Beruflich Dokumente
Kultur Dokumente
FOR
COLLOID MILL MACHINE
MODEL: CICM 3 - HORIZONTAL
Purchase Order No.: HPP/181439 Dated 06-10-04
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
Confidential
CIP MACHINERIES
PVT. LTD.
PAGE 2 of 31
Confidential
CIP MACHINERIES
PVT. LTD.
PAGE 3 of 31
INSTALLATION QUALIFICATION
EQUIPMENT NAME
EQUIPMENT MANUFACTURER
EQUIPMENT LOCATION
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.
INSTALLATION QUALIFICATION
01.0 EQUIPMENT FEATURES
EQUIPMENT NAME
MODEL NO.
DEPARTMENT
VALIDATION TEAM
NAME
DESIGNATION
SIGNATURE
DATE:
PAGE 4 of 31
Confidential
CIP MACHINERIES
PVT. LTD.
PAGE 5 of 31
INSTALLATION QUALIFICATION
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
VENDER'S ADDRESS
MANUFACTURE'S NAME
DESIGNATION
SIGNATURES
DATE
Confidential
CIP MACHINERIES
PVT. LTD.
PAGE 6 of 31
INSTALLATION QUALIFICATION
02.1 PRE QUALIFICATION
EQUIPMENT QUALIFICATION AS PER
PURCHASE ORDER
ANY DEVIATION
(A)
MATERIAL OF CONSTRUCTION
INSTALLATION COMPLETED ON
Confidential
CIP MACHINERIES
PVT. LTD.
02.2
PAGE 7 of 31
INSTALLATION QUALIFICATION
MATERIAL / COMPONENT
SPECIFIED
ACTUAL
FIG : 1
Motor Housing
FIG : 1
3 way cock
FIG : 5
Circulating Pipe
FIG : 5
FIG : 4
Hopper
FIG : 1
Date :
Confidential
CIP MACHINERIES
PVT. LTD.
02.3
PAGE 8 of 31
INSTALLATION QUALIFICATION
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
INSTALLATION QUALIFICATION
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.
Confidential
CIP MACHINERIES
PVT. LTD.
PAGE 10 of 31
INSTALLATION QUALIFICATION
4.0
REVISION
DATE
Operating
Cleaning
Preventive Maintenance
Comments :
History card is prepared for each equipment, which includes preventive maintenance.
Confidential
CIP MACHINERIES
PVT. LTD.
PAGE 11 of 31
INSTALLATION QUALIFICATION
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.
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.
08.
09.
10.
02.
Yes/No
Comments: All the above mentioned consideration are being checked and found satisfactory.
Date :
Confidential
CIP MACHINERIES
PVT. LTD.
PAGE 12 of 31
INSTALLATION QUALIFICATION
06.0
DRAWINGS
Date :
Confidential
CIP MACHINERIES
PVT. LTD.
PAGE 13 of 31
INSTALLATION QUALIFICATION
07.0
SUPPORTING UTILITIES
List the supporting utilities and record whether or not they are properly connected and identified.
Utility
Date :
Checked by
Date
Confidential
CIP MACHINERIES
PVT. LTD.
PAGE 14 of 31
INSTALLATION QUALIFICATION
08.0
Date :
Date :
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CIP MACHINERIES
PVT. LTD.
PAGE 15 of 31
INSTALLATION QUALIFICATION
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.
Certification :
Installation of Colloid Mill Machine is done and found satisfactory.
Date :
Confidential
CIP MACHINERIES
PVT. LTD.
PAGE 16 of 31
INSTALLATION QUALIFICATION
10.0
APPENDIX
Abbreviations and Definition
Reference Documents
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
INSTALLATION QUALIFICATION
10.1
APPENDIX (Continued)
Reference Documents
01.
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
02.
Purchase Order. Attached (Yes / No.) If no, state Location.
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
Date :
Confidential
CIP MACHINERIES
PVT. LTD.
OPERATIONAL QUALIFICATION
EQUIPMENT NAME
: HOMO COLLOID MILL MACHINE
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
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
OPERATIONAL QUALIFICATION
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:
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
OPERATIONAL QUALIFICATION
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
OPERATIONAL QUALIFICATION
03.0 SOP VERIFICATION :
Subject
Testing Date
Operating Personnel :
Observing Personnel :
Observation
Observation - Yes / No
(If no state why in comments)
Date :
Confidential
CIP MACHINERIES
PVT. LTD.
PAGE 22 of 31
OPERATIONAL QUALIFICATION
04.0
SAFETY FEATURE :
Checked by ____________________________________Date:
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CIP MACHINERIES
PVT. LTD.
PAGE 23 of 31
OPERATIONAL QUALIFICATION
05.0
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
OPERATIONAL QUALIFICATION
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.
B.
PAGE 25 of 31
Confidential
CIP MACHINERIES
PVT. LTD.
PAGE 26 of 31
OPERATIONAL QUALIFICATION
05.3
Reviewed by : _____________________
Date :
Confidential
CIP MACHINERIES
PVT. LTD.
PAGE 27 of 31
OPERATIONAL QUALIFICATION
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
OPERATIONAL QUALIFICATION
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
WORKS MANAGER
MAINTENANCE
MANAGER
Q.C. MANAGER
Q.A. MANAGER
Confidential
CIP MACHINERIES
PVT. LTD.
PERFORMANCE QUALIFICATION
EQUIPMENT NAME
: HOMO COLLOID MILL MACHINE
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
PERFORMANCE QUALIFICATION
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
PERFORMANCE QUALIFICATION
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
WORKS MANAGER
MAINTENANCE
MANAGER
Q.C. MANAGER
Q.A. MANAGER