Installation Qualification (IQ) Page1 / 25

Document No.: Version No.: Date of issue.:

Customer Ref. No.:
ESPL-IQ-08-0017 0.00

Model : Bin Blender 10L, 20L, 40 L

Batch No. : ESPL-120

Sr. No. : ESPL-08-0017

 Installation Qualification (IQ)

Change history

Version Reference Description, Ref. to Clauses or Chapters/Sections

Page No.

0.00 -- First official Issue, Dt

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 Installation Qualification (IQ)

Index
1 Table Of Content .................................................................................................................... 3
2 Pre- Approval .......................................................................................................................... 4
3 Objective ................................................................................................................................. 5
4 Scope ....................................................................................................................................... 5
5 Responsibility ........................................................................................................................ 6
6 Pre-Installation Check List ................................................................................................... 7
7 Installation Qualification Tests ............................................................................................... 9
7.1 Document & Drawing Verification ...................................................................................... 10
7.2 Identification Of Major Components .................................................................................... 12
7.3 Utility Verification ................................................................................................................ 16
7.4 Software Verification ............................................................................................................ 17
7.5 Network Verification ............................................................................................................ 18
7.6 Digital Input Verification...................................................................................................... 19
7.7 Digital Output Verification ................................................................................................... 20
8 Acceptance Criteria / Checks During Installation.................................................................. 21
9 Qualification Document Report Approval ............................................................................. 22
10 Discrepancy and Corrective Action Report ........................................................................... 23
11 Final Approval………………………………………………………………………………24
12 Remark If Any ....................................................................................................................... 25

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 Installation Qualification (IQ)

3. Objective:
To design, engineer, and supply the Bin Blender as per cGMP and GEP guidelines and 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.

4. Scope:
The scope of this qualification document is limited to the Installation Qualification of Bin
Blender
The scope of this document includes all of the operating functions, control functions, & alarm
of the Conta Blender.
In addition to an introduction to the machine functionality, this document provides a detailed
description for each identifiable separate function performed by the machine.

Qualification of support utilities is not within the scope of this qualification document. For the
support of utilities, details are given regarding total requirement of electric power, compressed
air etc.

The Equipment shall operate under dust free environment and conditions as per the cGMP
requirements.

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 Installation Qualification (IQ)

5. Responsibilities

A. Client: -
 To provide the URS for the Equipment.
 To perform the Installation Qualification Test. (IQ).

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 Installation Qualification (IQ)

6.0 Pre-Installation Check List

This check list needs to be verified by customer once the machine is received at location. This is to
ensure everything is intact before service engineer reached to the site to help to reduce the
installation time to smooth installation and commissioning. This check list also help customer to
install the utilities of correct specification.

6.1 Foundation preparation

Not required.

6.2 Procedure for Foundation preparation

Select the location for the machine to be installed by taking care the space required for maintenance from
all sides of the machine preferably about 300 mm minimum space.

6.3 Prerequisites and Conditions to be prepared for Installation

1. Minimum space required to house the basic Machine Bin Blender

1635mm x 1272mm x 1842 mm (L x W x H)
6. Maintain temperature at the Machine site between 20 Degree and 25 Degree Depending
upon formulation requirement if any
7. Maintain humidity at the Machine site between 40% RH and 50% RH and / or lower
Depending upon formulation requirement if any
8. Sufficient lighting at the Machine site.
9. Ensure electrical supply connections for the Machine and the accessories as per their
technical specifications.
10. Ensure Pneumatic compressed air supply connections for the Machine and the
Accessories as per their technical specifications.
11. Availability of isolator of for 3 phase 415 V + Earth / ground, 50 Hz.
12. Provide proper earthing for the Machine and accessories.
13. Keep sufficient quantity of formulation ready for conducting machine trials minimum
for 2 batches of production.
14. Operating and maintenance personnel to be designated so that they can be trained by our
engineer. The above activities carried out prior to arrival of our engineer will help him
devote more time towards setting formulations and training your personnel.

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 Installation Qualification (IQ)

6.4 Leveling the Machine

CAUTIONS:
Do not operate the machine until the machine is fixed properly.

Top portion of the Machine should be checked with spirit level.

Tighten all nuts and bolts firmly as they may be loosened during transportation.

Check if there is oil inside the gear box through the indication port provided.

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 Installation Qualification (IQ)

7. Installation Qualification Test

Description Specification Remark

Equipment Bin Blender 10L, 20L, 40 L. (Interchangeable Bowl)
Blending/Mixing, Lubricating of Pharmaceutical
Application
Powders/granules by rotating Bin at Desired RPM.
Overall dimensions 1335mm(L) X 972mm(W) X 1542mm(H)
Gross Capacity (10 LTR) 10 LTR
Maximum Working 8 LTR (80%)
Capacity
Minimum WorkingCapacity 3 LTR (30%)
Gross Capacity (20 LTR) 20 LTR
Maximum Working
16 LTR (80%)
Capacity
Minimum WorkingCapacity 6 LTR (30%)
Gross Capacity (40 LTR) 40 LTR
Maximum Working
32 LTR (80%)
Capacity
Minimum WorkingCapacity 12 LTR (30%)

The table below lists the tests to be performed as part of the Installation Qualification phase.

Serial Number Critical Feature

7.1 Documents & Drawings Verification

7.2 Identification of major Components

7.3 Utility Verification

7.4 Software Verification

7.5 Network Verification

7.6 Digital Input Verification

7.7 Digital Output Verification

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 Installation Qualification (IQ)

7.1 Document & Drawings Verification:

Purpose:
To verity that the documents provided are complete and correct technical references and
permits servicing of the units.

Test equipment:
Not Required.

Procedure:
1. Review the documents and drawings for completeness and exactness with the installed units.
Sign and date all copies of the drawings once verification is completed.

[Link] Description Verified Remark

(Yes/No)
1. G.A. Drawing
2. Electrical Wiring Diagram from Instruction Manual
3. Certificates of bought out components and MOC certificate

i. Blending Motor
ii. Blending Gearbox
iii. Power Pack
iv. castor wheel
v. VFD
vi. PLC
vii. HMI
viii. Material
2. Attach the copies of the drawings to this protocol or reference the location from where
they can be easily retrieved.
3. Any items in the installation, which are not conforming to the corresponding drawings,
must be commented on in the appropriate space. List the non-conformances and the
reasons for them in an attachment if necessary.

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 Installation Qualification (IQ)

Acceptance Criteria:
1. The documents must be accurate and complete.
2. The drawing information must correspond to the physical installation.
3.
Documentation Verification Results:
1. G.A. Drawing, Electrical Wiring reviewed.
2. Installation & Operating Manuals from OEM are reviewed.

Conclusions / Comments:

Result: - _______________________________________________________________

Verified By: _______________________ Date: ______________

Reviewed By: ________________________ Date: ______________

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7.2 Identification of Major Components

I. Mechanical Components:

Verified By
Sr. No. Description Remark
Yes /No

1. Make Hindustan Electric Motor

1 HP/0.75 kw, RPM -1415

2. Specification
415V/50 HZ
3. Qty. 1

2. Blending gear box

Verified By
Sr. No. Description Remark
Yes /No

1. Make Bonfiglioli

W 86 UF1 64 P80 B5 B3
2. Type
Ratio -64
3. Qty. 1

3. Ball Bearing

Verified By
Sr. No. Description Remark
Yes /No
1. Make SKF
2. Model 6008-2Z
3. Qty. 1

4. Castor Wheel

Verified By
Sr. No. Description Remark
Yes /No
1. Make Swiss Engineering

2. Size HDPU-10032-SSPL

3. Qty. 12

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 Installation Qualification (IQ)

II. Electrical Components:

1. PLC

Verified By
Sr. No. Description Remark
Yes /No
1. Make Mitsubishi
2. Model FX5U-32MT/ESS

2. HMI

Verified By
Sr. No. Description Remark
Yes /No
1. Make Mitsubishi
2. Model GS2107-WTBD-N
3. Size 7 Inch
3. VFD

Verified By
Sr. No. Description Remark
Yes /No
1. Make Mitsubishi Electric
2. Model FR-D740-022-E16

4. Main Switch

Verified By
Sr. No. Description Remark
Yes /No
1. Make Siemens
2. Model 3LD2003-OTK53

5. EMC Filter

Verified By
Sr. No. Description Remark
Yes /No
1. Make Elcom
2. Model EF-1B006BO1E-CO2

6. Transformer

Verified By
Sr. No. Description Remark
Yes /No
1. Make Arihant Electricals

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Input 110V/ Output 230V, AC220-

2. Specification
230VA

7. SMPS

Verified By
Sr. No. Description Remark
Yes /No
1. Make Phoenix Contact
2. Specification PS/1AC/24DC/120W/EE

8. Supply Monitoring Relay

Verified By
Sr. No. Description Remark
Yes /No
1. Make Selec
2. Model 900 VPR

9. MCB

Verified By
Sr. No. Description Remark
Yes /No
1. Make Siemens
2. Specification 3 pole ,6 Ampere
3. Qty 1 Nos

10. MCB

Verified By
Sr. No. Description Remark
Yes /No
1. Make Siemens
2. Specification 2 pole ,6 Ampere
3. Qty 5 Nos

11. Input Choke

Verified By
Sr. No. Description Remark
Yes /No
1. Make Arihant Electricals
2. Specification 0.75 KW

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12. Emergency Switch

Verified By
Sr. No. Description Remark
Yes /No
1. Make Schneider
2. Model ZBE-102N

13. Relay Board

Verified By
Sr. No. Description Remark
Yes /No
1. Make Omron
2. Model E207626
3. Qty 2

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 Installation Qualification (IQ)

1.3 Utility Verification

Purpose:
To verify that all necessary utilities are correctly installed.

Test Equipment:
Calibrated digital multi-meter

Procedure:
Confirm that utilities connections are configured as per specification and in compliance with local codes.
Record the results in the table below. Note any deviations or discrepancies.

Acceptance Criteria:
All services and connections must be installed and documented as per Specifications.

Utilities Specification Data Recording & Results:

Description Specified Measured Complies Remark

Results Yes / No/ NA

Phase: 3 Phase
Electrical Voltage: 415 VA + 10 %
Supply Frequency: 50 Hz
Power: 1 KW (approx.)

Conclusions / Comments:

Result: -
_______________________________________________________________

Verified By: _______________________ Date:______________

Reviewed By: ________________________ Date:______________

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7.4 Software Verification

Purpose:
To verity that all software for the Bin Blender has been updated before starting the Installation
Qualification.

Procedure:
Verify that all software is updated using an approved procedure, against a traceable standard.
Note any deviations or discrepancies and recommend follow up actions if required.
For all software, attach copies of certificates to this protocol.

Acceptance Criteria:
All software for the Bin Blender shall be in a state of software.

Complies
Description Model No. Software Version Remark
Yes / No/ NA
GT Designer 3
HMI GS2107-WTBD-N Version 1.290C
GX Works 3,
PLC FX5U-32MT/ESS Version 1.090L

Conclusions / Comments:

Result: -
_______________________________________________________________

Verified By: _______________________ Date: ______________

Reviewed By: ________________________ Date:______________

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7.5 Network Verification

Purpose:
To verity that all network for the Bin Blender has been updated before starting the
Installation Qualification.

Procedure:
Verify that all networks are updated using an approved procedure, against a traceable
standard.
Note any deviations or discrepancies and recommend follow up actions if required.
For all software, attach copies of certificates to this protocol.

Acceptance Criteria:
All networks for the Bin Blender shall be in a state of network.

Present Complies
Description Type Remark
(Yes / No) Yes / No/ NA
1. Ethernet Ethernet

Conclusions / Comments:

Result: -
_______________________________________________________________

Verified By: _______________________ Date: ______________

Reviewed By: ________________________ Date: ______________

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 Installation Qualification (IQ)

7.6 Digital Input Verification

Purpose:
To verity that all digital input for the Bin Blender has been working before starting the Installation
Qualification.

Procedure:
Verify that all digital inputs are working using an approved procedure, against a traceable standard.
Note any deviations or discrepancies and recommend follow up actions if required.

Acceptance Criteria:
All digital inputs for the Bin Blender shall be in a state of INPUT status.

Conclusions / Comments:

Result: -
_______________________________________________________________

Verified By: _______________________ Date: ______________

Reviewed By: ________________________ Date: ______________

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 Installation Qualification (IQ)

7.7 Digital Output Verification

Purpose:
To verity that all digital output for the Bin Blender has been working before starting the
Installation Qualification.

Procedure:
Verify that all digital outputs are working using an approved procedure, against a traceable standard.
Note any deviations or discrepancies and recommend follow up actions if required.

Acceptance Criteria:
All digital outputs for the
Bin Blender shall be in a state of OUTPUT status.

Conclusions / Comments:

Result: - _______________________________________________________________

Verified By: _______________________ Date: ______________

Reviewed By: ________________________ Date: ______________

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8.0 Acceptance Criteria / Checks During Installation

[Link]. Description Remark

1. Verification of the Machine serial number

2. Unpack of the machine as per the instruction given in the manual.

3. Verify that the machine is shifted at the notified block/location

Verify the correct Location of placement of the machine in such a way that the
4. machine should not foul with any wall, partition, pillar or any other object around the
machine.
5. Verify & check all the items as per packing list supplied along with the machine.

6. Verify the assembly of all the loose parts at the decided location.
Verify electrical supply connections for the machine and the accessories as per their
7.
technical specification.
8. Verify availability of isolator of For 3 phase 415 V + Earth / ground, 50 Hz.
Ensure mounting of the operating panel on the stand is proper and all the electrical
9.
connections are complied.

10. Ensure the Conta Bin is locking & unlocking properly.

11. Ensure the discharge butterfly valve of Conta bin is opening & closing properly.

12. Verify that the Main supply is ON

Ensure whether all the ON/ OFF switches, HMI and PLC are working properly with
13.
proper communication.

14. Ensure if all the indication and displaying components are working properly.

15. Ensure that all the Electrical connections are completed.

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9. Qualification Document Report Approval

9.1 Summary:

9.2 Certification:

Verified By: _______________________ Date: ______________

Reviewed By: ________________________ Date: ______________

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10.0 Discrepancy and Corrective Action Report

10.1 Description of discrepancy:

10.2 Person, responsible for corrective action and date assigned:

10.3 Corrective action taken:

10.4 Any other (Please specify):

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11.0 Final Approval

Manufacturer -

Prepared By Name & Designation Signature & Date

Commissioning Engineer

Reviewed By Name & Designation Signature & Date

Commissioning Engineer

Customer: -

Reviewed By Name & Designation Signature & Date

Approved By Name & Designation Signature & Date

Quality Assurance

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12.0 Remark If Any

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