A Design Qualification (DQ) is the documented verification that the proposed

design of the facilities, systems, and equipment is suitable for the intended
purpose. For a semi-solid production mixer homogenizer tank in the
pharmaceutical industry, a comprehensive DQ is crucial to ensure that the
equipment, once built, will be capable of consistently producing high-quality
semi-solid products (creams, gels, ointments, etc.) meeting all regulatory
and product-specific requirements.

Design Qualification (DQ) Template for Semi-Solid Production Mixer

Homogenizer Tank

Document Title: Design Qualification (DQ) Protocol for Semi-Solid Production

Mixer Homogenizer Tank

Document Number: [DQ-MIX-001] (Assign a unique number)

Version: [1.0]

Effective Date: [DD-MM-YYYY]

Prepared By: [Name/Department]

Reviewed By: [Name/Department]

Approved By: [Name/Department]

1. Introduction

This document outlines the Design Qualification (DQ) for the [Specific
Model/Name] Semi-Solid Production Mixer Homogenizer Tank. The purpose of
this DQ is to confirm that the design of the equipment meets the User
Requirement Specification (URS), regulatory requirements (e.g., cGMP, ICH
guidelines), and is suitable for its intended use in the manufacturing of
[Specific Product Types, e.g., creams, ointments].

2. Equipment Information

 Equipment Name: Semi-Solid Production Mixer Homogenizer Tank

 Manufacturer: [Manufacturer Name]

 Model No.: [Model Number]

  Serial No.: [To be confirmed upon purchase order]

 Proposed Location: [Building, Room, Area]

 Intended Use: [Briefly describe the primary function, e.g., mixing,

heating, cooling, and homogenization of active pharmaceutical
ingredients (APIs) and excipients to produce homogeneous semi-solid
formulations under vacuum.]

3. User Requirement Specification (URS) Review and Traceability

Matrix

This section verifies that all requirements specified in the URS are addressed
in the proposed design. A Traceability Matrix is highly recommended here,
linking each URS requirement to the corresponding design document(s) (e.g.,
P&ID, Functional Design Specification, Component Specifications).

Complete URS Requirements (Examples - Customize based on actual

product and process):

3.1. General Requirements

 Capacity: [Specify working volume and total volume, e.g., 500 Liters
working volume, 600 Liters total volume].

 Product Type Compatibility: Capable of handling semi-solid

formulations with a viscosity range of [e.g., 5,000 cP to 200,000 cP].

 cGMP Compliance: Design must comply with current Good

Manufacturing Practices (cGMP) regulations (e.g., EU GMP Annex 15,
FDA 21 CFR Part 211).

 Safety Features: Inclusion of emergency stop buttons, interlocks,

pressure relief valves, over-temperature protection.

 Ergonomics: Designed for ease of operation, maintenance, and

cleaning.

3.2. Material of Construction (MOC)

 Product Contact Parts: All surfaces in contact with the product must
be made of [e.g., Stainless Steel 316L, Ra < 0.8 µm electropolished].

 Non-Product Contact Parts: [e.g., Stainless Steel 304].

  Seals/Gaskets: [e.g., EPDM, Viton, PTFE] for all product contact
points, FDA-approved/USP Class VI compliant.

 Welds: All welds in product contact areas to be smooth, crevice-free,

and full penetration.

3.3. Mixing System

 Type of Agitator: [e.g., Anchor agitator with scrapers, Counter-

rotating agitator, Propeller agitator].

 Homogenizer Type: [e.g., Rotor-stator homogenizer (bottom-

mounted/inline), High Shear Mixer].

 Speed Control: Variable speed control for both agitator and

homogenizer, with precise RPM display.

 Mixing Efficiency: Capable of achieving required homogeneity levels

for [Specific Product Attributes, e.g., API dispersion, droplet size] within
specified timeframes.

 Scrapers: Inclusion of PTFE scrapers for effective wall scraping and

heat transfer.

3.4. Temperature Control System

 Heating/Cooling Medium: [e.g., Jacket for steam/hot water heating

and chilled water cooling].

 Temperature Range: Capable of heating product from [e.g., Ambient]

to [e.g., 90°C] and cooling from [e.g., 90°C] to [e.g., 25°C].

 Temperature Uniformity: Achieves and maintains uniform

temperature distribution throughout the batch.

 Temperature Probes: [Specify type, e.g., RTD PT100] for accurate

temperature measurement.

3.5. Vacuum System

 Vacuum Capability: Capable of achieving and maintaining a vacuum

level of [e.g., -0.8 to -0.9 bar] during processing.

 Vacuum Pump: [Specify type, e.g., Liquid ring pump, Dry vacuum
pump].

 Vacuum Monitoring: Pressure transducer for real-time vacuum

display.
3.6. Dosing/Loading System

 Raw Material Addition: Designed for [e.g., Manual addition through

manway, Vacuum transfer of liquids/powders].

 Liquid/Powder Addition Ports: [Specify number and size, e.g.,

multiple ports for liquid and powder addition].

 Load Cells (Optional): If automated raw material addition by weight

is required, specification for load cells and integration with control
system.

3.7. Discharge System

 Discharge Method: [e.g., Bottom discharge valve, Transfer pump].

 Discharge Pipework: Designed for complete drainage and ease of

cleaning.

 Discharge Port Size: [Specify size].

3.8. Cleaning-In-Place (CIP) / Sterilization-In-Place (SIP) Capabilities

(if applicable)

 CIP Nozzles: Inclusion of spray balls/nozzles for effective internal

cleaning.

 CIP Coverage: Ensures 100% internal surface coverage during CIP.

 Drainability: Designed for complete drainage after cleaning cycles.

 SIP Compatibility: If SIP is required, tank and components must be

capable of withstanding steam sterilization conditions.

3.9. Instrumentation and Control System

 Control System: [e.g., PLC-based control system with HMI (Human

Machine Interface)].

 HMI: User-friendly interface with clear graphics and real-time process

data display.

 Data Logging: Capability to log critical process parameters

(temperature, pressure, agitator speed, homogenizer speed, vacuum
level).

 Alarm System: Configurable alarms for critical parameters (e.g., over-

temperature, over-pressure, low vacuum).
  Access Levels: Multi-level user access control with audit trail.

 Recipe Management: Capability for storing and executing multiple

recipes.

3.10. Documentation Requirements

 Drawings: Provision of P&IDs (Piping and Instrumentation Diagrams),

Mechanical Drawings, Electrical Schematics, and Layout Drawings.

 Manuals: Operating Manuals, Maintenance Manuals, Spare Parts Lists.

 Certificates: Material certificates (3.1/3.1B), weld certificates,

instrument calibration certificates.

 Software Documentation: Functional Design Specification (FDS),

Software Design Specification (SDS), Software Test Plan.

 Validation Support Documentation: Provision of FAT/SAT protocols,

IQ/OQ/PQ templates.

4. Risk Assessment

A preliminary Risk Assessment (e.g., using FMEA - Failure Mode and Effects
Analysis) should be conducted at the DQ stage to identify potential risks
associated with the design and to ensure that appropriate mitigation
strategies are incorporated into the design.

 Identify potential failure modes related to the design (e.g.,

inadequate mixing, poor heat transfer, material contamination).

 Assess the severity, occurrence, and detectability of each failure

mode.

 Propose design solutions to mitigate identified risks.

5. Design Review and Approval

This section documents the formal review and approval of the design by all
relevant stakeholders (e.g., Engineering, Production, Quality Assurance,
Validation, Maintenance).

 Review of Design Documentation:

o P&IDs, Mechanical Drawings, Electrical Schematics

 o Functional Design Specification (FDS)

o Software Design Specification (SDS) (if applicable)

o Material Specifications

o Component Datasheets

o Proposed Control Philosophy

 Approval Signatures: All reviewers and approvers must sign and

date the DQ protocol, indicating their agreement that the design is
suitable.

6. Deviations and Resolutions

Any deviations from the URS or identified risks that could not be fully
mitigated by design should be clearly documented here.

 Deviation Number: [Unique ID]

 Description of Deviation: [Detail the deviation]

 Impact on Product Quality/Process: [Explain potential impact]

 Proposed Resolution/Mitigation: [Action taken or planned]

 Responsible Person: [Name]

 Date: [DD-MM-YYYY]

7. Conclusion

Based on the review of the design documentation and the traceability to the
User Requirement Specification, the design of the [Specific Model/Name]
Semi-Solid Production Mixer Homogenizer Tank is considered
[Acceptable/Not Acceptable] for its intended purpose. All identified risks
have been assessed, and appropriate mitigation strategies are either
incorporated into the design or addressed as part of the overall validation
plan.

8. Attachments

 User Requirement Specification (URS)

  Traceability Matrix

 P&ID (Piping and Instrumentation Diagram)

 Mechanical Drawings

 Electrical Schematics

 Functional Design Specification (FDS)

 Preliminary Risk Assessment (FMEA report)

 Vendor Quotation/Technical Proposal

 Material Certificates (if available at this stage)

9. Approval Signatures

Name Signatur Dat

Role
(Print) e e

Prepared By

Reviewed By
(QA)

Reviewed By
(Eng)

Reviewed By
(Prod)

Approved By