CTX Life sciences Pvt. Ltd., Sachin, Surat.

INSTALLATION QUALIFICATION REPORT

Equipment Name SS Blender Equipment Number BL-004
Report Number IQR001/BL-004/08/00
Area API-I PPA-C Location G. Floor

TABLE OF CONTENTS

S. No Title Page No.

1.0 Objective 02

2.0 Scope 02

3.0 Execution team 03

4.0 Equipment / system description 03

5.0 Identification of major components / accessories 04

6.0 Installation check / review 05

7.0 Inspection check / review 06

8.0 Identification, classification & verification of process control parts 14

9.0 Identification and verification of material of construction 15

10.0 Identification and verification of supporting utilities 16

11.0 Identification of standard operating procedure 16

12.0 Identification and verification of documents 17

13.0 Deficiencies and Corrective action report 18

14.0 Summary and Evaluation of Results 19

15.0 Installation Qualification Report Approval 20

Page 1 of 20
 CTX Life sciences Pvt. Ltd., Sachin, Surat.
INSTALLATION QUALIFICATION REPORT
Equipment Name SS Blender Equipment Number BL-004
Report Number IQR001/BL-004/08/00
Area API-I PPA-C Location G. Floor

1.0 OBJECTIVE

The objective of this protocol is to provide an outline for the inspection of Blender, Tag No.:
BL-004 which is shifted from PPA –A to PPA-C old Tag No. BL-001 and to verify that the
following boundaries:

o Each Installed subcomponent complies with the engineering design and equipment data
sheet / design specifications & manufacturer’s recommendations.

o To ensure that all the safety features are defined before the start up of operational
qualification exercise.

o The system meets the current Good Manufacturing Practice requirements and all other
applicable regulatory requirements.

o To identify the Standard operating procedures for Operational Qualification.

2.0 SCOPE
The scope of this Report is to outline procedure for Installation qualification of the subjected
equipment are found within the following boundaries:

o Identification and verification of its Major components / Accessories

o Identification, Classification and Verification of Process Control Instruments / Gauges /

Devices

o Identification and verification of Material of Construction

o Identification and verification of Supporting Utilities

o Identification of Standard Operating Procedures

o Identification and Verification of Documents

o No unauthorized or unrecorded modification has taken place.

Page 2 of 20
 CTX Life sciences Pvt. Ltd., Sachin, Surat.
INSTALLATION QUALIFICATION REPORT
Equipment Name SS Blender Equipment Number BL-004
Report Number IQR001/BL-004/08/00
Area API-I PPA-C Location G. Floor

3.0 EXECUTION TEAM

Department Name Designation Signature

Pramit Patel To provide Engineering Sr. Executive –
support for execution. Engineering
R. B. Jadhav To provide Engineering Manager –
support for execution. Engineering
Rakesh Purohit To check the Report for the Dept. Manager -
execution. Quality Assurance
Manoj Katiyar To approval Report. Sr. Manager -
Quality Assurance

4.0 EQUIPMENT / SYSTEM DESCRIPTION

The octagonal blender is designed for blending of two or more batches to get
homogenous bled with bigger batch size as per the requirement. It is constructed of SS 316. All
contact parts like shell, cone, neck flange, baffle plate, etc. are made of SS 316. Non-contact
parts like stand and railing are made of SS 304. Baffles are provided inside the blender for
thorough mixing and to provide homogenous blended material. Blender shall have smooth
finish to have ease of cleaning.

Blender is provided with suitable gear box and drive mechanism. Necessary
attachments like flameproof motor, SS railing with interlocking is also provided.

Page 3 of 20
 CTX Life sciences Pvt. Ltd., Sachin, Surat.
INSTALLATION QUALIFICATION REPORT
Equipment Name SS Blender Equipment Number BL-004
Report Number IQR001/BL-004/08/00
Area API-I PPA-C Location G. Floor

5.0 IDENTIFICATION OF MAJOR COMPONENTS / ACCESSORIES

Details of each major component identified in this section is recorded in a data sheet under the
section 07.0.

Present Verified by
Name of Component / Accessories Observations
Yes No (Sign. & Date)

Shell

Charging / Discharge Chute

Baffle

Drive

 Motor

 Gear box

Gaskets and valves

Page 4 of 20
 CTX Life sciences Pvt. Ltd., Sachin, Surat.
INSTALLATION QUALIFICATION REPORT
Equipment Name SS Blender Equipment Number BL-004
Report Number IQR001/BL-004/08/00
Area API-I PPA-C Location G. Floor

6.0 INSTALLATION CHECK / REVIEW

Verified by
S. No. Statement Yes / No Observations
(Sign. & Date)
1 Verify that the “as built’ drawings are
complete and represent the design concept
2 Verify that major components / accessories
are securely anchored and shock proof.
3 Verify that there is no observable physical
damage.
4 Verify that there is sufficient room of
servicing provided
5 Verify that all utilities, piping and electrical
connections have been done according to
the drawings.
6 All access parts are examined and cleared
of any debris.
7 Walking access to ground mounted
equipment provided.
8 Required electric connections are tight,
weather proof and earthed.
9 Wiring diagram glued or / taped to inside
section of control panel.
10 Equipment identification nameplate visible.

11 Units installed on foundation and secure in

place as per manufacturer’s
recommendations.
12 Verify that the equipment is installed and
leveled properly on the floor
13 Verify that the Material of Construction is
proper and meeting the requirements.

Page 5 of 20
 CTX Life sciences Pvt. Ltd., Sachin, Surat.
INSTALLATION QUALIFICATION REPORT
Equipment Name SS Blender Equipment Number BL-004
Report Number IQR001/BL-004/08/00
Area API-I PPA-C Location G. Floor

7.0 INSPECTION CHECK / REVIEW

Instructions for completing the check / review

1. For each data sheet, record the required information with pen. Wherever required record
“Yes” for acceptance and “No” for non-compliance. “No” replies must be explained.

2. When more than one component of same specification/type exists in the same equipment,
individual data sheets should be filled for each component.

3. When a list of acceptable options is presented, tick () the option that is actually present.

4. In the “Method of Verification” column indicate that item is installed and inspected
according to manufacturer’s specifications, such as by Visual / Physical check, SOP, Test
Certificate, Manual, etc.

5. After each data is completed, sign with date in the assigned space, using pen.

Page 6 of 20
 CTX Life sciences Pvt. Ltd., Sachin, Surat.
INSTALLATION QUALIFICATION REPORT
Equipment Name SS Blender Equipment Number BL-004
Report Number IQR001/BL-004/08/00
Area API-I PPA-C Location G. Floor

Data Sheet # 07.1

Equipment / Component Name: Shell

Tag/Identification No.:

Method of
Description Specified Actual Sign & Date
Verification
Physical State Intact, clean, without any
damage
Finish Smooth finish, without
any sharp or rough edges.
Make Bectochem Engineers
Type Octagonal
MOC SS 316
Total chamber 300 lit.
volume
Overall height 2415
Thickness 14 Gauge

Page 7 of 20
 CTX Life sciences Pvt. Ltd., Sachin, Surat.
INSTALLATION QUALIFICATION REPORT
Equipment Name SS Blender Equipment Number BL-004
Report Number IQR001/BL-004/08/00
Area API-I PPA-C Location G. Floor

Data Sheet # 07.2

Equipment / Component Name: Charging / Discharging Chute

Tag/Identification No.:

Method of
Description Specified Actual Sign & Date
Verification
Physical State Intact, clean, without any
damage and properly
connected
Finish Smooth finish, without
any sharp or rough edges.
Make Bectochem Engineers
MOC SS 316
Height of Charging 1795
port
Diameter of 400
Charging port
Height of 470
Discharging port
Diameter of 400
Discharging port

Page 8 of 20
 CTX Life sciences Pvt. Ltd., Sachin, Surat.
INSTALLATION QUALIFICATION REPORT
Equipment Name SS Blender Equipment Number BL-004
Report Number IQR001/BL-004/08/00
Area API-I PPA-C Location G. Floor

Data Sheet # 07.3

Equipment / Component Name: Shaft

Tag/Identification No.:

Method of
Description Specified Actual Sign & Date
Verification
Physical State Intact, clean, without any
damage and properly
connected
Make Bectochem Engineers
MOC SS 304
Diameter 68

Page 9 of 20
 CTX Life sciences Pvt. Ltd., Sachin, Surat.
INSTALLATION QUALIFICATION REPORT
Equipment Name SS Blender Equipment Number BL-004
Report Number IQR001/BL-004/08/00
Area API-I PPA-C Location G. Floor

Data Sheet # 07.4

Equipment / Component Name: Drive

Tag/Identification No.:

Method of
Description Specified Actual Sign & Date
Verification
Physical State Intact, clean, without any
damage and properly
connected
Motor
Make Crompton Greaves
Type FLP, Foot mounted
HP 1
RPM 1440
Power 3 Phase
Voltage 415 V / 50 Hz
Gear Box
Make NORD
Type Worm Reduction
Gear Box Ratio 60 : 1

Page 10 of 20
 CTX Life sciences Pvt. Ltd., Sachin, Surat.
INSTALLATION QUALIFICATION REPORT
Equipment Name SS Blender Equipment Number BL-004
Report Number IQR001/BL-004/08/00
Area API-I PPA-C Location G. Floor

Data Sheet # 07.5

Equipment / Component Name: Top Cone

Tag/Identification No.:

Method of
Description Specified Actual Sign & Date
Verification
Physical State Intact, clean, without any
damage
Finish Smooth finish, without
any sharp or rough edges.
Make Bectochem Engineers
Type Octagonal
MOC SS 316
Thickness 14 Gauge
Surface finish
Internal 240 grit mirror
External 180 grit matt

Page 11 of 20
 CTX Life sciences Pvt. Ltd., Sachin, Surat.
INSTALLATION QUALIFICATION REPORT
Equipment Name SS Blender Equipment Number BL-004
Report Number IQR001/BL-004/08/00
Area API-I PPA-C Location G. Floor

Data Sheet # 07.6

Equipment / Component Name: Bottom Cone

Tag/Identification No.:

Method of
Description Specified Actual Sign & Date
Verification
Physical State Intact, clean, without any
damage
Finish Smooth finish, without
any sharp or rough edges.
Make Bectochem Engineers
Type Octagonal
MOC SS 316
Thickness 14 Gauge
Surface finish
Internal 240 grit mirror
External 180 grit matt

Page 12 of 20
 CTX Life sciences Pvt. Ltd., Sachin, Surat.
INSTALLATION QUALIFICATION REPORT
Equipment Name SS Blender Equipment Number BL-004
Report Number IQR001/BL-004/08/00
Area API-I PPA-C Location G. Floor

Data Sheet # 07.7

Equipment / Component Name: Gasket

Tag/Identification No.:

Method of
Description Specified Actual Sign & Date
Verification
Physical State Intact, clean, without any
damage and properly
connected
MOC Silicon Rubber (Food
Grade)
Type Flat and circular

Page 13 of 20
 CTX Life sciences Pvt. Ltd., Sachin, Surat.
INSTALLATION QUALIFICATION REPORT
Equipment Name SS Blender Equipment Number BL-004
Report Number IQR001/BL-004/08/00
Area API-I PPA-C Location G. Floor

8.0 IDENTIFICATION, CLASSIFICATION & VERIFICATION OF PROCESS CONTROL

INSTRUMENTS

(1). Critical (C) – the instruments whose performance will directly affect the quality attributes
of the processed material.

(2). Monitor (M) – the instruments whose performance failure would not affect product quality
and which are used for process control.

Check the instrument for any Physical Damage, Name plate details and functions
Verified by
Instruments Check Observation / Result Class
Sign & Date
ON/OFF Push Check for any
Button Physical Damage
Nameplate details

Page 14 of 20
 CTX Life sciences Pvt. Ltd., Sachin, Surat.
INSTALLATION QUALIFICATION REPORT
Equipment Name SS Blender Equipment Number BL-004
Report Number IQR001/BL-004/08/00
Area API-I PPA-C Location G. Floor

9.0 IDENTIFICATION AND VERIFICATION OF MATERIAL OF CONSTRUCTION

Identify and list down all components of the equipments which may come in direct / indirect
contact with the product probably affecting the product safety, purity and efficacy. Method of
Test may be Molybdenum Test, Test Certificate, etc.

9.1 CONTACT SURFACES

Preparation of this qualification plan is the responsibility of Validation Coordinator.

Method of Test Verified by

Component (s) MOC Observation
Verification Result Sign & Date
Cone SS 316

Baffles SS 316
Charging Chute /
Discharging SS 316
Chute
Valves SS 316
Silicon
rubber
Gaskets
(Food
Grade)

9.2 NON – CONTACT SURFACES

Method of Test Verified by

Component (s) MOC Observation
Verification Result Sign & Date
Guard rail SS 304

Plummer block C.I.

Gear box cover SS 304

Stand SS 304

Page 15 of 20
 CTX Life sciences Pvt. Ltd., Sachin, Surat.
INSTALLATION QUALIFICATION REPORT
Equipment Name SS Blender Equipment Number BL-004
Report Number IQR001/BL-004/08/00
Area API-I PPA-C Location G. Floor

10.0 IDENTIFICATION AND VERIFICATION OF SUPPORTING

UTILITIES

List the supporting utilities are properly connected and identified.

Verified
by
Utilities Check Observation / Result
Sign &
Date
415 ±20Volts
Power
1 H.P.

11.0 IDENTIFICATION OF STANDARD OPERATING PROCEDURE

SOP SOP No. Title Sign

Operation TS012 Operation of Blender.
Cleaning TS012 Cleaning of Blender

Preventive EN020 Preventive maintenance of Blender.

maintenance
Calibration CMT/O/035 Calibration of Equipment and
Instrument through external agency.

Page 16 of 20
 CTX Life sciences Pvt. Ltd., Sachin, Surat.
INSTALLATION QUALIFICATION REPORT
Equipment Name SS Blender Equipment Number BL-004
Report Number IQR001/BL-004/08/00
Area API-I PPA-C Location G. Floor

12.0 IDENTIFICATION AND VERIFICATION OF DOCUMENTS

12.1 DRAWINGS

Received by
Title Drawing No. Date
(QA)

As built drawing

P&I Diagram

12.2 GENERAL DOCUMENTS

Document Verified by
Title Date
No. Sign & Date

GENERAL

Purchase Order No.

Data sheet No.

Warranty certificate

Electric motor test

certificate

INSTALLATION CERTIFICATES

MOC Certificate

Page 17 of 20
 CTX Life sciences Pvt. Ltd., Sachin, Surat.
INSTALLATION QUALIFICATION REPORT
Equipment Name SS Blender Equipment Number BL-004
Report Number IQR001/BL-004/08/00
Area API-I PPA-C Location G. Floor

13.0 DEFICIENCIES AND CORRECTIVE ACTION REPORT

Department Engineering Quality Assurance

Sign. / Date

Page 18 of 20
 CTX Life sciences Pvt. Ltd., Sachin, Surat.
INSTALLATION QUALIFICATION REPORT
Equipment Name SS Blender Equipment Number BL-004
Report Number IQR001/BL-004/08/00
Area API-I PPA-C Location G. Floor

14.0 SUMMARY AND EVALUATION OF RESULTS:

Department Engineering Quality Assurance

Sign. / Date

Page 19 of 20
 CTX Life sciences Pvt. Ltd., Sachin, Surat.
INSTALLATION QUALIFICATION REPORT
Equipment Name SS Blender Equipment Number BL-004
Report Number IQR001/BL-004/08/00
Area API-I PPA-C Location G. Floor

15.0 INSTALLATION QUALIFICATION REPORT APPROVAL:

15.1 Prepared by
Preparation of this qualification report is the responsibility of Validation Coordinator.
Name Designation Signature Date
Sr. Executive –
Pramit Patel
Engineering

15.2 Checked by

Checking of this qualification report is the responsibility of Task Force.

Name Designation Signature Date
Manager –
R. B. Jadhav
Engineering
Dept. Manager –
Rakesh Purohit
Quality Assurance

15.3 Approved by

Final approval of this qualification report is the responsibility of the Head QA.
Name Designation Signature Date
Sr. Manager –
Manoj Katiyar
Quality Assurance

Note: This report is effective from the date of approval.

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