Operational Qualification (OQ) Page1 / 32

Document No: Version No.: Date of issue:

Customer Ref. No:
ESPL-OQ-01-0014 0.00

Model : FBD 25&10 LTR

Batch No. : ESPL-120

Sr. No. : ESPL-01-0014

 Operational Qualification (OQ)

Change history

Version Reference Description, Ref. to Clauses or Chapters/Sections

Page No.

0.00 -- First official Issue, Dt.

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 Operational Qualification (OQ)

Index
1 Table Of Content .................................................................................................................... 3
2 Pre-Approval ........................................................................................................................... 4
3 Objective ................................................................................................................................. 5
4 Scope ....................................................................................................................................... 5
5 Responsibility ........................................................................................................................ 6
6 Machine Description .............................................................................................................. 7
7 Sequence Of FBD Operation ................................................................................................ 11
8 Verification Of Privileges ..................................................................................................... 12
9 Safety Features Alarms and Interlocks ................................................................................. 13
10 Validation Requirement ........................................................................................................ 16
11 Operational Qualification Tests ............................................................................................ 17
11.1 Testing of Programmable Logic Controller’s Processor ....................................................... 18
11.2 Verification of Human Machine Interface Screens – HMI ................................................... 19
11.3 Power & Communication Failure Recovery Verification ..................................................... 21
11.4 Emergency Operation Verification ....................................................................................... 22
11.5 Verification of Alarms. .......................................................................................................... 23
12 Operational Qualification Tests Status ................................................................................. 27
13 Qualification Document report Approval .............................................................................. 28
14 Discrepancy and Corrective Action Report ........................................................................... 29
15 Final Approval……………………………………………………………………………….30
16 Remark If Any ....................................................................................................................... 31
17 Appendix ............................................................................................................................... 32

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 Operational Qualification (OQ)

3. Objective:

To design, engineer, and supply the Fluid Bed Dryer –25& 10 Ltr as per cGMP and
GEP guidelines and to provide assurance that the machine is manufactured as per
the URS and 12 it complies with the Scope of Supply.
To prove that each operation proceeds as per the design specification and the
tolerances prescribed there in the document, are the same at utmost transparency.
Validation procedure is set for complete satisfaction of the customer & building
confidence of the user about the machine.

4. Scope:

The scope of this qualification document is limited to the Operational Qualification

of Fluid Bed Dryer –25& 10
This qualification document is part of a validation activity for the Fluid Bed Dryer –
25& 10
Qualification of support utilities is not within the scope of this qualification document.
The equipment shall be used for granulation and drying of different powders to be
usedin the formulation.
The equipment shall operate under dust free environment and conditions as per the
cGMP requirements.

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 Operational Qualification (OQ)

1. Responsibilities:

a) Client: -
1. To provide the URS for the Equipment.
2. To perform the Operational Qualification Test (OQ).

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 Operational Qualification (OQ)

6. Machine Description:

Process Equipment Description

The purpose of Fluid Bed Dryer is to put substances in powdery or granular form (bulk
materials) into a suspended state. The fluidizing air in this equipment will enable a very
efficient heat and mass transfer (heating, cooling, drying, and granulating).
Complete machine can be divided in following sub sections:
 Inlet Air Handling Unit
 Machine Tower (Lower Plenum, plug in process inserts, Filter Housing)
 Exhaust filtration
 Control system
Inlet Air Handling Unit: It consists of 3µm fine filter (EU7) section with Electric
heating unit and temperature measuring devices. Inlet air handling unit receives air from
the environment and processes the inlet air and controls the inlet airflow.
Product Bowl: interchangeable 25 L &10 L capacity
product bowl is manufactured in AISI 316 material for all contact parts. product bowl
holds the wet material that needs drying .its usually wet granules produced by the high
shear mixture .provision for mounting of interchangeable air distributed plate.viewing
glass ,product sample port ,product temperature port. Are provided.
Max working capacity -100%
Min working capacity- 20%
Fluidized chamber with blow back mechanism: fluidized chamber is used to fluidize
material. it’s the area just above the product container. The connection between it and
product bowl is also made airtight with an silicon gasket .its place in which fluidization
takes place as air is drawn into the main tower phase through the lower plenum and
product bowl.
The expansion chamber forms the middle part of the tower. its integrated with the filter
housing chamber that holds the filter assembly .air flow upward during fluidization and
may carry in its small particle known as fines .the filter bag prevent fines from being
exhausted. The filtering bag become clogged with particles and require cleaning to
dislodge this dust layer pneumatic operated shaking cylinder is provided for degusting the
filter bags. FDA approved silicon seals mounted at bottom to lock the product bowl
.pneumatic actuated butterfly valve at outlet.
Exhaust blower: 750 CMH
To exhaust contaminated, noxious fumes or hot air away from a process to allow
machine operators to breathe cleaner air.
It consists of centrifugal type blower with powder coated M.S housing and SS304
impeller.
CMH-750
Motor – FLP

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 Operational Qualification (OQ)

Control Panel:
A programmable logic controller (PLC) will execute the direction of the sequence of
operation. The PLC is of Mitsubishi make, model FX5U-32M series. The complete set of
control system includes field sensors, PLC system, and printer interface and command
panel. Main control system having features like detailed alarm messages, integrated
operator guide, small command panels etc.
The system shall have a PLC based control system for the following
- Controlling and maintain process parameters
- Operating the system
-Displaying essential equipment functions and parameters.
-Printing batch parameters
- Alarm annunciation.

Control System
a. The control 10 Inch Mitsubishi PLC based control HMI(Model GS2110) as
standard operating terminal with control switches.
b. All the transmitters are to be mounted inside the panel.
c. All interfacing tubing / cables will be passed through SS conducts in
manufacturingarea.
d. Automatic/manual filter bag shaking facility will be provided through PLC.
e. All the major parameters including Alarms, Filters and Product container will
bemonitored through control panel.
f. One Mains On/OFF for switching off the machine in emergency will be provided.
g. One manual setting knob with dial gauge for adjusting atomizing air pressure.
h. Four level password protections are provided
(For operator, supervisor, maintenance and Administrator).

1. Operator: This level password is normally to access parameter which operator

needs to change during batch processing, for e.g. Bag shaking time & pause
time,as operator needs to decide this based in differential pressure across filter.
2. Supervisor: Set parameter which have direct influence as process like Product
temp, Inlet temp are categorized under supervisor level password.
3. Maintenance: Certain parameters, which are related to equipment setting from
engineering point of view. This need not be change for day-to-day operation of
machine. For e.g. P, I, D setting for Inlet Temp.
4. Administrator: This level is for reference parameter for each product. This
parameter is standardizing parameter after validation hence categorized under this
level.

i. The following functions will be operated through the PLC screen

i. Fan ON/OFF
ii. Filter Active / Filter Change

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 Operational Qualification (OQ)

iii. Container Up/ Down

iv.Inlet air temperature – set & actual with PID control
v. Filter shaking interval
vi. Duration of filter shaking
vii. Manual or automatic shaking of the filter bag
viii. Process ON/OFF
ix. Heater ON/OFF
x. Different safety alarms
xi.Basic recipe handling with critical parameter setting only for reference and not
as sequence control operation
j. Printer will be provided to print the following data online.
i. Real time & date
ii. Product Name
iii. Batch number information
iv. Operator code / name
v. Set parameters (Inlet)
vi. Actual Parameters (Inlet, exhaust & Product temp.)
vii. Exhaust Fan speed (Actual / Set in %)
viii. Alarms and error messages

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 Operational Qualification (OQ)

PLC Description
The main function of a PLC is to translate the instructions into the digital or analog codes
needed to operate the device or machine.
The main function of this PLC system is to collect data from field instrumentation & display
the information on the operator station. The instruments are connected to the system
equipment and piping. The collected data will be utilized by the PLC for process control.
The user interface, based in an industrial type HMI, will assist the operator to supervise and
control the process. Based on the displayed information the operator, by means of the user
interface, can provide commands to the PLC.
The PLC then executes the operator instructions. A Mitsubishi Family FX5U-32M PLC has
been chosen as the Central Processing Unit (CPU).

The PLC system layout for the FBD machine automation is as shown below:

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 Operational Qualification (OQ)

7. Sequence of FBD Operation:

Actual
Description Specified function
Observation
Ensure Availability of
Electrical Supply and 3 phase indication lamp will be ON the control panel.
Switch ON the main And HMI will be start up on the operating panel.
switch.
Ensure availability of Pneumatic switch on the machine will indicate the
Pneumatic Supply. pneumatic pressure in green.
Login into the HMI. User access level, put user ID and Password.

Ensure all the input status. Will be displayed on the Input status list in the HMI.
Ensure the interlocks are Will be displayed on the Interlock list in the HMI.
healthy. And will be in green colour.

Select Operational Mode – HMI Menu  Mode Selection  Manual Mode 

Manual Operational parameters  Start the process.

HMI Menu  Recipe  Create Recipe  Put

necessary operational parameters  Save recipe 
Preparing Recipe
Load Recipe.

HMI Menu  Recipe Load  Load desired Recipe

Select Operational Mode –  HMI Menu  Mode Selection  Auto Mode 
Auto Operational parameters  Start the process.

Alarm Verification Will be displayed in Alarm History

Note:
Above explained sequence is a standard sequence of Operations, which can be altered
(if required) according to the requirements during commissioning & actual observations.

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8.0 Verification of Privileges:

Purpose:
To protect screen access by user levels

Test Equipment:
Not required.

Procedure:
1. Login by using user name & password allocated as per level.
2. Check the access as mentioned in table.
3. Verify that the specified user gets access/restrict as mentioned in table.

Acceptance Criteria:
1. Unauthorized person can’t access the system.

Access Operator Supervisor Manager Maintenance Admin

Auto Mode Yes Yes Yes No Yes

Manual Mode Yes Yes Yes No Yes
Recipe
No Yes Yes No Yes
Edit/Save
Recipe Load Yes Yes Yes No Yes
Recipe Delete No No Yes No Yes

Alarm Yes Yes Yes Yes Yes

Alarm Set-
No Yes Yes Yes Yes
points
Overview Yes Yes Yes Yes Yes
Manual
No Yes Yes No Yes
Settings
Maintenance No No No Yes Yes

Conclusions / Comments:

Result: - _______________________________________________________________

Verified By: _______________________ Date: ______________

Reviewed By:________________________ Date: ____________

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 Operational Qualification (OQ)

9.0 Safety Features Alarms and Interlocks: -

Sr.
Alarm Interlocks Observation
No
If Motor Circuit Breaker trip because of overload or
1. Blower MCB Tripped short circuit or it is kept off, then this alarm will be
generated.
Due to malfunction in electrical supply i.e. over voltage,
Check Electrical
2. under voltage, single phase etc, then this alarm will be
Monitor Relay
generated.
Emergency Stop If emergency stop button is pressed then this alarm will
3. Pressed be generated.

During the machine operation, if the inlet air

Inlet Temperature <
4. temperature drops below the minimum set value, then
Minimum
this alarm will be generated.

During the machine operation, if the inlet air

Inlet Temperature <
5. temperature drops below the minimum minimum set
Minimum Minimum
value, then this alarm will be generated.

During the machine operation, if the Inlet air

Inlet Temperature >
6. temperature crosses the maximum set value, then this
Maximum
alarm will be generated.

During the machine operation, if the Inlet air

Inlet Temperature >
7. temperature crosses the maximum maximum set value,
Maximum Maximum
then this alarm will be generated.

Inlet Temperature During M/C operation if Sensor disconnection detected,

8. Sensor Fail then this alarm will be generated

During the machine operation, if the Product

Product Temperature <
9. temperature drops below the minimum set value, then
Minimum
this alarm will be generated.

During the machine operation, if the Product

Product Temperature <
10. Minimum Minimum temperature drops below the minimum minimum set
value, then this alarm will be generated.

During the machine operation, if Product temperature

Product Temperature >
11. Maximum crosses the maximum set value, then this alarm will be
generated.

During the machine operation, if Product temperature

Product Temperature >
12. Maximum Maximum crosses the maximum maximum set value, then this
alarm will be generated.

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 Operational Qualification (OQ)

During machine operation, if Product temperature is less

Product Temperature < than set point and Operator tries to start Spray Pump or
13. Set during machine operation Product temperature drops
below set point, then this alarm will be generated.

Product Temperature During M/C operation if Sensor disconnection detected,

14. Sensor Fail then this alarm will be generated

During the machine operation, if exhaust air

Exhaust Temperature <
15. Minimum temperature drops below the minimum set value, then
this alarm will be generated.
During the machine operation, if exhaust air
Exhaust Temperature <
16. Minimum Minimum temperature drops below the minimum minimum set
value, then this alarm will be generated.

During the machine operation, if exhaust Air

Exhaust. Temperature >
17. Maximum temperature crosses the maximum set value, then this
alarm will be generated.

During the machine operation, if exhaust Air

Exhaust. Temperature >
18. Maximum Maximum temperature crosses the maximum maximum set value,
then this alarm will be generated.

Exhaust Temperature During M/C operation if Sensor disconnection detected,

19. Sensor Fail then this alarm will be generated

During the machine operation if Air Flow drops below

Inlet Air Flow <
20. Minimum the minimum set value, then this alarm will be
generated.

During the machine operation if Inlet Air Flow drops

Inlet Air Flow <
21. Minimum Minimum below the minimum minimum set value, then this alarm
will be generated.

Inlet Air Flow Sensor During M/C operation if Sensor disconnection detected,
22. Fail then this alarm will be generated
Operating Air Pressure If the Air Pressure drops below the minimum set value,
23. < Minimum then this alarm will be generated.

During the machine operation or Spray Test if

Atomisation Air
24. Pressure < Minimum Atomisation air pressure drops below minimum set
value, then this alarm will be generated.

During the machine operation, if differential pressure

DP HEPA Inlet >
25. Maximum across Inlet HEPA filter crosses the maximum set value,
then this alarm will be generated.

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During the machine operation, if differential pressure

DP HEPA Inlet >
26. Maximum Maximum across Inlet HEPA filter crosses the maximum
maximum set value, then this alarm will be generated.

During the machine operation, if differential pressure

DP HEPA Inlet <
27. Minimum across Inlet HEPA filter drops below the minimum set
value, then this alarm will be generated.

During the machine operation, if differential pressure

DP HEPA Inlet <
28. Minimum Minimum across Inlet HEPA filter drops below the minimum
minimum set value, then this alarm will be generated.

During process if DP across the filter bag crosses the

29. DP Filter > Maximum maximum set value, then this alarm will be generated.

DP Filter > Maximum During process if DP across the filter bag crosses the
30. Maximum maximum set value, then this alarm will be generated.

DP Product > During process if DP across the product crosses the

31. Maximum maximum set value, then this alarm will be generated.

During process if DP across the product crosses the

DP Product >
32. Maximum Maximum maximum maximum set value then this alarm will be
generated.
If operator Deflates the Container Seal while
Disconnect Product
33. Temperature Probe Temperature probe in connected condition, then this
message will appear.
If operator tries to start process with Product
Connect Product Temp.
34. Probe temperature probe disconnected, then this message will
appear.

If any one of the alarms occurs there will be RED flashing Bell Symbol on HMI Control
along with the buzzer mounted inside the control panel. This Audio- Visual indication will
guide the operator about the tripping of machine, operator then have to click the button
“Bell Symbol” on the HMI, which will show the actual reason for the machine tripping.
Conclusions / Comments:

Result: - _______________________________________________________________

Verified By: _______________________ Date: ______________

Reviewed By: ________________________Date: ______________

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 Operational Qualification (OQ)

10.0 Validation Requirement:

The following requirement / practices apply to OQ activities:

Verify that system is installed in accordance with approved engineering drawings and
documents, which shall include the following (as applicable).

 G.A. Drawings, Layout Drawing & Electrical wiring drawings.

 OEM / Bought out Components Drawings, Installation & operating Manuals.

 Verify that the equipment and instrumentation are clearly described as per vendor, model,
Capacity, materials of construction and any critical criteria.

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 Operational Qualification (OQ)

11.0 Operational Qualification Tests:

Test Number Critical Feature

Testing of Programmable Logic Controller’s

11.1
Processor
Verification of Human Machine Interface
11.2
Screens – HMI
Power & Communication Failure Recovery
11.3
Verification

11.4 Emergency Operation Verification

11.5 Verification of Alarms.

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11.1 Testing of Programmable Logic Controller’s Processor

Purpose:
To verify the normal operation of PLC Processor by observing the processor module’s LED status indicator
after turning on the PLC.
Test Equipment:
Not required.
Procedure:
1. Turn panel power to ON position.
2. Turn PLC power to ON position.
3. Check that PLC Processor is in RUN Mode.
4. Document the following indicators located on PLC front panel.

Acceptance Criteria:
The processor should function as specified in the verification table.

Verification results:

Complies Remarks
Indicator Specified Actual
Yes / No/ NA

LED on when PLC power

Power LED
applied

LED on when PLC is in

RUN LED
RUN Mode
If actual result is not like that of, expected result. Turn power
to panel “OFF” and notify to engineer. Document any
discrepancies on the operational qualification deviation report.

Conclusions / Comments:

Result: - _______________________________________________________________

Checked By: _______________________ Date: ______________

Verified By: ________________________Date: ______________

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11.2 Verification of Human Machine Interface Screens – HMI

Purpose:
To verify that the screens displayed by the HMI according to the system requirements.
Test Equipment:
Not required.
Procedure:
1. Access the HMI and verify that all of the functions on each of the screens listed below confirm to the
Manual.
2. Record the results of verification on test data sheets.

Acceptance Criteria:
1. The system shall operate as per design specification.

Results of HMI screen verification:

Stimulate Complies Remarks

Procedure Expected Result
Yes / No/ NA

Start Up This screen will display Operator station will

Screen whenever the operating display the Start Up
terminal starts. screen at the startup.
Selection Press the MENU button on the
Operator station will
Screen startup screen and check
display the Selection
whether that Selection screen
screen.
opens
Enter respective user ID and
Auto Mode password, then Press the
Operator station will
Screen AUTO MODE key on the
display the Auto
Mode Selection screen and
Mode screen.
check whether that Auto Mode
screen opens.
Press the
Manual
MANUAL MODE key on the Operator station will
Mode screen display the Manual
Mode Selection screen and
check whether that Manual Mode screen.
Mode screen opens.

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 Operational Qualification (OQ)

Stimulate Complies
Procedure Expected Result Yes / No/ NA Remarks
Press the Alarm Log key on
Operator station will
Alarm the Selection screen and check
display the Alarm
history whether that Alarm History
Log screen.
Screen screen opens.
Input / Press the IO Status key on the
Operator station will
Output Status Selection screen and check
display the Input &
Screen whether that IO Status screen
Output screen.
opens.
Batch Report Press the Reports key on the Operator station will
and Audit Selection screen and check display the reports
Trail whether that Manual Mode generated on the
screen opens. screen

Note: - Screens are accessible only for authorized person, means operator should enter the password via
LOG IN key before operate the specific password level of HMI.

Conclusions / Comments:

Result: - _______________________________________________________________

Checked By: _______________________ Date: ______________

Verified By: ________________________Date: ______________

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11.3 Power & Communication Failure Recovery Verification

Purpose:
To verify that in the event of a power failure, the equipment will stop in safe condition and
the operating parameter will not be lost or corrupted.

Test Equipment:
Not required.

Sr. Procedure Checked Observed

No. Value Value
1
Operate the equipment in automatic mode or Manual mode.
2 Start the operation and not the set and actual parameters of the
process.
3
While the FBD is in operation, shut down the main power switch.

4
Record if the equipment stops in a safe and secure condition.
5
Wait for 3 minutes then restore power to the equipment.
6 Restart the equipment. Record whether the equipment starts
normally, and note any adverse condition.
7 Verify that the parameters recorded in the step 2 are unchanged
after the power failure and they are retentive.

8 Record the displayed date and time after the power failure.

Conclusions / Comments:

Result: - _______________________________________________________________

Verified By: _______________________ Date: ______________

Reviewed By: ________________________ Date: ______________

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11.4 Emergency Operation Verification

Purpose:
To deactivate the equipment in the event of an emergency stop.

Test Equipment:
Not required.
Procedure:
1. With the emergency stop pressed in, try to cause movement of an operating function.
2. With the equipment in operation, activate (press in) the emergency stop.

Acceptance Criteria:
1. The equipment will be inoperative.
2. The operation will ramp to a complete stop in four seconds or less.

Failsafe Results:
Emergency Stop
Complies
Test Acceptance Criteria Yes / No/ NA Remarks
With the emergency stop The equipment will be
pressed in, try to perform an inoperative.
operation of machine
With the equipment in The process will stop in 5
operation, press the emergency seconds or less.
stop button.

Conclusions / Comments:

Result: -
_______________________________________________________________

Checked By: _______________________ Date: ______________

Verified By: ________________________Date: ______________

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11.5 Verification of Alarms

Purpose:
To verify alarms function and respond according to the system design.

Test Equipment:
Not required.

Procedure:
1. Place the equipment into normal operation mode.
2. Trigger each alarm outline in the table below.
3. Verify that the specified alarm response is obtained and the correct alarm is displayed on the HMI Screen.
4. Once the alarm has been activated, resolve the problem and reset.
5. Verify that the equipment returns to normal operation mode.

Acceptance Criteria:
1. The alarms function and respond according to the system design.

Results of Verification of Alarms:

Alarm Verification
Sr.
Alarm Actual Occurrence Simulation Impact Remark
No
If Motor Circuit Breaker trip because
Blower MCB of overload or short circuit or it is Trip the Blower VFD Process
1. Tripped kept off, then this alarm will be MCB. Will Stop
generated.
Due to malfunction in electrical
Check
supply i.e. over voltage, under Switch off the 3 phase Process
2. Electrical voltage, single phase etc, then this supply. Will Stop
Monitor Relay
alarm will be generated.
Emergency If emergency stop button is pressed Press the Emergency Stop Process
3. Stop Pressed then this alarm will be generated. on the control panel. Will Stop
During the machine operation, if the
Put the value lower then
inlet air temperature drops below the
Inlet the actual inlet temp in
minimum set value, then this alarm Only
4. Temperature < will be generated.
the alarm setpoint screen
Alarm
Minimum wherever applicable and
start the process.
Put the value lower then
Inlet During the machine operation, if the
the actual inlet temp in
Temperature < inlet air temperature drops below the Process
5. Minimum the alarm setpoint screen
minimum minimum set value, then Will Stop
wherever applicable and
Minimum this alarm will be generated.
start the process.
Put the value greater then
During the machine operation, if the
Inlet the actual inlet temp in
Inlet air temperature crosses the Only
6. Temperature > maximum set value, then this alarm
the alarm setpoint screen
Alarm
Maximum wherever applicable and
will be generated.
start the process.

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Put the value greater then

Inlet During the machine operation, if the
the actual inlet temp in
Temperature > Inlet air temperature crosses the Process
7. Maximum the alarm setpoint screen
maximum maximum set value, then Will Stop
wherever applicable and
Maximum this alarm will be generated.
start the process.
Inlet During M/C operation if Sensor Disconnect the Inlet
Process
8. Temperature disconnection detected, then this temperature sensor from
Will Stop
Sensor Fail alarm will be generated the control panel.
Put the value lower then
During the machine operation, if the
Product the actual product temp in
Product temperature drops below the Only
9. Temperature < minimum set value, then this alarm
the alarm setpoint screen
Alarm
Minimum wherever applicable and
will be generated.
start the process.
Put the value lower then
Product During the machine operation, if the
the actual product temp in
Temperature < Product temperature drops below the Process
10. Minimum the alarm setpoint screen
minimum minimum set value, then Will Stop
wherever applicable and
Minimum this alarm will be generated.
start the process.
Put the value greater then
During the machine operation, if
Product the actual product temp in
Product temperature crosses the Only
11. Temperature > maximum set value, then this alarm
the alarm setpoint screen
Alarm
Maximum wherever applicable and
will be generated.
start the process.
Put the value greater then
Product During the machine operation, if
the actual product temp in
Temperature > Product temperature crosses the Process
12. Maximum the alarm setpoint screen
maximum maximum set value, then Will Stop
wherever applicable and
Maximum this alarm will be generated.
start the process.
During machine operation, if
Product temperature is less than set Put the value lower then
Product point and Operator tries to start the actual product temp in
Process
13. Temperature < Spray Pump or during machine the alarm setpoint screen
Will Stop
Set operation Product temperature drops wherever applicable and
below set point, then this alarm will start the process.
be generated.
Product During M/C operation if Sensor Disconnect the Product
Process
14. Temperature disconnection detected, then this temperature sensor from
Will Stop
Sensor Fail alarm will be generated the control panel.
Put the value lower then
During the machine operation, if
Exhaust the actual inlet temp in
exhaust air temperature drops below Only
15. Temperature < the minimum set value, then this
the alarm setpoint screen
Alarm
Minimum wherever applicable and
alarm will be generated.
start the process.
Put the value lower then
During the machine operation, if
Exhaust the actual exhaust temp in
exhaust air temperature drops below Process
16. Temperature < the minimum minimum set value,
the alarm setpoint screen
Will Stop
Minimum wherever applicable and
then this alarm will be generated.
start the process.
Put the value greater then
During the machine operation, if
Exhaust. the actual exhaust temp in
exhaust Air temperature crosses the Only
17. Temperature > maximum set value, then this alarm
the alarm setpoint screen
Alarm
Maximum wherever applicable and
will be generated.
start the process.

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 Operational Qualification (OQ)

Put the value greater then

Exhaust. During the machine operation, if
the actual exhaust temp in
Temperature > exhaust Air temperature crosses the Process
18. Maximum the alarm setpoint screen
maximum maximum set value, then Will Stop
wherever applicable and
Maximum this alarm will be generated.
start the process.
Exhaust During M/C operation if Sensor Disconnect the Exhaust
Process
19. Temperature disconnection detected, then this temperature sensor from
Will Stop
Sensor Fail alarm will be generated the control panel.
Put the value lower then
During the machine operation if Air
the actual CFM in the
Inlet Air Flow Flow drops below the minimum set Only
20. < Minimum alarm setpoint screen
value, then this alarm will be Alarm
wherever applicable and
generated.
start the process.
Put the value lower then
During the machine operation if Inlet
Inlet Air Flow the actual CFM in the
Air Flow drops below the minimum Process
21. < Minimum minimum set value, then this alarm
alarm setpoint screen
Will Stop
Minimum wherever applicable and
will be generated.
start the process.
During M/C operation if Sensor Disconnect the Inlet CFM
Inlet Air Flow Process
22. Sensor Fail disconnection detected, then this sensor from the control
Will Stop
alarm will be generated panel.
Operating Air If the Air Pressure drops below the Cutoff the Main incoming
Process
23. Pressure < minimum set value, then this alarm Air supply to the control
Will Stop
Minimum will be generated. panel.
Put the value lower then
During the machine operation or
the actual Atomisation air
Atomisation Spray Test if Atomisation air
pressure in the alarm Only
24. Air Pressure < pressure drops below minimum set
setpoint screen wherever Alarm
Minimum value, then this alarm will be
applicable and start the
generated.
process.
Put the value greater then
During the machine operation, if
the actual Exhaust Hepa
DP HEPA differential pressure across Inlet
DP in the alarm setpoint Only
25. Inlet > HEPA filter crosses the maximum
screen wherever Alarm
Maximum set value, then this alarm will be
applicable and start the
generated.
process.
Put the value greater then
During the machine operation, if
DP HEPA the actual Exhaust Hepa
differential pressure across Inlet
Inlet > DP in the alarm setpoint Process
26. Maximum HEPA filter crosses the maximum
screen wherever Will Stop
maximum set value, then this alarm
Maximum applicable and start the
will be generated.
process.
Put the value lower then
During the machine operation, if
the actual Exhaust Hepa
DP HEPA differential pressure across Inlet
DP in the alarm setpoint Only
27. Inlet < HEPA filter drops below the
screen wherever Alarm
Minimum minimum set value, then this alarm
applicable and start the
will be generated.
process.
Put the value lower then
During the machine operation, if
DP HEPA the actual Inlet Hepa DP
differential pressure across Inlet
Inlet < in the alarm setpoint Process
28. Minimum HEPA filter drops below the
screen wherever Will Stop
minimum minimum set value, then
Minium applicable and start the
this alarm will be generated.
process.
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 Operational Qualification (OQ)

During process if DP across the filter Put the value less then the
DP Filter > Only
29. Maximum bag crosses the maximum set value actual Filter Dp in the
Alarm
then this alarm will be generated. Alarm setpoints.
During process if DP across the filter
DP Filter > Put the value less then the
bag crosses the maximum maximum Process
30. Maximum set value then this alarm will be
actual Filter Dp in the
Will Stop
Maximum Alarm setpoints.
generated.
During process if DP across the
Put the value less then the
DP Product > product crosses the maximum set Only
31. Maximum actual Product Dp in the
value then this alarm will be Alarm
Alarm setpoints.
generated.
During process if DP across the
DP Product > Put the value less then the
product crosses the maximum Process
32. Maximum maximum set value then this alarm
actual Product Dp in the
Will Stop
Maximum Alarm setpoints.
will be generated.
Disconnect If operator Deflates the Container Deflate the container seal
Product Seal while Temperature probe in when the Product temp Only
33. Temperature connected condition, then this sensor is connected to the Alarm
Probe message will appear. bowl.
If operator tries to start process with
Connect Remove the Product temp
Product temperature probe Only
34. Product Temp. disconnected, then this message will
sensor from the bowl and
Alarm
Probe start the process.
appear.

Conclusions / Comments:

Result: - _______________________________________________________________

Checked By: _______________________ Date: ______________

Verified By: ________________________Date: ______________

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 Operational Qualification (OQ)

12.0 Operational Qualification Tests Status

The table below lists the tests performed and related results.

Critical Feature Complies Remarks

Yes / No/ NA

Testing of Programmable Logic

Controller’s Processor

Verification of Human Machine Interface

Screens – HMI
Power & Emergency Failure Recovery
Verification
Emergency Operation Verification

Verification of Alarms

Description Complies Remarks

Yes / No

All critical test/verification have been

performed and acceptance criteria were
met and/or major deviation completed.

Conclusions / Comments:

Result: -
_______________________________________________________________

Checked By: _______________________ Date: ______________

Verified By: ________________________Date: ______________

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 Operational Qualification (OQ)

13.0 Qualification Document report Approval

13.1Summary:

13.2 Certification:

Checked By: _______________________ Date: ______________

Verified By: ________________________Date: ______________

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 Operational Qualification (OQ)

14.0 Discrepancy and Corrective Action Report

14.1 Description of discrepancy:

14.2 Person, responsible for corrective action and date assigned:

14.3 Corrective action taken:

14.4 Any other (Please specify):

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 Operational Qualification (OQ)

15.0 Final Approval

Manufacturer -

Prepared By Name & Designation Signature & Date

Commissioning Engineer

Reviewed By Name & Designation Signature & Date

Commissioning Engineer

Customer: -

Reviewed By Name & Designation Signature & Date

Approved By Name & Designation Signature & Date

Quality Assurance

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 Operational Qualification (OQ)

16. Remark If Any

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 Operational Qualification (OQ)

16. Appendix

List Of Abbreviations

Sr. No. Short Form Full Form

1 cGMP Current Good Manufacturing Practices

2 GEP Current Good Engineering practices

3 AISI American Iron & Steel Institute

4 WIP Wash In Place

5 MS Mild steel

6 FLP Flame Proof

7 SS Stainless Steel

8 CFM Cubic Feet Per Minute

9 KW Kilo Watt

10 DQ Design Qualification

11 HEPA High Efficiency Particulate Air Filter

12 HMI Human Machine Interface

13 FAT Factory acceptance test

14 DP Differential Pressure

15 PLC Programmable Logic Controller

16 Controller- Algorithm for control loops with Proportional

PID
(P), Integral (I), and Differential (D) factor.

17 IQ Installation Qualification

18 OQ Operational Qualification

19 PIC/S Pharmaceutical Inspection Convention Scheme

21 PQ Performance Qualification

22 URS User Requirement Specification

23 MOC Material of construction

24 RPM Revolutions per minute

25 V Volts

26 Hz Hertz

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