Learn the complete SOP for Design Qualification Of Automatic Linear Vial Washing Machine, including URS, FAT, technical specifications, and GMP compliance guidelines for pharmaceutical industries.
1.0 Purpose
The purpose of this SOP is to define the procedure for Design Qualification Of Automatic Linear Vial Washing Machine to ensure that the equipment design complies with User Requirement Specifications (URS) and meets GMP (Good Manufacturing Practices) standards.
2.0 Scope
This SOP applies to the Design Qualification (DQ) of the Automatic High-Speed Linear Vial Washing Machine (Tunnel Type) supplied by LAXMI Pharma Machines for pharmaceutical manufacturing facilities.
3.0 Protocol Approval
Approval of this Design Qualification protocol confirms that:
- The design approach meets agreed specifications
- Both manufacturer and customer accept the design
- Any modifications will be handled through a change control system
- Approved protocol becomes a binding reference document
4.0 Overview of Equipment
4.1 Introduction
This document covers the Design Qualification Of Automatic Linear Vial Washing Machine, ensuring that the machine is designed according to GMP and URS requirements.
- Manufacturer: LAXMI Pharma Machines
- Customer: Selmore Pharmaceuticals
- Machine Type: Tunnel Type Linear Vial Washer
4.2 Objective
- To verify that the machine design meets URS
- To ensure compliance with GMP & cGMP guidelines
- To provide documented evidence of design suitability
5.0 Responsibilities
5.1 Responsibilities of Client
- Provide User Requirement Specification (URS)
- Perform Factory Acceptance Test (FAT)
- Provide product samples for trials
5.2 Responsibilities of Manufacturer
- Provide complete design and engineering documentation
- Share machine drawings, layout, and specifications
- Identify calibration components
- Ensure GMP-compliant construction
- Provide safety features and alarms
- Support FAT execution
- Ensure safe delivery and installation
- Follow strict change control procedures
6.0 User Requirement Specifications (URS)
|
Parameter |
Specification |
|
Model |
GMP compliant
HLVW-120 (Tunnel Type) |
|
Output |
Up to 120
Vials Per Minute |
|
Vial Size |
5 ml to 30 ml
(Tubular & Moulded) |
|
Process |
Complete vial
washing system |
|
Calibration |
Mandatory for
critical components |
|
Safety |
Operator
& material safety ensured |
|
Electrical |
cGMP
compliant electrical system |
|
Documentation |
Complete
qualification documents |
7.0 Machine Description
The Automatic Linear Vial Washing Machine (Tunnel Type) is installed in a controlled washing area with restricted access.
Key Features
- Handles 5 ml to 30 ml vials
-
Multi-stage washing using:
- DM Water
- WFI (Water for Injection)
- Re-circulated water
- Compressed air
- Speed up to 120 vials/minute
-
Equipped with:
- 3 SS-316 tanks (50 L each)
- 3 pumps
- 4 filters (3 water + 1 air)
8.0 Machine Specifications
8.1 Standard Features
- Inbuilt conveyor system
- SS-316 tanks and pumps
- Pressure gauges (glycerin-filled)
- Bonfiglioli gearbox
- Filter housing units
- Change parts for different vial sizes
8.2 Washing Sequence
Internal Washing Stages:
- Compressed Air
- Re-circulated Water
- Re-circulated Water
- Compressed Air
- Fresh DM Water
- WFI Water
- Compressed Air
External Washing Stages:
- Re-circulated Water
- Fresh DM Water
9.0 Technical Specifications
- Power Supply: 440V, 3 Phase, 50 Hz
- Total Power: 6 HP
- Output: 120 VPM
- Water Consumption: 200–400 L/hr
- Air Requirement: 30–35 CFM @ 5 Bar
- Dimensions: 96” × 68” × 68”
- Weight: Approx. 1250 kg
10.0 Material of Construction (MOC)
- Machine Body: SS 304
- Water Contact Parts: SS 316
- Tanks & Pumps: SS 316
- Gaskets: Silicon
- Conveyor: Modular Belt
- Bottle Holders: Food-grade HDPE
11.0 Utilities Requirement
- Electrical Supply: 3 Phase, 440V
- Water: 200–400 L/hr
- Compressed Air: 30–35 CFM
12.0 Calibration Requirements
Critical instruments requiring calibration:
- Pressure Gauges
Calibration ensures accuracy, compliance, and consistent performance.
13.0 Documentation
The manufacturer must provide:
- Operation & Instruction Manual
- Test Certificates
- IQ Protocol
- OQ Protocol
- FAT Protocol
14.0 Factory Acceptance Test (FAT)
FAT Procedure Includes:
- Design verification checklist
- Performance testing
- Deficiency reporting
- Pre-installation verification
- Final FAT report
FAT is conducted at the manufacturer’s site before dispatch.
15.0 Design Change Control
- All design changes must follow a formal change control procedure
-
Changes must be:
- Documented
- Reviewed
- Approved by both parties
16.0 Deficiency & Corrective Action
If any deviation is observed:
- Record deficiency
- Implement corrective action
- Verify compliance before approval
17.0 Summary & Conclusion
The Design Qualification Of Automatic Linear Vial Washing Machine ensures that the equipment:
- Meets URS requirements
- Complies with GMP standards
- Is safe, efficient, and reliable
- Is ready for Installation Qualification (IQ) and Operational Qualification (OQ)
18.0 Abbreviations
- DQ – Design Qualification
- GMP – Good Manufacturing Practices
- cGMP – Current GMP
- URS – User Requirement Specification
- FAT – Factory Acceptance Test
- VPM – Vials Per Minute
- SS – Stainless Steel
Frequently Asked Questions (FAQs)
1. What is Design Qualification Of Automatic Linear Vial Washing Machine?
Design Qualification (DQ) ensures that the vial washing machine design meets GMP standards and user requirements before manufacturing.
2. Why is DQ important in pharmaceutical equipment?
DQ ensures compliance, safety, and performance reliability before installation, reducing risks during production.
3. What is the role of FAT in DQ?
FAT verifies that the equipment performs as per design specifications before delivery to the site.
4. What utilities are required for vial washing machines?
Key utilities include electrical power, purified water, WFI, and compressed air.
5. What materials are used in vial washing machines?
Typically SS 304 for structure and SS 316 for product-contact parts to meet GMP standards.
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