HSM Iq

Installation Qualification (IQ) Page1 / 26
Document No.: Version No.: Date of issue.:

Customer Ref. No.:
ESPL-IQ-02-0012 0.00
Model : High Shear Mixer 30&10 LTR
Batch No. : ESPL-120
Sr. No. : ESPL-02-0012

Installation Qualification (IQ)
Change history
Version Reference Description, Ref. to Clauses or Chapters/Sections

Page No.
0.00 -- First official Issue, Dt.
Page 2 of 26
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 ................................................................................................................ 17
7.4 Software Verification ............................................................................................................ 18
7.5 Network Verification ............................................................................................................ 19
7.6 Digital Input Verification ...................................................................................................... 20
7.7 Digital Output Verification ................................................................................................... 21
8 Acceptance Criteria / Checks During Installation.................................................................. 22
9 Qualification Document Report Approval ............................................................................. 23
10 Discrepancy and Corrective Action Report ........................................................................... 24
11 Final Approval……………………………………………………………………………….25
12 Remark If Any ....................................................................................................................... 26
Page 3 of 26
3. Objective:
To design, engineer, and supply the High Shear Mixer- 30 & 10 LTR 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 High
Shear Mixer 30 & 10 LTR
The scope of this document includes all of the operating functions, control functions, &
alarm of the High Shear Mixer.
In addition to an introduction to the machine functionality, this document provides a detailed
description for each identifiable separate function performed by the machine.
Page 5 of 26
5. Responsibilities
A. Client: -
 To provide the URS for the Equipment.
 To perform the Installation Qualification Test (IQ).
Page 6 of 26
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 Applicable.
6.2 Procedure for Foundation preparation

Not Applicable.
6.3 Prerequisites and Conditions to be prepared for Installation
1. Minimum space required to house the basic Machine High Shear Mixer-30&10 Ltr
2300mm x 1270mm x 1970 mm (L x W x H)
2. Maintain temperature at the Machine site between 20 Degree and 25 Degree

Depending upon formulation requirement if any
3. Maintain humidity at the Machine site between 40% RH and 50% RH and / or
lower Depending upon formulation requirement if any
4. Sufficient lighting at the Machine site.
5. Ensure electrical supply connections for the Machine and the accessories as per
their technical specifications.
6. Ensure Pneumatic compressed air supply connections for the Machine and the
Accessories as per their technical specifications.
7. Availability of isolator of for 3 phase 415 V + Earth / ground, 50 Hz.
8. Provide proper earthing for the Machine and accessories.
9. Keep sufficient quantity of formulation ready for conducting machine trials

minimum for 1 / 2 batches of production.
10. 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
Page 7 of 26
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.
Page 8 of 26
7. Installation Qualification Test
Sr. No. Description Specification Remark
High Shear Mixer – 30 &10 LTR

1 Equipment
(Interchangeable Bowl)
2 Application Mixing & Granulation of PharmaceuticalPowders
3 Overall Dimension 2000mmX970mmX1657mm (LXWXH)
4 Gross volume 30 LTR

Maximum Working
5 24 LTR (80%)
Capacity
Minimum Working
6 6 LTR (20%)
Capacity
Gross volume 10 LTR
Maximum Working
8 LTR (80%)
Capacity
Minimum Working
2 LTR (20%)
Capacity
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
Page 9 of 26
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. Verify that the required documents and drawings listed in the tables below are available.
Sr. Description Verified Remark

No (Yes/No)
1. G.A. Drawing
2. Electrical Wiring Diagram from Instruction Manual
3. Certificates of bought out components and MOC certificate
i. Impeller motor
ii. Chopper motor
iii. Gear box
iv. pressure transmitter
v. IR Sensor
vi. Cylinders
vii. Gasket (inflatable silicone seal)
viii. Castor wheel
ix. Lamp
x. HMI
xi. PLC
xii. VFD - chopper motor
xiii. VFD - Impeller motor
xiv. Contact & Non Contact Parts
2. 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.
3. Attach the copies of the drawings to this protocol or reference the location from where
they can be easily retrieved.
4. 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.
Page 10 of 26
Acceptance Criteria:
1. The documents must be accurate and complete.
2. The drawing information must correspond to the physical installation.
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: ______________
Page 11 of 26
7.2 Identification Of Major Components
Verified By
Sr. No. Description Specifications
Yes /No
6.1 Product Bowl Assembly
 Product Bowl
Manufacturer Exenity Systems Pvt Ltd, Pune.
MOC SS316
Gross Volume: 30 &10 LTR
Working Volume: 24 – 6 LTR And
Volumetric Capacity 8 – 2 LTR
[ Working Volume Min. & Max capacity by
considering bulk density ≤ 0.45 gm/cc]
Surface Finish Inside Mirror Finish & Outside Matt Finish
 Product Bowl Lid

MOC SS 316
Surface Finish Inside Mirror Finish & Outside Matt Finish
Position of Top Lid On the bowl
 Product Bowl Lid hinge assembly

MOC SS 304
Surface Finish Matt Finish
 Impeller (Z Type Design)

MOC SS 316
Surface Finish Mirror Finish
No. Of Blades 03 Nos.
 Chopper (Multi Blade)

MOC SS 316
Surface Finish Mirror Finish
No. Of Blades 04 Nos.
Page 12 of 26
Verified By
Yes /No
 Impeller Motor with Gear Box
Make Sew Eurodrive
Type/Model KAF49AMS100
 Impeller Motor (FLP)

Make Hindustan Motors
Type Flange mounted
Power 3 HP / 2.2 KW, RPM-1440
 Chopper Motor (FLP)

Make Hindustan Motors
Type Flange+ Foot mounted
Power 2 HP / 1.5 KW, RPM-2880
 Machine Lamp
Make Bold India
Specification 21Watt
 Product Bowl Lid Proximity Switch

Make Baumer
Model IGYX 12P17B3/S14L
 Infra-Red Sensor
Make Accurate sensors technologies
Model AST TL8
Range 0-500 0C
 Product Bowl Transmitter

Make Baumer
Model CTX-323B720
 Filter -2 Qty
Make KPC
Size 0.5/2& 0.5/4 INCH
 HSM Base Structure

Base Structure MS Powder Coated with SS 304 Cladding
Doors SS 304, Removable type
Page 13 of 26
Verified By
Yes /No
6.2 Purge Air Assembly
 Flow Switch – 2Qty
Make SMC
Model PFMB7201-C8-D
 Atomization pressure regulator
Make SMC
Model ITV2050-012CS3
 5/2 Solenoid Valves - 2Qty
Make SMC
Model SY5320-5DZ-01
 Mist Separator
Make SMC
Model AC30X-X5B867-B
 Regulator with Gauge -2Qty
Make SMC
Model AR20-02BG1-B
 Pressure Switch
Make SMC
Model ISE20A-V-01-J
Verified By
Yes /No
6.3 Discharge Assembly
 Discharge Assembly
MOC SS316
 Discharge Port Pneumatic Cylinder

Manufacturer SMC
Model MDB1KF63TF-200Z-M9PL
 Chopper sliding Pneumatic Cylinder
Manufacturer SMC
Model MDB1KL80TF-200Z-M9PL
Page 14 of 26
Verified By
Yes /No
6.4 Control Assembly
 Analog Output Card: 1 No.
Make Mitsubishi
Model FX5-4DA-ADP
Analog Output Card: 1 No.

Make Mitsubishi
Model FX5-4AD-ADP
 HMI
Make Mitsubishi
Specification GS2110-WTBD-N
 PLC
Make Mitsubishi
Model FX5U-32MT/ESS
 SMPS
Make Phoenix Contact
Model PS/1AC/24DC/240W/ESS
 Supply Monitoring Relay
Make Selec
Model 900 VPR
 Line Filter
Make ELCOM
Model EF-1B0061E-C02
 MCB
Make Siemens
Specification 3 Pole ,10 AMP (Qty-1)
 MCB
Make Siemens
Specification 3 Pole ,6AMP (Qty-1)
Page 15 of 26
Verified By
Yes /No
 MCB
Make Siemens
 MCB
Make Siemens
Specification 2 Pole ,10AMP (Qty-1)
 MCB
Make Siemens
 Choke
Make Arihant Electricals
Specification 2.2 KW
 Choke
Specification 0.75 KW
 Transformer
Input 110V/ Output 230V ,
Specification
AC220-230VA
 Main switch
Make Siemens
Model 3LD2003-OTK53
 Drive Section
VFD for Impeller Motor
Mak
Mitsubishi
e
Mod
FR-D740-050-E16
el
VFD for Chopper Motor
Mak
Mitsubishi
e
Mod
FR-D740-036-E16
el
Page 16 of 26
7.3 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.
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 VAC + 10 %
Supply Frequency: 50 Hz
Power: 5 KW (approx.)
Result: -
_______________________________________________________________
Verified By: _______________________ Date: ______________
Reviewed By: ________________________ Date: ______________
Page 17 of 26
7.4 Software Verification
Purpose:
To verity that all software for the High Shear Mixer has been updated before starting the
Installation Qualification.
Procedure:
Verify that all software 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.
All software for the High Shear Mixer shall be in a state of software.
Complies
Description Model No. Software Version Remark
Yes / No/ NA
HMI GS2110-WTBD-N Zenon Supervisor 7.60
GX Works 3,
PLC FX5U-32MT/ESS
Version 1.090U
Result: -
_______________________________________________________________
Verified By: _______________________ Date: ______________
Reviewed By: ________________________ Date: ______________
Page 18 of 26
7.5 Network Verification
Purpose:
To verity that all network for the High Shear Mixer has been updated before starting the
Procedure:
Verify that all networks are updated using an approved procedure, against a traceable
standard.
For all software, attach copies of certificates to this protocol.
All networks for the High Shear Mixer shall be in a state of network.
Present Complies
Description Type Remark
(Yes / No) Yes / No/ NA
1. Ethernet Ethernet
Result: -
_______________________________________________________________
Verified By: _______________________ Date: ______________
Reviewed By: ________________________ Date: ______________
Page 19 of 26
7.6 Digital Input Verification
Purpose:
To verity that all digital input for the High Shear Mixer has been working before starting the Installation
Qualification.
Procedure:
Verify that all digital inputs are working using an approved procedure, against a traceable standard.
All digital inputs for the High Shear Mixer shall be in a state of INPUT status.
Result: -
_______________________________________________________________
Verified By: _______________________ Date: ______________
Reviewed By: ________________________ Date: ______________
Page 20 of 26
7.7 Digital Output Verification
Purpose:
To verity that all digital output for the High Shear Mixer has been working before starting the
Procedure:
Verify that all digital outputs are working using an approved procedure, against a traceable standard.
All digital outputs for the
High Shear Mixer shall be in a state of OUTPUT status.
Result: - _______________________________________________________________
Verified By: _______________________ Date: ______________
Reviewed By: ________________________ Date: ______________

Page 21 of 26
8.0 Acceptance Criteria / Checks During Installation
Sr.No. 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 machine
4.
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.
Verify availability of isolator of
8.
For 3 phase 415 V + Earth / ground, 50 Hz.
9. Ensure the top lid opening and closing easily without any hindrance.
10. Ensure the discharge plug is opening and closing properly.

Ensure the direction of Rotation of Impeller blade is correct,
11.
i.e., Anti-Clockwise from top
12. Introduction to the machine and main assemblies
13. Verify that the Main supply is ON
14. Put the control switch to ON & verify the function of the control switches.
15. Ensure the functioning of process timer and operating push buttons.
16. Ensure that all the Electrical connections are completed.
Page 22 of 26
9. Qualification Document Report Approval
9.1 Summary:
9.2 Certification:
Verified By: _______________________ Date: ______________
Reviewed By: ________________________ Date: ______________
Page 23 of 26
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):
Page 24 of 26
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
Page 25 of 26
11.0 Remark If Any
Page 26 of 26

HSM Iq

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

HSM Iq

Uploaded by

Copyright:

Available Formats

Installation Qualification (IQ) Page1 / 26

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

Model : High Shear Mixer 30&10 LTR

Batch No. : ESPL-120

Sr. No. : ESPL-02-0012

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

0.00 -- First official Issue, Dt.

6.0 Pre-Installation Check List

6.1 Foundation preparation

6.2 Procedure for Foundation preparation

6.3 Prerequisites and Conditions to be prepared for Installation

2. Maintain temperature at the Machine site between 20 Degree and 25 Degree

4. Sufficient lighting at the Machine site.

7. Availability of isolator of for 3 phase 415 V + Earth / ground, 50 Hz.

8. Provide proper earthing for the Machine and accessories.

9. Keep sufficient quantity of formulation ready for conducting machine trials

10. Operating and maintenance personnel to be designated so that they can be

6.4 Leveling the Machine

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

7. Installation Qualification Test

Sr. No. Description Specification Remark

High Shear Mixer – 30 &10 LTR

2 Application Mixing & Granulation of PharmaceuticalPowders

3 Overall Dimension 2000mmX970mmX1657mm (LXWXH)

4 Gross volume 30 LTR

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

7.1 Document & Drawings Verification:

Sr. Description Verified Remark

Documentation Verification Results:

Verified By: _______________________ Date: ______________

Reviewed By: ________________________ Date: ______________

7.2 Identification Of Major Components

Surface Finish Inside Mirror Finish & Outside Matt Finish

 Product Bowl Lid

Surface Finish Inside Mirror Finish & Outside Matt Finish

Position of Top Lid On the bowl

 Product Bowl Lid hinge assembly

 Impeller (Z Type Design)

 Chopper (Multi Blade)

 Impeller Motor (FLP)

 Chopper Motor (FLP)

 Product Bowl Lid Proximity Switch

 Product Bowl Transmitter

 HSM Base Structure

 Flow Switch – 2Qty

 Discharge Port Pneumatic Cylinder

Analog Output Card: 1 No.

7.3 Utility Verification

Utilities Specification Data Recording & Results:

Description Specified Measured Complies Remark

Verified By: _______________________ Date: ______________

Reviewed By: ________________________ Date: ______________

7.4 Software Verification

Verified By: _______________________ Date: ______________

Reviewed By: ________________________ Date: ______________

7.5 Network Verification

Verified By: _________ Date:

Reviewed By: __________ Date:

Verified By: _________ Date:

Reviewed By: __________ Date:

Verified By: _________ Date:

Reviewed By: __________ Date:

Verified By: _________ Date:

Reviewed By: __________ Date:

Verified By: _________ Date:

Reviewed By: __________ Date:

Verified By: _________ Date:

Reviewed By: __________ Date:

Verified By: _________ Date:

Reviewed By: __________ Date: