Colloid IQOQPQ

VALIDATION PROTOCOL
FOR
COLLOID MILL MACHINE
MODEL: CICM 3 - HORIZONTAL
Purchase Order No.: HPP/181439 Dated 06-10-04
Cip Machineries Pvt. Ltd.

Registered Office :
10,11 Umiya Estate,
Nr.Bharat Party Plot, N.H.No.8,
Amraiwadi, Ahmedabad 380 026.
Gujarat, INDIA.
Phone: 91-79-2287 54 10
91-79-2289 25 30
91-79-2297 04 06-7-8
TeleFax: 91-79-2289 14 10
Works :
Plot No.1903, Phase IV,
Opp. Maradia Steel Unit-3,
G.I.D.C., Vatva,
Ahmedabad 380 026.
Gujarat, INDIA.
Phone: 91-79-2583 59 08
91-79-2583 53 41-2-3
TeleFax: 91-79-2583 58 53
E-Mail : cipmachad1@sancharnet.in
sales@cipmach.com
Visit us on Internet at :
www.cipmach.com / www.roll-compactor.com
OUR VISION : TO ACHIEVE LEADERSHIP THROUGH QUALITY
Confidential
CIP MACHINERIES
PVT. LTD.
VALIDATION PROTOCOL FOR

HOMO COLLOID MILL MACHINE
PAGE 2 of 31
OBJECTIVE AND SCOPE:

It is the objective of this protocol to describe in detail the methodology to be adopted to validate the
Homo Colloid Mill Machine, Plain, GMP Model with all contact parts SS 316, for use in the
manufacturing process. It is to establish confidence that the Homo Colloid Mill Machine is capable
of consistently operating within established limits and tolerance.
The protocol comprises of the following.
A) Installation Qualification :
It should describe the following
1. Equipment specification as against contained in purchase order.
2. Utilities and services are properly connected.
3. Critical instruments / necessary devices are calibrated and are attached to the equipment.
4. Standard operating procedure are identified and written.
5. Manufacturer's certificate is taken whenever necessary.
B) Operational Qualification :
It should cover the operating parameters set for the equipment operation. Validation of equipment
against these parameters should also be described.
It should also describe.
1. Evaluation of process operation with simulating the product.
2. Qualitative / Quantitative analysis of the simulated product.
3. Reproducibility of performance.
C) Performance Qualification:
It should cover the performance parameters set for the equipment performance. Validation of
equipment against these parameters should also be described.
It should also describe.
01. Equipment validation.
02. Performance qualification evaluation.
03. Final report.
E) Conclusion:
The Homo Colloid Mill Machine meets the acceptance criteria in reference to above parameters are
declared validated and released for use.
Confidential
CIP MACHINERIES
PVT. LTD.

PAGE 3 of 31
INSTALLATION QUALIFICATION
EQUIPMENT NAME
EQUIPMENT MANUFACTURER
EQUIPMENT LOCATION
: HOMO COLLOID MILL MACHINE

: CIP MACHIERIES PVT. LTD.
:
TABLE OF CONTENTS
01.0 Equipment Features
02.0 Pre Qualification
03.0 Statement of Purpose
04.0 Standard Operating Procedures
05.0 Installation Checklist
06.0 Drawings
07.0 Supporting Utilities
08.0 Deficiency and Corrective Action Report
09.0 Final Report
10.0 Appendix - Reference Documents.
Confidential
CIP MACHINERIES
PVT. LTD.

01.0 EQUIPMENT FEATURES
EQUIPMENT NAME
: Homo Colloid Mill Machine.
MODEL NO.
: CICM 3 Horizontal Model - Plain
DEPARTMENT
VALIDATION TEAM
NAME
DESIGNATION
SIGNATURE
DATE:
PAGE 4 of 31
Confidential
CIP MACHINERIES
PVT. LTD.

PAGE 5 of 31
02.0 PRE QUALIFICATION
DESIGN PARAMETERS AND CAPACITY: Homo Colloid Mill Machine Horizontal
Plain - GMP Model all contact parts SS 316
STANDARD EQUIPMENT OR MADE
AS PER CUSTOMER DESIGNATION
: Standard Equipment
VENDOR SELECTED
: M/s Cip Machineries Pvt. Ltd.

Ahmedabad.
VENDER'S ADDRESS
: Plot No.1903, G.I.D.C,

Phase IV, Opp. Maradia Steeel Unit No. 3,
Vatva, Ahmedabad.
Gujarat - 382 445
MANUFACTURE'S NAME
: M/s Cip Machineries Pvt. Ltd.

Ahmedabad.
TEAM INVOLVED IN SELECTION OF :

EQUIPMENT AND DESIGN
NAME
DESIGNATION
SIGNATURES
DATE
Confidential
CIP MACHINERIES
PVT. LTD.

PAGE 6 of 31
02.1 PRE QUALIFICATION
EQUIPMENT QUALIFICATION AS PER
PURCHASE ORDER
: Colloid Mill Machine Horizontal

Plain GMP Model all contact
Parts SS 316
EQUIPMENT RECEIVED AS PER P.O.
ANY DEVIATION
CERTIFICATION FROM VENDOR FOR
(A)
MATERIAL OF CONSTRUCTION
ACCEPTED FOR INSTALLATION

INSTALLATION TEAM
INSTALLATION COMPLETED ON
THE EQUIPMENT INSTALLATION IS CARRIED OUT AS PER GUIDELINES FRAMED BY

THE MANUFACTURER.
Confidential
CIP MACHINERIES
PVT. LTD.
02.2

PAGE 7 of 31
MATERIAL / COMPONENT
SPECIFIED
ACTUAL
(As specified by manufacturer)

Base
FIG : 1
Motor Housing
FIG : 1
3 way cock
FIG : 5
Circulating Pipe
FIG : 5
Main Housing Assembly
FIG : 4
Hopper
FIG : 1
Reviewed & Inspected by :
Date :
Confidential
CIP MACHINERIES
PVT. LTD.
02.3

PAGE 8 of 31
CRITICAL COMPONENT
NAME
IDENTIFICATION
NO.
Hand-wheel
for
gap
adjustment between stator
and rotor.
N. A.
PURPOSE
For machine micro fine
Adjustment.
RANGE
5 to 10 microns
Confidential
CIP MACHINERIES
PVT. LTD.

PAGE 9 of 31
03.0 STATMENTS OF PURPOSE
The purpose of this protocol is to provide an outline for the inspection of equipment for
static attributes to verify that :
Each installed sub-component complies with the engineering design and equipment data
sheets / specifications.
The system is installed according to the design specifications and manufacturers

Recommendations.
No unauthorized or unrecorded modifications have taken place.
Standard Operating Procedures have been identified and listed.
All supporting utilities are properly connected.
All safety features are accounted for.
All installation-testing reports are available and maintained on file.
Confidential
CIP MACHINERIES
PVT. LTD.

PAGE 10 of 31
4.0
STANDARD OPERATING PROCEDURE

NUMBER
REVISION
DATE
Operating
Cleaning
Preventive Maintenance
Comments :
History card is prepared for each equipment, which includes preventive maintenance.
Reviewed & Inspected by: ________________________ Date:
Confidential
CIP MACHINERIES
PVT. LTD.

PAGE 11 of 31
05.0
INSTALLATION CHECKLIST
Consideration
No.
Statement
01.
03.
Verify that the "As Built" drawings are complete and represent the design
concept.
Verify that major components are securely anchored and protected from
shock.
Verify that there is no observable physical damage
04.
Verify that there is sufficient room for servicing provided
05.
06.
Verify that all piping and electrical connections have been done according
to the drawings.
All access ports are examined and cleared of any debris.
07.
Walking access to roof mounted equipment provided.
08.
09.
Required electric connections are tight weather proof and grounded.

Equipment identification name plate is visible.
10.
Proper earthing is made
02.
Yes/No
Comments: All the above mentioned consideration are being checked and found satisfactory.
Reviewed & Inspected by:____________________
Date :
Confidential
CIP MACHINERIES
PVT. LTD.

PAGE 12 of 31
06.0
DRAWINGS
Drawings are provided by the manufacturer and are complete.

1. Machine GA Drawing
2. Extension Housing Assembly
3. Main Housing Assembly
4. Cock Body Assembly
5. Wiring Diagram
Reviewed & Inspected by : ______________________
Date :
Confidential
CIP MACHINERIES
PVT. LTD.

PAGE 13 of 31
07.0
SUPPORTING UTILITIES
List the supporting utilities and record whether or not they are properly connected and identified.
Utility
Properly Connected and

Identified (Yes/No)
Electrical connection 3 phase
Comments : Utilities are properly attached.
Reviewed & Inspected by : ______________________
Date :
Checked by
Date
Confidential
CIP MACHINERIES
PVT. LTD.

PAGE 14 of 31
08.0
DEFICIENCY AND CORRECTIVE ACTION REPORT
Description of deficiency and date observed:

No deficiency found during installation.
_______________________________________________________________________________
_______________________________________________________________________________
Person responsible for corrective action and date assigned:
_____________________________________N.A.______________________________________
_______________________________________________________________________________
_______________________________________________________________________________
Corrective actions taken and date conducted :
_____________________________________N.A.______________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
SIGNATURES
Conducted by: _____________________
Approved by: _____________________
Date :
Date :
Confidential
CIP MACHINERIES
PVT. LTD.

PAGE 15 of 31
09.0
FINAL REPORT
09.1
Summary :
The equipment is procured as per specification of M/s Alembic Limited
Installation is carried out as per manufacturers recommendations. Supporting utilities
are connected.
09.2 Analysis / Evaluation :

The machine is installed at the location. Supporting utilities are well connected and
functioning properly. Standard operating procedure are identified and listed. History card
is prepared for the equipment. All relevant critical document and drawing are
supplied by the manufacturer.
09.3
Certification :
Installation of Colloid Mill Machine is done and found satisfactory.
Reviewed & Inspected by : ___________________
Date :
Confidential
CIP MACHINERIES
PVT. LTD.

PAGE 16 of 31
10.0
APPENDIX
Abbreviations and Definition
Reference Documents
A) Instruction Manual of M/s. Cip Machineries Pvt. Ltd.

B) Following Drawings of Homo Colloid Mill Machine are available in instruction manual.
Base
FIG : 1
Motor Housing
FIG : 1
3 way cock
FIG : 5
Circulating Pipe
FIG : 5
FIG : 4
Hopper
FIG : 1
Confidential
CIP MACHINERIES
PVT. LTD.

PAGE 17 of 31
10.1
APPENDIX (Continued)
Reference Documents
01.
Manufacturers Brochure (s) / Manual (s) (Title and Location).
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
02.
Purchase Order. Attached (Yes / No.) If no, state Location.
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
Reviewed & Inspected by : _________________
Date :
Confidential
CIP MACHINERIES
PVT. LTD.

OPERATIONAL QUALIFICATION
EQUIPMENT NAME
EQUIPMENT MAKE
: CIP MACHINERIES PVT. LTD.
EQUIPMENT LOCATION :
TAB LE O F C O N T E N T S
1.0
System Description
2.0
Statement of Purpose
3.0
SOP Verification
4.0
Safety Features Test
5.0
Simulation of process
6.0
Maintenance Schedule
7.0
Final Report
PAGE 18 of 31
Confidential
CIP MACHINERIES
PVT. LTD.

PAGE 19 of 31
01.0 SYSTEM DESCRIPTION
CIP, Homo Colloid Mill Machine is a machine for milling of viscous liquid and paste. The hopper
capacity is 15 liters and electrical motor 3 Hp, 2850 RPM, 3 Phase. The unit consists of:
Motor Housing Assembly

Extension Housing Assembly
Hopper
Cock Body Assembly
The speed of the rotor is very high. To increase the gap between stator and rotor, de-lock the
handles by unscrewing the turn adjusting ring by rotating the handles anticlockwise and to increase
the milling rotate the handles clockwise and also lock the handles.
Due to the slightly deviating tapering of the milling surfaces of stator and rotor, the gap becomes
narrower towards the discharge section. The special design type facilitates adjustment of the
grinding gap by an exterior screw ever during operation.
By three-way cock assembly we can re-circulate liquid type product till you get your required
result.
The system has utilities like electrical connection and vacuum connection connected to it.
Confidential
CIP MACHINERIES
PVT. LTD.

PAGE 20 of 31
NAME OF EQUIPMENT: HOMO COLLOID MILL MACHINE
02.0
STATEMENT OF PURPOSE
The purpose of this protocol is to validate the above equipment for the operational qualification to
1. Demonstrate that the equipment / system will perform reproductivity and consistently within its
full dynamic range of operation according to manufacturers specifications.
2. Documents initial performance of the equipment / system.
3. Assure that the equipment / system performance is adequate to support the process for which the
system is designed.
4. Demonstrate the suitability of the SOP is established for the equipment / system.
Confidential
CIP MACHINERIES
PVT. LTD.

PAGE 21 of 31
03.0 SOP VERIFICATION :
Subject
: Standard Operating procedure for the operation of

Homo Colloid Mill Machine.
Testing Date
Operating Personnel :
Observing Personnel :
Observation
Observation - Yes / No
(If no state why in comments)
Most current revision in use

Operating Personnel understand and follow SOP
description and requirements.
SOP provides adequate direction and control to
ensure uniform equipment operation.
Comments : Machine is operated as per Standard Operating Procedure.
Reviewed & Inspected by : _____________________
Date :
Confidential
CIP MACHINERIES
PVT. LTD.

PAGE 22 of 31
04.0
SAFETY FEATURE :
1. Safety Provision against leakage of the liquid:

Oil seals and O rings are provided to avoid the leakage of the liquid and prevent the main motor.
If any seal will damage you can see the liquid at the particular portion, so by replacing that seal we
can avoid further damage.
Checked by ____________________________________Date:
Inspected by: _____________________________________Date:
Confidential
CIP MACHINERIES
PVT. LTD.

PAGE 23 of 31
05.0
EQUIPMENT VALIDATION THROUGH SIMULATION OF THE PROCESS.
The simulation of the process was carried out by milling of the liquid or suspension.
Simulation of the process consist of the following:
A)
Milling of liquid or suspension has been done at desired particle size and to check it.
B)
Particle size has been checked for its effectiveness in decreasing and increasing
of the gap between the stator and rotor by handles.
Confidential
CIP MACHINERIES
PVT. LTD.

PAGE 24 of 31
05.1
Stage / Parameter
1. At Maximum Milling
Condition
2. At Optimum Milling
Condition
3. At Minimum Milling
Condition
Location / Sample
Liquid from the coke
Tests
Particle size reduction
Confidential
CIP MACHINERIES
PVT. LTD.

05.2 QUALITY CONTROL RESULT

PHYSICAL APPEARANCE
A.
Sample from the Hopper before milling
B.
Sample from the container after milling
PAGE 25 of 31
Confidential
CIP MACHINERIES
PVT. LTD.

PAGE 26 of 31
05.3
DATA EVALUATION AND CONCLUSION :

Based on the quality control results generated by simulating the process and its review, it
can be said that machine performs satisfactory and producing tablets conforming to the
acceptance criteria.
Reviewed by : _____________________
Date :
Confidential
CIP MACHINERIES
PVT. LTD.

PAGE 27 of 31
06.0
MAINTENANCE SCHEDULE
Check list
SR.NO.
1
Check for cleanliness of hopper, stator, rotor, circulating pipe, 3 way cock.
2
Check visually any leakage of liquid from extension housing due to oil seal
or O ring damage
3
Check the all rubber packing
4
Lubrication of grease nipples of Housing.
5
Check motor mounting bolts.
6
Check / Clean electrical connection and contact points
D = Daily
W = Weekly
M = Monthly
Inspected by : ___________________________
Date :
D
D
D
W
M
M
Confidential
CIP MACHINERIES
PVT. LTD.

PAGE 28 of 31
07.0
FINAL REPORT
Summary
Analysis / Evaluation
Certification
The operation of the equipment HOMO COLLOID MILL MACHINE was carried
out as per standard operating procedure. The equipment performs within the assigned limits
when operated as per approved standard operating procedure.
Operating parameters that have a significant impact on the equipment ability to operate and
achieve the process are satisfactory and conforms to the acceptance criteria.
The equipment HOMO COLLOID MILL MACHINE
MODEL NO.
: CICM 3 HORIZONTAL
DEPARTMENT
Purpose
: Milling of viscous liquids and pastes.
Frequency of Validation : Validation due on Date_________or the event of any change in

critical component of the machine.
"THE EQUIPMENT "HOMO COLLOID MILL MACHINE" IS VALIDATED
AND RELEASED FOR USE.
DATE
WORKS MANAGER
MAINTENANCE
MANAGER
Q.C. MANAGER
Q.A. MANAGER
Confidential
CIP MACHINERIES
PVT. LTD.

PERFORMANCE QUALIFICATION
EQUIPMENT NAME
EQUIPMENT MAKE
: CIP MACHINERIES PVT. LTD.
EQUIPMENT LOCATION :
TAB LE O F C O N T E N T S
1.0
Statement of Purpose
2.0
Final Report
PAGE 29 of 31
Confidential
CIP MACHINERIES
PVT. LTD.

PAGE 30 of 31
NAME OF EQUIPMENT: HOMO COLLOID MILL MACHINE
01.0
STATEMENT OF PURPOSE
The purpose of this protocol is to validate the above equipment for the performance qualification to
1. The equipment / system will perform reproductively and consistently within its full dynamic
range of performance according to manufacturers specifications.
2. Documents initial performance of the equipment / system.
3. Assure that the equipment / system performance is adequate to support the process for which the
system is designed.
4. Demonstrate the suitability of the SOP is established for the equipment / system.
Confidential
CIP MACHINERIES
PVT. LTD.

PAGE 31 of 31
02.0
FINAL REPORT
Summary
Analysis / Evaluation
Certification
The performance of the equipment HOMO COLLOID MILL MACHINE was
carried out as per Standard Operating Procedure. The equipment performs within the
assigned limits when operated as per approved standard operating procedure.
Operating parameters that have a significant impact on the equipment ability to perform and
achieve the process are satisfactory and conforms to the acceptance criteria.
The equipment HOMO COLLOID MILL MACHINE
MODEL NO.
: CICM - 3 HORIZONTAL
DEPARTMENT
Purpose
: Milling of viscous liquids and pastes.
Frequency of Validation : Validation due on Date_________or the event of any change in

critical component of the machine.
"THE EQUIPMENT "HOMO COLLOID MILL MACHINE" IS VALIDATED
AND RELEASED FOR USE.
DATE
WORKS MANAGER
MAINTENANCE
MANAGER
Q.C. MANAGER
Q.A. MANAGER

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VALIDATION PROTOCOL

Cip Machineries Pvt. Ltd.

OUR VISION : TO ACHIEVE LEADERSHIP THROUGH QUALITY

VALIDATION PROTOCOL FOR

OBJECTIVE AND SCOPE:

VALIDATION PROTOCOL FOR

: HOMO COLLOID MILL MACHINE

VALIDATION PROTOCOL FOR

: Homo Colloid Mill Machine.

: CICM 3 Horizontal Model - Plain

VALIDATION PROTOCOL FOR

: M/s Cip Machineries Pvt. Ltd.

: Plot No.1903, G.I.D.C,

: M/s Cip Machineries Pvt. Ltd.

TEAM INVOLVED IN SELECTION OF :

VALIDATION PROTOCOL FOR

: Colloid Mill Machine Horizontal

EQUIPMENT RECEIVED AS PER P.O.

CERTIFICATION FROM VENDOR FOR

ACCEPTED FOR INSTALLATION

THE EQUIPMENT INSTALLATION IS CARRIED OUT AS PER GUIDELINES FRAMED BY

VALIDATION PROTOCOL FOR

(As specified by manufacturer)

Main Housing Assembly

Reviewed & Inspected by :

VALIDATION PROTOCOL FOR

VALIDATION PROTOCOL FOR

The system is installed according to the design specifications and manufacturers

No unauthorized or unrecorded modifications have taken place.

Standard Operating Procedures have been identified and listed.

All supporting utilities are properly connected.

All safety features are accounted for.

All installation-testing reports are available and maintained on file.

VALIDATION PROTOCOL FOR

STANDARD OPERATING PROCEDURE

Reviewed & Inspected by: ________________________ Date:

VALIDATION PROTOCOL FOR

Verify that there is sufficient room for servicing provided

Walking access to roof mounted equipment provided.

Required electric connections are tight weather proof and grounded.

Proper earthing is made

Reviewed & Inspected by:____________________

VALIDATION PROTOCOL FOR

Drawings are provided by the manufacturer and are complete.

VALIDATION PROTOCOL FOR

Properly Connected and

Electrical connection 3 phase

Comments : Utilities are properly attached.

Reviewed & Inspected by : ______________________

VALIDATION PROTOCOL FOR

DEFICIENCY AND CORRECTIVE ACTION REPORT

Description of deficiency and date observed:

VALIDATION PROTOCOL FOR

09.2 Analysis / Evaluation :

Reviewed & Inspected by : ___________________

VALIDATION PROTOCOL FOR

A) Instruction Manual of M/s. Cip Machineries Pvt. Ltd.

Main Housing Assembly

VALIDATION PROTOCOL FOR

Manufacturers Brochure (s) / Manual (s) (Title and Location).

Reviewed & Inspected by : _________________

VALIDATION PROTOCOL FOR