The document provides a design qualification protocol for a dispensing booth for a customer. It includes specifications for the dispensing booth such as dimensions, materials of construction, blower details, filtration scheme and technical specifications for pre-filters, fine filters and HEPA filters. Responsibilities of the supplier and client are also outlined.
The document provides a design qualification protocol for a dispensing booth for a customer. It includes specifications for the dispensing booth such as dimensions, materials of construction, blower details, filtration scheme and technical specifications for pre-filters, fine filters and HEPA filters. Responsibilities of the supplier and client are also outlined.
The document provides a design qualification protocol for a dispensing booth for a customer. It includes specifications for the dispensing booth such as dimensions, materials of construction, blower details, filtration scheme and technical specifications for pre-filters, fine filters and HEPA filters. Responsibilities of the supplier and client are also outlined.
The document provides a design qualification protocol for a dispensing booth for a customer. It includes specifications for the dispensing booth such as dimensions, materials of construction, blower details, filtration scheme and technical specifications for pre-filters, fine filters and HEPA filters. Responsibilities of the supplier and client are also outlined.
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I DA C HE RLA PA LL I, H YD ERA BA D - 5 0 0 0 5 1 .
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DESIGN QUALIFICATION PROTOCOL APPROVAL
This document is prepared by the documentation team of M/S. PHARMA ENGINEERS
for EQUIPMENT : DISPENSING BOOTH PLANT /PROJECT : CLIENT : Hence this document before being effective shall be approved by Client / Customer M/s. PHARMA ENGINEERS:
Equipment: DISPENSING BOOTH (______W x _____D x ______H mm)
Page 5 of 10
DESIGN QUALIFICATION (DQ)
3. RESPONSIBILITIES
M/s. Pharma Engineers:
1. Shall agree and follow the URS.
2. To Prepare the detailed engineering drawings. 3. To submit the technical details of equipment as per the scope of supply. 4. To ensure safe delivery of equipment 5. To Complete the equipment qualification. Client:
Equipment: DISPENSING BOOTH (______W x _____D x ______H mm)
Page 6 of 10
DESIGN QUALIFICATION (DQ)
4. EQUIPMENT DESCRIPTION
Dispensing Booth is designed to obtain cleanliness level complies with
Class 100/ISO-5 at rest condition and ability to sweep away contaminants generated during handling and to maintain the required classified conditions.
MAXIMUM CONCENTRATED LIMITS
(PARTICLE/M3 OF AIR) FOR PARTICLE EQUAL & ISO STD LARGER THAN THE CONSIDERED SIZES AS PER ISO 14644-1 (2015) ISO-5 0.5 micron 5 microns Particles per Cubic 3520 29 Meter
Dispensing Booth chamber is constructed in stainless steel of grade SS 304,
20G, with PVC split curtain operation.
The top portion of dispensing booth is housed with blower motor assembly followed by HEPA filter and bottom portion shall have return air path with pre-filter and fine filter.
Blower was sized to maintain the laminar air below the HEPA Filter and also to take care of pressure drop across the filter. The speed of the blower shall be adjusted with Speed regulator.
The air is drawn through pre-filter and blows over the HEPA Filter with a velocity of 90 feet per minute; however, the variation of velocity is accepted up to ±20% feet per minute. Thus, the chamber is maintained for a class of cleanliness confirms to Class 100 / ISO-5.
Pressure differential across the HEPA Filter, Fine Filter and Pre-Filter shall be monitored with a differential pressure gauge.
Lights shall be provided at working area. Approx. 400 Lux intensities shall be maintained.
Required ports are provided for D.O.P and pressure drop measurement Client:
Equipment: DISPENSING BOOTH (______W x _____D x ______H mm)
Page 7 of 10
DESIGN QUALIFICATION (DQ)
5. SYSTEM ARCHITECTURE
DESCRIPTION PARAMETER
Room Name / Location of Equipment
Classification Grade
Pressure Maintained
6. TECHNICAL SPECIFICATIONS: NOMENCLATURE: Equipment TAG Number DISPENSING BOOTH Manufacturers name M/s Pharma Engineers Qty 01 No. CONSTRUCTION DETAILS: Working Area (width x Depth x Height) mm 1870 x 1280 x 2000 mm Overall Size (width x Depth x Height) mm 1970 x 1830 x 2400 mm M.O.C SS 304, 20G, Matt Finish BLOWER DETAILS Make KRUGER Model KDD 9X9 S Power 405 W, 1 Ø, 50 Hz R.P.M 1150 RPM Qty 2 No FILTRATION SCHEME WITH IN EQUIPMENT PRE-FILTER Make M/s. ULTRAFIL AIR SYSTEMS Type Flange Type Test Method EN 779 Filter Classification as per EN779 G4 Media Synthetic media Avg. arrestance of synthetic dust 90 ≤ Am Equivalent particle size in terms of market 10 microns –Un authenticated data language Size 855x690x75 mm Qty 2 No. I.P.D of Filter (Approximate) 1 to 06 mm of WC F.P.D of Filter (Approximate) 25 mm of WC Client:
Equipment: DISPENSING BOOTH (______W x _____D x ______H mm)
Page 8 of 10
DESIGN QUALIFICATION (DQ)
NOTE: I.P.D & F.P.D values change based on AIRFLOW; hence customer should set the limits after commissioning. FINE FILTER Make M/s. ULTRAFIL AIR SYSTEMS Type Flange Type Test Method EN 779 Filter Classification as per EN779 M-5 Media Synthetic media Avg. arrestance of synthetic dust 40 ≤ Em < 60% Equivalent particle size in terms of market 5 microns–Un authenticated data language Size 775 X 615 X 150 mm Qty 2 No. I.P.D of Filter (Approximate) 5 to 15 mm of WC F.P.D of Filter (Approximate) 45 mm of WC NOTE: I.P.D & F.P.D values change based on AIRFLOW; hence customer should set the limits after commissioning. HEPA FILTER Make AAF Type of filter BOX Test method EN 1822 Filter classification H-14 Avg.efficiency at MPPS 99.995% Media MOC Micro fiber glass Washable compatibility No Equivalent particle size in terms of market 99.999% down to 0.3 micron–Un language authenticated data Size 915 X 610 X 69 mm Qty 4 No’s I.P.D of Filter (Approximate) 10 to 15 mm of WC F.P.D of Filter (Approximate) 50 mm of WC NOTE: I.P.D & F.P.D values change based on AIRFLOW; hence customer should set the limits after commissioning. EXHAUST HEPA FILTER Make AAF Type of filter BOX Test method EN 1822 Filter classification H-14 Avg.efficiency at MPPS 99.995% Client:
Equipment: DISPENSING BOOTH (______W x _____D x ______H mm)
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DESIGN QUALIFICATION (DQ)
Media MOC Micro fiber glass
Washable compatibility No Equivalent particle size in terms of market 99.999% down to 0.3 micron–Un language authenticated data Size 610 X 150 X 69 mm Qty 2 No’s INSTRUMENTATION DETAILS DIFFERENTIAL PRESSURE GAUGES Make DWYER Type Analog Gauge Range 0 to 50 mm of WC Across Pre-Filter, Fine Filter, HEPA Location Filter Qty 3 No CFL LIGHT Make Havells Length 4’ Qty 1 No ACCESSORIES ON/OFF Switch for Blower 6 Amps Selector Switches / 01 No’s ON/OFF Switch for CFL LIGHT 6 Amps Selector Switches / 01 No’s PAO, ATM & DOP Ports SS 304 with Matt finish Gasket Food grade gasket
7. SAFTEY FEATURES & INTERLOCKS
Sr.No. ACTIVITY ACTION ALARMS
Indication is Beep sound blows, and 1. Blower Over loaded provided with blower is switched OFF Alarm Client:
