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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:
Description Specification
1.0. Equipment Description
Name Vertical Laminar Reverse Flow Powder Containment Station Model: 2256-RF-SS-SP-4
Hepa Area 1900 mm(L) X1900 mm (W)
Overall dimensions 2050 mm (W) X 2565 mm (D) X 2535 mm (H)
2.0.  HEPA Filter (Exhaust)
Micron Rating 0.3µ
Filter Efficiency 99.997% of 0.3µ
Size 24” x 06” x 03”
Filter media Micro Fibre Glass
Batch No. 07/06
Type T/E
Grade I
Rated Capacity 150 CFM
Pressure Drop 25 mm
Performance Type Vertical
Make
Qty. 02 Nos.
3.0. HEPA Filter
Micron Rating 0.3µ
Filter Efficiency 99.997 % of 0.3µ
Size 36” x 24” x 03”
Filter media Micro Fibre Glass
Batch No. 07/06
Type T/E
Grade I
Rated Capacity 1080 CFM
Pressure Drop 25 mm
Performance Type Vertical
Make
Qty. 06 Nos.
4.0. Intermediate Filter
Filter Efficiency 70-65% on ASHRAE STD 52-76 equivalent to 99 % on BS-2831 Test Dust II for Particles down to 3 µ
Micron Rating
Size 24”x18”x06”
Flow Rate 750 cfm at 0.20”
Filter media Fibre Glass Media
MOC of frame SS
Gasket Neoprene
Make
Qty. 03 Nos.
5.0. Pre filter
Micron Rating
Filter Efficiency 60-65 % on ASHRAE STD 52-76 equivalent to 98% on BS- 2831 Test Dust II for Particles down to 5 m
Size 30”  x 24” x 03”
Flow Rate 625 cfm at 0.15”
Filter media Fibre Glass Media
MOC of frame S.S.
Gasket Neoprene
Make
Qty. 03 Nos.
6.0. Motor Blower
Type Single phase, Induction Motor
Motor Construction Non Flame Proof
Power Rating 0.37 KW / 0.5 HP / 230 V / 50 Hz / 1400 RPM
Make West End Electricals
Qty. 04 Nos.
7.0. Differential Pressure Gauge Across Pre-filter
Range 0-10 mm WC
Least Count 0.2 mm WC
Model 2000-10 MMC
Max. Pressure 15 PSIG
Make Dwyer
8.0. Differential Pressure Gauge Across Intermediate filter
Range 0-25 mm WC
Least Count 0.5 mm WC
Model 2000-25MMC
Max. Pressure 15 PSIG
Make Dwyer
9.0. Differential Pressure  Gauge Across HEPA Filter
Range 0-50 mm WC
Least Count 1 mm WC
Model 2000-50 MMC
Max. Pressure 15 PSIG
Make Dwyer
  • Details of Utilities
  • Utilities Specification
Description Specified
Electrical To be provided
  • MATERIAL OF CONSTRUCTION
    • Material of Construction verification Results
Description Specification
Module of equipments SS 304 [18 G]
Side Panels SS 304 [18 G]
Table SS 304 [18 G]
  • Identification of Components for Calibration
    • Critical Instrument Calibration Verification
Sr. No. Description
1 Differential Pressure Gauge Across HEPA
2 Differential Pressure Gauge Across Intermediate Filter
3 Differential Pressure Gauge Across Prefilter
  • GENERAL ARRANGMENT DRAWING
01 Enclosed Drawing No.
  • 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

cGMP current Good Manufacturing Practices
GEP Good Engineering practices
MS Mild steel
NFLP Non Flame Proof
SS Stainless Steel
WC Water Column
KW Kilo Watt
DQ Design Qualification
URS User Requirement Specifications
FAT Factory acceptance test
HEPA High Efficiency Particulate air
LFT Lift
VFD Variable frequency drive
RPM Revolution per minute
MMI Man machine interface
SCADA Supervisory control & data acquisition
MCB Miniature circuit breaker

 

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