Performance Qualification Protocol for Fluid Bed Dryer

EQUIPMENT ID: ____________

LOCATION: GRANULATION AREA ( _________BLOCK)

DATE OF QUALIFICATION:
SUPERSEDE PROTOCOL No.:

PROTOCOL CONTENTS

1. Protocol Approval 
2. Objective 
3. Scope 
4. Responsibility 
5. Equipment Details 
6. System Description 
7. Reason for Requalification 
8. Site of Study 
9. Frequency of Requalification 
10. Tests and Checks 
11. References 
12. Documents to Be Attached 
13. Non-Compliance 
14. Deviation from Pre-Defined Specification, If Any 
15. Change Control, If Any 
16. Abbreviations

PROTOCOL APPROVAL:  INITIATED BY Designation Name Signature Date   Officer/Executive (QA) REVIEWED BY Designation Name Signature Date Head (Production) Head (Quality Control) Head (Engineering) APPROVED BY Designation Name Signature Date Head (QA)   OBJECTIVE: To provide documented evidence that the equipment is performing as per the parameter defined in performance qualification and that it gives results as per the predetermined acceptance criteria. To demonstrate that the equipment will operate reproducibly and consistently within its operating range. To confirm the suitability of the Standard Operating Procedures for all routine activities associated with the equipment. SCOPE: The Protocol covers all aspects of Performance qualification for the Fluid bed dryer being used at XYZ Limited. This Protocol will define the methods and documentation used to qualify the Fluid bed dryer for PQ. RESPONSIBILITY: The Qualification Team, comprising of a representative from each of the following Departments, shall be responsible for the overall compliance of this Protocol: EQUIPMENT DETAILS: Equipment Name:                FLUIDIZED BED DRYER Manufacturer’s Name: Location of Installation: Granulation Area: Equipment ID No.: SYSTEM DESCRIPTION: The principle of FBD is to operate fluidal turbulence in a granulated or powdery wet product by means of hot air flowing in an upward direction and to dry the same to the final required degree. In a fluid bed dryer, the wet material is transposed to a fluidized state by hot airstreams that surround the material completely & therefore the heat transfer rate achieved is very high & the temperature distribution throughout the product is uniform. Due to this drying time is considerably reduced & therefore high production rates are achieved in comparison to other dryers as the product is in close contact with hot air at low temperature & also for a short duration. The physical & chemical properties of the product are generally not affected & therefore the dryer can effectively be used for heat-sensitive products. Due to the movement of the product during drying, lump formation, case hardening, etc is minimized. The fluid bed dryers are not suitable for drying of liquids or pasty material. The equipment shall be qualified against the specification described in the User Requirement Specification, the Design datasheet used as purchase order specification, and the Specification provided by the supplier. ALSO READ: Installation Qualification of Disintegration Tester Fluid Bed Dryer mainly consists of: Main Body: The main body of FBD is a cylindrical retarding chamber & filter bag housing with a vertical explosion chamber i.e. shell-type slab-mounted machine with a dish-type cylindrical bottom body. The Accessories fitted on the main body are: Sealing Gaskets Glass Windows & Covers Product Container Stoppers Earthing Device Pneumatic Shaking Cylinder mounting bar. Blower inlet nozzle Explosion frame & flap Outlet Shut-Off Valve: It is an isolating valve between the main body & air preparation unit. The type of valve is ON/OFF type butterfly valve & a pneumatic actuator operates the flap. This remains closed when the equipment is not in use or during bag shaking. Air Preparation Unit: It is a rectangular housing to accommodate air filter (10 + 5 + 0.3 microns) one end is provided with filter mounting frame while other with a transition duct for changing rectangular section to narrow duct. The Accessories fitted in this unit are: Steam Inlet & Outlet Nozzle Duct Reducer S.S 304 Radiator Air Filter 10 + 5 + 0.3 microns Product Container & Trolley Explosion Frame & Flap Filter Bag Shaking Device Blower Assembly Sealing Gaskets REASON FOR REQUALIFICATION: Scheduled requalification is required as per the requalification schedule and shall be performed according to detailed written procedures with the original qualification parameters and limits used as the evaluation criteria.  The requalification studies shall be documented in detail and the results of the studies shall be compared to the original validation results and evaluated to the same extent. If the results are satisfactory, the equipment shall be certified. If the results are not satisfactory the modified system shall require new qualification studies. SITE OF STUDY:  Granulation Area. FREQUENCY OF REQUALIFICATION: Once in two years After any major breakdown or after major modification. After Change of Location TESTS AND CHECKS Optimization of Drying time & temperature: The following tests shall be carried out to establish the Performance qualification of the “Fluidized bed dryer”. Objective: To verify the maximum drying time & temperature (Operational) for smooth running & confirmation of the required moisture level in the product. Test Requirements: Stop Watch Moisture Analyser Product batch Size Procedure: The test should be carried out in Triplicate. Switch “ON” the machine & Operate it as per SOP. Load the product batch size & in the FBD trolley as per capacity load. Set the drying time & temperature as per requirement in the product batch & all the Parameters should be recorded in the performance requalification report. Run the FBD & collect the sample at a different location at different time intervals as per Annexure -I. Quantity of Sample:  3.0gm each. No. of Samples:  3 Sample from top 3 Samples from middle 3 Samples from lower U1 = Upper Left side of FBD.  U2= Upper middle side of FBD.  U3 = Upper right of FBD. M1 = Middle left of FBD.  M2 = Middle side of FBD.  M3= Middle side of FBD.  L1= Lower left side of FBD.  L2= Lower middle side of FBD.  L3= Lower right side of FBD. REFERENCES: The Principle Reference are the following: Validation Master Plan. Schedule – M – “Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products.” WHO Essential Drugs and Medicines Policy, QA of Pharmaceuticals, Vol-2. Good Manufacturing Practices and Inspection. ALSO READ: SOP for Operation and Cleaning of Fluidized Bed Dryer The following references are used to give additional guidance: FDA/ISPE Baseline Pharmaceutical Engineering Guide-Volume 5:- Commissioning and Qualification Guide, First Edition/March 2001. EU Guide to Good Manufacturing Practice, Part 4, 1997. European Commission’s working party on control of medicines and inspections document, Validation Master Plan, Design Qualification, Installation & Operational Qualification, Non-Sterile Process Validation, Cleaning Validation, October 1999. DOCUMENTS TO BE ATTACHED: Calibration Certificates QC Raw Data NON COMPLIANCE: In case of any deviation observed during PQ, inform to Head QA for necessary action. Document the deviation detail in the observed deviation section. The Head QA shall study the impact of deviation. If the deviation is acceptable and it does not have an impact on operation as well as on the performance of the machine, prepare a final conclusion. DEVIATION FROM PRE-DEFINED SPECIFICATION, IF ANY: All deviations, non-conformances and out-of-specification results obtained shall be investigated in accordance with corresponding SOPs and documented in the requalification report. CHANGE CONTROL, IF ANY:  Details of change controls initiated during the re-qualification activity, shall be documented in the requalification report. ABBREVIATION: No. : Number WHO : World Health Organization  FDA : Food and Drug Administration  CFR : Code of Federal Regulations cGMP : current Good Manufacturing Practices  EU : European Union QA : Quality Assurance PQ : Performance Qualification  mm : Millimeter Amp. : Ampere FBP : Fluid Bed Processor GMP : Good Manufacturing Practices  SOP : Standard Operating Practices  ISPE : International Society for Pharmaceutical Engineering ALSO READ: Design Qualification for Rapid Mixer Granulator