Document ID: DQ-FBG-001

Version: 1.0

Effective Date: [Insert Date]

Review Date: [Insert Date]

Prepared by: [Your Name]

Approved by: [Approver’s Name]

Design Qualification Protocol for Fluid Bed Granulator

Meta Description: This document outlines the Design Qualification Protocol for the Fluid Bed Granulator used in the production of Solid Dosage Forms, ensuring compliance and validation in pharmaceutical manufacturing.

Tags: Equipment Validation, Design Qualification, Fluid Bed Granulator, Pharmaceutical Manufacturing, Solid Dosage Form

Objective

The objective of this Design Qualification (DQ) Protocol is to ensure that the Fluid Bed Granulator (FBG) is suitable for its intended use in the granulation of solid dosage forms, meeting all specified requirements and regulatory standards.

Scope

This protocol applies to the Fluid Bed Granulator located in the Production/Granulation area and is intended for use in the granulation of pharmaceutical products.

Responsibilities

The Validation Team is responsible for executing this protocol, ensuring compliance with all applicable regulations and standards. The Quality Assurance (QA) team will review and approve the documentation.

Prerequisites

Completion of User Requirements Specification (URS) for the Fluid Bed Granulator.
Installation Qualification (IQ) must be completed prior to DQ execution.
Staff training on equipment operation and safety procedures.

Equipment Description

The Fluid Bed Granulator (FBG) is a critical piece of equipment used for the granulation process in solid dosage form manufacturing. It operates by suspending powder in a fluidized state and applying a binding solution to form granules.

Test Plan

Test ID	Procedure	Acceptance Criteria	Evidence
T1	Verify temperature control functionality.	Temperature maintained within +/- 2°C of set point.	Calibration records, temperature logs.
T2	Check airflow rates.	Airflow rates within specified limits.	Airflow measurement logs.
T3	Evaluate spray rate accuracy.	Spray rate within +/- 5% of target rate.	Spray rate test results.
T4	Assess filter differential pressure (DP).	DP within acceptable limits.	DP measurement logs.
T5	Verify PLC functionality.	PLC operates without errors.	PLC test logs.

Detailed Test Cases

Test Case T1: Temperature Control

Procedure: Set the temperature to the desired set point and monitor for stability.

Acceptance Criteria: The temperature must remain stable within +/- 2°C of the set point for a duration of 30 minutes.

Evidence: Temperature logs to be maintained for review.

Test Case T2: Airflow Rate

Procedure: Measure airflow during operation under defined conditions.

Acceptance Criteria: Airflow must be within specified limits as per URS.

Evidence: Airflow measurement logs will be documented.

Test Case T3: Spray Rate

Procedure: Measure the spray rate during operation.

Acceptance Criteria: Spray rate must be within +/- 5% of the target rate.

Evidence: Results from spray rate tests to be recorded.

Test Case T4: Filter DP

Procedure: Monitor the differential pressure across the filter during operation.

Acceptance Criteria: DP must remain within acceptable limits as defined in the URS.

Evidence: DP logs to be maintained for review.

Test Case T5: PLC Functionality

Procedure: Test the PLC for any operational errors during a simulated run.

Acceptance Criteria: The PLC should operate without errors throughout the test.

Evidence: PLC test logs to be documented.

Deviations

Any deviations from the acceptance criteria must be documented and approved by the QA team. A root cause analysis must be performed for any critical deviations.

Approvals

Prepared by: ____________________ Date: ___________

Reviewed by: ____________________ Date: ___________

Approved by: ____________________ Date: ___________