NDB HEALTHCARE
USER’S REQUIREMENT SPECIFICATION
Document No :
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NDB/URS/006 Equipment : LAMINAR AIR FLOW
Table of Contents
Sr. Page
Contents
No. No.
1.0 Introduction 2
2.0 Overview 2
3.0 Operational Requirements 2
3.1 Safety & Compliance 2
4.0 Compatibility and Support 3
4.1 Utilities 3
4.2 Availability 3
4.3 Procedural Document Requirements 3
5.0 Glossary 3
6.0 References 3
7.0 Approval 3
NDB HEALTHCARE
USER’S REQUIREMENT SPECIFICATION
Document No :
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NDB/URS/006 Equipment : LAMINAR AIR FLOW
1.0 Introduction:
1.1 Purpose of the LAF unit (e.g., aseptic handling, contamination control)
1.2 Brief description of the equipment
2.0 Overview:
Intended Use: For sterile operations or microbiological testing
Capacity: Dimensions of the working area
Space Requirements: Installation space including height, width, and depth
Cleaning Requirements: Compatibility with disinfectants like 70% IPA
3.0 Operational Requirements
Airflow Type: Horizontal or vertical laminar flow
HEPA Filter Efficiency: Typically ≥99.97% for particles ≥0.3 microns
UV Light: For sterilization between operations
Lighting: Fluorescent or LED for visibility
Noise Level: Acceptable decibel range
Control System: ON/OFF switches, UV timer, airflow monitor
3.1 Safety & Compliance
Material of Construction: SS-304 or SS-316 for cleanability and corrosion resistance
Electrical Safety: MCB protection, grounding
Regulatory Compliance: Must meet GMP and ISO standards
NDB HEALTHCARE
USER’S REQUIREMENT SPECIFICATION
Document No :
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NDB/URS/00 Equipment : LAMINAR AIR FLOW
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4.0 Compatibility and Support
4.1 Utilities: The supplier shall indicate the requirement of utilities to be provided by
the user while submitting the design specification.
Base Utilities Worksheet:
Electricity: 3 phase, 415V +/-10%, AC 50 Hertz +/-2%
Uninterrupted Power Supply: Not required.
Other utility requirements shall be discussed as needed.
4.2 Availability: The Octogonal Blender 500 litre is intended to be operated:
Regularly 2 shifts.
4.3 Procedural Document requirement:
Supplier has to provide, Detailed functional specification and Design Qualification
protocols, Drawings, electrical circuit diagrams, Operation & Maintenance Manual,
Warranty letter, List of Standard spares, List of change parts.
5.0 Glossary / Abbreviations:
V - Volts
NMT - Not more than
MOC - Material of construction
MS - Mild steel
SS - Stainless steel
MCB - Miniature Circuit Breaker
6.0 References: IN-HOUSE
7.0 Approval
Name & Designation Department Signature Date
Prepared By
Checked By
Approved By
