PERFORMANCE RE-QUALIFICATION

OF
FLUID BED DRYER
NAME OF THE EQUIPMENT :

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 Fluid Bed Dryer

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TABLE OF CONTENTS

S. No. TITLE PAGE No.

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 Procedure 6 -10
3.1 Training 6
3.2 Equipment Identification 6
3.0 3.3 General Consideration/Prerequisite 7
3.4 Performance Re-qualification procedure 8
3.5 Uniformity of drying in Fluid Bed Dryer 10
3.6 Deviation and Corrective Action 11
4.0 Acceptance criteria 13
5.0 Summary and conclusion 13
6.0 Post approval signature 13
Appendix 14
7.0 7.1 Abbreviation 14
7.2 List of Document 14
 JSA VALIDATION SERVICES
BADDI, H.P-BHARAT (INDIA)

Performance Re-Qualification Protocol for Fluid Bed Dryer

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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 Fluid Bed Dryer is carrying out in order to provide the high
degree of assurance that the equipment performed as intended 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 drying of the wet mass with the help of hot air
drying and fluidization process.
2.2 BACKGROUND
The Fluid Bed Dryer supplied by Falcon Machineries, Equipment I.D. XXXX installed in Granulation
at XYZ (Company Name) This protocol defines the methods and documentation that shall be used to
evaluate the performance attributes of Fluid Bed Dryer. 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 departments
• 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.
• To monitor protocol completeness and technical accuracy.
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• 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 principle of Fluidized Bed Dryer is to create a fluidal turbulence in an granulated or powdery wet
product by means of hot air (or dehumidified air) flowing in an upward Direction and to dry the same
to the final required degree in a careful manner. The Fluidized Bed Dryer and its subassemblies design
will be based on technical requirement, cGMP requirement, performance requirement and control
logics.
In Fluidized Bed Dryer the wet material is transposed to a fluidized state by hot air stream that
surrounds the material completely and therefore the heat transfer rate achieved is very high and the
temperature distribution throughout the product is uniform. Due to this drying time is considerably
reduced and therefore high production rate are achieved. As the product is in closed contact with hot
air at low temp, and also for short duration, the physical and chemical properties of the product
generally not affected & therefore the dryer can effectively be used for heat sensitive products. Due to
movement of product during drying, lump formation, case hardening etc, are minimized.
Air preparation unit is rectangular in shape. It is housing to accommodate air filter (10µ + 5 µ + 0.3µ
HEPA) air Heater. The one end is provide with filter mounting frame while other with a transition duct
for changing rectangular section to circular duct.
Product container is conical shaped container having the formed end at top and a welded flange at
bottom. The wet product is loaded in the container, as per its working capacity Container contains
bottom perforated plate, Dutch weave mesh, L/S Glass window, sampling device, support bars,
temperature sensor etc.
Product container trolley is a tubular structure to support the product container, provided with S.S. 304
swivel castors wheel. There are four Nos. guide wheel brackets provided for easy locating with main
body.
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Filter bag shaking device is an automatic type bag shaking arrangement. The shaking is required to
remove the adhered product particles on the bag contact surface to improve its permeability and avoid
choking of the bags. The system contains filter bag sealing gasket, FBT housing ring, multiple finger
filter bag, filter bag hanger, quick change coupling and pneumatic cylinder for shaking & lowering.
3.0 PERFORMANCE RE-QUALIFICATION OF FLUID BED DRYER
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

Name of the Supplier

Model

Sr. No.
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Description Specification Observation Remark

I.D. No.

Capacity

Equipment Location

Facility

Area

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

3.3 General Consideration/Prerequisite:

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

3.3.2 Approved analytical methods for testing the samples collected during the processing

3.3.3 The minimum and maximum capacity of the equipment shall be verified by taking the batch/lot
to full fill the requirement.

3.3.4 The installation and operational qualification of the equipment shall be successfully completed
before the execution of the Performance Re-Qualification.

3.3.5 The impact analysis of the equipment’s shall be recorded in the summary sheet.

3.3.6 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.
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3.3.7 The LOD test results shall be recorded in the Performance Re-Qualification of the equipment and
finally verified.

3.3.8 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 performance of Fluid Bed Dryer:
• 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 with charging of Wet granulated material manufactured as per
BMR. equipment.
• Drying of Material is done as per parameters mentioned in the Batch Manufacturing record.
• Sample for LOD shall be done from the 06 different location mentioned in protocol
• Record the Results of LOD in respective section given in the protocol.
• Sample quantity shall be collected approximately 2 g in at each location.
• All data shall be recorded in respective BMR and results shall be recorded in report observation
table.
• 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
LOD of samples from all location should meet the specification limit mentioned in BMR
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3.4.2 Performance Verification of the Fluid Bed Dryer

Product Name/Batch No.

Observed Temperature Checked By Verified By
Set Inlet air Temperature (OC)
(OC) Sign/Date Sign/Date

Observed Temperature Checked By Verified By

Exhaust air Temperature (OC)
(OC) Sign/Date Sign/Date

Observed Time Checked By Verified By

Drying Time (Minutes)
(Minutes) Sign/Date Sign/Date
To be Recorded

3.4.3 Sampling location LOD uniformity after completion of During process from FBD

T1 T2

M1

T1 = Top left portion

T2 = Top Right portion
B1 B2
B1 = Bottom Left portion
B2 = Bottom Right portion
M1 = Middle central portion
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3.5 Uniformity of drying in Fluid Bed Dryer

Uniformity of Drying has been checked by % LOD after completion of Drying and its results
tabulated as below.
LOD Acceptance Criteria________________

Batch No.:-
Location for LOD Samples
% LOD Results
T1

T2

MI

B1

B2

Minimum

Maximum

Average

SD

RSD (%)

Checked By: Sign/Date

Verified By: Sign/Date

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3.6 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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4.0 ACCEPTANCE CRITERIA

Performance Re-Qualification of Fluid Bed Dryer shall be considered acceptable when requirements
listed in section 3.0 of this protocol has been fulfilled and all the components of Fluid Bed Dryer 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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7.1 ABBREVIATIONS

Sr. No. : Serial number

LOD : Loss on Drying

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

FBD : Fluid Bed Dryer

7.2 LIST OF DOCUMENTS

Annexure No. Name of Annexure

END OF DOCUMENT