/

Three130 VDC/0.25 A T.E.S., Electrical Dept.

Rpm N/AP N/AP 3000 29 T.E.S., Electrical Dept.

Power N/AP N/AP 0.75 HP 1/23 HP T.E.S., Electrical Dept

Cycle N/AP N/AP 60Hz - T.E.S., Electrical Dept

COMMENTS:

_____________________________________________________________________________________ _____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________


Form # 1030 09A








EQUIPMENT NAME: TES TES-E (7) HARD CAPSULE MACHINE

COMPONENT: GREASER SECTION

Description

Lower Conveyor

Motor

Upper Conveyor

Motor Source of Data

Data Data

Manufacturer BODINE BODINE T.E.S., Electrical Dept.

Model Number BODINE #1573 BODINE #6165 T.E.S., Electrical Dept.

Serial Number Installation

Volt/Amp/Phase220VAC/0.45A/1

Phase130VDC/ 0.71A T.E.S., Electrical Dept.

Rpm 47 417 T.E.S., Electrical Dept.

Power 1/45HP 1/12 W T.E.S., Electrical Dept

Cycle 60 - T.E.S., Electrical Dept

COMMENTS:



Form # 1030 010A







EQUIPMENT NAME: TES TES-E (7) HARD CAPSULE MACHINE

COMPONENT: TABLE SECTION

DescriptionMain Drive

Source of DataData

Manufacturer SEW EURODRIVE (W/ BRAKE @110 VAC) T.E.S., Electrical Dept.

Model Number SEW EURODRIVE #RX57DT100L4BMG4HF T.E.S., Electrical Dept.

Serial Number N/AV Installation

Volt/Amp/Phase 208VAC/13.6A/3 Phases T.E.S., Electrical Dept.

Rpm 823 T.E.S., Electrical Dept.

Power 5HP T.E.S., Electrical Dept

Cycle 60 T.E.S., Electrical Dept

COMMENTS: _____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________


Form # 1030 011A








EQUIPMENT NAME: TES TES-E (7) HARD CAPSULE MACHINE MODEL HGCM-0

COMPONENT: HYDRAULIC SECTION

DescriptionHydraulic Pump

Source of DataData

Manufacturer LEESON T.E.S., Electrical Dept.

Model Number LEESON #G15014000 T.E.S., Electrical Dept.

Serial Number Installation

Volt/Amp/Phase 230VAC/20.0A/3 Phases T.E.S., Electrical Dept.

Rpm 1760 T.E.S., Electrical Dept.

Power 10HP T.E.S., Electrical Dept

Cycle 60 T.E.S., Electrical Dept

COMMENTS:



Form # 1030 012A






TEST EQUIPMENT AND MATERIALS


ITEM MANUFACTURER MODEL # SERIAL # CAL. DATE

Digital Photo/Contact

Tachometer.Kleton K4010 L270529

March 10,

2003

Multimeter Micro Cal 2+ Hoskin Scientific DHT920 960489 Feb 5, 2003

NOTE: The calibration of all test equipment must be NIST traceable

COMMENTS:

______________________________________________________________________________________

______________________________________________________________________________________ ______________________________________________________________________________________

______________________________________________________________________________________



Form # 1030 013A






TESTING PROCEDURES


1.0 Main Screen

1.1 Turn the Main Power Circuit Breaker Handle on; the touch screen lights up and “Log On” screen comes

up. __________(y/n)

1.2 Touch “Log On” on the screen and the keypad comes up __________(y/n)

1.3 Enter the password and the “Main Menu” screen comes up __________(y/n)

1.4 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)

1.5 Return to the “Main Menu” and touch “Motors” on screen. “Motors” screen comes up.

__________(y/n)

1.3 Return to “Main Menu”, touch “Dipping” on screen. “Dipping” screen comes up.

__________(y/n)

1.6 Return to “Main Menu”, touch “Hydraulics” on screen. “Hydraulics” screen comes up.

__________(y/n)

1.7 Return to “Main Menu”, touch “Temperatures” on screen. “Temperatures” screen comes up. __________(y/n)

1.8 Return to “Main Menu”, touch “Viscosity” on screen. “Viscosity” screen comes up.

__________(y/n)

1.9 Return to “Main Menu”, touch “Auxiliary” on screen. “Auxiliary” screen comes up.

__________(y/n)

1.10 Return to “Main Menu”, touch “Production” on screen. “Production” screen comes up.

__________(y/n)1.11 Return to “Main Menu”, touch “Bad Dip” on screen. “Bad Dip” screen comes up.

__________(y/n)

1.12 Return to “Main Menu”, touch “Lubrication” on screen. “Lubrication” screen comes up.

__________(y/n)

1.13 Return to “Main Menu”, touch “Alarms History” on screen. “Alarms History” screen comes up.

__________(y/n)1.14 Return to “Main Menu”, touch “Access Control” on screen. “Access Control” screen comes up.

__________(y/n)1.15 Return to “Main Menu”, touch “Log Off” on screen. “Log Off” screen comes up.

__________(y/n)

____________________________

Signature/Date

Form # 1030 014A






TESTING PROCEDURES (cont’d)

EQUIPMENT NAME: TES-E (7) HARD CAPSULE MACHINE

2.0 Motors Control Screen – General Functions

2.1 From the “Main Menu”, access the “Motors Control Screen”.

2.1.1 Push “Main Drive On” button. Machine starts running . __________(y/n)

2.1.2 Push “Main Drive stopped” button. Machine stops running . __________(y/n)

2.1.3 Push “Upper Conveyor On” button. The dipper conveyor starts running. __________(y/n)

2.1.4 Push “Upper Conveyor Stopped” button. The dipper conveyor stops running __________(y/n)

2.1.5 Push “Lower Conveyor On” button. The lower conveyor starts running. __________(y/n)

2.1.6 Push “Lower Conveyor Stopped” button. The lower conveyor stops running __________(y/n)

2.1.7 Push “Cyclone On” button. The cyclone motor starts running. ____N/AP_(y/n)

2.1.8 Push “Cyclone Stopped” button. The cyclone motor stops running. ___N/AP__(y/n)

2.1.9 Push “Body Water Pump On” button. The body water pump starts running. __________(y/n)

2.1.10 Push “Body Water Pump Stopped” button. The body water pump stops running._________(y/n)

2.1.11 Push “Cap Water Pump On” button. The cap water pump starts running. __________(y/n)

2.1.12 Push “Cap Water Pump Stopped” button. The cap water pump stops running. __________(y/n)

2.1.13 Push “Body Dish Drive Off” button. The body dish motor starts running. __________(y/n)

2.1.14 Push “Cap Dish Drive Off” button. The cap dish motor starts running. __________(y/n)

2.1.15 Push “Speed Ctrl” button. “Speed Control” screen comes up. __________(y/n)

2.1.16 Push “Hydr” button. “Hydraulics” screen comes up. __________(y/n)

2.1.17 Push “Dip” button. “Dipper Control” screen comes up. __________(y/n)

2.1.18 Push “Heat” button. “Temperature” screen comes up. __________(y/n)

2.1.19 Push “Visc” button. “Viscosity” screen comes up. __________(y/n)

Form # 1030 015A






Signature/Date

____________________________

TESTING PROCEDURES (cont’d)EQUIPMENT NAME: TES-E (7) HARD CAPSULE MACHINE

2.1.20 Push “Prod” button. “Production” screen comes up. __________(y/n)

2.1.21 Push “Lubr” button. “Lubrication” screen comes up. __________(y/n)

2.1.22 Push “Aux” button. “Auxiliary” screen comes up. __________(y/n)

2.1.23 Push “Bad Dip” button. “Bad Dip” screen comes up. _________(y/n)

2.1.24 Push “Alarm” button. “Alarm History” screen comes up. __________(y/n)

2.1.25 Push “Main Menu” button. “Menu Screen” screen comes up. __________(y/n)

Motors Screen – Speed Controls

2.2 From the “Motors” screen, access the “Speed Controls” screen. __________(y/n)

2.2.1 Under the heading “Main Drive”, set to 30.0 RPM. Verify that the actual reading is 30.0 RPM (+ or –

6%). __________(y/n)

2.2.2 Under the heading “Body Dish Drive”, adjust to 45%. Verify that the motor is working at that capacity.

__________(y/n)2.2.3 Under the heading “Cap Dish Drive”, adjust to25%. Verify that the motor is working at that capacity.

__________(y/n)

2.2.4 Under the heading “Upper Conveyor”, adjust to 50%. Verify that the conveyor is running at that

capacity. __________(y/n)2.2.5 Push “Motors” button. “Motors” screen comes up. __________(y/n)






2.2.12 Push “Aux” button. “Auxiliary” screen comes up. __________(y/n)

2.2.13 Push “Bad Dip” button. “Bad Dip” screen comes up. __________(y/n)


Form # 1030 016A







____________________________

Signature/Date



Dipping Control Screen – General Functions

3.1 From the “Main Menu”, access the “Dipper Control Screen”. N/AP

3.1.1 Push “Dipping Motors Off” button, when in automatic mode (button in Hydraulics screen). The dipping

motors start running __________(y/n)

3.1.2 Push “Dipping Motors On” button, when in automatic mode. The dipping motors stops running

__________(y/n)

3.1.3 If Body Dipping Motor is not home, the button flashes; push “Body Dipping Not Home”. Body dipping

motor is homing . __________(y/n)

3.1.4 If Cap Dipping Motor is not home, the button flashes; push “Cap Dipping Not Home”. Cap dipping

motor is homing . __________(y/n)

3.1.5 If Dipper Elevators Motors are not home, the button flashes; push “Dipper Elevators Not Home”. Both

motors are homing . N/AP ___(y/n)

3.1.6 If an error occurs on Body Elevator Stepper Motor then push “Body Elevator Reset Errors”. The errors

are reset. _N/AP__(y/n)

3.1.7 If an error occurs on Cap Elevator Stepper Motor then push “Cap Elevator Reset Errors”. The errors arereset. _ N/AP ___(y/n)

3.1.8 Push “Body Dipping Jog Down”. Body Dipping Stepper motor jogs down. __________(y/n)

3.1.9 Push “Body Dipping Jog Up”. Body Dipping Stepper motor jogs up . __________(y/n)

3.1.10 Push “Cap Dipping Jog Down”. Cap Dipping Stepper motor jogs down . __________(y/n)

3.1.11 Push “Cap Dipping Jog Up”. Cap Dipping Stepper motor jogs up . __________(y/n)

3.1.12 Push “Dipper Elevators Jog Down”. Dipper Elevators Stepper motor jogs down ____N/AP_(y/n)

.3.1.13 Push “Dipper Elevators Jog Up”. Dipper Elevators Stepper motor jogs up. ___N/AP__(y/n)

__________________________

Signature/Date

Form # 1030 017A








Dipper Control Screen – General Functions

3.1.14 If an error occurs on Body Dipping Stepper Motor then push “Body Reset Errors”. The errors are reset.

_________(y/n)

3.1.15 If an error occurs on Cap Dipping Stepper Motor then push “Cap Reset Errors”. The errors are reset.

__________(y/n)

3.1.16 Push “Body Dipping Test” button. Body Dipping Stepper motor runs the profile input in Body Dipping

Profile screen __________(y/n)

3.1.17 Push “Cap Dipping Test” button. Cap Dipping Stepper motor runs the profile input in Cap Dipping

Profile screen

__________(y/n)

3.1.18 Push “Dipper Elevators Down” button. Dipper Elevators runs down

_N/AP___(y/n)

3.1.19 Push “Dipper Elevators Up” button. Dipper Elevators runs

__N/AP__(y/n)

3.1.20 Push “Motors” button. “Motors” screen comes up. __________(y/n)

3.1.21 Push “Hydr” button. “Hydraulics” screen comes up.

__________(y/n)

3.1.22 Push “Heat” button. “Temperature” screen comes up.

__________(y/n)

3.1.23 Push “Visc” button. “Viscosity” screen comes up.

__________(y/n)3.1.24 Push “Prod” button. “Production” screen comes up.

__________(y/n)

3.1.25 Push “Lubr” button. “Lubrication” screen comes up.

__________(y/n)

3.1.26 Push “Aux” button. “Auxiliary” screen comes up.

__________(y/n)3.1.27 Push “Bad Dip” button. “Bad Dip” screen comes up.

__________(y/n)

3.1.28 Push “Alarm” button. “Alarm History” screen comes up.

__________(y/n)3.1.29 Push “Main Menu” button. “Menu Screen” screen comes up.

__________(y/n)

__________________________

Form # 1030 018A






Signature/Date



Hydraulic Movements Screen – Hydraulic movements Verification

4.1 From the “Main Menu”, access the “Hydraulic Movements” screen.

4.2 Push the “Hydraulic Pump ON” button. The hydraulic pump will start and the button label will changeto “Hydraulic Pump Running”, allowing any hydraulic movement to be performed.

__________(y/n)

4.3 Push the “Hydraulic Pump Stopped” button. Hydraulic pump will stop and so all corresponding

movements. __________(y/n)

4.4 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 absoluteencoder 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 Push the “7-Bar Advance” button. Seven bars are moving forward. ________(y/n)

4.8 Push the “7-Bar Return” button. Seven bars are moving backward. _________(y/n)

4.9 Push the “Dipper Ejectors In” button. Ejectors are pushing in . __________(y/n)

4.10 Push the “Dipper Ejectors Out” button. Ejectors are coming out. __________(y/n)

4.11 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






4.15 Push the “Rear Middle Bar Push Advance” button. Rear middle bar arm is pushing forward.

_N/AP_____(y/n)

__________________________

Signature/Date

TESTING PROCEDURES (cont’d.)


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 Push “Dipper Elevators Down” button. Dipper Elevators runs down __________(y/n)

4.30 Push “Dipper Elevators Up” button. Dipper Elevators runs up __________(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 Push “Visc” button. “Viscosity” screen comes up. __________(y/n)

4.33 Push “Prod” button. “Production” screen comes up. __________(y/n)

4.34 Push “Lubr” button. “Lubrication” screen comes up. __________(y/n)

__________________________

Signature/DateTESTING PROCEDURES (cont’d.)


4.35 Push “Aux” button. “Auxiliary” screen comes up. __________(y/n)

4.36 Push “Bad Dip” button. “Bad Dip” screen comes up. __________(y/n)

4.37 Push “Alarm” button. “Alarm History” screen comes up. __________(y/n)

4.38 Push “Main Menu” button. “Menu Screen” screen comes up. __________(y/n)

Temperature Screen – Temperature Verification

5.1 From the “Main Menu”, access the “Temperature” screen. __________(y/n)

5.2 Push “Hydraulic Tank Off” button. Hydraulic oil tank temperature control starts. __________(y/n)

5.3 Push “Hydraulic Tank On” button. Hydraulic oil tank temperature control stops. __________(y/n)

5.4 Beside the label “SV” push the button and key in 45°C. Verify that the hydraulic oil temperature is

. 55°C (± 3%) __N/AP_(y/n)

5.5 Push “Body Dish Off” button. Body Dish temperature control starts. _________(y/n)

5.6 Push “Body Dish On” button. Body Dish temperature control stops. __________(y/n)

5.7 Beside the label “SV” push the button and key in 45°C. Verify that the body dish temperature is 45°C(± 3%) N/AP ___(y/n)

5.8 Push “Cap Dish Off” button. Cap Dish temperature control starts. __________(y/n)

Form # 1030 021A






5.9 Push “Cap Dish On” button. Cap Dish temperature control stops. __________(y/n)

5.10 Beside the label “SV” push the button and key in 45°C. Verify that the cap dish temperature is

45 C (± 3%) N/AP_____(y/n)

5.11 Push “Motors” button. “Motors” screen comes up. __________(y/n)

5.12 Push “Hydraulics” button. “Hydraulics” screen comes up. __________(y/n)

5.13 Push “Dipping” button. “Dipping” screen comes up. __________(y/n)


__________________________

Signature/Date





5.17 Push “Aux” button. “Auxiliary” screen comes up. __________(y/n)




Auxiliary Screen

7.1 Push “Machine Lights Off” button. The lights on the machine turn on. __________(y/n)

7.2 Push “Machine Lights On” button. The lights on the machine turn off. __________(y/n)

7.3 Push “Main Brake Off” button. The main motor brake is released. __________(y/n)

7.4 Push “Main Brake Engaged” button. The main motor brake is on. __________(y/n)

7.4 Push “Motors” button. “Motors Control” screen comes up. __________(y/n)

7.5 Push “Hydr” button. “Hydraulics” screen comes up. __________(y/n)

7.6 Push “Dip” button. “Dipper Control” screen comes up. __________(y/n)

Form # 1030 022A






7.7 Push “Heat” button. “Temperature buttons” screen comes up. __________(y/n)







__________________________

Signature/Date



Bad Dip – Bad Dip Table Verification

9.1 Push “Set Bad Dip Table” button. The first table is marked as bad dip every time you push this

button. __________(y/n)

9.2 Verify that the bad dip table is moving to the next position every time the front bar pusher advancemovement occurs. __________(y/n)

9.3 Push “Motors” button. “Motors” screen comes up. __________(y/n)

9.4 Push “Hydr” button. “Hydraulics” screen comes up. __________(y/n)

9.5 Push “Dip” button. “Dipper” screen comes up. ____N/AP__(y/n)

9.5 Push “Heat” button. “Temperature” screen comes up. __________(y/n)




9.9 Push “Aux” button. “Aux” screen comes up. __________(y/n)



Form # 1030 023A






Access Control – Administrator Screen

12.1.1 Push date button. The key pad comes up allowing the administrator to change the date.

__________(y/n)

12.1.2 Push time button. The key pad comes up allowing the administrator to change the time.

__________(y/n)12.1.3 Push “Body Dipping Profile” button. The “Body Dipping Profile” screen comes up.

__________(y/n)

12.1.4 Push “Cap Dipping Profile” button. The “Cap Dipping Profile” screen comes up.

__________(y/n)

12.1.5 Push “Tempearture PID” button. The “PID Control Screen” comes up.

N/AP__(y/n)

12.1.6 Push “Dipper Elevators Profile” button. The “Dipper Elevators Profile” screen comes up.

__________(y/n)

__________________________

Signature/Date




12.1.7 Push “Timing Control” button. The “Timing Setup” screen comes up. __________(y/n)

12.1.8 Push “Reset Encoder” button. The encoder position is set to zero. N/AP ___N/AP___(y/n)12.1.9 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. __________(y/n)

12.1.13 Push “Reset Downtime” button. The downtime is set to zero. __________(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. __________(y/n)

12.1.17 Push “Motors” button. “Motors Control” screen comes up. __________(y/n)


Form # 1030 024A






12.1.19 Push “Dip” button. “Dipper” screen comes up. __________(y/n)

12.1.20 Push “Heat” button. “Temperature” screen comes up. N/AP __________(y/n)




12.1.24 Push “Aux” button. “Aux” screen comes up. __________(y/n)

121..25 Push “Bad Dip” button. “Bad Dip” screen comes up. __________(y/n)

____________________________ Signature/Date






Body Dipping Profile – General Functions

12.2.1 From the “Administrator Screen”, access the “Body Dipping Profile”. __________(y/n)

12.2.2 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 Under “Speed” (Downwards Dipper Profile) enter a value. ____N/AP__(y/n)

12.2.8 Under “Downwards Dipper Profile” press Delete to delete the record. ____N/AP__(y/n)

12.2.9 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






12.2.11 Under “Speed” (Upwards Dipper Profile) enter a value. _____N/AP_(y/n)

12.2.12 Under “Upwards Dipper Profile” press Delete to delete a record. ___N/AP__(y/n)

_________________________

Signature/Date



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.







Form # 1030 026A











_________________________

Signature/Date



Cap Dipping Profile – General Functions

12.3.1 From the “Administrator Screen”, access the “Cap Dipping Profile”. _________(y/n)

12.3.2 Push “Dipper Elevators Profile” button. “Dipper Elevators Profile” screen comes up._N/AP__(y/n)

12.3.3 Return to “Cap Dipping Profile”. Push “Body Dipping Profile” button. Cap Dipping Profile comes up.

__________(y/n)12.3.4 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)

12.3.5 Under “Downwards Dipper Profile” press Add to add a record. Up to 5 records can be added.

____N/AP_(y/n)

12.3.6 Under “Position” (Downwards Dipper Profile) enter a value. ___N/AP__(y/n)

12.3.7 Under “Speed” (Downwards Dipper Profile) enter a value. ____N/AP_(y/n)

12.3.8 Under “Downwards Dipper Profile” press Delete to delete the record. ____N/AP__(y/n)

12.3.9 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






12.3.12 Under “Upwards Dipper Profile” press Delete to delete a record. ___N/AP__(y/n)

12.3.13 In the record next to “Delay” label enter a value. _________(y/n)

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)


_________________________

Signature



12.3.20 Push “Hydr” button. “Hydraulics” screen comes up. ______ __(y/n)

12.3.21 Push “Dip” button. “Dipper Control” screen comes up. _________(y/n)









Form # 1030 028A






_________________________

Signature/Date



Dipper Elevator Profile – General Functions N/.AP

12.4.1 From the “Access Control” screen, access the “Dipper Elevator Profile”. ___N/AP__(y/n)

12.4.2 Push “Body Dipping Profile” button. Body Dipping Profile comes up. ___N/AP__(y/n)

12.4.3 Push “Cap Dipping Profile” button. Cap Dipping Profile comes up. ____N/AP_(y/n)

12.4.4 The indicators on both sides of the Dipper Rolls Position label indicate the actual position

. of the elevators. _N/AP__(y/n)12.4.5 Under “Downwards Body Dipper Elevator Profile” press Add to add a record. _ N/AP __(y/n)

12.4.6 Under “Position” (Downwards Body Dipper Elevator Profile) enter a value. __ N/AP _(y/n)

12.4.7 Under “Speed” (Downwards Body Dipper Elevator Profile) enter a value. __ N/AP _(y/n)

12.4.8 Under “Downwards Body Dipper Elevator Profile” press Delete to delete the record. N/AP_(y/n)

12.4.9 Under “Downwards Cap Dipper Elevator Profile” press Add to add a record. __ N/AP _(y/n)

12.4.10 Under “Position” (Downwards Cap Dipper Elevator Profile) enter a value. _ N/AP _(y/n)

12.4.11 Under “Speed” (Downwards Cap Dipper Elevator Profile) enter a value. __ N/AP _(y/n)

12.4.12 Under “Downwards Cap Dipper Elevator Profile” press Delete to delete the record. __ N/AP _(y/n)

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






12.4.14 Under “Position” (Upwards Body Dipper Elevator Profile) enter a value. __ N/AP __(y/n)

12.4.15 Under “Speed” (Upwards Body Dipper Elevator Profile) enter a value. __ N/AP _(y/n)

12.4.16 Under “Upwards Body Dipper Elevator Profile” press Delete to delete a record. ___ N/AP _(y/n)

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. ___ N/AP _(y/n)

12.4.20 Under “Upwards Cap Dipper Elevator Profile” press Delete to delete a record. __ 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 arereset. _ 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 __ N/AP _(y/n)

12.4.25 Push “Dipper Elevators Jog Down”. Dipper Elevators Stepper motor jogs down _ N/AP__(y/n)

.

12.4.26 Push “Dipper Elevators Jog Up”. Dipper Elevators Stepper motor jogs up . _ 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)




Form # 1030 030A












_________________________ Signature/Date



Timing Setup Screen – Hydraulic movements setup for auto mode

12.5.1 From the “Access Control” screen, touch “Timing Control” button to access “Timing Setup” screen

__________(y/n)

12.5.2 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


12.5.8 Under the heading “Stop” push “DEC” button to decrement the stop position of the selected movement in


12.5.9 Under the heading “Encoder Value” is displayed the actual position of the encoder in the range 0 to 1024.

__________(y/n)



Form # 1030 031A












_________________________ Signature/Date



Timing Setup Screen – Hydraulic movements setup for auto mode




_________________________

Signature/Date

Form # 1030 032A






COMMENTS

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________



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








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






“HGM-200-0 Revision 1” _________ (y/n)

COMMENTS

All printout of screens will be supplied with the electrical manual.



UTILITIES REQUIREMENTS


List below all utilities required by the equipment for satisfactory operation.

Electrical Voltage Amperage Phases

AC 110/220VAC 200A Three

Compressed Air Pressure Flow Rate

Yes 2 - 5 bars N/AP

Vacuum Inches of Hg Volume

N/AP N/AP N/AP

Form # 1030 035A






Water Pressure Flow Rate Temperature

N/AP N/AP N/AP. N/AP

COMMENTS:

_____________________________________________________________________________________

_____________________________________________________________________________________ _____________________________________________________________________________________________

_____________________________________________________________________________



MANUALS


The following reference manuals are on file at Technophar Equipment & Service Ltd.

Vendor Manual Title

Technophar Equipment & Service Ltd. Mechanical Components Manual

Technophar Equipment & Service Ltd. Electrical Components Manual

.

Form # 1030 036A






COMMENTS:



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 # Drawing Title Revision # Revision Date

09920 HGCM General Assembly N/AP Jan.20.03

30675 Bases assembly N/AP May.03

30760 Dipper General assembly N/AP Jan.10.03

07390 Greaser N/AP Aug.21 03

1-00044,1-00046,1-00047

Automatics Assembly N/AP Jan.02

09688, 09630, 09531 Table Section Assembly N/AP Jul.02

30214 Main Drive N/AP Mar.21.03

Form # 1030 037A






09777 Foundation Layout A Sep.29.03

30300 Frame assembly N/AP Mar.03.03

06041, 06512, 06043,

09518, 09486Transferring N/AP Aug.99

30550 Drying Kiln Assembly N/AP Aug.03

COMMENTS:

______________________________________________________________________________________

______________________________________________________________________________________ ______________________________________________________________________________________

______________________________________________________________________________________



SUMMARY AND CONCLUSION


1 All requirements of the Installation/Operational Qualification Protocol have been completed, and the

appropriate data forms reviewed.

____________________________

Signature/Date

2. 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

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.

____________________________

. ` Signature/Date


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