Design Qualification of Vertical Laminar Reverse Flow Powder Containment

Station
Posted By: Pharma Editor on: May 02, 2017 In: email, Other Topic, Qualification No Comments

• 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

Vertical Laminar Reverse Flow Powder Containment Station Model: 2256-RF-SS-

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

Description Specification

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

70-65% on ASHRAE STD 52-76 equivalent to 99 % on BS-2831 Test Dust II for

Micron Rating 3µ

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.
Description Specification

5.0. Pre filter

Micron Rating 5µ

60-65 % on ASHRAE STD 52-76 equivalent to 98% on BS- 2831 Test Dust II for
Filter Efficiency
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

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

Lab Liquid Handlers