Design Qualification of Vertical Laminar Reverse Flow Powder Containment Station

• OBJECTIVE
• To design, engineer and supply the Vertical Laminar Reverse Flow Powder Containment Station to provide assurance that the machine is manufactured as per the URS and it complies with the Scope of Supply.
• To prove that each operation proceeds as per the design specification and the tolerances prescribed there in the document are the same at utmost transparency. Validation procedure is set for complete satisfaction of the customer & building confidence of the user about the machine.

• SCOPE:
• The scope of this qualification document is limited to the Design Qualification of Vertical Laminar Reverse Flow Powder Containment Station. This qualification document is part of a validation activity for the Vertical Laminar Reverse Flow Powder Containment Station.

• RESPONSIBILITIES:

• CLIENT:
• To provide the URS for the equipment.

• To Check and approve the Design Qualification

• MANUFACTURER:

• To design, engineer and provide the complete technical details of the equipment pertaining to its design qualification viz.

• Machine overview
• Brief description of System
• Specification of the sub-components / bought out items, and their make, model & quantity.
• Details of Utilities
• Material of construction of equipment
• Identification of components for calibration
• General Arrangement Drawing
• Installation requirement

• To confirm the safe delivery of the equipment to the user site.
• To ensure that no un-authorized and / or unrecorded design modification shall take place. If at any point in time, any change is desired in the mutually agreed design, change control procedure shall be followed and documented in the Design Change Control Format.
• To ensure the proper installation and commissioning of the equipment.

• BRIEF DESCRIPTION OF SYSTEM
• Basically these are Vertical Laminar Flow Clean air work station with HEPA filtered air sweeping the area from top to bottom for protection the products from contamination as well as preventing the operators from inhaling potentially harmful active materials during sampling, weighing and / or dispensing of powders. The filtered air picks up aerosolized particles and forces them to travel in a predetermined flow pattern until trapped by the Scavenging filters on the back panel of the unit. The air flow pattern is so maintained that the operators in the safe zone (approx in the 300 to 450 mm in to the open front of the cubicle) are not exposed to the dispersed particles. The return air passes through intermediates filters and enters the positive pressure plenum to be pushed downward through HEPA filters. 10% of the air is exhausted out of the zone through HEPA filters for maintaining a slight negative pressure inside to ensure that at no point of time air movement can be outward.
• Two sets of motor blower in series ensures adequate air flow velocities and in- built glare free lighting forms a standard features of the execution.

• TECHNICAL SPECIFICATIONS:

• Details of Utilities
• Utilities Specification

• MATERIAL OF CONSTRUCTION
  • Material of Construction verification Results

• Identification of Components for Calibration
  • Critical Instrument Calibration Verification

• GENERAL ARRANGMENT DRAWING

• CHANGE CONTROL PROCEDURE
• Change in the agreed design shall be addressed through the well-defined Change control procedure through Design Change Control Format.

• DESIGN QUALIFICATION REPORT

 Abbreviation

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