FOR
COMMINUTING MILL MACHINE
Purchase Order No.: HPP/170291 DATED 11-03-04
Works :
Plot No.1903, Phase IV,
Opp. Maradia Steel Unit-3,
G.I.D.C., Vatva,
Ahmedabad 380 026.
Gujarat, INDIA.
Phone: 91-79-583 59 08
91-79-583 53 41-2-3
TeleFax: 91-79-583 58 53
E-Mail : cipmachad1@sancharnet.in
sales@cipmach.com
Visit us on Internet at :
www.cipmach.com / www.roll-compactor.com
Confidential
VALIDATION PROTOCOL FOR
COMMINUTING MILL MACHINE
Table of Content
Section
No.
1.0
2.0
3.0
4.0
5.0
6.0
7.0
Description
7.1
7.2
7.3
7.4
7.5
7.6
8.0
9.0
10.0
11.0
12.0
13.0
14.0
15.0
16.0
Title
Objective
Scope
Re qualification criteria
Over view of equipments / description
Definition
Responsibilities
Quality Engineering
Quality Assurance
Quality Control
Purchase
Production
Engineering
Indented use of instrument
Acceptance Criteria
Reference
Installation Qualification
Standard Operating Procedure
Operation Qualification
Performance Qualification
Preventive Maintenance Schedule
Final Conduction and recommendations
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6.0 Definition
Qualification: The process of ensuring that equipment is appropriate for its intended use. It consists
of the following:
a. Installation Qualification: A documents verification of the installation in the selected user
environment to comply with the approved design, the manufacturers recommendations and or
user requirements.
b. Operation Qualification: A documents demonstration that facilities and operation work to
functional design specifications.
c. Performance Qualification: A documents verification of the performance in the selected user
environment to comply with the approved design, the manufacturers recommendations and or
user requirements.
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VALIDATION PROTOCOL FOR
COMMINUTING MILL MACHINE
7.0 Responsibilities:
7.1 Quality Engineering:
- Preparation, approval and implementation of the protocol.
- On going compliance of the system.
- Organizing the activities related to qualification.
- Co ordination with production, engineering purchase department.
- Qualification reports preparation.
7.2 Quality Assurance:
- Review, monitoring and approval of the protocol.
- On going compliance of the quality system.
7.3 Quality Control:
- Analysis of samples if any.
- Recording the QC raw data.
7.4 Purchase:
- Organization Preparation, approval and implementation of the protocol.
- Purchase order preparation.
- Co-ordination with vendor for related activites.
7.5 Production:
- Organizing the activities related to qualification in production area.
- SOP preparation for operation.
- Routine calibration and maintenance implementation.
- Report review and training of users.
7.6 Engineering:
- Providing the design specification.
- Inspection at vendor site.
- Utilities arrangement for equipment.
- Organize the calibration of parts of equipments & instruments as a whole.
- Organizing the activities related to qualification.
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8.0 Intended use of the Equipment: The Comminuting Mill shall be used for milling of the
product.
10.0
a.
b.
c.
d.
Reference:
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VALIDATION PROTOCOL FOR
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11.0
PAGE 6 of 16
Installation Qualification:
Comminuting Mill.
Designed By
Equipment Type
Location (Floor)
Location (Plant)
Date of Installation
Description
Specification
Beaters
Rotor
Rotor Pin
Rotor Shaft
Perforated screen
Charging hopper
Discharge hopper
Gasket
Bearing Housing
Belt Guard
Pulley Guard
Legs
Wheel
Wheel Bracket
Motor
Handle for rack
SS 316
SS 316
SS 316
SS 316
SS 316
SS 316
SS 316
White silicon
SS 304
SS 304
SS 304
SS 304
White nylon
SS 304
7.5 Hp, 1440 RPM ,
SS 304
Actual
Remarks
Utility connected
with the
equipment
Remarks
Utilities recommended by
the vendor
Specification
01
02
03
04
05
Electrical
Chilled water
Cooling water
Hot water
Compressed air
3 Hp, 3 phase
NA
NA
NA
NA
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06
Steam pressure
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NA
Test
Position as per GA drawing
02
03
Electrical connection
04
Direction of Motor
05
Earthing
06
07
Screen fixing
08
Discharge Hopper
Test Procedure
Observation
Verified by:
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VALIDATION PROTOCOL FOR
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11.5
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FINAL REPORT
Summary:
The equipment shall be procured as per specification. Installation is carried out as per
manufacturers recommendations and user applicability. Supporting utilities will be connected.
Analysis / Evaluation:
The machine shall be installed at the location. Supporting utilities shall be connected and Used for
Functioning properly. Standard operating procedure shall be identified and listed. History card
shall be prepared for the equipment. The user shall verify all relevant critical document and
drawing.
Date :
Approval:
Area Representative
Production
Engineering Services
Quality Engineering
Signature
Date
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Quality Assurance
12.0
Title
Location
Effective
Date
Revision
No.
Remarks
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13.0
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Operational Qualification:
13.1 Procedure: The equipment (Comminuting Mill) shall be checked for the following parameters:
13.2 Operational Checks:
Sr.
No.
01
Activity
Specification
On / Off Test
Machine should be
ON and OFF with
operating buttons
02
04
05
06
03
Observation
Remarks
750
1500
3000
Smooth running
Smooth running
No abnormal
vibration
No abnormal Noise
should be there.
Machine should
STOP
Safety features
provided with
the equipment
Proper earthing to
the machine
Safety interlocks
if any
Method of
Verification
Target
Complete
earthing
No deviation
Actual
Remarks
13.4 Training:
Following operating / maintenance personnel were trained by the vendor and authorized to operate
or carryout routine maintenance of the equipment.
Name
Designation
Date of Training
Trained by
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as per
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 confirms to the acceptance criteria.
Equipment: COMMINUTING MILL MACHINE
Location
Purpose
:
: Use for milling of the powder.
Approval:
Area Representative
Production
Engineering Services
Quality Engineering
Quality Assurance
Signature
Date
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EQUIPMENT VALIDATION
The simulation of the process was carried out by milling of the powder from the machine.
Simulation of the process consist of the following:
Sr.No. Activity
01
02
Position of Sieve
03
Pouring of Powder
04
Powder collection
Functional Acceptance
Criteria
As per the details given with
the operating manual
It should be properly fixed
with the wings nut.
It should from the feed
hopper.
It should be from the
discharge chute.
Status / Observation
APPERANCE
SIEVE ANAYALSIS
14.3
Based on the quality control results generated by simulating the process and its review, it
said that machine performs satisfactory and confirming to the acceptance criteria.
can be
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per
The equipment performs within the assigned limits when operated as per approved standard
operating procedure.
Performance parameters that have a significant impact on the equipment ability to operate and
achieve the process are satisfactory and confirms to the acceptance criteria.
Equipment: COMMINUTING MILL MACHINE
Location
Purpose
:
: Use for milling of the powder.
Approval:
Area Representative
Production
Engineering Services
Quality Engineering
Quality Assurance
Signature
Date
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Preventive maintenance
details
Any major
change
Performed by
Remarks
Reason for
change
Modification Details
Re-qualification Remark
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Approval:
Area Representative
Production
Engineering Services
Quality Engineering
Signature
Date
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Quality Assurance
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