PERFORMANCE RE-QUALIFICATION

OF
RAPID MIXER GRANULATOR
NAME OF THE EQUIPMENT : Rapid Mixer Granulator

EQUIPMENT NO. :

RQ PROTOCOL NO. :

RQ REPORT NO. :

MAKE :

CAPACITY :

LOCATION :

JSA VALIDATION SERVICES

BADDI, H.P-BHARAT (INDIA)
 JSA VALIDATION SERVICES
BADDI, H.P-BHARAT (INDIA)

Performance Re-Qualification Protocol for Rapid Mixer Granulator

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TABLE OF CONTENTS
S. No. TITLE PAGE
N
o.
1.0 Pre Approval 3
Overview 4-5
2.1 Purpose 4
2.0 2.2 Background 4
2.3 Responsibility 4
2.4 Equipment Description 5
Performance Re-Qualification of Rapid Mixer Granulator 6 -9
3.1 Training 6
3.2 Equipment Identification 7
3.0
3.3 General Consideration/Prerequisite 8
3.5 Performance Re-Qualification Procedure 9
3.4 Deviation And Corrective Action 10
4.0 Acceptance criteria 11
5.0 Summary and conclusion 11
6.0 Post approval signature 12
Appendix 13
7.0 7.1 Abbreviation 13
7.2 List of Document 13
 JSA VALIDATION SERVICES
BADDI, H.P-BHARAT (INDIA)

Performance Re-Qualification Protocol for Rapid Mixer Granulator

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1.0 PRE APPROVAL

Activity Name Designation Department Signature

Prepared by

Reviewed by

Approved by

Authorized by
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2.0 OVERVIEW
The Performance Re-Qualification of Rapid Mixer Granulator is carrying out in order to provide the
high degree of assurance that the equipment performed as per functional specification and remain in the
state of control.
2.1 PURPOSE
The purpose is to provide an outline for the Performance Re-Qualification of equipment for
performance attributes to verify that:
• Documented the verification of all aspects of the equipment that can affect product quality.
• To make an impact assessment of the critical components of the equipment’s on the material.
• To establish, check and document the performance of equipment in the established/predetermined
operating ranges.
• The protocol shall define the test procedures, documentation, references and acceptance criteria to
establish that the performance of the equipment shall meet the predetermined acceptance criteria.
• The equipment shall be used for the homogeneous mixing of the dry material and wet kneading by
mixing and crushing the material with the help of high shear force accomplished by agitator.
2.2 BACKGROUND
The Rapid Mixer Granulator supplied by Falcon Machineries, Equipment I.D. XXXXX installed in
Granulation at XYZ (Company Name). This protocol defines the methods and documentation that
shall be used to evaluate the performance attributes of Rapid Mixer Granulator in accordance with the
URS specifications and intended use. The Reason for this requalification is Periodic/Schedule
Performance Requalification
2.3 RESPONSIBILITIES:
2.3.1 Quality Assurance:
• To prepare/Review and Approval of the Performance Re-Qualification protocol and report.
• To Impart the Training to the team before the execution of protocol
• To execute the Performance Re-Qualification protocol along with other department
• To monitor protocol completeness and technical accuracy.
2.3.2 User Department
• To Review of the Performance Re-Qualification Protocol/Report.
• To monitor the validation activities and ensuring performance attributes as per the protocol.
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• To monitor protocol completeness and technical accuracy.

• To review the data and approved the qualification procedure, if found satisfactory.
• To provide personnel to assist in the execution of the protocol/report.
2.3.3 Engineering Department
• To Review the Performance Re-Qualification Protocol/Report.
• To monitor the validation activities and ensuring the performance attributes as per the protocol.
• To monitor protocol completeness and technical accuracy.
• To review the data and approved the qualification procedure, if found satisfactory.
• To provide personnel to assist in the execution of the protocol/report.
2.4 EQUIPMENT DESCRIPTION
The mixing bowl is circular with a large diameter and flat base. The top portion of the bowl is conical
in shape to assist mixing of cohesive powders. The bowl is constructed from S.S.316 material. A large
diameter tube surrounds the drive shaft where it enters the base of the bowl. The main drive, shaft seal
is further improved by automatic air purge. The seal housing and drive shaft may be flushed with
cleaning water, which is then drained away from the machine through built in drain tubes.
A high speed granulator is inserted horizontally through the wall of the bowl to assist blending of the
powder and to break the large lumps to granules of required size. The granulator rotates at two speeds
slow and fast. The granulator head is of highly polished stainless steel and is easily removable for
cleaning. The granulator shaft where it enters the bowl incorporates air purged seal. The motor is
provided with a removable stainless steel shroud which covers it meet cGMP norms.
A High shear Mixer is provided for mixing and granulation of material. The Mixer rotates
anticlockwise direction at slow speed and fast speed
Discharge valve is provided on the bowl bottom side of the shell. It is operated by a S.S. Piston
connected to the pneumatic cylinder. In closed position, the gate is flushed with the contour of the
bowl. The hinge type cover is provided for easy opening & closing for cleaning of the inside portion of
the discharge. A safety lock in the form of a limit switch is provided at the discharge port to prevent the
valve or the motor to start during the cleaning operation. The pneumatic cylinder is covered by a
stainless steel shroud to meet cGMP standard.
 JSA VALIDATION SERVICES
BADDI, H.P-BHARAT (INDIA)

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3.0 PERFORMANCE RE-QUALIFICATION OF RAPID MIXER GRANULATOR

3.1 TRAINING
The validation team member shall be trained on the protocol execution of validation activity and report
compilation.
Sr.
Name of Trainee Employee Code Department Sign/Date
No.

Name of Trainer _______________________

Trainer Sign/Date______________________

Department___________________________

3.2 EQUIPMENT IDENTIFICATION

Description Specification Observation Remark

Equipment Name Rapid Mixer Granulator

Name of the Supplier
I.D. No.
Capacity
Model
Equipment Location
Facility Oral Dosages Facility
Area Granulation Area

Checked By: Sign/Date Verified By: Sign/Date

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BADDI, H.P-BHARAT (INDIA)

Performance Re-Qualification Protocol for Rapid Mixer Granulator

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3.3 General Consideration/Prerequisite:

3.3.1 Approved standard operating procedure of the equipment shall be available.

3.3.2 The equipment shall be verified by taking the batch/lot to full fill the requirement.

3.3.3 All the instruments should be calibrated before the execution of the Performance Re-
Qualification.

3.3.4 All the deficiencies and discrepancies related to the equipment which affect the product quality
and corrective action taken shall be recorded in the appropriate section of the protocol.

3.3.5 After completion of RQ activities, equipment shall be cleaned as per respective cleaning SOP’s
and released for manufacturing.
3.4 Performance Re-Qualification Procedure:

The following procedure shall be used for Requalification of Rapid Mixer Granulator:
• Training shall be imparted to the concerned personal on Performance Re-Qualification protocol.
• Operate the machine as per respective standard operating procedure and set the required parameter in
control panel as per product BMR.
• Record the observation in the protocol.
• The equipment shall be challenged by using wet granulation product manufacturing process
• All the data shall be recorded in Batch manufacturing record.
• All the raw materials after sifting through the specified sieve are collected in the double lined
polybags. The Rapid mixer granulator is charged with the material the quantity of which is
mentioned in the bill of material.
• Dry mixing shall be carried out at slow RPM of impeller.
• After dry mixed, materials shall be used for granulation by using a freshly prepared binder. The
binder shall be added to the dry mix blend at a uniform rate and the end point is decided by
observing the coherent mass.
• The capacity of the rapid mixer granulator is 250 L as per the manufacturer’s specification.
• The performance of the equipment is challenged by charging with wet mass.
• All data shall be recorded in respective BMR and results shall be recorded in report observation
table.
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• The granulated mass shall be collected in the trolley and is taken for drying in the fluidized bed
dryer.
• Suitable conclusion shall be drawn after completion of Performance Re-Qualification.
• Any deviation observed during qualification shall be recorded in the observed deviation, corrective
action and justification report section.
• Observed deviation shall be reported to the department head and quality head.
• If the observed deviation does not have any major impact on the qualification the final conclusion
shall be provided.
• If the observed deviation has major impact on the qualification, deviation shall be reported to the
manufacturer for the corrective action and qualification activity shall be done.
3.4.1 ACCEPTANCE CRITERIA
➢ Dry mix blend
❖ Material should be mix properly.
❖ No overflow or under flow of material during dry mixing.
❖ No lumps formation should be seen in the dry mixing material
➢ Granulation
❖ The dry mix blend shall be granulated using binder
❖ The binder shall be added to the dry mix blend at a uniform rate.
❖ The end point of the granulation is decided by observing the coherent mass
❖ No abnormal should be observed during wet mixing.
❖ Granulating Mass should be uniformly wetted and mixed
❖ The granulated mass shall be dried using fluidized bed dryer

3.4.2 Process Parameters’ During granulation:

.
Parameters Set Parameters Observed Parameters
Dry Mixing Stage

Dry Mixing

Impeller speed
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Parameters Set Parameters Observed Parameters

Chopper speed

Observations

Wet Mixing Stage

Binder addition time

Impeller speed

Chopper

Granulation time

Impeller speed

Chopper speed
Additional qty. of purified
water Used (If required)

Observations

Checked BY (Sign/Date)
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3.5 DEVIATION AND CORRECTIVE ACTION

Description of deviation and date observed

Person responsible for corrective action and date assigned

Corrective action taken and date conducted

Checked by: __________________ Date: ____________________

Verified by: ___________________ Date: ____________________

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BADDI, H.P-BHARAT (INDIA)

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4.0 ACCEPTANCE CRITERIA

Performance Re-Qualification of Rapid Mixer Granulator shall be considered acceptable when
requirements listed in section 3.0 of this protocol has been fulfilled and all the components of Rapid
Mixer Granulator are performed as per the user requirement specifications.

5.0 SUMMARY AND CONCLUSION

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6.0 POST APPROVAL SIGNATURE

Activity Name Designation Department Signature

Executed by

Reviewed by

Approved by

Authorized by

7.0 APPENDIX
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BADDI, H.P-BHARAT (INDIA)

Performance Re-Qualification Protocol for Rapid Mixer Granulator

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7.1 ABBREVIATIONS

Sr. No. : Serial number

RPM : Rotation per minutes

SOP : Standard operating procedure

Kg : Kilogram

NMT : Not more than

S.S. : Stainless Steal

cGMP : Current Good manufacturing Practice

I.D. No. : Identification number

RQ : Re-Qualification

RMG : Rapid Mixer Granulator

7.2 LIST OF DOCUMENTS

Annexure No. Name of Annexure

END OF DOCUMENT