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无锡零界净化设备有限公司 Wuxi unmixed cleanse equipment co.,Ltd

INSTALLATION QUALIFICATION
FOR
DISPENSING BOOTH

CUSTOMER: M/s-Globex Pharmaceuticals Limited

EQUIPMENT:
DISPENSING BOOTH
( 1870 W x 1280 D x 2000H mm)

SUBMITTED BY:

Wuxi unmixed cleanse equipment co.,Ltd

Address
XUELANG SHUANGXIN ECONIMIC PARK,
BINHU DISTRICT,WUXI CITY,JIANGSU,
CHINA WUXI CITY,
JIANGSU JIANGSU PROVINCE
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无锡零界净化设备有限公司 Wuxi unmixed cleanse equipment co.,Ltd

INSTALLATION QUALIFICATION PROTOCOL APPROVAL

This document is prepared by the documentation team of M/S. Wuxi unmixed cleanse equipment
co.,Ltd for M/S –GLOBEX PHARMACEUTICALS LTD,BANGLADESH

EQUIPMENT : DISPENSING BOOTH

PLANT /PROJECT : Pharmaceuticals

CLIENT : Globex Pharmaceuticals Ltd.
Hence this document before being effective shall be approved by Client / Customer.

M/s. Wuxi unmixed cleanse equipment co.,Ltd:

Name Designation Signature Date

Prepared By

Reviewed By

CLIENT / CUSTOMER: GLOBEX PHARMACEUTICALS LTD.

Name Designation Signature Date

Reviewed By

Approved By
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无锡零界净化设备有限公司 Wuxi unmixed cleanse equipment co.,Ltd

INSTALLATION QUALIFICATION (IQ)

TABLE OF CONTENT

1. OBJECTIVE................................................................................................................................4

2. RESPONSIBILITIES................................................................................................................4

3. SCOPE OF SUPPLY OF COMPONENTS............................................................................5

4. VERIFICATION OF CALIBRATION OF INSTRUMENTS............................................9

5. LIST OF DOCUMENTS ENCLOSED.................................................................................10

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无锡零界净化设备有限公司 Wuxi unmixed cleanse equipment co.,Ltd

INSTALLATION QUALIFICATION (IQ)

1. OBJECTIVE

The objective of this document is to verify that the Dispensing

booth is installed with due considerations as specified in DQ of Dispensing
booth.

2. RESPONSIBILITIES

M/s. Wuxi unmixed cleanse equipment co.,Ltd

1. To install and position the equipment with proper orientation.

2. To provide the necessary test certificates as per technical specifications
specified in DQ.
3. To complete the equipment qualification.
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无锡零界净化设备有限公司 Wuxi unmixed cleanse equipment co.,Ltd

INSTALLATION QUALIFICATION (IQ)

3. SCOPE OF SUPPLY OF COMPONENTS:

PURPOSE
This test is to verify that the equipment dimensions, position and sizes of utility
connections are in compliance with the design qualification and also with as-
built drawing.

PRE-REQUISITES
1. As built drawing
2. Measuring tape
3. Approved Design Qualification Document
TEST METHOD

1. Physically check the dimension of the equipment in length, width, and

height and confirm with design document.
2. Physically check and confirm that required indications are mentioned on
the equipment like, safety indication.
3. Deviations or remarks may be documented along with summary of all test
results

COMPONENT VERIFICATION

CRITERIA
SPECIFICATIONS AS PER
SR.NO DESCRIPTION FULL
DESIGN QUALIFICATION
FILLED
(YES/NO)
CONSTRUCTIONAL DETAILS:
Equipment TAG Number
Unit Serial Number
Manufacturers name M/s- Wuxi unmixed cleanse
1. equipment co.,Ltd
Qty 01 No.
Internal size (width x Depth x Height) 1870x1280x2000mm
mm
External size (width x Depth x Height) 1970x1830x2400mm
mm
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无锡零界净化设备有限公司 Wuxi unmixed cleanse equipment co.,Ltd

INSTALLATION QUALIFICATION (IQ)

CRITERIA
SPECIFICATIONS AS
SR.NO DESCRIPTION FULL
PER DESIGN
FILLED
QUALIFICATION
(YES/NO)
M.O.C SS 304, 20G, Matt Finish
BLOWER DETAILS
Make ZIEL - ABEGG
Model GR19V 41P.Z8.AR
2.
Power Ø1, 50 Hz, 150 W
Qty 4 Nos
Serial Number
FILTRATION SCHEME WITH IN EQUIPMENT
PRE-FILTER
M/s. ULTRA FIL AIR
Make
SYSTEMS
Type Flange Type
Test Method EN 779
Filter Classification as per EN779 G4
3. Media Synthetic media
Avg. arrestance of synthetic dust 90 ≤ Am
Equivalent particle size in terms of 10 microns –Unauthenticated
market language data
Size 610X305X50 mm
Qty 4 No’s
Serial Number
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
4. Washable compatibility No
Equivalent particle size in terms of 99.999% down to 0.3 micron–
market language Unauthenticated data
Size 915 X 762 X 69 mm
Qty 2 No’s
Serial Number
I.P.D of Filter (Approximate) 10 to 15 mm of WC
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无锡零界净化设备有限公司 Wuxi unmixed cleanse equipment co.,Ltd

INSTALLATION QUALIFICATION (IQ)

CRITERIA
SPECIFICATIONS AS PER
SR.NO DESCRIPTION FULL
DESIGN QUALIFICATION
FILLED
(YES/NO)
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.
INSTRUMENTATION DETAILS
DIFFERENTIAL PRESSURE GAUGES
Make DWYER
Type Analog Gauge
5. Range 0 to 50 mm of WC
Location Across HEPA Filter
Qty 1 No
Serial Number

CFL LIGHT
Make HAVELLS
6.
Length 4’
Qty 1 No
UV LIGHT
Make OSRAM
7.
Length 4’
Qty 1 No.
HOUR METER
Make Selec
8.
Range 999999 Hrs
Qty 01 No’s
ACCESSORIES
6 Amps Selector Switches /
ON/OFF Switch for Blower
9. 01 No’s
6 Amps Selector Switches /
ON/OFF Switch for UV/ CFL LIGHT
01 No’s
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无锡零界净化设备有限公司 Wuxi unmixed cleanse equipment co.,Ltd

INSTALLATION QUALIFICATION (IQ)

CRITERIA
SPECIFICATIONS AS PER
SR.NO DESCRIPTION FULFILLED
DESIGN QUALIFICATION
(YES/NO)
PAO, ATM & DOP Ports SS 304 with Matt finish
Gasket Food grade gasket

ACCEPTANCE CRITERIA
Dimensions and supply connections of the system should comply with DQ document and
as built drawings.
However, the acceptance is up to the judgment of experts if any deviation in the readings.

REMARKS (IF ANY):

Test Conducted By Test Witnessed By

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无锡零界净化设备有限公司 Wuxi unmixed cleanse equipment co.,Ltd

INSTALLATION QUALIFICATION (IQ)

4. VERIFICATION OF CALIBRATION OF INSTRUMENTS

Instrument Calibration
S.no. Instrument Type Location Calibrated on
Tag Number Due
1.

2.

3.

Remarks (if any):

Submitted By Checked By
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无锡零界净化设备有限公司 Wuxi unmixed cleanse equipment co.,Ltd

INSTALLATION QUALIFICATION (IQ)

5. LIST OF DOCUMENTS ENCLOSED

ENCLOSED
S.NO DOCUMENT NAME
(YES / NO)
1. TEST CERTIFICATE OF VERTICAL LAF
2. TEST CERTIFICATE OF BLOWER
3. TEST CERTIFICATE OF FILTERS
4. TEST CERTIFICATE OF MAGNEHELIC GAUGE

Remarks (if any):

Submitted By Checked By