Document Control Number: PQ-DCB-001

Version: 1.0

Effective Date: [Insert Date]

Reviewed By: [Insert Name]

Approval Date: [Insert Date]

Performance Qualification Protocol for Double Cone Blender

Meta Description: This document outlines the Performance Qualification (PQ) protocol for the Double Cone Blender used in Solid Dosage Form (OSD) production, detailing objectives, scope, responsibilities, and test plans.

Tags: Equipment Validation, Performance Qualification, Double Cone Blender, Solid Dosage Form

Objective

The objective of this Performance Qualification (PQ) protocol is to ensure that the Double Cone Blender operates consistently and reliably within specified parameters to produce a homogeneous blend of powders/granules for solid dosage forms.

Scope

This protocol applies to the Performance Qualification of the Double Cone Blender utilized in the production area for blending powders and granules. It covers the validation of critical parameters affecting product quality.

Responsibilities

The following roles are responsible for the implementation and execution of this protocol:

Validation Team: Oversee the execution of the PQ protocol and documentation.
Quality Assurance: Review and approve the protocol and results.
Production Personnel: Execute the blending process as per the protocol.

Prerequisites

Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
Training of personnel on the Double Cone Blender operation.
Availability of all necessary materials and equipment.

Equipment Description

The Double Cone Blender is designed for blending powders and granules. It features a double-cone shape that promotes uniform mixing and is equipped with a motor to control the RPM and blending time.

Test Plan

Test ID	Procedure	Acceptance Criteria	Evidence
PQ-001	Measure RPM during blending.	RPM within specified range as per URS.	Calibration certificate, logbook entries.
PQ-002	Record blending time.	Blending time meets URS specifications.	Process log, time stamps.

Detailed Test Cases

Test Case 1: RPM Measurement

Procedure: During the blending process, use a calibrated tachometer to measure the RPM. Record the RPM at specified intervals throughout the blending time.

Acceptance Criteria: RPM must remain within the range specified in the User Requirements Specification (URS).

Evidence: Documented RPM readings and calibration records.

Test Case 2: Blending Time Verification

Procedure: Start the blending process and record the total blending time using a stopwatch. Ensure that the blending time aligns with the specifications outlined in the URS.

Acceptance Criteria: The total blending time must not exceed the maximum limit specified in the URS.

Evidence: Recorded time logs and process documentation.

Deviations

Any deviations from the established acceptance criteria must be documented and justified. A formal deviation report must be submitted for review and approval.

Approvals

This protocol must be reviewed and approved by the Quality Assurance and Validation Team prior to execution.