Pharmaceutical Guidelines Operational Qualification Equipment: Rapid Mixer Granulator Equipment ID: PG/MFG/EQ/001 Document No: PG/OQ/001

Pharmaceutical Guidelines
OPERATIONAL QUALIFICATION
RAPID MIXER GRANULATOR (150 Liters)

Document No: PG/OQ/001 Page no 1 of 18
Operational Qualification
Equipment: Rapid Mixer Granulator
Equipment ID: PG/MFG/EQ/001
Document No: PG/OQ/001
info@pharmaguideline.com © www.pharmaguideline.com

TABLE OF CONTENTS
Sr. No. Content Page No.
1.0 Pre Approval 3

2.0 Purpose 4
3.0 Scope 4
4.0 Reference 4
5.0 Study of Qualification 4
6.0 Responsibility 5
7.0 Documentation 5
8.0 Machine Description 6
9.0 Procedure 6
10.0 Acceptance Criteria 7
11.0 Control Penal 7
12.0 Operating Inputs 8
13.0 PLC Screen 11
13.1 Manual Mode 11
13.2 Auto Mode 12
14.0 Summery of Operational Qualification 16
14.1 Observed Deviation 16
14.2 Recommendations 17
14.3 Conclusion 17
15.0 Post Approval 18

1.0 PRE-APPROVAL:
Prepared by Designation Signature Date
Reviewed By Designation Signature Date
HOD Production
HOD Engineering
Executive Quality
Assurance
Unit Head
Approved By Designation Signature Date
HOD Quality
Assurance

2.0 PURPOSE: To ensure that the Rapid Mixer Granulator is operated as per the
specifications given by the manufacturer and also meets the design criteria.
3.0 SCOPE: This protocol is applicable for operational qualification of the Rapid Mixer
Granulator. The operational qualification is an essential part of GMP documentation and
serves as a base document for the validation activity.
3.1 INTENDED USE: For uniform mixing of powder.
3.2 LOCATION: ABC Pharmaceuticals Ltd. at Location.
4.0 REFERENCE: Operating Instruction Manual for Rapid Mixer Granulator RMG 150.
4.1 ATTACHMENTS: Purchase order and drawing
5.0 STUDIES FOR QUALIFICATION:

Design Qualification: To design, engineer, and supply the Rapid Mixer Granulator RMG 150
as per cGMP and cGEP and to provide assurance that the machine is manufactured as per
the URS and it complies with the Scope of Supply.
This is a validation document for the machine, to prove that each operation proceeds as per
the design specification prescribed there in the document.
Installation Qualification: To check that machine and accessories are supplied as per
purchase order requirement.
To check that the machine is installed at its specified location
To check that the utilities required by the machine is provided
Operational Qualification: To measure the dimension wherever possible.

To ensure that all the instruments if any associated with the machine are calibrated before
operational qualification.

Performance Qualification: To operate the machine as per proposed procedure.

To challenge the operating parameters associated with the machine.
To challenge the safety features associated with the machine.
6.0 RESPONSIBILITY:
6.1 Pharmacist/ Officer Production and Engineering:

1. Carry out the activity as per protocol
2. Compile the results
3. Prepare summary report

6.2 HOD Production, HOD Engineering and General Manager:
Review the results
6.3 HOD- QA & QC
Conclude and approve the results
7.0 DOCUMENTATION:
All documentation work shall be completed concurrently during execution of the qualification.
However the protocol does not define the sequence of the test/ documentation to be carried
out.
1. Use indelible black ink for the recording.
2. Fill out complete information in the format provided.
3. Do not leave any blank space.
4. Correct the wrong entry by drawing single line through incorrect data, recording the correct
data and then signing and dating the change.
5. Enter “N/A” in space that is not applicable.
6. During execution of the protocol any deviation must be implemented as per defined
procedure.
7. During protocol execution, report shall be prepared with following details.
 Discussion of all study in observation column
 Qualification is successfully completed or not
 Conclusion
 Recommendation, if any.

8.0 MACHINE DESCRIPTION:

The Rapid Mixer Granulator is a high shear machine, developed for mixing as well as
granulation. The multibladed dual speed impeller & chopper performs the mixing and breaking
of materials. The granulating solution is gently distributed in the base material as it is added.
The Impeller makes the uniform mixer of materials and binder. Impeller is designed to mix by
circulating the materials from up to low and vise versa while running. The chopper set in the
centerline of the material flow has the effect of constant cutting action by which it breaks the
mass. The effect of the impeller blades is often to compact the material during discharge. So
the Lumps can be easily crumbled but the dense particles that they are composed of retain
their form.
9.0 PROCEDURE:
1. After completions of successful installation qualification initiate the actual operation of the
Rapid Mixer Granulator (250 lit.) to ensure that machine is operating within specification.
2. Check the operation qualification parameters against their specifications.
3. Record the observation in the respective Table.
4. In case of any deviation, document in ‘Remark’ column and inform to department head and
Quality head for necessary action.
5. Document the deviation details in Observed deviation section.
6. The Quality head and the department head shall decide whether deviation is acceptable or
not.
7. If the deviation is acceptable and it does not have impact on operation as well as on
performance, initiate performance qualification.
8. If the deviation is not acceptable inform to department head and Quality head for necessary
action.
9. If deviation is acceptable and it will not affect quality of the product and operation, go for
performance qualification.
10. If deviation is not acceptable inform to concern department head and Quality head for
necessary action.

10.0 ACCEPTANCE CRITERIA:

1. All operating inputs provided on the equipment when tested shall successfully comply to
their intended use & meet tolerance limit given by the manufacturer.
2. The equipment should successfully perform when operated as per standard operating
procedure.
3. Critical gauges/indicators provided on the equipment are calibrated to their correctness as
per laid down procedure.
4. The equipment when operated shall not produce any abnormal sound or show any
discrepancy in its smooth operation.
11.0 CONTROL PENAL:

12.0 OPERATING INPUTS:
Sr. Facility Specification Method of inspection/ Observation

No. Description Measurement
1. Compressed  The power supply Open compressed air
air supply should be ON/ supply to machine min.
OFF respectively up to 4.0 kg/ sq. cm. &
when compressed ensure that power
air supply is ON & supply gets ON.
OFF respectively. Close the air supply or
 Minimum air maintain the pressure
pressure required below 4 kg/ sq.cm. &
is 4.0 kg/ sq.cm. ensure that power
supply gets OFF.
2. AUTO / Machine should Switch on to AUTO
MANUAL operate in AUTO/ mode & ensure
selector MANUAL mode as machine operates in
switch per the selection auto mode.
Switch on to MANUAL
using this switch mode & ensure
machine operates in
manual mode.
3. OPEN / When machine is in Switch on to OPEN
CLOSE MANUAL mode, mode & ensure that
selector discharge valve discharge valve opens
switch for should OPEN / Switch on to CLOSE
discharge CLOSE as per the mode & ensure that
valve selection using this discharge valve closes
switch
4. Mixer Push When machine is in Press the Mixer slow
button MANUAL mode, button & ensure beater
When pressed this blade rotate at slow
button beater blade speed.
 Mixer Slow should rotate at
slow speed.
 Mixer Fast When pressed this Press the Mixer fast
button beater blade button & ensure beater
should rotate at blade rotate at Fast
Fast speed. speed.
 Mixer OFF When pressed this Press the Mixer off
button beater blade button & ensure beater
should stops blade stops rotating
rotating.
5. Chopper Push When machine is in Press the Chopper
button MANUAL mode, slow button & ensure
 Chopper When pressed this chopper blade rotate at
Slow button chopper slow speed.
blade should rotate
at slow speed.

Sr. Facility Specification Method of inspection/ Observation

No. Description Measurement
 Chopper Fast When pressed this Press the Chopper fast
button beater blade button & ensure
should rotate at chopper blade rotate at
Fast speed. Fast speed.
 Chopper OFF When pressed this Press the Chopper off

button beater blade button & ensure
should stops chopper blade stops
rotating. rotating
6. Mixer / When mixer / Run the mixer/ chopper
Chopper chopper are in in Slow/ Fast speed &
ammeter running condition, ensure that mixer /
the mixer/ chopper chopper ammeter
ammeter should displays the current
display the current drawn.
drawn.
7. Safety Machine should not Try to start the
Features start if incoming air machine with incoming
pressure is less air pressure less than 4
than 4 kg. / sq.cm. kg. / sq.cm. & ensure
machine doesn’t start.
Machine should not Keep the mixer top lid
start if mixer top lid open & try to start the
is open machine, & ensure
machine doesn’t start.
Machine should not Keep the discharge
start if discharge valve open & try to
valve is open start the machine, &
ensure machine
doesn’t start.
8. Beater Speed
 Slow 55 + 5 RPM Check the RPM using
 Fast 110 + 5 RPM tachometer
9. Chopper
Speed 1500 + 50 RPM Check the RPM using
 Slow 3000 + 50 RPM tachometer
 Fast

13.0 PLC SCREEN:
13.1 MANUAL MODE:

13.2 AUTO MODE:




Sr. Facility description Specification Method of inspection/ Observation

No Measurement
1. Key description This key is used to Touch the key with
move cursor upside finger & ensure cursor
moves upside,
2. This key is used to Touch the key with
move cursor down finger & ensure cursor
side moves downside,
3. This is a cursor key Touch up & down arrow
which moves up & key & ensure cursor key
down as per selection. moves along with.
4. AUTO / MANUAL Machine should Move cursor up & down

mode selection operate in AUTO/ to select AUTO /
MANUAL mode as MANUAL mode &
per the selection ensure desired mode is
selected.
5. MIXER SLOW In manual mode mixer Touch the key with
should move in slow finger & ensure mixer
speed with this key (beater) moves at slow
speed.
6. MIXER FAST In manual mode mixer Touch the key with
should move in fast finger & ensure mixer
speed with this key (beater) moves at fast
speed.
7. MIXER OFF In manual mode mixer Touch the key with
should stop with this finger & ensure mixer
key. stops.
8. GRN. SLOW In manual mode with Touch the key with
chopper should move finger & ensure chopper
in slow speed with moves at slow speed.
this key
9. GRN. FAST In manual mode with Touch the key with
chopper should move finger & ensure chopper
in fast speed with this moves at fast speed.
key
10. GRN OFF In manual mode Touch the key with
chopper should stop finger & ensure chopper
with this key. stops.
11. D Valve OPEN In manual mode Touch the key with
discharge valve finger & ensure
should open with this discharge valve get
key opens.

12. D Valve CLOSE In manual mode Touch the key with

discharge valve finger & ensure
should close with this discharge valve get
key close.
13. Select mode To move to first Touch the key with
(Selection Mode) finger & ensure it moves
screen this key is to first screen.
used.
14. NEXT To move next screen Touch the key with
this key is used. finger & ensure it moves
to next screen.
15. PREV. To move previous Touch the key with
screen this key is finger & ensure it moves
used. to previous screen.
16. RELEASE PAUSE Machine should not Try to start the machine
run when the status is & ensure machine
RELEASE PAUSE doesn’t starts.
When touched twice Touch the key twice &
the status should ensure status changes
change to PAUSE. & from RELEASE
machine should able PAUSE to PAUSE.
to run & ensure machine starts
17. SETTING To set operation Touch the key with
parameter this key is finger & ensure setting
used. parameter screen is
display.
18. START To Start the machine Touch the key with
this key is used. finger & ensure machine
start.
19. MAIN To move Initial screen Touch the key with
this key is used. finger & ensure it moves
to initial screen.
14.0 SUMMARY OF OPERATIONAL QUALIFICATION:

14.1 OBSERVED DEVIATION:

14.2 RECOMMENDATIONS:
14.3 CONCLUSION:

15.0 POST APPROVAL:
Reviewed By Designation Signature Date
HOD Engineering
HOD Production
Executive Quality
Assurance
Unit Head
Approved By Designation Signature Date
HOD Quality
Assurance

Pharmaceutical Guidelines Operational Qualification Equipment: Rapid Mixer Granulator Equipment ID: PG/MFG/EQ/001 Document No: PG/OQ/001

Загружено:

Сведения о документе

Оригинальное название

Авторское право

Доступные форматы

Поделиться этим документом

Поделиться или встроить документ

Параметры публикации

Этот документ был вам полезен?

Это неприемлемый материал?

Авторское право:

Доступные форматы

Pharmaceutical Guidelines Operational Qualification Equipment: Rapid Mixer Granulator Equipment ID: PG/MFG/EQ/001 Document No: PG/OQ/001

Загружено:

Авторское право:

Доступные форматы

Pharmaceutical Guidelines

RAPID MIXER GRANULATOR (150 Liters)

RAPID MIXER GRANULATOR (150 Liters)

1.0 Pre Approval 3

RAPID MIXER GRANULATOR (150 Liters)

Prepared by Designation Signature Date

Reviewed By Designation Signature Date

Approved By Designation Signature Date

RAPID MIXER GRANULATOR (150 Liters)

3.1 INTENDED USE: For uniform mixing of powder.

3.2 LOCATION: ABC Pharmaceuticals Ltd. at Location.

4.1 ATTACHMENTS: Purchase order and drawing

5.0 STUDIES FOR QUALIFICATION:

Operational Qualification: To measure the dimension wherever possible.

RAPID MIXER GRANULATOR (150 Liters)

Performance Qualification: To operate the machine as per proposed procedure.

6.1 Pharmacist/ Officer Production and Engineering:

2. Compile the results

3. Prepare summary report

RAPID MIXER GRANULATOR (150 Liters)

8.0 MACHINE DESCRIPTION:

RAPID MIXER GRANULATOR (150 Liters)

10.0 ACCEPTANCE CRITERIA:

11.0 CONTROL PENAL:

RAPID MIXER GRANULATOR (150 Liters)

12.0 OPERATING INPUTS:

Sr. Facility Specification Method of inspection/ Observation

RAPID MIXER GRANULATOR (150 Liters)

Sr. Facility Specification Method of inspection/ Observation

 Chopper OFF When pressed this Press the Chopper off

RAPID MIXER GRANULATOR (150 Liters)

13.0 PLC SCREEN:

13.1 MANUAL MODE:

RAPID MIXER GRANULATOR (150 Liters)

13.2 AUTO MODE:

RAPID MIXER GRANULATOR (150 Liters)

RAPID MIXER GRANULATOR (150 Liters)

RAPID MIXER GRANULATOR (150 Liters)

RAPID MIXER GRANULATOR (150 Liters)

Sr. Facility description Specification Method of inspection/ Observation

4. AUTO / MANUAL Machine should Move cursor up & down

RAPID MIXER GRANULATOR (150 Liters)

12. D Valve CLOSE In manual mode Touch the key with

14.0 SUMMARY OF OPERATIONAL QUALIFICATION:

RAPID MIXER GRANULATOR (150 Liters)

RAPID MIXER GRANULATOR (150 Liters)

15.0 POST APPROVAL:

Reviewed By Designation Signature Date

Approved By Designation Signature Date

Вам также может понравиться