Design Qualifications Protocol for Rapid Mixer Granulator

Ensure compliance with cGMP guidelines and user requirements with our comprehensive design qualifications protocol for Rapid Mixer Granulator. This detailed document covers material construction, surface finish, design parameters, control and automation features, and essential safety measures. Perfect for guaranteeing high-quality powder and granules processing equipment

Objective

The purpose of this document is to design, engineer, and supply equipment for powder and granules processing in compliance with cGMP guidelines. This ensures the equipment is manufactured to meet user requirements and complies with the defined scope of supply.

Scope

This qualification document is restricted to the Preliminary Design Qualification of the Rapid Mixer Granulator (RMG).

Responsibilities

Client

• Provide the data sheet for the requirement.
• Perform the Factory Acceptance Test (FAT).

Manufacturer

• Design, engineer, and provide complete technical details of the equipment, including:
  • Machine overview
  • P & ID drawing
  • Equipment orientation with layout
  • Specifications of sub-components/bought-out items and their make, model, quantity, and backup records/brochures
  • Details of utilities
  • Identification of components for calibration
  • Material of construction of all components
  • Brief process description
  • Safety features and alarms
  • Pre-installation requirements
• Facilitate the client for the FAT at their site.
• Ensure the safe delivery of the equipment to the user’s site.
• Prevent unauthorized and/or unrecorded design modifications.
• Ensure proper installation and commissioning of the equipment.

Design Specifications in Design Qualifications Protocol for Rapid Mixer Granulator

Material of Construction (MOC)

Surface Finish

Design Parameters

Area Specifications

Product Specifications

Documents to be Provided

Norms & Guidelines Followed:

Controls and Automation

Electrical and Pneumatic Control Panel

• MS powder-coated Non-FLP control module in the service area housing complete hardware including MCB’s Relay Frequency drive & PLC.
• SS304 operating panel near the machine room for operator interface to run the machine with audio/video alarms, operating push buttons, operator lock, and MMI.
• Control system includes:
  • Main incoming isolating switch
  • Phase indicating lamps
  • Voltmeter
  • Electrical logic circuit for motors, pneumatic controls, heating controls, and logic control of the sequence
  • PLC control integrating electrical and pneumatic circuits with timer and logic-based sequence
  • Emergency stop on the machine to isolate it electrically and pneumatically
  • Interlocks
  • FRL solenoids, gauges, logic, and complete pneumatic circuit
  • Optionally, higher protection enclosures with IP65 rated enclosures

Control and Automation Features

• Digital PLC with Required I/O
• Expansion modules
• Analog Module/s
• Temperature module
• Color Touch Screen 7” Diagonal MMI with Printer port, USB port, and Ethernet port
• Optionally higher size HMI 12”, 15” etc.
• Printer Dot Matrix/ Laser
• IPC 15” or PC
• Hard disc

21 CFR Part 11 Implementations:

• Security & E-Signatures features
• Audit and Alarm Reports
• Electronic Records Batch Reports
• Auto Data Backup
• RAID Hardware
• Validation Documentation
• IT System / OS Security Requirement
• Complete GAMP5 Implementation
• Signature Manifestations

Documentation:

• URS Compliance
• Functional Design Specifications (FDS)
• Screenshots of HMI
• I/O matrix
• Security matrix
• System architecture
• Design Qualification (DQ)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• FAT (Factory Acceptance Test) Procedure
• Risk Assessment (Optional)
• HMI User Manuals

Safety Features (As applicable)

• Drive elements fully covered.
• Overload relay for all drives.
• Mechanical guards.
• Fixed guards at all rotating parts.
• All moving parts provided with position sensors.
• Interlocking at the safety gate.
• Non-Return Valve.
• Additional safety features can be provided on request.

This document outlines the comprehensive design qualification protocol for the Rapid Mixer Granulator, ensuring compliance with cGMP guidelines and fulfilling user requirements.

Design Qualification Protocol of Rapid Mixer

Introduction

Design Qualification (DQ) is a critical process in the pharmaceutical industry to ensure that equipment and systems are designed and built according to the required specifications and regulatory standards. This protocol focuses on the Design Qualification of a Rapid Mixer Granulator (RMG), which is an essential piece of equipment in the production of granules for tablet formulation. The primary objective of the DQ is to verify and document that the Rapid Mixer Granulator is designed in compliance with Good Manufacturing Practice (GMP) requirements and other applicable standards.

Objectives

The main objectives of the Design Qualification protocol for the Rapid Mixer Granulator are:

1. To ensure that the RMG design meets the intended manufacturing requirements.
2. To confirm that all design aspects comply with regulatory and safety standards.
3. To document the design specifications and ensure traceability.
4. To establish a foundation for subsequent qualification phases such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Scope

This protocol covers all aspects of the design of the Rapid Mixer Granulator, including mechanical, electrical, and control system components. It applies to new installations as well as modifications to existing systems.

Responsibilities

• Engineering Department: Responsible for preparing and reviewing the DQ protocol, ensuring that the design meets technical and regulatory requirements.
• Quality Assurance (QA) Department: Responsible for approving the DQ protocol and ensuring compliance with GMP standards.
• Equipment Manufacturer: Responsible for providing detailed design specifications and documentation.
• Project Team: Responsible for executing the DQ protocol and documenting the findings.

Design Specifications

Mechanical Design

• Mixing Bowl: The RMG should have a stainless steel mixing bowl with a capacity suitable for the intended batch sizes. The bowl should be designed to prevent dead spots and ensure uniform mixing.
• Impeller and Chopper: The impeller and chopper should be designed to provide efficient granulation with adjustable speeds to accommodate different formulation requirements.
• Seals and Bearings: All seals and bearings should be food-grade and capable of withstanding the operational conditions of the RMG.

Electrical Design

• Control System: The RMG should be equipped with a PLC-based control system that allows for precise control of mixing parameters. The system should include user-friendly HMI for operation and monitoring.
• Safety Interlocks: The design should incorporate safety interlocks to prevent operation under unsafe conditions, such as open covers or overloading.
• Power Supply: The electrical components should be designed to operate within the specified voltage and frequency ranges.

Control System Design

• Software Validation: The control system software should be validated to ensure accuracy and reliability. This includes testing all control algorithms and user interfaces.
• Data Logging: The system should have the capability to log operational data for batch records and traceability.
• Alarm Management: The design should include an alarm management system to alert operators of any deviations from set parameters.

Documentation

The DQ protocol should include the following documents:

1. Design Specifications: Detailed descriptions of the mechanical, electrical, and control system designs.
2. Component Lists: Lists of all major components, including part numbers and manufacturers.
3. Design Drawings: Engineering drawings of the RMG, including layout and assembly diagrams.
4. Validation Plans: Plans for software validation and testing of control systems.
5. Risk Assessments: Documentation of risk assessments performed during the design phase to identify and mitigate potential issues.

Acceptance Criteria

The design of the Rapid Mixer Granulator will be considered acceptable if:

1. All design specifications are met.
2. The equipment complies with regulatory standards and GMP requirements.
3. All critical design elements are documented and traceable.
4. Risk assessments are completed and all identified risks are mitigated.

Conclusion

The Design Qualification protocol for the Rapid Mixer Granulator ensures that the equipment is designed to meet the specific needs of the manufacturing process while adhering to regulatory and safety standards. Successful completion of the DQ protocol provides confidence that the RMG will perform reliably and consistently, laying the groundwork for subsequent qualification and validation activities.

Approval

• Engineering Manager: ______________________ Date: ___________
• QA Manager: _____________________________ Date: ___________
• Project Manager: __________________________ Date: ___________