Fluid Bed Processor PQ is a qualification activity that demonstrates a Fluid Bed Processor can consistently perform as intended during routine pharmaceutical manufacturing. Before the equipment is approved for commercial production, it must be verified that it operates within its predefined process parameters and produces granules that meet the required quality standards. A properly executed Performance Qualification (PQ) provides documented evidence that the equipment is capable of delivering consistent and reproducible results under actual operating conditions while complying with Good Manufacturing Practices (GMP). In this article, you’ll find a complete Fluid Bed Processor PQ Protocol, including its objective, scope, qualification procedure, acceptance criteria, sampling plan.
Related Articles
Thermal Mapping in Pharmaceuticals industries – complete procedure
Auto coater Performance Qualification
Pre Approval of Fluid Bed Processor PQ protocol
This performance qualification protocol of Fluid bed Coater/ fluid bed processor has been reviewed and approved by the following authorities:
Prepared By
| Name | Designation | Department | Signature | Date |
Reviewed By
| Name | Designation | Department | Signature | Date |
Approved By
| Name | Designation | Department | Signature | Date |
Objective of Fluid Bed Processor PQ Protocol:
The objective of developing and executing this protocol is to
Document 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 remove excess moisture from different materials & drying the materials without changing their physical attributes.
Purpose include for Fluid Bed Processor PQ
The purpose of this protocol is to verify that the equipment which produces the desired output. Performance qualification of the equipment is planned after the successful completion of the installation and operational qualification.
The performance of the equipment is verified by taking different batch and the equipment working capacity is challenged by charging the equipment with the maximum and minimum capacity of the equipment.
Scope considered:
The Scope of this protocol is limited to the performance qualification of Fluid bed dryer in your facility.
Once the performance qualification of Fluid bed dryer completed successfully, the equipment shall be released for the routine production purpose
Responsibilities:
| Responsibilities | Details |
| QA | Preparation of Protocol. Review of Protocol. To verify entire qualification exercise and to document the data. Review the data documented during equipment qualification. Approval of Protocol. |
| Production | Review of Protocol. Execution of studies according to the Protocol. To operate the equipment as per the standard operating procedure. Documentation of data during the qualification study. |
| Engineering | Review of Protocol. To ensure that the required utilities and electrical connections provided to the equipment. Providing assistance to QA during preparation & Execution. |
| Quality Control | Review of Protocol. Review the data documented during equipment qualification. Responsible for Analysis of sample. |
Reason for qualification:
Equipment is new.
Decommissioning of equipment.
Multiple breakdown of equipment
Schedule qualification
Training:
The purpose of the training is to trained the trainees with the principle of Working & Technical Specifications and qualification procedure of Fluid Bed Processor (FBP).
Execution of qualification functional checks & calibration verification:
The satisfactory operation of the Fluid Bed Processor (FBP) shall be verified by executing the qualification studies described in this protocol. The successfully executed protocol document that the Fluid Bed Processor is installed and satisfactorily operational.
Basic GMP Requirements For Equipment Design And System / Equipment Description /Prerequisite for Fluid Bed Processor PQ
| Equipment Name | Fluid bed Processor |
| Serial No. | 123456 |
| Equipment ID | Company Name/FBP/001 |
| Capacity | 1000 L |
| Location | Granulation |
Fluid Bed Processor Description:
The Fluid Bed is used for drying of granules as well as bottom spry granulation. The Material to be processed is loaded into the product container.
The Container has 80# bottom sieve for bottom spray & ADP. The air used for drying/Fluidizing is sequentially processed through pre filter-10 micron, chilling coil. Fine filter-3 micron & HEPA filter 0.3Micron.
Filtered air is passed at high velocity from the bottom of the product bowl through the process material: because of the high velocity of the air the process material is fluidized.
The Fluidized air results into a very efficient heat and mass transfers (cooling, drying, granulation). The Exhaust air is passed through system blower & finally air will exhaust atmosphere.
The machine can be divided in following sub section
- Inlet Air Filtration Section
- Air Balancing
- Product Processing Section
- Lower Plenum
- Product Container
- Filter Socks cum retarding chamber
- Exhaust Section
- Spraying System
- Product transfer System
- WIP System
- Control System
Wash in Place (WIP):
The Anish Wash in Place AWIP is used for washing the other equipment.
The WIP (Wash in Place) System is installed in technical area near to machine and operated through HMI. The Machine can be divided in following sub section
- Wash in Place system (WIP System)
- Control System
Principle
In the fluidised bed, hot air is passed at high pressure through a perforated bottom of the container containing granules to be dried. The granules are suspended in the stream of air and are lifted from the bottom. This condition is called fluidized state. The hot air is surrounded every granule to completely dry them. Thus materials or granules are uniformly dried.
Process
The wet granules to be dried are placed in the product container. The container is fixed in between plenum chamber and retarding chamber cum filter housing.
The air used for drying, is sequentially processed through pre filter – 10 µ, dehumidification chamber, main heater, Fine filter- 3 µ& HEPA filter 0.3 µ.
The air is subsequently heated by passing through steam coil and filtered by passing through air filters.
The hot air flows through the bottom of the product container through Hollander mesh. Simultaneously the blower is allowed to rotate. The air velocity is gradually increased. When the velocity of the air is greater than the settling velocity of granules, the granules remains partially suspended in the gas stream.
After sometimes a point of pressure is reached at which the frictional drag on the particles is equal to the force of the gravity. The granules rise in the container because of high velocity air and later fall back in a random boiling motion.
This condition is said to be fluidised state. The air surrounds every granule to completely dry them. The air leaves the dryer by passing through the bag filters. The entrained particles remain adhered to the inside the surface of the bags. Periodically the bags are purged with compressed air to remove the entrained particles.
Intense mixing between the granules and hot air is provided uniform conditions of the temperature, composition and particle size distribution. Drying is achieved at constant rate and falling period is very short.
After complete drying, the material is left for the sometimes in the dryer for reaching ambient temperature. After finishing the process, the product container is taken out for the discharging.
Pre – requisites for Fluid Bed Processor PQ
Approved standard operating procedure of the equipment shall be available.
Approved analytical methods for testing the samples collected during the processing
The minimum and maximum capacity both size bowel of the equipment shall be verified by taking the batch/lot to full fill the requirement.
The installation and operational qualification of the equipment shall be successfully completed before the execution of the performance qualification.
The impact analysis of the Equipments shall be recorded in the summary report.
All the deficiencies and discrepancies related to the equipment which affect the product quality and corrective action taken shall be recorded in report.
The analytical test results and other reports related with the equipment shall be attached with the performance qualification of the equipment and finally verified.
The parts that are in contact with the FBP must not be reactive, additive form adsorptive to such an extent that it will affect.
After completion of PQ activities, equipment shall be cleaned as per respective cleaning SOP’s and released for manufacturing.
Fluid Bed Processor PQ Procedure:
The wet granules to be dried are placed in the product container. The container is fixed in between plenum chamber and retarding chamber cum filter housing, formulated as per batch manufacturing record at equipment capacity.
Equipment shall be challenge for minimum and maximum capacity of both size bowel formulations by taking FPB trial.
Check the in-process and functional parameter of minimum and maximum capacity.
For taking FBP trial charge the material in Fluid bed processor, set FBP parameter as per instruction given in respective manufacturing record. Run the Fluid bed processor as per standard operating procedure.
Start the process of fluid be processor and collected approximately 5 g sample performed LOD and physical appearance every 30 minute.
After getting LOD between as per respective BMR limit stop process, remove bowl and collect sample approximately 5 g in duplicate from each 10 locations and 1 composite 20 gm sample and sent to QC for check the Physical Appearance, Bulk Density, Tapped density, and Assay.
Sampling Points for Fluid Bed Processor PQ:
- T1 – Top Right
- T2 – Top Middle
- T3 – Top left
- M1 – Middle Right
- M2 – Middle Middle
- M3 – Middle Left
- B1 – Bottom Right
- B2 – Bottom middle
- B3 – Bottom Left
Acceptance criteria:
The physical appearance, Bulk density, Tapped Density pellets fine ratio and assay of the dried material shall be as per product specification mentioned in the BMR and specification.
Requalification criteria:
Re-qualification shall be considered in the case of:
- Change in location of the equipment.
- In case of any major maintenance or modification, this affects performance of the equipment.
- Periodic re-qualification as per VMP.
Deviation & Change control (if any):
All deviations and change controls during the execution of Performance Qualification Protocol shall be investigated.
Conclusion:
Record the result in respective report. Clearly stating the achievement or non-compliance of the acceptance criteria, effect of the deviations made during the qualification and in case of failure investigation carried out and their findings.
Reference documents:
- User Requirement Specification
- Design Qualification
- Installation Qualification
- User operating manual
- Equipment SOPs
- Good Manufacturing Practice guide for Qualification ICH 2000 (Q7a).
- Validation master plan
Acronym used:
| PQP | Performance Qualification Protocol |
| EQ | Equipment |
| MFG | Manufacturing |
| QA | Quality Assurance |
| SOP | Standard Operating Procedure |
| ICH | International Council for Hormonisation |
| FBP | Fluid Bed Processor |
| VMP | Validation Master Plan |
Frequently Asked Questions (FAQs) for Fluid Bed Processor PQ
1. What is Fluid Bed Processor PQ?
Fluid Bed Processor PQ is the documented process of verifying that a Fluid Bed Processor consistently performs as intended under normal operating conditions.
2. Why is Fluid Bed Processor PQ important?
Fluid Bed Processor PQ provides evidence that the equipment operates reliably and consistently during routine production.
3. What tests are performed during Fluid Bed Processor PQ?
During PQ, parameters such as drying performance, Loss on Drying (LOD), physical appearance, bulk density, tapped density, assay, and other product-specific quality attributes.
4. How many batches are required for Fluid Bed Processor PQ?
There should be minimum 3 batches for initial qualification and 1 batch for any other qualification.
Related Articles
LAF (Laminar Air Flow) operation Qualification