Performance Re-Qualification FBD - 120 KG
Performance Re-Qualification FBD - 120 KG
Performance Re-Qualification FBD - 120 KG
OF
FLUID BED DRYER
NAME OF THE EQUIPMENT :
EQUIPMENT NO. :
RQ PROTOCOL NO. :
RQ REPORT NO. :
MAKE :
CAPACITY :
LOCATION :
TABLE OF CONTENTS
Prepared by
Reviewed by
Approved by
Authorized by
JSA VALIDATION SERVICES
BADDI, H.P-BHARAT (INDIA)
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.
JSA VALIDATION SERVICES
BADDI, H.P-BHARAT (INDIA)
• 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.
JSA VALIDATION SERVICES
BADDI, H.P-BHARAT (INDIA)
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.
Equipment Name
Model
Sr. No.
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BADDI, H.P-BHARAT (INDIA)
I.D. No.
Capacity
Equipment Location
Facility
Area
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.
JSA VALIDATION SERVICES
BADDI, H.P-BHARAT (INDIA)
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.
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
JSA VALIDATION SERVICES
BADDI, H.P-BHARAT (INDIA)
3.4.3 Sampling location LOD uniformity after completion of During process from FBD
T1 T2
M1
Batch No.:-
Location for LOD Samples
% LOD Results
T1
T2
MI
B1
B2
Minimum
Maximum
Average
SD
RSD (%)
Executed by
Reviewed by
Approved by
Authorized by
7.0 APPENDIX
JSA VALIDATION SERVICES
BADDI, H.P-BHARAT (INDIA)
7.1 ABBREVIATIONS
Kg : Kilogram
RQ : Re-Qualification
END OF DOCUMENT